Sputnik V COVID-19 vaccine

{{Short description|Russian vaccine against COVID-19}} {{redirect|Sputnik V|the Soviet satellite known as Sputnik 5|Korabl-Sputnik 2}} {{cs1 config|name-list-style=vanc|display-authors=6}} {{use British English|date=November 2021}} {{Use dmy dates|date=November 2021}} {{Infobox drug  | drug_name = Sputnik V COVID-19 vaccine | type = vaccine | image =Sputnik V logo.svg | image2 = Вакцина Спутник V (cropped).jpg | alt = A lab tabletop with several out-of-focus vials of vaccine on it, with the two front and center in focus | caption2 = Russian Ministry of Health image of Gam-COVID-Vac vials | target = SARS-CoV-2 | vaccine_type = viral | pronounce = | tradename = {{ubl| | Sputnik V<ref name="Sputnik V">{{cite web | url = https://medum.ru/sputnik-v | publisher = Medum.ru | work = Russian drug reference | title = Sputnik V | access-date = 21 December 2020 | archive-date = 31 January 2021 | archive-url = https://web.archive.org/web/20210131085259/https://medum.ru/sputnik-v | url-status = live }}</ref> | Спутник V }} | licence_EU = BD | licence_US = | pregnancy_AU =  | pregnancy_category = | legal_AU =  | legal_AU_comment = | legal_BR = Exceptional import | legal_BR_comment =<ref name="reuters-brazil-importauth"/> | legal_CA =  | legal_UK =  | legal_US =  | legal_UN =  | legal_NZ =  | legal_status = {{abbr|RU|Russia|class=country-name}}: Registered on 11 August 2020

Full list of Sputnik V vaccine authorizations | routes_of_administration = Intramuscular  | CAS_number = 2541629-85-8 | CAS_number_Ref = <ref>{{cite web|url=https://www.wipo.int/edocs/pubdocs/en/wipo-pub-1075-en-covid-19-related-vaccines-and-therapeutics.pdf|title=Patent Landscape Report COVID-19-related vaccines and therapeutics}}</ref> | ATCvet = | ATC_prefix = J07 | ATC_suffix = BN02 | PubChem = | DrugBank = DB15848 | synonyms = {{ubl| | Gam-COVID-Vac | Гам-КОВИД-Вак }} }} {{COVID-19 pandemic sidebar|expanded=medical }} '''Sputnik V''' ({{langx|ru|Спутник V}}, the brand name from the Russian Direct Investment Fund or RDIF) or '''Gam-COVID-Vac''' ({{langx|ru|Гам-КОВИД-Вак}}, the name under which it is legally registered and produced<ref>{{Cite web|url=https://grls.rosminzdrav.ru/GRLS.aspx?RegNumber=&MnnR=&lf=&TradeNmR=%D0%B3%D0%B0%D0%BC-%D0%BA%D0%BE%D0%B2%D0%B8%D0%B4-%D0%B2%D0%B0%D0%BA&OwnerName=&MnfOrg=&MnfOrgCountry=&isfs=0&regtype=1,2,3,4,5,6&pageSize=10&order=RegDate&orderType=desc&pageNum=1|title=Государственный реестр лекарственных средств|website=grls.rosminzdrav.ru|access-date=12 April 2023|archive-date=14 April 2023|archive-url=https://web.archive.org/web/20230414162649/https://grls.rosminzdrav.ru/GRLS.aspx?RegNumber=&MnnR=&lf=&TradeNmR=%D0%B3%D0%B0%D0%BC-%D0%BA%D0%BE%D0%B2%D0%B8%D0%B4-%D0%B2%D0%B0%D0%BA&OwnerName=&MnfOrg=&MnfOrgCountry=&isfs=0&regtype=1,2,3,4,5,6&pageSize=10&order=RegDate&orderType=desc&pageNum=1|url-status=live}}</ref>) is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia. It is the world's first registered combination vector vaccine for the prevention of COVID-19, having been registered on 11 August 2020 by the Russian Ministry of Health.<ref name="nature">{{cite journal | vauthors = Callaway E | title = Russia's fast-track coronavirus vaccine draws outrage over safety | journal = Nature | volume = 584 | issue = 7821 | pages = 334–335 | date = August 2020 | pmid = 32782400 | doi = 10.1038/d41586-020-02386-2 | s2cid = 221107555 | quote = This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous, both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population. | doi-access = }}</ref><ref name="cohen">{{cite news |url=https://www.science.org/content/article/russia-s-approval-covid-19-vaccine-less-meets-press-release |title=Russia's approval of a COVID-19 vaccine is less than meets the press release |vauthors=Cohen J |magazine=Science |date=11 August 2020 |access-date=13 August 2020 |archive-date=20 April 2022 |archive-url=https://web.archive.org/web/20220420005223/https://www.science.org/content/article/russia-s-approval-covid-19-vaccine-less-meets-press-release |url-status=live }}</ref>

Gam-COVID-Vac was initially approved for distribution in Russia and then in 59 other countries (as of April 2021) on the preliminary results of Phase I–II studies eventually published on 4 September 2020.<ref name="Logunov01">{{cite journal | vauthors = Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL | title = Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia | journal = Lancet | volume = 396 | issue = 10255 | pages = 887–897 | date = September 2020 | pmid = 32896291 | pmc = 7471804 | doi = 10.1016/S0140-6736(20)31866-3 | doi-access = free }}</ref> Approval in early August of Gam-COVID-Vac was met with criticism in mass media and discussions in the scientific community as to whether approval was justified in the absence of robust scientific research confirming safety and efficacy.<ref name="nature" /><ref name="cohen" /><ref name="mahase">{{cite journal | vauthors = Mahase E | title = Covid-19: Russia approves vaccine without large scale testing or published results | journal = BMJ | volume = 370 | article-number = m3205 | date = August 2020 | pmid = 32816758 | doi = 10.1136/bmj.m3205 | doi-access = free }}</ref><ref name="burki">{{cite journal | vauthors = Burki TK | title = The Russian vaccine for COVID-19 | journal = The Lancet. Respiratory Medicine | volume = 8 | issue = 11 | pages = e85–e86 | date = November 2020 | pmid = 32896274 | pmc = 7837053 | doi = 10.1016/S2213-2600(20)30402-1 | title-link = doi | doi-access = free }}</ref><ref name="lovelace">{{cite news|date=11 August 2020|title=Scientists worry whether Russia's Sputnik V' coronavirus vaccine is safe and effective|work=CNBC|url=https://www.cnbc.com/2020/08/11/scientists-worry-whether-russias-sputnik-v-coronavirus-vaccine-is-safe-and-effective.html|access-date=11 August 2020|vauthors=Berkeley Jr L|archive-date=10 March 2021|archive-url=https://web.archive.org/web/20210310132427/https://www.cnbc.com/2020/08/11/scientists-worry-whether-russias-sputnik-v-coronavirus-vaccine-is-safe-and-effective.html|url-status=live}}</ref> A large-scale Brazilian study from Dec. 2020 to May 2021 confirmed its effectiveness and safety, as of Oxford–AstraZeneca's, i.e. above Sinopharm BIBP's.<ref name="Brazil"/>

Emergency mass-distribution of the vaccine began in December 2020 in countries including Russia, Argentina, Belarus, Hungary, Serbia, Pakistan (in limited quantities), the Philippines (in limited quantities), and the United Arab Emirates. The Sputnik V is currently registered and certified in 71 countries.<ref>{{Cite web|url=https://tass.com/world/1362249|title=Russia expects WHO approval of Sputnik V vaccine by end of 2021 — RDIF|access-date=24 November 2021|archive-date=24 November 2021|archive-url=https://web.archive.org/web/20211124105351/https://tass.com/world/1362249|url-status=live}}</ref> However, as of April 2022 less than 2.5% of the people vaccinated worldwide have taken a Sputnik V dose.<ref name=":6">{{Cite news |vauthors=Hoffman M |date=2022-04-09 |title=How Russia's Ukraine invasion doomed the Sputnik V coronavirus vaccine |newspaper=The Washington Post |url=https://www.washingtonpost.com/health/2022/04/09/russia-sputnik-vaccine-rejected/ |access-date=2022-05-03 |archive-date=10 April 2022 |archive-url=https://web.archive.org/web/20220410113928/https://www.washingtonpost.com/health/2022/04/09/russia-sputnik-vaccine-rejected/ |url-status=live }}</ref> In early 2022, as a result of the 2022 Russian invasion of Ukraine, the United States and other countries placed the Russian Direct Investment Fund (RDIF) on the list of sanctioned Russian entities and people,<ref name=":02">{{cite journal | vauthors = Webster P | title = Russian COVID-19 vaccine in jeopardy after Ukraine invasion | journal = Nature Medicine | pages = d41591–022–00042-y | date = March 2022 | pmid = 35293390 | doi = 10.1038/d41591-022-00042-y | s2cid = 247475281 }}</ref><ref name=":122">{{Cite web |title=Treasury Prohibits Transactions with Central Bank of Russia and Imposes Sanctions on Key Sources of Russia's Wealth |url=https://home.treasury.gov/news/press-releases/jy0612 |access-date=2022-04-25 |website=U.S. Department of the Treasury |language=en |archive-date=18 June 2023 |archive-url=https://web.archive.org/web/20230618014426/https://home.treasury.gov/news/press-releases/jy0612 |url-status=live }}</ref> significantly reducing Sputnik V's future commercial prospects.<ref name=":02" /><ref name=":6" />

The Gam-COVID-Vac vaccine itself is available in two forms: frozen (vaccine storage: below −18 °C) and liquid (vaccine storage: from +2 to +8 °C, produced a little). In addition to the main vaccine, vaccines and its derivatives were registered: Gam-COVID-Vac-Lyo ({{langx|ru|Гам-КОВИД-Вак-Лио}}, freeze dried powder version), Sputnik Light ({{langx|ru|Спутник Лайт}}, used for revaccination, as well as vaccination of foreigners in Russia), Gam-COVID-Vac-M ({{langx|ru|Гам-КОВИД-Вак-М}}, for vaccination of adolescents 12–17 years old<ref>According to Russian law, citizens aged 18 and over are considered adults and are vaccinated with the Gam-COVID-Vac vaccine.</ref>).

== Medical uses == The vaccine can be formulated in two ways: as a ready-to-use solution in water that is frozen at the common home-freezer storage temperature of {{convert|-18|C|disp=or}} or lower, and as a freeze-dried (lyophilized) powder, "Gam-COVID-Vac-Lyo", which can be stored at {{convert|2|-|8|C|disp=or}}. The freeze-dried powder must be reconstituted with sterile water before use.<ref>{{cite news |vauthors=Rinat S, Ivanova P |date=17 November 2020 |title=Russia focuses on freeze-dried vaccine doses as transport fix |url=https://www.reuters.com/article/health-coronavirus-russia-vaccine-transp-idUSL1N2I30ML |work=Reuters |location=Moscow |access-date=16 March 2021 |archive-date=16 May 2021 |archive-url=https://web.archive.org/web/20210516084302/https://www.reuters.com/article/health-coronavirus-russia-vaccine-transp-idUSL1N2I30ML |url-status=live }}</ref> The lyophilized formulation of Gam-COVID-Vac is similar to the smallpox vaccine, circumventing the need for continuous "colder chain" or cold-chain storage – as required for the Pfizer–BioNTech and Moderna vaccines – and allowing transportation to remote locations with reduced risk of vaccine spoilage.<ref>{{cite journal | vauthors = Balakrishnan VS | title = The arrival of Sputnik V | journal = The Lancet. Infectious Diseases | volume = 20 | issue = 10 | page = 1128 | date = October 2020 | pmid = 32979327 | pmc = 7511201 | doi = 10.1016/S1473-3099(20)30709-X | doi-access = free }}</ref><ref name="irfan">{{cite web |vauthors= Irfan U |title= Why staying cold is so important to a Covid-19 vaccine. The Moderna and Pfizer vaccines need to be stored at low temperatures. Are global health systems prepared? |url= https://www.vox.com/21552934/moderna-pfizer-covid-19-vaccine-biontech-coronavirus-cold-chain |publisher= Vox |access-date= 27 December 2020 |date= 11 December 2020 |archive-date= 17 August 2021 |archive-url= https://web.archive.org/web/20210817080502/https://www.vox.com/21552934/moderna-pfizer-covid-19-vaccine-biontech-coronavirus-cold-chain |url-status= live }}</ref>

The first dose (based on Ad26) is administered on the first day, and the second dose (based on Ad5) is administered on the 21st day to boost immune response.<ref name=":101">{{cite web|title=An Open Study of the Safety, Tolerability and Immunogenicity of the Drug 'Gam-COVID-Vac' Vaccine Against COVID-19|publisher=ClinicalTrials.gov|date=22 June 2020|url=https://clinicaltrials.gov/ct2/show/NCT04436471/|access-date=13 August 2020|archive-date=28 August 2021|archive-url=https://web.archive.org/web/20210828233123/https://clinicaltrials.gov/ct2/show/NCT04436471|url-status=live}}</ref><ref name="Соколов, 2020"> {{cite journal | vauthors = Sokolov A | date = 12 December 2020 | title = Сколько хотят заработать на прививках от коронавируса | url = https://www.vedomosti.ru/business/articles/2020/08/11/836418-sputnik-koronavirusom | archive-url = https://web.archive.org/web/20200812144536/https://www.vedomosti.ru/business/articles/2020/08/11/836418-sputnik-koronavirusom | archive-date = 2020-08-12 | journal = Vedomosti | access-date = 2020-12-20 }}</ref><ref name=normativ-doc-lp006395-110820>{{cite web |url = http://grls.rosminzdrav.ru/InstrImg/0001459746/0000613812/%D0%9B%D0%9F-006395%5B2020%5D_0.pdf |title = Нормативная документация ЛП-006395-110820 |date = 2020 |publisher = Russian Ministry of Health |access-date = 2020-09-21 |language = ru |archive-url = https://web.archive.org/web/20210210091230/http://grls.rosminzdrav.ru/InstrImg/0001459746/0000613812/%D0%9B%D0%9F-006395%5B2020%5D_0.pdf |archive-date = 10 February 2021 |archive-format = PDF |url-status = dead }}</ref> Both doses are administered into the deltoid muscle.

Sputnik Light is a registered single-dose vaccine consisting of only the first dose of Sputnik V. It is intended for areas with acute outbreaks and it will be used as a third (booster) dose for those who have received Sputnik V at least 6 months earlier.<ref>{{cite news |title=Russia launches Sputnik Light vaccine into wide circulation |url=https://www.reuters.com/world/europe/russia-launches-sputnik-light-vaccine-into-wide-circulation-kommersant-2021-06-25/ |access-date=2021-06-25 |work=reuters |date=2021-06-29 |location=Moscow |archive-date=3 July 2021 |archive-url=https://web.archive.org/web/20210703074815/https://www.reuters.com/world/europe/russia-launches-sputnik-light-vaccine-into-wide-circulation-kommersant-2021-06-25/ |url-status=live }}</ref><ref>{{Cite journal |display-authors=6 |vauthors=Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, Subbarao K, Kent SJ, Triccas JA, Davenport MP |date=May 2021 |title=Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection |journal=Nature Medicine |volume=27 |issue=7 |pages=1205–1211 |doi=10.1038/s41591-021-01377-8 |hdl=1959.4/105023 |issn=1546-170X |pmid=34002089 |s2cid=234769053 |doi-access=free |bibcode=2021NatMe..27.1205K |hdl-access=free}}</ref> It can be stored at a normal refrigerator temperature of {{convert|2|-|8|C}}.<ref>{{cite press release |title=Single dose vaccine, Sputnik Light, authorized for use in Russia |date=2021-05-06 |publisher=Russian Direct Investment Fund |url=https://rdif.ru/Eng_fullNews/6763/ |access-date=2021-05-07}}</ref> The institute says this version would be ideally suited for areas with acute outbreaks, allowing more people to be vaccinated quickly.<ref>{{cite news |date=2021-05-06 |title=Russia authorises single-dose Sputnik Light COVID vaccine for use -RDIF |url=https://www.reuters.com/business/healthcare-pharmaceuticals/russia-authorises-single-dose-sputnik-light-covid-vaccine-use-rdif-2021-05-06/ |access-date=2021-06-29 |work=Reuters |location=Moscow}}</ref>

Although Sputnik Light was not authorized by Ukraine or international organizations, tens of thousands of doses were shipped by Russia for use in non-government controlled parts of the eastern Donbas region from January 2021.<ref>{{Cite web |date=2021-07-30 |title=Moscow Plays Up Donbas As Part Of The Ukraine Conflict |url=https://warsawinstitute.org/moscow-plays-donbas-part-ukraine-conflict/ |access-date=2021-08-04 |website=Warsaw Institute |language=en-GB}}</ref> Ukrainian officials criticized the move.<ref>{{Cite web |title=Residents of ORDLO can become 'guinea pigs' for Russian pharmacists - Defense Ministry |url=https://en.interfax.com.ua/news/general/759489.html |access-date=2021-08-04 |website=Interfax Ukraine |date=3 August 2021 |language=en}}</ref>

In January 2021, Sputnik Light commenced phase I/II trials.<ref>{{ClinicalTrialsGov|NCT04713488|An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine}}</ref> In February, Sputnik Light commenced phase III trials.<ref name="NCT04741061">{{ClinicalTrialsGov|NCT04741061|Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light (SPUTNIK-LIGHT)}}</ref><ref>{{cite news |date=2021-06-29 |title=Russia launches Sputnik Light vaccine into wide circulation |url=https://www.reuters.com/world/europe/russia-launches-sputnik-light-vaccine-into-wide-circulation-kommersant-2021-06-25/ |access-date=2021-06-25 |work=reuters |location=Moscow}}</ref> Effectiveness is generally expected to slowly decrease over time.

A real-world study with participants aged 60–79 years in Argentina found that the single-injection vaccine is {{Estimate|79|75|82|unit=%|mini=no}} effective in preventing infections, {{Estimate|88|80|92|unit=%|mini=no}} effective against hospitalization, and {{Estimate|85|75|91|unit=%|mini=no}} against death.<ref name="lancet-effectiveness-argentina">{{cite journal |display-authors=6 |vauthors=González S, Olszevicki S, Salazar M, Calabria A, Regairaz L, Marín L, Campos P, Varela T, Martínez VV, Ceriani L, Garcia E |date=2021-10-01 |title=Effectiveness of the first component of Gam-COVID-Vac (Sputnik V) on reduction of SARS-CoV-2 confirmed infections, hospitalisations and mortality in patients aged 60-79: a retrospective cohort study in Argentina |journal=eClinicalMedicine |volume=40 |doi=10.1016/j.eclinm.2021.101126 |issn=2589-5370 |pmc=8435263 |pmid=34541480 |article-number=101126}}</ref> A phase III clinical trial in Russia also found an efficacy of 79%.<ref name="efficacy-russia">{{cite press release |title=Single dose vaccine, Sputnik Light, authorized for use in Russia |date=2021-05-06 |publisher=Russian Direct Investment Fund |url=https://rdif.ru/Eng_fullNews/6763/ |quote=The single dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analyzed data taken from 28 days after the injection was administered as part of Russia's mass vaccination program between 5 December 2020 and 15 April 2021. |access-date=2021-06-29}}</ref><ref name="NCT04741061" /> According to Nextstrain, lineage B.1.1.317 was the dominant variant in Russia during the study period (5 December 2020 to 15 April 2021),<ref name="efficacy-russia" /> while in Argentina (29 December 2020 to 21 March 2021)<ref name="lancet-effectiveness-argentina" /> lineage N.5 dominated at first, but soon many lineages coexisted in similar proportions.

Preliminary data from a study in Moscow in July 2021 indicate that the vaccine is {{Estimate|70|64|75|unit=%|mini=no}} effective against symptomatic disease from the Delta variant for three months after vaccination.<ref>{{Cite medRxiv |medrxiv=10.1101/2021.10.08.21264715v1 |title=One-shot immunization with Sputnik Light (the first component of Sputnik V vaccine) is effective against SARS-CoV-2 Delta variant: efficacy data on the use of the vaccine in civil circulation in Moscow |date=2021-10-14 |vauthors=Dolzhikova IV, Gushchin VA, Shcheblyakov DV, Tsybin AN, Shchetinin AM, Pochtovyi AA, Komissarov AB, Kleymenov DA, Kuznetsova NA, Tukhvatulin AI, Zubkova OV |display-authors=6}}</ref> In August 2021, RDIF announced that preliminary results from a study on heterologous prime-boost vaccination indicate that it is safe to administer Sputnik Light as the first dose, then the Oxford–AstraZeneca, Moderna or Sinopharm BIBP vaccine as the second dose, as well as the homologous course consisting of Sputnik Light as the second dose.<ref>{{cite press release |title=Combination of the first component of Sputnik V vaccine (Sputnik Light vaccine) with vaccines by AstraZeneca, Sinopharm and Moderna demonstrates high safety profile during the study in Argentina's Buenos-Aires province |date=4 August 2021 |publisher=Russian Direct Investment Fund |location=Moscow |url=https://rdif.ru/Eng_fullNews/7035/ |access-date=5 August 2021}}</ref>

On 11 August 2021, the developers of the Sputnik V vaccine offered its 'Sputnik Light' (Ad26) vaccine to Pfizer for trial against the Delta variant.<ref>{{Cite web|date=11 August 2021|title=RDIF offers Pfizer to start trial with Sputnik Light as booster|url=https://twitter.com/sputnikvaccine/status/1425449440119336960|access-date=2021-08-13|website=Sputnik Vaccine|publisher=Twitter|language=en|archive-date=5 November 2021|archive-url=https://web.archive.org/web/20211105161747/https://twitter.com/sputnikvaccine/status/1425449440119336960|url-status=live}}</ref><ref>{{Cite web|date=5 May 2021|title=Single dose vaccine, Sputnik Light, authorized for use in Russia|url=https://sputnikvaccine.com/newsroom/pressreleases/single-dose-vaccine-sputnik-light-authorized-for-use-in-russia/|access-date=2021-08-13|website=sputnikvaccine.com|language=en|archive-date=14 November 2021|archive-url=https://web.archive.org/web/20211114232050/https://sputnikvaccine.com/newsroom/pressreleases/single-dose-vaccine-sputnik-light-authorized-for-use-in-russia/|url-status=live}}</ref>

===Effectiveness=== The effectiveness of COVID-19 vaccines, or any other vaccine, is determined in a mass vaccination in a "real-world" setting (not in clinical trials). This is an assessment of how well the vaccine protects people from outcomes such as infection, symptomatic illness, hospitalization, and death. Effectiveness is evaluated outside of clinical trials, which by contrast, evaluate the efficacy of the vaccine.<ref name=":7" /><ref name=":8" /> A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.<ref>{{cite journal | vauthors = Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R | title = COVID-19 vaccine trials should seek worthwhile efficacy | journal = Lancet | volume = 396 | issue = 10253 | pages = 741–743 | date = September 2020 | pmid = 32861315 | pmc = 7832749 | doi = 10.1016/S0140-6736(20)31821-3 | quote = WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure. }}</ref> Effectiveness is generally expected to slowly decrease over time.<ref>{{cite journal | vauthors = Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, Subbarao K, Kent SJ, Triccas JA, Davenport MP | title = Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection | journal = Nature Medicine | volume = 27 | issue = 7 | pages = 1205–1211 | date = July 2021 | pmid = 34002089 | doi = 10.1038/s41591-021-01377-8 | s2cid = 234769053 | doi-access = free | bibcode = 2021NatMe..27.1205K | url = https://www.medrxiv.org/content/medrxiv/early/2021/03/11/2021.03.09.21252641.full.pdf | access-date = 2 February 2024 | archive-date = 2 February 2024 | archive-url = https://web.archive.org/web/20240202145724/https://www.medrxiv.org/content/medrxiv/early/2021/03/11/2021.03.09.21252641.full.pdf | url-status = live }}</ref>

On 25 August, a preliminary version of a case-control study indicated an unadjusted effectiveness<ref name=":7">{{Cite web |date=29 June 2022 |title=COVID-19 Vaccines are Effective |url=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/index.html |access-date=23 July 2022 |website=Center for Disease Control and Prevention |archive-date=22 July 2022 |archive-url=https://web.archive.org/web/20220722122039/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/index.html |url-status=live }}</ref><ref name=":8">{{Cite web |date=14 July 2022 |title=Vaccine efficacy, effectiveness and protection |url=https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection |website=World Health Organization |access-date=22 July 2022 |archive-date=15 September 2021 |archive-url=https://web.archive.org/web/20210915045357/https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection/ |url-status=live }}</ref> of about 50% against symptomatic disease. The authors expected that adjusting for age and sex would increase the estimate, citing an increase from 66% to 81% when adjusting the data for effectiveness against hospitalization.{{efn-ua|name=effectiveness-delta|Case-control study with 13,894 participants from 3 July 2021 to 9 August 2021 in Saint Petersburg. The study awaits peer review.<ref>{{cite web |vauthors=Dobrovidova O |date=26 August 2021 |title=Russia's Sputnik V protects against severe COVID-19 from Delta variant, study shows |url=https://www.science.org/content/article/russia-s-sputnik-v-protects-against-severe-covid-19-delta-variant-study-shows |access-date=2021-08-28 |website=Science AAAS |archive-date=4 September 2021 |archive-url=https://web.archive.org/web/20210904010156/https://www.science.org/content/article/russia-s-sputnik-v-protects-against-severe-covid-19-delta-variant-study-shows |url-status=live }}</ref><ref>{{Cite journal |vauthors=Barchuk A, Cherkashin M, Bulina A, Berezina N, Rakova T, Kuplevatskaya D, Stanevich O, Skougarevskiy D, Okhotin A |title=Vaccine effectiveness against referral to hospital after SARS-CoV-2 infection in St. Petersburg, Russia, during the Delta variant surge: A test-negative case-control study |journal=BMC Medicine |date=2022 |volume=20 |issue=1 |article-number=312 |doi=10.1186/s12916-022-02509-8 |doi-access=free |pmid=36123681 |pmc=9484844 |medrxiv=10.1101/2021.08.18.21262065v3}}</ref>{{Current event inline|date=December 2021}}}}

A large-scale study in Buenos Aires from 29 December 2020, to 15 May 2021, with 663,602 participants aged 60 and older who received Spunik V, the Oxford–AstraZeneca vaccine, or the Sinopharm BIBP vaccine observed an overall efficacy of {{Estimate|98|95|99|unit=%|mini=no}} against COVID-19-related deaths. The study noted that the three vaccines showed a similar effectiveness against death, and that the effectiveness against infection was similar to that of the Oxford-Astrazeneca vaccine and greater than that of the Sinopharm BIBP vaccine.<ref name="Brazil">{{cite journal | vauthors = Macchia A, Ferrante D, Angeleri P, Biscayart C, Mariani J, Esteban S, Tablado MR, de Quirós FG | title = Evaluation of a COVID-19 Vaccine Campaign and SARS-CoV-2 Infection and Mortality Among Adults Aged 60 Years And Older in a Middle-Income Country | journal = JAMA Network Open | volume = 4 | issue = 10 | pages = e2130800 | date = October 2021 | pmid = 34714342 | pmc = 8556631 | doi = 10.1001/jamanetworkopen.2021.30800 }}</ref>

{| class="wikitable" |+Initial effectiveness by variant |- !Doses !Severity of illness !Delta !Alpha |- !rowspan="2"|1 !Symptomatic |{{n/a|Not reported}} |{{n/a|Not reported}} |- !Hospitalization |{{shade|color=gold|inv=1|35|{{Estimate|35|-21|65|unit=%|mini=yes}}{{efn-ua|name=effectiveness-delta}}}} |{{n/a|Not reported}} |- !rowspan="4"|2 !Asymptomatic |{{n/a|Not reported}} |{{shade|color=gold|inv=1|86|{{Estimate|86|84|87|unit=%|mini=yes}}{{efn-ua|name=effectiveness-hungary}}}} |- !Symptomatic |{{n/a|Not reported}} |{{n/a|Not reported}} |- !Hospitalization |{{shade|color=gold|inv=1|81|{{Estimate|81|68|88|unit=%|mini=yes}}{{efn-ua|14 to 55 days after the second dose, higher in women, {{Estimate|84|66|92|unit=%|mini=yes}}, than in men, {{Estimate|76|51|88|unit=%|mini=yes}}. Increases to {{Estimate|85|72|92|unit=%|mini=yes}} 56 days or more after the second dose.}}{{efn-ua|name=effectiveness-delta}}}} |{{n/a|Not reported}} |- !Death |{{n/a|Not reported}} |{{shade|color=gold|inv=1|98|{{Estimate|98|96|99|unit=%|mini=yes}}{{efn-ua|name=effectiveness-hungary|22 January to 10 June 2021 in Hungary.<ref>{{cite journal | vauthors = Vokó Z, Kiss Z, Surján G, Surján O, Barcza Z, Pályi B, Formanek-Balku E, Molnár GA, Herczeg R, Gyenesei A, Miseta A, Kollár L, Wittmann I, Müller C, Kásler M | title = Nationwide effectiveness of five SARS-CoV-2 vaccines in Hungary-the HUN-VE study | journal = Clinical Microbiology and Infection | volume = 28 | issue = 3 | pages = 398–404 | date = March 2022 | pmid = 34838783 | pmc = 8612758 | doi = 10.1016/j.cmi.2021.11.011 | quote = Table 2 }}</ref>}}}} |} {{notelist-ua}}A large-scale study was conducted in Mexico.<ref>{{Cite journal |vauthors=Bello-Chavolla OY, Antonio-Villa NE, Valdés-Ferrer SI, Fermín-Martínez CA, Fernández-Chirino L, Ramírez-García D, Mancilla-Galindo J, Kammar-García A, Ávila-Funes JA, Zúñiga-Gil CH, García-Grimshaw M |date=2023-02-10 |title=Effectiveness of a nation-wide COVID-19 vaccination program in Mexico | journal = Int J Infect Dis | volume = 128 | pages = 188–196 | pmid = 36775188 | pmc = 9918316 |language=en |doi = 10.1016/j.ijid.2023.01.040}}</ref> The study compared 793,487 adults vaccinated with different vaccines with 4,792,338 unvaccinated adults between 24 December 2020, and 27 September 2021.The results were as follows:

{| class="wikitable sortable" style="text-align: center;" |+Effectiveness of vaccines in Mexico (2021) !Vaccine !Incidental infection effectiveness !Hospitalization effectiveness !Mortality effectiveness |- |Spikevax |91.45% |78% |93.46% |- |Comirnaty |80.34% |84.26% |89.83% |- |Sputnik V |78.75% |81.38% |87.7% |- |Covishield |80.79% |80.23% |86.81% |- |Janssen |82.18% |77.33% |85.79% |- |CoronaVac |71.93% |73.76% |80.38% |- |Convidecia |70.5% |72.31% |79.93% |}

===Efficacy=== The vaccine efficacy of a COVID-19 vaccine or any other vaccine is evaluated in controlled clinical trials. It is an estimate of how many people who received the vaccine got the disease compared to how many people who got a placebo had the same outcome. On 2 February 2021, an interim analysis from the Moscow trial was published in ''The Lancet'' reporting an efficacy of {{Estimate|91.6|85.6|95.2|unit=%}} after the second dose for all age groups, with no unusual side effects.<ref name=":0" /> For the age group of 60 years and older, the reported efficacy was 91.8%.<ref name=":0">{{cite journal | vauthors = Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL | title = Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia | journal = Lancet | volume = 397 | issue = 10275 | pages = 671–681 | date = February 2021 | pmid = 33545094 | pmc = 7852454 | doi = 10.1016/s0140-6736(21)00234-8 | doi-access = free }}</ref> On 12 May, a group of biostatisticians from Russia, the US, France, Italy and the Netherlands questioned the efficacy results in a correspondence in ''The Lancet'', highlighting <q>data discrepancies</q>, <q>substandard reporting</q>, <q>apparent errors and numerical inconsistencies</q> and a very unlikely homogeneity in vaccine efficacy across age groups.<ref name="bucci-discrepancies"/>

The authors responded by saying that they had provided the regulatory authorities with all the data necessary for obtaining approval, and that the data included with the paper were enough for readers to confirm the reported vaccine efficacy. They also addressed the protocol queries, and said numerical inconsistencies were "simple typing errors that were formally corrected".<ref>{{cite journal | vauthors = Logunov DY, Dolzhikova IV, Tukhvatullin AI, Shcheblyakov DV | title = Safety and efficacy of the Russian COVID-19 vaccine: more information needed - Authors' reply | journal = Lancet | volume = 396 | issue = 10256 | pages = e54–e55 | date = October 2020 | pmid = 32971043 | pmc = 7503057 | doi = 10.1016/S0140-6736(20)31970-X }}</ref>

In June 2022 a group of biostatisticians from Australia and Singapore published a paper suggesting that the almost identical efficacy for every age group from the ''Lancet'' paper is very unlikely to occur in genuine experimental data.<ref>{{cite journal | vauthors = Sheldrick KA, Meyerowitz-Katz G, Tucker-Kellogg G | title = Plausibility of Claimed Covid-19 Vaccine Efficacies by Age: A Simulation Study | journal = American Journal of Therapeutics | volume = 29 | issue = 5 | pages = e495–e499 | date = 2022-06-20 | pmid = 35723559 | doi = 10.1097/MJT.0000000000001528 | s2cid = 249869225 | doi-access = free }}</ref> The group called for a thorough investigation of the ''Lancet'' article, as well as the immediate release of anonymized individual patient data to an unbiased statistical expert, and suggested the article should be retracted. The Lancet Group recognized the concerns about the validity of data published in the article and invited the authors of the article to respond to these latest questions.<ref>{{Cite web |vauthors=King A |date=2022-06-23 |title=New questions raised over Sputnik Covid vaccine results point to fraudulent practices |url=https://www.chemistryworld.com/news/new-questions-raised-over-sputnik-covid-vaccine-results-point-to-fraudulent-practices/4015862.article |access-date=2022-07-18 |website=Chemistry World |language=en |archive-date=14 July 2022 |archive-url=https://web.archive.org/web/20220714011756/https://www.chemistryworld.com/news/new-questions-raised-over-sputnik-covid-vaccine-results-point-to-fraudulent-practices/4015862.article |url-status=live }}</ref><ref>{{Cite web |date=2022-07-13 |title=Sputnik Vaccine Efficacy Data Published In Lancet Are 'Statistically Impossible' - Health Policy Watch |url=https://healthpolicy-watch.news/sputnik-vaccine-efficacy-data/ |access-date=2022-07-18 |language=en-US |archive-date=18 July 2022 |archive-url=https://web.archive.org/web/20220718115200/https://healthpolicy-watch.news/sputnik-vaccine-efficacy-data/ |url-status=live }}</ref>

==Adverse effects== Side effects are mostly mild and similar to other adenovirus vector vaccines such as the Oxford-AstraZeneca and the Janssen vaccines. However, unlike the Oxford-AstraZeneca and Janssen vaccines evidence does not suggest a risk of vaccine-induced immune thrombotic thrombocytopenia.<ref name="nature-emerging-evidence">{{cite journal | vauthors = Nogrady B | title = Mounting evidence suggests Sputnik COVID vaccine is safe and effective | journal = Nature | volume = 595 | issue = 7867 | pages = 339–340 | date = July 2021 | pmid = 34230663 | doi = 10.1038/d41586-021-01813-2 | s2cid = 235757906 | bibcode = 2021Natur.595..339N | doi-access = free }}</ref> However, a report from Argentina published in the New England Journal of Medicine described fatal vaccine-induced thrombocytopenia and thrombosis in a young woman after receipt of Sputnik-V.<ref>{{cite journal | vauthors = Cines DB, Bussel JB | title = SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia | journal = The New England Journal of Medicine | volume = 384 | issue = 23 | pages = 2254–2256 | date = June 2021 | pmid = 33861524 | pmc = 8063912 | doi = 10.1056/NEJMe2106315 }}</ref>

==Pharmacology== [[File:COVID-19 vaccination center in Gostiny Dvor 17.jpg|thumb|right|200px|Sputnik V vaccination certificate issued in Moscow Gostiny Dvor vaccination point]] Gam-COVID-Vac is a viral vector vaccine based on two recombinant replication-defective human adenoviruses: Ad26 (serotype 26) and Ad5 (serotype 5) replicated in HEK 293 cells. The viruses contain the gene that encodes the full-length spike protein (S) of SARS-CoV-2 to stimulate an immune response.<ref name="Logunov01"/><ref name=":101" /><ref>{{Cite news|url=https://www.bloomberg.com/features/2020-coronavirus-drug-vaccine-status/|title=Coronavirus Vaccine Trials Advance in Race for Covid-19 Protection|newspaper=Bloomberg.com|publisher=Bloomberg|access-date=2020-08-10|archive-date=3 December 2020|archive-url=https://web.archive.org/web/20201203062313/https://www.bloomberg.com/features/2020-coronavirus-drug-vaccine-status/|url-status=live}}</ref> Adenoviral vectors<ref>{{cite journal | vauthors = Wold WS, Toth K | title = Adenovirus vectors for gene therapy, vaccination and cancer gene therapy | journal = Current Gene Therapy | volume = 13 | issue = 6 | pages = 421–433 | date = December 2013 | pmid = 24279313 | pmc = 4507798 | doi = 10.2174/1566523213666131125095046 }}</ref><ref>{{cite journal | vauthors = Zhang C, Zhou D | title = Adenoviral vector-based strategies against infectious disease and cancer | journal = Human Vaccines & Immunotherapeutics | volume = 12 | issue = 8 | pages = 2064–2074 | date = August 2016 | pmid = 27105067 | pmc = 4994731 | doi = 10.1080/21645515.2016.1165908 }}</ref> for expression of the SARS-CoV-2 spike protein have also been used in two other COVID-19 vaccines. One is the Janssen COVID-19 vaccine, which utilizes the Ad26COV2 viral vector based on the human virus Ad26. For this vaccine, the cell line PER.C6<ref>{{cite journal | vauthors = Kirschweger G | title = Crucell: biopharmaceuticals--as human as they get | language = English | journal = Molecular Therapy | volume = 7 | issue = 1 | pages = 5–6 | date = January 2003 | pmid = 12613447 | doi = 10.1016/S1525-0016(02)00045-X | doi-access = free }}</ref><ref name=":9">{{Cite journal |vauthors=Wadman M |date=5 June 2020 |title=Abortion opponents protest COVID-19 vaccines' use of fetal cells |url=https://www.science.org/content/article/abortion-opponents-protest-covid-19-vaccines-use-fetal-cells |journal=Science |access-date=31 July 2022 |archive-date=31 July 2022 |archive-url=https://web.archive.org/web/20220731203629/https://www.science.org/content/article/abortion-opponents-protest-covid-19-vaccines-use-fetal-cells |url-status=live }}</ref> is used to replicate the vector. Another one, the Oxford–AstraZeneca COVID‑19 vaccine, uses chimpanzee adenovirus (ChAdOx1) as the vector. For both the Oxford-AstraZeneca COVID-19<ref name=":9" /> and Gam-COVID-Vac vaccines the producer cells for the production of non-replicating adenoviral vectors were obtained from the HEK 293 cell line.<ref>{{cite journal | vauthors = Tan E, Chin CS, Lim ZF, Ng SK | title = HEK293 Cell Line as a Platform to Produce Recombinant Proteins and Viral Vectors | journal = Frontiers in Bioengineering and Biotechnology | volume = 9 | article-number = 796991 | date = 2021 | pmid = 34966729 | pmc = 8711270 | doi = 10.3389/fbioe.2021.796991 | doi-access = free }}</ref> Each dose of Gam-COVID-Vac contains (1.0 ± 0.5) × 10{{sup|11}} virus particles.<ref name=":0" />

Both Ad26 and Ad5 were modified to remove the E1 gene to prevent replication outside the HEK 293 cells.<ref name="sciencemag-anvisa-controversy"/> For the production of the vaccine, to propagate adenoviral vectors in which the E1 gene was deleted, HEK 293 cells are used, which express several adenoviral genes, including E1.<ref name="pmid9482916"/><ref name="pmid15862464"/> However, although rare, homologous recombination between the inserted cellular sequence and the vector sequence can restore the replication capacity to the vector,<ref name="pmid21994701"/> with less than 100 replicating adenovirus particles per dose of the vaccine.<ref name="sciencemag-anvisa-controversy"/>

==Chemistry==

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two doses.<ref>{{cite journal | vauthors = Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Ebisawa M, El-Gamal Y, Fineman S, Geller M, Gonzalez-Estrada A, Greenberger PA, Leung AS, Levin ME, Muraro A, Sánchez Borges M, Senna G, Tanno LK, Yu-Hor Thong B, Worm M | title = COVID-19 vaccine-associated anaphylaxis: A statement of the World Allergy Organization Anaphylaxis Committee | journal = The World Allergy Organization Journal | volume = 14 | issue = 2 | article-number = 100517 | date = February 2021 | pmid = 33558825 | pmc = 7857113 | doi = 10.1016/j.waojou.2021.100517 | quote = Tris (hydroxymethyl) aminomethane, sodium chloride, sucrose, magnesium chloride hexahydrate, Sodium EDTA, polysorbate 80, ethanol, water for injection }}</ref><ref>{{cite web |url=https://roszdravnadzor.gov.ru/i/upload/files/%D0%9D%D0%BE%D0%B2%D0%BE%D1%81%D1%82%D0%B8/%D0%A4%D0%B0%D0%B9%D0%BB%D1%8B/28.12.2020/%D0%B8%D0%BD%D1%81%D1%82%D1%80%D1%83%D0%BA%D1%86%D0%B8%D1%8F%20%D0%BF%D0%BE%20%D0%BF%D1%80%D0%B8%D0%BC%D0%B5%D0%BD%D0%B5%D0%BD%D0%B8%D1%8E%20%D0%9B%D0%A1.pdf |title=ИНСТРУКЦИЯ ПО МЕДИЦИНСКОМУ ПРИМЕНЕНИЮ ЛЕКАРСТВЕННОГО ПРЕПАРАТА Гам-КОВИД-Вак, Комбинированная векторная вакцина для профилактики коронавирусной инфекции, вызываемой вирусом SARS-CoV-2 |publisher=МИНИСТЕРСТВО ЗДРАВООХРАНЕНИЯ РОССИЙСКОЙ ФЕДЕРАЦИИ |access-date=13 March 2021 |archive-date=28 December 2020 |archive-url=https://web.archive.org/web/20201228212826/https://roszdravnadzor.gov.ru/i/upload/files/%D0%9D%D0%BE%D0%B2%D0%BE%D1%81%D1%82%D0%B8/%D0%A4%D0%B0%D0%B9%D0%BB%D1%8B/28.12.2020/%D0%B8%D0%BD%D1%81%D1%82%D1%80%D1%83%D0%BA%D1%86%D0%B8%D1%8F%20%D0%BF%D0%BE%20%D0%BF%D1%80%D0%B8%D0%BC%D0%B5%D0%BD%D0%B5%D0%BD%D0%B8%D1%8E%20%D0%9B%D0%A1.pdf |url-status=live }}</ref> * Tris(hydroxymethyl)aminomethane (buffer) * Sodium chloride (salt) * Sucrose (sugar) * Magnesium chloride hexahydrate * Disodium EDTA dihydrate (a chelation ligand; sequestrant) * Polysorbate 80 * Ethanol 95% * Water

No adjuvants<ref>{{cite journal | vauthors = Pushparajah D, Jimenez S, Wong S, Alattas H, Nafissi N, Slavcev RA | title = Advances in gene-based vaccine platforms to address the COVID-19 pandemic | journal = Advanced Drug Delivery Reviews | volume = 170 | pages = 113–141 | date = March 2021 | pmid = 33422546 | pmc = 7789827 | doi = 10.1016/j.addr.2021.01.003 | publisher = Elsevier | quote = Viral vector vaccines confer high gene transduction capabilities due to the natural ability of viruses to infect host cells. These vaccines do not require adjuvants due to the presence of viral components that stimulate the innate immune system. | doi-access = free }}</ref> and no other components or ingredients should be included in the vaccine.<ref name="Sputnik V" />

==Manufacturing== thumb|Pharmaceutical company União Quimica started production of Sputnik V in Brazil in January 2021.{{citation needed|date=April 2021}}

Large quantities of both adenoviruses are produced by HEK 293 cells that have the E1 gene necessary for viral replication.<ref name="pmid9482916">{{cite journal | vauthors = He TC, Zhou S, da Costa LT, Yu J, Kinzler KW, Vogelstein B | title = A simplified system for generating recombinant adenoviruses | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 95 | issue = 5 | pages = 2509–2514 | date = March 1998 | pmid = 9482916 | pmc = 19394 | doi = 10.1073/pnas.95.5.2509 | doi-access = free | bibcode = 1998PNAS...95.2509H }}</ref><ref name="pmid15862464">{{cite journal | vauthors = Thomas P, Smart TG | title = HEK293 cell line: a vehicle for the expression of recombinant proteins | journal = Journal of Pharmacological and Toxicological Methods | volume = 51 | issue = 3 | pages = 187–200 | date = 2005 | pmid = 15862464 | doi = 10.1016/j.vascn.2004.08.014 }}</ref><ref name="pmid21994701">{{cite journal | vauthors = Kovesdi I, Hedley SJ | title = Adenoviral producer cells | journal = Viruses | volume = 2 | issue = 8 | pages = 1681–1703 | date = August 2010 | pmid = 21994701 | pmc = 3185730 | doi = 10.3390/v2081681 | doi-access = free }}</ref> Rarely, Ad5 can acquire the E1 gene from the HEK 293 cells, restoring its ability to replicate.<ref name="pmid21994701"/> Gamaleya has set an acceptable limit of 5,000 replicating virus particles per vaccine dose, and quality control documents state that tested batches contain less than 100 replicating virus particles per dose.<ref name="sciencemag-anvisa-controversy"/>

The production of the frozen liquid formulation was developed for large-scale use, it is cheaper and easier to manufacture. The production of the freeze-dried formulation takes much more time and resources, although it is more convenient for storage and transportation. It was developed with vaccine delivery to hard-to-reach regions of Russia in mind.<ref name="Logunov01"/>

According to Russian media, the mass production of the Gam-COVID-Vac was launched by 15 August. By that moment, the Russian Federation has already received applications from 20 countries for the supply of 1{{nbsp}}billion doses of vaccine. Three facilities were able to produce about a million doses per month at each with a potential doubling of capacity by winter. By the end of 2020, Gamaleya Research Institute's production, according to an interview with the organization's spokesperson, was planned to produce 3–5{{nbsp}}million doses.<ref>{{Cite web |language=ru |url=https://www.interfax.ru/russia/719440 |title=Голикова назвала сроки выпуска первых партий вакцин НИЦ Гамалеи и "Вектора" |trans-title=Golikova announced the timing of the release of the first batches of vaccines of the Research Center of Gamaleya and "Vector" |publisher=Interfax |date=29 July 2020 |access-date=21 December 2020 |archive-date=28 March 2021 |archive-url=https://web.archive.org/web/20210328060535/https://www.interfax.ru/russia/719440 |url-status=live }}</ref><ref>{{cite web |url = https://www.vesti.ru/article/2442836 |title = Запущено производство российской антикоронавирусной вакцины |trans-title = Production of Russian anti-coronavirus vaccine launched |date = 15 August 2020 |publisher = Vesti |access-date = 2020-09-21 |language = ru |archive-date = 11 April 2021 |archive-url = https://web.archive.org/web/20210411041950/https://www.vesti.ru/article/2442836 |url-status = live }}</ref>

As of March 2021, the Russian Direct Investment Fund (RDIF) has licensed production in India, China, South Korea and Brazil. In the EU, RDIF has signed production agreements. By the end of March 2021 RDIF anticipates 33{{nbsp}}million doses will have been manufactured in Russia, less than 5% of which will have been exported.<ref name=ft-20210310>{{cite news |url=https://www.ft.com/content/905ee381-ef16-4fa1-ac38-a8b2bb2df16f |title=Russia seeks to make Sputnik V in Italy as overseas demand surges |vauthors=Foy H, Seddon M, Sciorilli SB |newspaper=Financial Times |url-access=subscription |date=10 March 2021 |access-date=10 March 2021 |archive-date=14 May 2021 |archive-url=https://web.archive.org/web/20210514033916/https://www.ft.com/content/905ee381-ef16-4fa1-ac38-a8b2bb2df16f |url-status=live }}</ref>

An agreement for the production of over 100{{nbsp}}million doses of vaccine in India was made with Dr. Reddy's Laboratories, which on 11 January 2021 submitted mid-stage trial data to the Indian regulator and recommended moving onto late-stage trials.<ref name=reuters-20210111>{{cite news |url=https://www.reuters.com/article/health-coronavirus-india-vaccine-idUSL4N2JM2XA |title=Russia's Sputnik V vaccine found safe in India mid-stage trial - Dr.Reddy's |vauthors=Ahmed A, Kumar AM |publisher=Reuters |date=11 January 2021 |access-date=26 January 2021 |archive-date=5 February 2021 |archive-url=https://web.archive.org/web/20210205084636/https://www.reuters.com/article/health-coronavirus-india-vaccine-idUSL4N2JM2XA |url-status=live }}</ref> The RDIF announced plans to sell 100{{nbsp}}million doses to India, 35{{nbsp}}million to Uzbekistan, and 32{{nbsp}}million to Mexico, as well as 25{{nbsp}}million each to Nepal and Egypt.<ref>{{cite news|date=13 November 2020|title=More Countries Line Up for Russia's Sputnik V Coronavirus Vaccine|work=The Moscow Times|url=https://www.themoscowtimes.com/2020/11/13/more-countries-line-up-for-russias-sputnik-v-coronavirus-vaccine-a72042|access-date=6 December 2020|archive-date=13 April 2021|archive-url=https://web.archive.org/web/20210413041854/https://www.themoscowtimes.com/2020/11/13/more-countries-line-up-for-russias-sputnik-v-coronavirus-vaccine-a72042|url-status=live}}</ref> In India, the first dose of Sputnik V vaccine was administered on 14 May 2021 at Hyderabad.<ref>{{Cite web|date=2021-05-14|title=Dr Reddy's Laboratories launches Sputnik V COVID-19 vaccine in India at Rs 995 per dose|url=https://www.firstpost.com/india/dr-reddys-laboratories-launches-sputnik-v-covid-19-vaccine-in-india-at-rs-995-per-dose-9621271.html|access-date=2021-05-14|website=Firstpost|archive-date=15 May 2021|archive-url=https://web.archive.org/web/20210515142714/https://www.firstpost.com/india/dr-reddys-laboratories-launches-sputnik-v-covid-19-vaccine-in-india-at-rs-995-per-dose-9621271.html|url-status=live}}</ref> Argentina became the first Latin American country to produce it.<ref>{{cite web|url=https://www.france24.com/en/live-news/20210420-in-latin-american-first-argentina-to-produce-russia-s-sputnik-v-vaccine|title=In Latin American first, Argentina to produce Russia's Sputnik V vaccine|website=France 24|date=2021-04-20|access-date=2021-07-02|archive-date=23 April 2021|archive-url=https://web.archive.org/web/20210423004639/https://www.france24.com/en/live-news/20210420-in-latin-american-first-argentina-to-produce-russia-s-sputnik-v-vaccine|url-status=live}}</ref> Large-scale production started in June 2021.<ref>{{cite web|url=https://batimes.com.ar/news/argentina/laboratorios-richmond-set-to-begin-manufacturing-sputnik-v-second-doses.phtml|title=Laboratorios Richmond set to begin manufacturing Sputnik V second doses|website=Buenos Aires Times|date=2021-06-30|access-date=2021-07-02|archive-date=18 August 2021|archive-url=https://web.archive.org/web/20210818031215/https://batimes.com.ar/news/argentina/laboratorios-richmond-set-to-begin-manufacturing-sputnik-v-second-doses.phtml|url-status=live}}</ref> As of 31 December 2021 277 million doses were manufactured, mostly (265 million) in Russia.<ref>{{Cite web |date=2022-01-12 |title=COVID-19 vaccine production, to December 31st, 2021 |url=https://globalcommissionforpostpandemicpolicy.org/covid-19-vaccine-production-to-december-31st-2021/ |access-date=2021-09-19 |website=Global Commission for Post-Pandemic Policy |language=en-CA |archive-date=20 May 2022 |archive-url=https://web.archive.org/web/20220520174715/https://globalcommissionforpostpandemicpolicy.org/covid-19-vaccine-production-to-december-31st-2021/ |url-status=live }}</ref>

On 28 February 2022, as a result of the 2022 Russian invasion of Ukraine, the United States placed RDIF and its chief executive on its list of sanctioned Russian entities and people.<ref name=":02"/><ref name=":122"/> The European Union, Ukraine, United Kingdom and Australia followed later in February and in March.<ref>{{Cite web |title=RUSSIAN DIRECT INVESTMENT FUND |url=https://www.opensanctions.org/entities/NK-CSTHWr7TNQckHEURKfFGMH/ |access-date=2022-04-25 |website=opensanctions.org |date=June 2011 |language=en |archive-date=14 April 2023 |archive-url=https://web.archive.org/web/20230414162648/https://www.opensanctions.org/entities/NK-CSTHWr7TNQckHEURKfFGMH/ |url-status=live }}</ref> This significantly reduces vaccine's future commercial prospects.<ref name=":02" /><ref name=":6" />

==History== 300px|thumb|Package and Vial for the first dose The Gam-COVID-Vac vaccine was developed by a cellular microbiologists team of the government-backed Gamaleya Research Institute of Epidemiology and Microbiology. The group was led by MD and RAS associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus.{{citation needed|date=August 2021}}

In May 2020, the Gamaleya Research Institute of Epidemiology and Microbiology announced that it had developed the vaccine without serious side effects. By August 2020, phases I and II of two clinical trials (involving 38 patients each) were completed. Only one of them used the formulation which later obtained marketing authorization under limited conditions.<ref>{{Cite web|url=https://www.dailysabah.com/world/europe/russia-plans-to-start-producing-coronavirus-vaccine-in-september|title=Russia plans to start producing coronavirus vaccine in September|date=2020-06-13|publisher=Daily Sabah|access-date=2020-08-10|archive-date=17 July 2020|archive-url=https://web.archive.org/web/20200717011540/https://www.dailysabah.com/world/europe/russia-plans-to-start-producing-coronavirus-vaccine-in-september|url-status=live}}</ref><ref name="Ермаков, 2020" >{{cite web |url=https://fontanka.ru/2020/08/11/69416050/ |title=Вакцина от COVID-19 – в словах чиновников и документах разработчика |trans-title=Vaccine for COVID-19 - in the words of officials and developer documents |vauthors=Ermakov A |date=11 August 2020 |publisher=Fontanka.ru |language=ru |access-date=2020-09-21 |archive-date=25 September 2020 |archive-url=https://web.archive.org/web/20200925015252/https://www.fontanka.ru/2020/08/11/69416050/ |url-status=live }}</ref> This vaccine was given the trade name "Sputnik V", after the world's first artificial satellite.<ref name=cohen/><ref name="burki" /><ref>{{cite news |vauthors=Tétrault-Farber G, Soldatkin V |date=11 August 2020 |title=Russia becomes first country to approve a COVID-19 vaccine, says Putin |url=https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-put/russia-becomes-first-country-to-approve-a-covid-19-vaccine-says-putin-idUSKCN25712U |work=Reuters |location=Moscow |access-date=11 August 2020 |archive-date=11 August 2020 |archive-url=https://web.archive.org/web/20200811093315/https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-put/russia-becomes-first-country-to-approve-a-covid-19-vaccine-says-putin-idUSKCN25712U |url-status=live }}</ref>

During preclinical and clinical trials, 38 participants who received one or two doses of the Gam-COVID-Vac vaccine had produced antibodies against SARS-CoV-2's spike protein, including potent neutralizing antibodies that inactivate viral particles.<ref name=nature/> On 11 August 2020, the Russian minister of Health Mikhail Murashko announced at a government briefing with the participation of President Vladimir Putin regulatory approval of the vaccine for widespread use. The state registration of the vaccine was carried out "conditionally" with post-marketing measures according to the decree of the Government of the Russian Federation. The registration certificate for the vaccine stated that it could not be used widely in Russia until 1 January 2021, and before that, it may be provided to "a small number of citizens from vulnerable groups", such as medical staff and the elderly, according to a Ministry of Health spokesperson.<ref name=cohen/> The license under register number No. ЛП-006395 (''LP-006395'') was issued on 11 August by the Russian Ministry of Health. Although the announcement was made even before the vaccine candidate had been entered into Phase III trials, the practice of marketing authorization "on conditions" also exists in other countries.<ref name=rospot>{{cite web|title=About the vaccine to prevent the novel coronavirus infection COVID-19, "Gam-COVID-Vac", developed by the National Research Centre for Epidemiology and Microbiology named after academician N. F. Gamalei of the Ministry of Health of the Russian Federation|url=https://roszdravnadzor.gov.ru/news/22768|website=Federal Service for Surveillance in Healthcare|date=12 August 2020|access-date=2020-08-18|archive-date=13 August 2020|archive-url=https://web.archive.org/web/20200813054856/https://roszdravnadzor.gov.ru/news/22768|url-status=live}}</ref><ref>{{cite web |url = https://roszdravnadzor.gov.ru/en/news/22789 |title = Ministry of Health of the Russian Federation has issued a registration certification No. ЛП-006395 dated 11 August 2020 for a vaccine to prevent the novel coronavirus infection COVID-19 |date = 2020-08-11 |publisher = Federal Service for Surveillance in Healthcare |access-date = 2020-09-21 |archive-date = 26 December 2020 |archive-url = https://web.archive.org/web/20201226143227/https://roszdravnadzor.gov.ru/en/news/22789 |url-status = live }}</ref> On 26 August, certificate No. ЛП-006423 (''LP-006423'') was issued for the lyophilized formulation "Gam-COVID-Vac-Lyo".<ref name=nature/><ref name=cohen/><ref name="burki" /><ref>{{cite news |author= |title=Coronavirus: Putin says vaccine has been approved for use |url=https://www.bbc.com/news/world-europe-53735718 |work=BBC |date=11 August 2020 |access-date=11 August 2020 |archive-date=11 August 2020 |archive-url=https://web.archive.org/web/20200811153310/https://www.bbc.com/news/world-europe-53735718 |url-status=live }}</ref><ref name=Logunov01/>

On 12 June 2021, developers announced that they had developed and tested a nasal vaccine for children aged 8 to 12, with no side effects found, and that they expected to release it on 15 September 2021.<ref>{{cite news |vauthors=Ivanova P |title=Russia tests COVID-19 vaccine as nasal spray for children |url=https://www.reuters.com/world/europe/russia-tests-covid-19-vaccine-nasal-spray-children-agencies-2021-06-12/ |access-date=11 July 2021 |work=Reuters |date=12 June 2021 |location=Moscow |archive-date=11 July 2021 |archive-url=https://web.archive.org/web/20210711152353/https://www.reuters.com/world/europe/russia-tests-covid-19-vaccine-nasal-spray-children-agencies-2021-06-12/ |url-status=live }}</ref>

===Clinical trials=== ====Phase I–II==== A phase I safety trial began on 18 June 2020.<ref name=nature/> On 4 September 2020, data on 76 participants in a phase I–II trial were published, indicating preliminary evidence of safety and an immune response.<ref name=Logunov01/> The results were challenged by international vaccine scientists as being incomplete, suspicious, and unreliable when identical data were reported for many of the trial participants,<ref name="ellyatt">{{cite news |vauthors=Ellyatt H |title=Scientists question 'strange' data in Russian coronavirus vaccine trial after 'unlikely' patterns |url=https://www.cnbc.com/2020/09/10/scientists-question-russian-vaccine-trial-data-on-unlikely-patterns.html |access-date=2020-09-10 |work=CNBC |date=2020-09-10 |archive-date=29 March 2021 |archive-url=https://web.archive.org/web/20210329044735/https://www.cnbc.com/2020/09/10/scientists-question-russian-vaccine-trial-data-on-unlikely-patterns.html |url-status=live }}</ref> but the authors responded that there was a small sample size of nine, and the measured results of titration could only take discrete values (800, 1600, 3200, 6400). Coupled with the observation that values tended to reach a plateau after three to four weeks, they contend that it is not unlikely that several participants would show identical results for days 21 to 28.<ref name=Logunov02>{{cite journal | vauthors = Logunov DY, Dolzhikova IV, Tukhvatullin AI, Shcheblyakov DV | title = Safety and efficacy of the Russian COVID-19 vaccine: more information needed - Authors' reply | journal = Lancet | volume = 396 | issue = 10256 | pages = e54–e55 | date = October 2020 | pmid = 32971043 | pmc = 7503057 | doi = 10.1016/S0140-6736(20)31970-X | s2cid = 221805026 }}</ref>

====Phase III==== [[File:SputnikVEfficacy001.svg|thumb| Sputnik V, efficacy for different conditions. The error bars indicate the confidence interval containing the efficacy with 95% probability.]] In early November 2020, Israel Hadassah Medical Center director-general Zeev Rotstein stated that Hadassah's branch in Moscow's Skolkovo Innovation Center was collaborating on a phase III clinical trial.<ref>{{Cite web|title=Hadassah bringing 1.5 million doses of Russian COVID-19 vaccine to Israel|url=https://m.jpost.com/health-science/hadassah-bringing-15-million-doses-of-russian-covid-19-vaccine-to-israel-648093/amp|access-date=2020-11-19|website=The Jerusalem Post|archive-date=15 November 2020|archive-url=https://web.archive.org/web/20201115005046/https://m.jpost.com/health-science/hadassah-bringing-15-million-doses-of-russian-covid-19-vaccine-to-israel-648093/amp|url-status=live |issn=0792-822X}}</ref>

The ongoing phase III study is a randomised, double-blind, placebo-controlled, multi-centre clinical trial involving 40,000 volunteers in Moscow, and is scheduled to run until May 2021.<ref name="ct.gov">{{cite web|title=Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19|url=https://clinicaltrials.gov/ct2/show/NCT04530396|access-date=28 September 2020|publisher=National Library of Medicine|archive-date=22 October 2020|archive-url=https://web.archive.org/web/20201022111333/https://clinicaltrials.gov/ct2/show/NCT04530396|url-status=live}}</ref> In 2020–2021, phase III clinical studies were also being conducted in Belarus,<ref>{{Cite journal|title=Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 in Belarus|url=https://clinicaltrials.gov/ct2/show/NCT04564716|access-date=2021-01-14|website=clinicaltrials.gov|date=December 2020|archive-date=24 December 2020|archive-url=https://web.archive.org/web/20201224134421/https://clinicaltrials.gov/ct2/show/NCT04564716|url-status=live}}</ref> UAE,<ref>{{cite news|url=https://www.khaleejtimes.com/coronavirus-pandemic/video-uae-volunteers-receive-russian-covid-19-vaccine|title=UAE volunteers receive Russian Covid-19 vaccine|date=10 January 2021|work=Khaleej Times|access-date=19 January 2021|archive-date=12 January 2021|archive-url=https://web.archive.org/web/20210112193605/https://www.khaleejtimes.com/coronavirus-pandemic/video-uae-volunteers-receive-russian-covid-19-vaccine|url-status=live}}</ref> India,<ref>{{cite news|url=https://timesofindia.indiatimes.com/business/india-business/dr-reddys-gets-dcgi-nod-for-covid-19-vaccine-sputnik-v-phase-iii-trials/articleshow/80291011.cms|title=Dr Reddy's gets DCGI nod for Covid-19 vaccine Sputnik V Phase III trials|vauthors=Bharadwaj S|date=15 January 2021|work=The Times Of India|access-date=19 January 2021|archive-date=18 January 2021|archive-url=https://web.archive.org/web/20210118175911/https://timesofindia.indiatimes.com/business/india-business/dr-reddys-gets-dcgi-nod-for-covid-19-vaccine-sputnik-v-phase-iii-trials/articleshow/80291011.cms|url-status=live}}</ref> Kazakhstan<ref>{{Cite web |url=https://clinicaltrials.gov/ct2/show/NCT04871841 |title=Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan |date=18 August 2021 |access-date=9 April 2023 |archive-date=9 April 2023 |archive-url=https://web.archive.org/web/20230409174122/https://clinicaltrials.gov/ct2/show/NCT04871841 |url-status=live }}</ref> and Venezuela.<ref>{{ClinicalTrialsGov|NCT04642339 |Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela}}</ref>

On 13 April 2021, India's health ministry said its drug regulator had found that safety and immunogenicity data from a local trial of Sputnik V coronavirus vaccine was comparable to that of a late-stage trial done in Russia.<ref>{{cite web|url=https://www.reuters.com/article/idUSFWN2M517R|title=India says its safety study of Sputnik V vaccine comparable to Russian trial|date=13 April 2021|website=Reuters|access-date=13 April 2021|archive-date=13 April 2021|archive-url=https://web.archive.org/web/20210413184126/https://www.reuters.com/article/idUSFWN2M517R|url-status=live}}</ref>

====Variants==== In May 2021, a study by researchers of the National University of Córdoba, Argentina, found that the vaccine produced antibodies capable of neutralizing the Gamma variant.<ref>{{cite tech report |vauthors=Rodríguez R, Caeiro JP, Juri H, Pizzi R, Gallego S, Blanco S, Konigheim B, Spinsanti L, Díaz A, Aguilar J, Beranek M |title=Evaluacion de la respuesta de anticuerpos neutralizantes a la vacuna Sputnik V en una cohorte en Cordoba y evaluación de las propiedades neutralizantes de anticuerpos naturales y vacunales frente a la variante Manaos |trans-title=Evaluation of the neutralizing antibody response to the Sputnik V vaccine in a cohort in Cordoba and evaluation of the neutralizing properties of natural and vaccine antibodies against the Manaus variant |language=Spanish |institution=National University of Córdoba |date=25 May 2021 |url=http://hdl.handle.net/11086/18497 |access-date=22 June 2021}}</ref>

A study in Argentina found that neutralization is maintained against Alpha and Lambda and reduced against Gamma. The degree of reduction, however, does not necessarily imply reduced protection.<ref>{{cite news |title=Coronavirus: la vacuna Sputnik V genera anticuerpos para las variantes que circulan en el país |trans-title=Coronavirus: the Sputnik V vaccine generates antibodies for the variants that circulate in the country |url=https://www.lanacion.com.ar/sociedad/coronavirus-la-vacuna-sputnik-v-genera-anticuerpos-para-batallar-las-variantes-que-circulan-en-el-nid30062021/ |access-date=11 July 2021 |work=La Nación |date=30 June 2021 |language=Spanish |archive-date=11 July 2021 |archive-url=https://web.archive.org/web/20210711152236/https://www.lanacion.com.ar/sociedad/coronavirus-la-vacuna-sputnik-v-genera-anticuerpos-para-batallar-las-variantes-que-circulan-en-el-nid30062021/ |url-status=live }}</ref>

A small study of 12 serum samples found that antibodies from the vaccine effectively neutralize the Alpha variant, with moderately reduced neutralization against the E484K substitution (median 2.8 fold reduction). However, neutralization of the Beta variant was markedly reduced (median 6.1 fold reduction).<ref>{{cite journal | vauthors = Ikegame S, Siddiquey MN, Hung CT, Haas G, Brambilla L, Oguntuyo KY, Kowdle S, Chiu HP, Stevens CS, Vilardo AE, Edelstein A, Perandones C, Kamil JP, Lee B | title = Neutralizing activity of Sputnik V vaccine sera against SARS-CoV-2 variants | journal = Nature Communications | volume = 12 | issue = 1 | article-number = 4598 | date = July 2021 | pmid = 34312390 | pmc = 8313705 | doi = 10.1038/s41467-021-24909-9 | bibcode = 2021NatCo..12.4598I }}</ref>

===Authorizations===

{{See also|List of COVID-19 vaccine authorizations#Sputnik V}} [[File:Совещание с членами Правительства (В. Путин; 11 августа 2020) – (01).jpg|thumb |alt=See caption |President Putin's meeting with government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered vaccine against COVID-19<ref name=nature/><ref name=cohen/>]] In August 2020, British and American officials stated that the Gam-COVID-Vac vaccine would likely be rejected due to concerns that the normally rigorous process of vaccine clinical testing was not followed.<ref>{{cite news | vauthors = Mullin J, Malnick E |title=Britain unlikely to use Russia's 'untrustworthy' Covid vaccine |url=https://www.telegraph.co.uk/news/2020/08/01/britain-unlikely-use-russias-untrustworthy-covid-vaccine/ |archive-url=https://web.archive.org/web/20200819152533/https://www.telegraph.co.uk/news/2020/08/01/britain-unlikely-use-russias-untrustworthy-covid-vaccine/ |archive-date=19 August 2020 |access-date=6 September 2020 |work=The Telegraph |date=1 August 2020}}</ref>

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.<ref>{{cite news |title=Belarus registers Sputnik V vaccine, in first outside Russia – RDIF |url=https://www.reuters.com/article/us-health-coronavirus-vaccine-belarus/belarus-registers-sputnik-v-vaccine-in-first-outside-russia-rdif-idINKBN28V0ZG |access-date=22 December 2020 |work=Reuters |date=21 December 2020 |archive-date=8 January 2021 |archive-url=https://web.archive.org/web/20210108025629/https://www.reuters.com/article/us-health-coronavirus-vaccine-belarus/belarus-registers-sputnik-v-vaccine-in-first-outside-russia-rdif-idINKBN28V0ZG |url-status=live }}</ref> On 21 January 2021, Hungary became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the Persian Gulf region.<ref>{{cite news |vauthors=Turak N |title=Russia's Sputnik vaccine gets its first approval in the EU, greenlight from UAE amid ongoing trials |url=https://www.cnbc.com/2021/01/21/russias-sputnik-vaccine-gets-its-first-approval-in-the-eu-uae.html |work=CNBC |date=21 January 2021 |access-date=22 January 2021 |archive-date=6 April 2023 |archive-url=https://web.archive.org/web/20230406062329/https://www.cnbc.com/2021/01/21/russias-sputnik-vaccine-gets-its-first-approval-in-the-eu-uae.html |url-status=live }}</ref><ref>{{cite news |title=Coronavirus: Hungary first in EU to approve Russian vaccine |url=https://www.bbc.com/news/world-europe-55747623 |work=BBC News |date=21 January 2021 |access-date=22 January 2021 |archive-date=22 January 2021 |archive-url=https://web.archive.org/web/20210122162924/https://www.bbc.com/news/world-europe-55747623 |url-status=live }}</ref><ref>{{cite news |vauthors=Walker S |title=Hungary breaks ranks with EU to license Russian vaccine |url=https://www.theguardian.com/world/2021/jan/21/hungary-breaks-ranks-with-eu-to-license-russian-vaccine-sputnik-v |work=The Guardian |date=21 January 2021 |access-date=22 January 2021 |archive-date=22 January 2021 |archive-url=https://web.archive.org/web/20210122013307/https://www.theguardian.com/world/2021/jan/21/hungary-breaks-ranks-with-eu-to-license-russian-vaccine-sputnik-v |url-status=live }}</ref><ref>{{cite news |title=Hungary Becomes First in EU to Approve Russian Covid Vaccine |url=https://www.bloomberg.com/news/articles/2021-01-21/hungary-becomes-first-in-eu-to-approve-russia-s-covid-vaccine |work=Bloomberg.com |date=21 January 2021 |access-date=22 January 2021 |archive-date=22 January 2021 |archive-url=https://web.archive.org/web/20210122110324/http://www.bloomberg.com/news/articles/2021-01-21/hungary-becomes-first-in-eu-to-approve-russia-s-covid-vaccine |url-status=live }}</ref><ref>{{cite news |title=COVID: Hungary fast-tracks Russian vaccine with EU approval in the works {{!}} DW {{!}} 21.01.2021 |url=https://www.dw.com/en/covid-hungary-fast-tracks-russian-vaccine-with-eu-approval-in-the-works/a-56306084#:~:text=Hungary%20has%20become%20the%20first,Russia's%20Sputnik%20V%20coronavirus%20vaccine.&text=Hungary%20approved%20the%20vaccine%20independently,European%20Medicines%20Agency%20(EMA) |work=DW.COM |access-date=22 January 2021 |archive-date=22 January 2021 |archive-url=https://web.archive.org/web/20210122141450/https://www.dw.com/en/covid-hungary-fast-tracks-russian-vaccine-with-eu-approval-in-the-works/a-56306084#:~:text=Hungary%20has%20become%20the%20first,Russia's%20Sputnik%20V%20coronavirus%20vaccine.&text=Hungary%20approved%20the%20vaccine%20independently,European%20Medicines%20Agency%20(EMA) |url-status=live }}</ref>

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.<ref>{{cite news |title=Russia files for Sputnik vaccine registration in EU |url=https://www.euractiv.com/section/health-consumers/news/russia-files-for-sputnik-vaccine-registration-in-eu/ |work=Euractiv.com |date=20 January 2021 |access-date=24 January 2021 |archive-date=22 January 2021 |archive-url=https://web.archive.org/web/20210122010654/https://www.euractiv.com/section/health-consumers/news/russia-files-for-sputnik-vaccine-registration-in-eu/ |url-status=live }}</ref> On 10 February, the European Medicines Agency (EMA) said that they had "not received an application for a rolling review or a marketing authorisation for the vaccine". The developers have only expressed their interest that the vaccine be considered for a rolling review, but EMA's Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) need to give their agreement first before developers can submit their application for initiation of the rolling review process.<ref>{{cite press release|url=https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process|title=Clarification on Sputnik V vaccine in the EU approval process|date=10 February 2021|publisher=European Medicines Agency (EMA)|access-date=17 February 2021|archive-date=24 February 2021|archive-url=https://web.archive.org/web/20210224190804/https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process|url-status=live}}</ref> On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.<ref name="Sputnik V rolling review" /> The EU applicant is R-Pharm Germany GmbH, a subsidiary of the Russian R-Pharm.<ref name="Sputnik V rolling review">{{cite press release | title=EMA starts rolling review of the Sputnik V COVID-19 vaccine | publisher=European Medicines Agency (EMA) | date=4 March 2021 | url=https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sputnik-v-covid-19-vaccine | access-date=4 March 2021 | archive-date=4 March 2021 | archive-url=https://web.archive.org/web/20210304100908/https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sputnik-v-covid-19-vaccine | url-status=live }}</ref> On 16 June, Reuters reported that approval of Sputnik V will be delayed at least until September because not all the necessary clinical data has been submitted by the deadline.<ref>{{cite news |vauthors=Rinke A, Parodi E |title=EU approval of Russia's Sputnik V vaccine delayed, sources say |url=https://www.reuters.com/world/europe/eu-approval-russias-sputnik-v-vaccine-delayed-sources-say-2021-06-16/ |access-date=2021-06-16 |work=Reuters |date=2021-06-16 |location=Berlin |archive-date=16 June 2021 |archive-url=https://web.archive.org/web/20210616093921/https://www.reuters.com/world/europe/eu-approval-russias-sputnik-v-vaccine-delayed-sources-say-2021-06-16/ |url-status=live }}</ref> As of June 2021, Sputnik V is under rolling review process by EMA, but the marketing authorisation application was not submitted yet.<ref>{{Cite web|title=COVID-19 vaccines|date=17 February 2021|url=https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines|access-date=2021-06-16|publisher=European Medicines Agency|archive-date=16 June 2021|archive-url=https://web.archive.org/web/20210616125516/https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines|url-status=live}}</ref>{{Update inline|date=September 2025|reason=Is the vaccine still under review? Has it been approved since 2021?}}

Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,<ref name=reuters-20210111/> and Mexico.<ref>{{cite news|url=https://www.yucatan.com.mx/mexico/agilizan-la-autorizacion-para-que-la-vacuna-sputnik-v-se-aplique-en-mexico|title=Da la Cofepris autorización para que la vacuna Sputnik V se aplique en México|date=2 February 2021|work=Diario de Yucatán|language=es|access-date=3 February 2021|archive-date=21 April 2021|archive-url=https://web.archive.org/web/20210421163305/https://www.yucatan.com.mx/mexico/agilizan-la-autorizacion-para-que-la-vacuna-sputnik-v-se-aplique-en-mexico}}</ref>

On 25 January 2021, Iran approved the vaccine, with Foreign Minister Mohammad Javad Zarif saying the country hopes to begin purchases and start joint production of the shot "in the near future", after Supreme Leader Ayatollah Ali Khamenei banned the government from importing vaccines from the United States and United Kingdom.<ref>{{cite news |title=Iran approves Russia's Sputnik V COVID-19 vaccine |url=https://www.aljazeera.com/news/2021/1/26/iran-approves-russias-sputnik-v-covid-19-vaccine |work=Al Jazeera |access-date=27 January 2021 |archive-date=27 January 2021 |archive-url=https://web.archive.org/web/20210127060805/https://www.aljazeera.com/news/2021/1/26/iran-approves-russias-sputnik-v-covid-19-vaccine |url-status=live }}</ref><ref>{{cite news |title=Iran approves Russian coronavirus vaccine Sputnik V |url=https://www.reuters.com/article/us-health-coronavirus-russia-iran/iran-approves-russian-coronavirus-vaccine-sputnik-v-idUSKBN29V1A8 |work=Reuters |date=26 January 2021 |access-date=27 January 2021 |archive-date=26 January 2021 |archive-url=https://web.archive.org/web/20210126135243/https://www.reuters.com/article/us-health-coronavirus-russia-iran/iran-approves-russian-coronavirus-vaccine-sputnik-v-idUSKBN29V1A8 |url-status=live }}</ref>

The Czech Republic was also considering buying Sputnik V, and Prime Minister Andrej Babis dismissed the Minister of Health, Jan Blatný, who was a loud opponent to the use of Sputnik V.<ref>{{cite news |title=Czech Republic turns to Russian vaccine amid soaring COVID cases |url=https://www.aljazeera.com/news/2021/2/28/czech-places-order-for-russias-sputnik-amid-covid-soaring-cases |work=Al Jazeera |date=28 February 2021 |access-date=1 March 2021 |archive-date=1 March 2021 |archive-url=https://web.archive.org/web/20210301025037/https://www.aljazeera.com/news/2021/2/28/czech-places-order-for-russias-sputnik-amid-covid-soaring-cases |url-status=live }}</ref><ref>{{Cite news|vauthors=Muller R, Hovet J|date=2021-04-07|title=Czech PM names fourth health minister amid Sputnik vaccine strife|language=en|work=Reuters|url=https://www.reuters.com/article/us-czech-government-idUSKBN2BU110|access-date=2021-04-08|archive-date=8 April 2021|archive-url=https://web.archive.org/web/20210408021801/https://www.reuters.com/article/us-czech-government-idUSKBN2BU110|url-status=live}}</ref><ref>{{Cite web | vauthors = Šnajdrová T | title = Arenberger má záznamy ve složkách StB. Byl jsem člen KSČ, spolupracovník StB ne, brání se nový ministr | trans-title = Arenberger has records in the StB files. I was a member of the Communist Party of the Czech Republic, but not an employee of the StB, the new minister is defending himself | language = cs | work = Refresher | url = https://refresher.cz/96849-Arenberger-ma-zaznamy-ve-slozkach-StB-Byl-jsem-clen-KSC-spolupracovnik-StB-ne-brani-se-novy-ministr | access-date = 2021-04-08 | archive-date = 12 April 2021 | archive-url = https://web.archive.org/web/20210412200530/https://refresher.cz/96849-Arenberger-ma-zaznamy-ve-slozkach-StB-Byl-jsem-clen-KSC-spolupracovnik-StB-ne-brani-se-novy-ministr | url-status = live }}</ref>

On 4 March 2021, EMA's human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia's Gamaleya National Centre of Epidemiology and Microbiology.<ref>{{Cite news|title=EMA starts rolling review of the Sputnik V COVID-19 vaccine|url=https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sputnik-v-covid-19-vaccine|work=www.ema.europa.eu|date=4 March 2021|access-date=4 March 2021|archive-date=4 March 2021|archive-url=https://web.archive.org/web/20210304100908/https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sputnik-v-covid-19-vaccine|url-status=live}}</ref> When asked about the prospect of Austria giving Sputnik V the approval (as some other European countries chose to do), EMA management board chair Christa Wirthumer-Hoche pointed to the fact there was not yet sufficient safety data about those who had already been given the vaccine. "We could have Sputnik V on the market in future, when we've examined the necessary data," she said, adding that the vaccine needed to match up to European criteria on quality control and efficacy.<ref>{{Cite news|title=EU medical official warns of Sputnik jab 'Russian roulette'|url=https://www.france24.com/en/live-news/20210308-eu-medical-official-warns-of-sputnik-jab-russian-roulette|work=www.france24.com|date=2021-03-08|access-date=13 March 2021|archive-date=12 March 2021|archive-url=https://web.archive.org/web/20210312140930/https://www.france24.com/en/live-news/20210308-eu-medical-official-warns-of-sputnik-jab-russian-roulette|url-status=live}}</ref>

On 18 March 2021, German regional leaders including State Premiers and the mayor of Berlin called for the swift approval of the Russian vaccine by the European Medicines Agency to counteract the acute shortages of effective vaccines in Europe. German medical experts have recommended its approval also, and consider the Sputnik Vaccine "clever" and "highly safe".<ref>[https://www.thelocal.de/20210318/german-leaders-urge-quick-eu-approval-of-russias-sputnik-v-jab/ "German leaders urge quick EU approval of Russia's Sputnik V jab"] {{Webarchive|url=https://web.archive.org/web/20210318173316/https://www.thelocal.de/20210318/german-leaders-urge-quick-eu-approval-of-russias-sputnik-v-jab/ |date=18 March 2021 }} ''thelocal.de''. Retrieved 20 March 2021.</ref>

On 19 March 2021, the Philippine Food and Drug Administration granted emergency use authorization for Sputnik V, the fourth COVID-19 vaccine to be given authorization. The Philippine government planned to buy 20{{nbsp}}million doses of the vaccine.<ref>{{cite news |url=https://www.abs-cbn.com/news/03/19/21/philippines-grants-emergency-authorization-for-russias-sputnik-v-vaccine |title=Philippines grants emergency authorization for Russia's Sputnik V vaccine |date=19 March 2021 |website=ABS-CBN News |access-date=19 March 2021 |archive-date=19 March 2021 |archive-url=https://web.archive.org/web/20210319022732/https://news.abs-cbn.com/news/03/19/21/philippines-grants-emergency-authorization-for-russias-sputnik-v-vaccine |url-status=live }}</ref><ref name="cnnphilippines.com">{{cite web |url=https://cnnphilippines.com/news/2021/3/19/Russia-Gamaleya-emergency-use-PH.html |title=Russia's Sputnik V approved for emergency use in PH |date=19 March 2021 |website=CNN Philippines |access-date=19 March 2021 |archive-date=19 March 2021 |archive-url=https://web.archive.org/web/20210319023615/https://cnnphilippines.com/news/2021/3/19/Russia-Gamaleya-emergency-use-PH.html }}</ref>

On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data.<ref>{{cite news |title=Russia's Covid vaccine Sputnik V gets nod from expert panel for emergency use in India: Report |url=https://indianexpress.com/article/india/sputnik-v-covid-vaccine-india-7270310/ |work=The Indian Express |date=12 April 2021 |language=en |access-date=12 April 2021 |archive-date=12 April 2021 |archive-url=https://web.archive.org/web/20210412113609/https://indianexpress.com/article/india/sputnik-v-covid-vaccine-india-7270310/ |url-status=live }}</ref><ref>{{cite news |vauthors=Das KN |title=Indian panel gives emergency approval for Russia's Sputnik V vaccine -sources |url=https://www.reuters.com/article/health-coronavirus-india-vaccine/india-approves-russias-sputnik-v-covid-19-vaccine-economic-times-idUSKBN2BZ11Y |work=Reuters |date=12 April 2021 |language=en |access-date=12 April 2021 |archive-date=12 April 2021 |archive-url=https://web.archive.org/web/20210412113050/https://www.reuters.com/article/health-coronavirus-india-vaccine/india-approves-russias-sputnik-v-covid-19-vaccine-economic-times-idUSKBN2BZ11Y |url-status=live }}</ref>

As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization.<ref>{{Cite web|date=12 April 2021|title=Sputnik V Vaccine Authorized in India|url=https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-authorized-for-use-in-india/|access-date=2021-04-12|website=sputnikvaccine.com|archive-date=14 April 2021|archive-url=https://web.archive.org/web/20210414180548/https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-authorized-for-use-in-india/|url-status=live}}</ref>

On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use.<ref>{{cite news|title=Bangladesh approves emergency use of Russian vaccine Sputnik V|url=https://www.newagebd.net/article/136506/bangladesh-approves-emergency-use-of-russian-vaccine-sputnik-v|work=New Age|date=27 April 2021|access-date=27 April 2021|language=en|archive-date=27 April 2021|archive-url=https://web.archive.org/web/20210427090219/https://www.newagebd.net/article/136506/bangladesh-approves-emergency-use-of-russian-vaccine-sputnik-v|url-status=live}}</ref>

On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use.<ref>{{cite news |title=Turkey OKs emergency use of Sputnik-V vaccine |url=https://www.aa.com.tr/en/latest-on-coronavirus-outbreak/turkey-oks-emergency-use-of-sputnik-v-vaccine/2225824 |access-date=30 April 2021 |website=Anadolu Agency |language=en |archive-date=1 May 2021 |archive-url=https://web.archive.org/web/20210501105241/https://www.aa.com.tr/en/latest-on-coronavirus-outbreak/turkey-oks-emergency-use-of-sputnik-v-vaccine/2225824 |url-status=live }}</ref><ref>{{Cite web|title=Russian Direct Investment Fund|url=https://rdif.ru/Eng_fullNews/6761/|access-date=2021-05-07|website=rdif.ru|language=en|archive-date=7 May 2021|archive-url=https://web.archive.org/web/20210507133054/https://rdif.ru/Eng_fullNews/6761/|url-status=live}}</ref>

====Slovakia==== On 1 March 2021, Slovakia bought 2{{nbsp}}million doses of the Sputnik V vaccine. Slovakia received the first batch of 200,000, and expected to receive another 800,000 doses in March and April. Another 1{{nbsp}}million doses were set to arrive in May and June.<ref>{{cite news |title=Sputnik V vaccines landed in Slovakia |url=https://spectator.sme.sk/c/22607893/slovakia-receives-first-sputnik-v-vaccines.html |work=The Slovak Spectator |date=1 March 2021 |access-date=2 March 2021 |archive-date=1 March 2021 |archive-url=https://web.archive.org/web/20210301205114/https://spectator.sme.sk/c/22607893/slovakia-receives-first-sputnik-v-vaccines.html |url-status=live }}</ref>

On 8 April, Slovakia's drug regulator said that the Sputnik V vaccine it received did "not have the same characteristics and properties" as the version endorsed by ''The Lancet''.<ref>{{Cite news| vauthors = Higgins A |date=2021-04-08|title=Slovakia Claims a Bait-and-Switch With the Russian Vaccines it Ordered|language=en-US|work=The New York Times|url=https://www.nytimes.com/2021/04/08/world/europe/slovakia-coronavirus-russia-vaccine-sputnik.html |archive-url=https://ghostarchive.org/archive/20211228/https://www.nytimes.com/2021/04/08/world/europe/slovakia-coronavirus-russia-vaccine-sputnik.html |archive-date=2021-12-28 |url-access=limited|access-date=2021-04-11|issn=0362-4331| url-status=live }}</ref> The Slovak State Institute for Drug Control stated that Sputnik V has not yet been approved for use, as the first 200,000 doses received on 31 March were different from the product currently being reviewed by the European Medicines Agency as well as from the vaccine used in studies published in ''The Lancet''. The producers have failed to reply to requests for documentation, and approximately 80% of the data was not supplied even after repeated requests. Due to the inconsistencies, it was not possible to review the safety and efficacy of the vaccine.<ref name=":1">{{Cite news|date=2021-04-08|title=Russia calls on Slovakia to return Sputnik V doses after dispute|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-slovakia-sputnik-idUSKBN2BV2GP|access-date=2021-04-12|archive-date=12 April 2021|archive-url=https://web.archive.org/web/20210412083248/https://www.reuters.com/article/us-health-coronavirus-slovakia-sputnik-idUSKBN2BV2GP|url-status=live}}</ref><ref>{{Cite web|date=2021-04-08|title=Výrobca Sputnika V nedodal kontrolórom väčšinu potrebných dát|url=https://domov.sme.sk/c/22634104/koronavirus-sputnik-ockovanie-vakcina-covid-sukl.html|access-date=2021-04-12|website=domov.sme.sk|language=sk|archive-date=12 April 2021|archive-url=https://web.archive.org/web/20210412083251/https://domov.sme.sk/c/22634104/koronavirus-sputnik-ockovanie-vakcina-covid-sukl.html|url-status=live}}</ref> The Russian Direct Investment Fund replied that the Slovak laboratory which tested the vaccine was not certified by the EMA.{{citation needed|date=November 2025}}

Slovak Prime Minister Igor Matovič resigned on 30 March, due to the political crisis started by the order of the Sputnik V vaccine.<ref>{{Cite news|title=Slovak Regulator Says Sputnik V It Got Differs From Vaccine In Reviews|url=https://www.rferl.org/a/slovakia-sputnik-vaccine-different/31193492.html|access-date=2021-04-08|newspaper=Radio Free Europe/Radio Liberty|date=8 April 2021|language=en|archive-date=8 April 2021|archive-url=https://web.archive.org/web/20210408135303/https://www.rferl.org/a/slovakia-sputnik-vaccine-different/31193492.html|url-status=live}}</ref> On 6 April 2021, the RDIF asked to return the delivered first batch of the vaccine due to "multiple contract violations".<ref name=":1" /><ref>{{Cite web|date=2021-04-08|title=Russian Direct Investment Fund asks Slovakia to return batch of 'Sputnik V' vaccines|url=https://meduza.io/en/news/2021/04/08/russian-direct-investment-fund-asks-slovakia-to-return-batch-of-sputnik-v-vaccines|access-date=2021-04-12|website=meduza.io|archive-date=12 April 2021|archive-url=https://web.archive.org/web/20210412083248/https://meduza.io/en/news/2021/04/08/russian-direct-investment-fund-asks-slovakia-to-return-batch-of-sputnik-v-vaccines|url-status=live}}</ref>

On 29 April 2021, the Slovak Ministry of Health published the Sputnik V contract.<ref name=":3">{{Cite web|title=964/2021 {{!}} Centrálny register zmlúv|url=https://www.crz.gov.sk/zmluva/5716242/|access-date=2021-05-11|website=www.crz.gov.sk|archive-date=12 May 2021|archive-url=https://web.archive.org/web/20210512082013/https://www.crz.gov.sk/zmluva/5716242/|url-status=live}}</ref> According to the contract, the RDIF as a seller is not liable for any adverse events following administering of the vaccine, nor its effectiveness.<ref name=":3" /><ref name=":4">{{Cite news|vauthors=Osvaldová L|date=2021-04-30|title=Zmluva o nákupe Sputnika je nevýhodná a môže vojsť do dejín ako ďalší amatérsky počin, hovoria právnici|url=https://dennikn.sk/2372187/zmluva-o-nakupe-vakciny-sputnik-v-je-nevyhodna-a-moze-vojst-do-dejin-ako-dalsi-amatersky-pocin-hovoria-pravnici/|access-date=2021-05-11|website=Denník N|language=sk-SK|archive-date=12 May 2021|archive-url=https://web.archive.org/web/20210512134437/https://dennikn.sk/2372187/zmluva-o-nakupe-vakciny-sputnik-v-je-nevyhodna-a-moze-vojst-do-dejin-ako-dalsi-amatersky-pocin-hovoria-pravnici/|url-status=live}}</ref> According to the Slovak lawyers, the contract is explicitly disadvantageous for Slovakia.<ref name=":4" /><ref>{{Cite web|date=2021-04-30|title=Výhody jen pro Rusko, lži Matoviče. Slováci znají obsah smlouvy o Sputniku|url=https://www.idnes.cz/zpravy/zahranicni/slovensko-sputnik-rusko-smlouva-matovic-krajci-koronavirus.A210430_111228_zahranicni_kha|access-date=2021-05-11|website=iDNES.cz|archive-date=11 May 2021|archive-url=https://web.archive.org/web/20210511225304/https://www.idnes.cz/zpravy/zahranicni/slovensko-sputnik-rusko-smlouva-matovic-krajci-koronavirus.A210430_111228_zahranicni_kha|url-status=live}}</ref>

On 8 May 2021, the Russian Direct Investment Fund sent a letter to the ''Denník N'' newspaper requesting the removal of the statements of the drug regulator, calling them "unsubstantiated and false" and "fake news".<ref name="dennink-2021-05-11">{{cite news |url = https://dennikn.sk/2385562/matovic-oznamuje-ockovanie-sputnikom-lengvarsky-o-tom-nevie/ |title = Matovič oznamuje očkovanie Sputnikom, Lengvarský o tom nevie |trans-title = Matovič announces vaccination with Sputnik, Lengvarský is unaware |language = sk |newspaper = Denník N |access-date = 11 May 2021 |archive-date = 11 May 2021 |archive-url = https://web.archive.org/web/20210511201640/https://dennikn.sk/2385562/matovic-oznamuje-ockovanie-sputnikom-lengvarsky-o-tom-nevie/ |url-status = live }}</ref><ref name="rdif-to-dennikn">{{cite web |url=https://www.scribd.com/embeds/507489023/content?start_page=1&view_mode=scroll&access_key=key-fhxBfLODdsRzMbfLZb0l |archive-url=https://web.archive.org/web/20210511200339/https://www.scribd.com/embeds/507489023/content?start_page=1&view_mode=scroll&access_key=key-fhxBfLODdsRzMbfLZb0l |archive-date = 2021-05-11 |title = List RDIF Denníku N |quote = On the 8th of April Dennik N published an article by Veronika Folentová entitled "Čo píše v stanovisku štátny ústav o Sputniku? Vakcíny v rôznych krajinách spája len názov" dennikn.sk/2343450/co-pise-v-stanovisku-statny-ustav-o-sputniku-vakciny-v-roznych-krajinach-spaja-len-nazov/ The article referred to the number of incorrect and misleading statements made by the Slovak regulator – State Institute for Drug Control (SUKL), which used for incorrect testing not EU-certified laboratory. RDIF and the Gamaleya Institute repeatedly insisted that all these statements were false and incorrect and rejected the Slovak allegations as "fake news". <...> We are concerned that your article in its current form contains unsubstantiated and false statements made by SUKL earlier and now refuted by the certified lab. <...> Therefore, we ask you to either remove the article entirely or reflect our position by publishing the above mentioned comments in full by the end of the day on May 9, 2021, as it is absolutely critical for us and shows the reality of the situation as well as reflects the enormous efforts by RDIF and partners in fighting the pandemic. Otherwise, RDIF reserves all rights to protect its reputation and legitimate interests and be compensated for any caused harm, including by commencing court proceedings against Dennik N in any relevant jurisdiction. }}</ref> RDIF threatened the newspaper with legal action if they didn't comply with the demand by 9 May.<ref name="dennikn-2021-05-11-en">{{cite news |url=https://e.dennikn.sk/2386564/dennik-n-rejects-russias-demand-to-withdraw-story-on-sputnik-vaccine/ |title = Denník N Rejects Russia's Demand to Withdraw Story on Sputnik Vaccine |newspaper = Denník N |archive-url=https://web.archive.org/web/20210511211019/https://e.dennikn.sk/2386564/dennik-n-rejects-russias-demand-to-withdraw-story-on-sputnik-vaccine/ |archive-date = 2021-05-11 }}</ref> The newspaper's editors refused.<ref name="dennikn-2021-05-11-en"/>

After the samples were sent to the EU-certified laboratory in Hungary and it was stated that "the results were satisfactory",<ref>{{Cite web|date=2021-05-09|title=Slovak health ministry says Sputnik V doses tested in Hungary satisfactory|url=https://www.reuters.com/world/europe/slovak-health-ministry-says-sputnik-v-doses-tested-hungary-satisfactory-2021-05-09/|access-date=2021-05-26|website=Reuters|archive-date=25 May 2021|archive-url=https://web.archive.org/web/20210525070829/https://www.reuters.com/world/europe/slovak-health-ministry-says-sputnik-v-doses-tested-hungary-satisfactory-2021-05-09/|url-status=live}}</ref> the Slovak government approved the vaccine, and announced that vaccination with Sputnik V would begin in June 2021, despite the negative review by Slovakia's drug regulator.<ref>{{Cite web|vauthors=Hopková D|title=Koronavírus: Sputnikom V by sa mohlo na Slovensku očkovať od júna|url=https://www.aktuality.sk/clanok/890365/koronavirus-sputnikom-v-by-sa-mohlo-na-slovensku-ockovat-od-juna/|access-date=2021-05-26|website=Aktuality.sk|date=12 May 2021|language=sk|archive-date=26 May 2021|archive-url=https://web.archive.org/web/20210526151801/https://www.aktuality.sk/clanok/890365/koronavirus-sputnikom-v-by-sa-mohlo-na-slovensku-ockovat-od-juna/|url-status=live}}</ref><ref>{{Cite news|date=2021-05-12|title=Slovakia could start giving Sputnik shots in June, minister says|language=en|work=Reuters|url=https://www.reuters.com/article/health-coronavirus-slovakia-vaccines-idUSL8N2MZ5MH|access-date=2021-05-26|archive-date=26 May 2021|archive-url=https://web.archive.org/web/20210526151759/https://www.reuters.com/article/health-coronavirus-slovakia-vaccines-idUSL8N2MZ5MH|url-status=live}}</ref> Vaccinations started on 7 June,<ref>{{Cite web|last=Teraz.sk|date=2021-06-05|title=Očkovanie vakcínou Sputnik V sa spúšťa v krajoch postupne|url=https://www.teraz.sk/slovensko/ockovanie-vakcinou-sputnik-v-sa-spus/554105-clanok.html|access-date=2021-06-16|website=TERAZ.sk|language=sk|archive-date=24 June 2021|archive-url=https://web.archive.org/web/20210624195907/https://www.teraz.sk/slovensko/ockovanie-vakcinou-sputnik-v-sa-spus/554105-clanok.html|url-status=live}}</ref> but without significant interest in the Sputnik V vaccine.<ref name=":5">{{Cite web|title=Slovakia has no plans to receive new batches of Sputnik V vaccine - minister|url=https://tass.com/society/1302095|access-date=2021-06-16|website=TASS|archive-date=13 June 2021|archive-url=https://web.archive.org/web/20210613220007/https://tass.com/society/1302095|url-status=live}}</ref><ref>{{Cite web|last=Teraz.sk|date=2021-06-08|title=Na vakcínu Sputnik V aktuálne čaká 4423 ľudí|url=https://www.teraz.sk/slovensko/na-vakcinu-sputnik-v-aktualne-caka-4/554621-clanok.html|access-date=2021-06-16|website=TERAZ.sk|language=sk|archive-date=8 June 2021|archive-url=https://web.archive.org/web/20210608113722/https://www.teraz.sk/slovensko/na-vakcinu-sputnik-v-aktualne-caka-4/554621-clanok.html|url-status=live}}</ref> Slovakia had no plans to order new batches<ref name=":5" /> and planned to sell or donate unused vaccines to Balkans countries.<ref>{{Cite web|last=Teraz.sk|date=2021-06-16|title=Lengvarský: Zvyšné dávky Sputniku V by SR mohla predať či darovať|url=https://www.teraz.sk/slovensko/zvysne-davky-sputniku-v-by-sr-mohla-p/556622-clanok.html|access-date=2021-06-16|website=TERAZ.sk|language=sk|archive-date=19 June 2021|archive-url=https://web.archive.org/web/20210619155614/https://www.teraz.sk/slovensko/zvysne-davky-sputniku-v-by-sr-mohla-p/556622-clanok.html|url-status=live}}</ref> The registrations for vaccination were closed on 30 June. In July 2021, 160,000 doses of the vaccine from the first batch of 200,000 were shipped back to Russia.<ref>{{Cite web|date=2021-07-02|title=Slovakia sells most Sputnik V vaccine doses back to Russia|url=https://www.reuters.com/world/europe/slovakia-sells-most-sputnik-v-vaccine-doses-back-russia-2021-07-02/|access-date=2021-07-08|website=Reuters|archive-date=9 July 2021|archive-url=https://web.archive.org/web/20210709191923/https://www.reuters.com/world/europe/slovakia-sells-most-sputnik-v-vaccine-doses-back-russia-2021-07-02/|url-status=live}}</ref> Temporary government approval for Sputnik V expired on 31 August 2021.<ref>{{Cite news|date=2021-03-01|title=Povolenie na terapeutické použitie neregistrovaného lieku|url=https://www.health.gov.sk/Zdroje?/Sources/kategorizacia/doku_kl/ziad_lieky/sputnik.pdf|access-date=2021-07-08|archive-date=17 August 2021|archive-url=https://web.archive.org/web/20210817230915/https://www.health.gov.sk/Zdroje?/Sources/kategorizacia/doku_kl/ziad_lieky/sputnik.pdf|url-status=live}}</ref><ref>{{Cite web|date=2021-04-14|title=Zmätky s vakcínami pokračujú. Aký Sputnik máme v skladoch?|url=https://spravy.pravda.sk/domace/clanok/584380-zmatky-s-vakcinami-pokracuju-aky-sputnik-mame-v-skladoch/|access-date=2021-07-08|website=Pravda.sk|language=sk-SK|archive-date=9 July 2021|archive-url=https://web.archive.org/web/20210709192355/https://spravy.pravda.sk/domace/clanok/584380-zmatky-s-vakcinami-pokracuju-aky-sputnik-mame-v-skladoch/|url-status=live}}</ref> In total, 18,500 people have been vaccinated.<ref>{{Cite web|date=2021-09-01|title=After low demand, Slovakia delivers its last doses of Sputnik V|url=https://www.euronews.com/2021/09/01/after-low-demand-slovakia-delivers-its-last-doses-of-sputnik-v|access-date=2021-09-02|website=euronews|language=en|archive-date=2 September 2021|archive-url=https://web.archive.org/web/20210902093724/https://www.euronews.com/2021/09/01/after-low-demand-slovakia-delivers-its-last-doses-of-sputnik-v|url-status=live}}</ref>

The purchase of Sputnik V, which led to a political crisis and contributed to a fall of Igor Matovič's Cabinet was investigated by Slovak Police Force with the investigation levered against Marek Krajčí. No violation of the law was found in October 2022.<ref>{{Cite web |title=Kauzu Sputnik V, po ktorej padla Matovičova vláda, polícia uzavrela |url=https://standard.sk/259868/kauzu-sputnik-v-po-ktorej-padla-matovicova-vlada-policia-uzavrela/ |access-date=2022-10-11 |website=Denník Štandard |language=sk-SK |archive-date=11 October 2022 |archive-url=https://web.archive.org/web/20221011205024/https://standard.sk/259868/kauzu-sputnik-v-po-ktorej-padla-matovicova-vlada-policia-uzavrela/ |url-status=live }}</ref>

====Brazil==== On 26 April 2021, the Brazilian health regulator Anvisa rejected the use of Sputnik V, alleging a lack of consistent and reliable data and the presence of replicating adenovirus in the vaccine. RDIF and Sputnik V's official Twitter account said the decision may be politically motivated, pointing to a report by the United States government stating that the Office of Global Affairs persuaded Brazil to reject the vaccine.<ref>{{cite tweet |user=sputnikvaccine |number=1371418576096219143 |title=US Dep. of Health publicly confirmed that it pressured Brazil against Sputnik V}}</ref> Several Brazilian states in the North and Northeast regions had already signed contracts for the acquisition of more than 30 million doses.<ref>{{cite news |title=COVID: Brazil regulator rejects Russia's Sputnik vaccine |url=https://www.dw.com/en/covid-brazil-regulator-rejects-russias-sputnik-vaccine/a-57345002 |access-date=2021-04-27 |work=Deutsche Welle |agency=Reuters |date=2021-04-27 |archive-date=27 April 2021 |archive-url=https://web.archive.org/web/20210427122400/https://www.dw.com/en/covid-brazil-regulator-rejects-russias-sputnik-vaccine/a-57345002 |url-status=live }}</ref><ref>{{cite news |vauthors=Brito R, Ivanova P |title=Brazil health regulator rejects Russia's Sputnik vaccine |url=https://www.reuters.com/world/americas/brazil-health-regulator-anvisas-technical-staff-recommend-against-importing-2021-04-26/ |access-date=2021-04-27 |work=Reuters |date=2021-04-27 |archive-date=27 April 2021 |archive-url=https://web.archive.org/web/20210427115236/https://www.reuters.com/world/americas/brazil-health-regulator-anvisas-technical-staff-recommend-against-importing-2021-04-26/ |url-status=live }}</ref><ref>{{cite news |title=Russia says Brazil refusal to import Sputnik V 'Political' |url=https://www.aljazeera.com/news/2021/4/27/brazil-regulator-denies-permission-to-import-russia-covid-vaccine |access-date=2021-04-27 |work=Al Jazeera |date=2021-04-27 |archive-date=27 April 2021 |archive-url=https://web.archive.org/web/20210427122400/https://www.aljazeera.com/news/2021/4/27/brazil-regulator-denies-permission-to-import-russia-covid-vaccine |url-status=live }}</ref> Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation:<ref>{{Cite web|vauthors=Brito R|date=2021-04-26|title=Brazil health regulator rejects Russia's Sputnik vaccine|url=https://www.ctvnews.ca/health/coronavirus/brazil-health-regulator-rejects-russia-s-sputnik-vaccine-1.5403539|access-date=2021-04-28|website=Coronavirus|language=en|archive-date=28 April 2021|archive-url=https://web.archive.org/web/20210428154554/https://www.ctvnews.ca/health/coronavirus/brazil-health-regulator-rejects-russia-s-sputnik-vaccine-1.5403539}}</ref><ref name=":2">{{Cite news|title=Anvisa nega pedido de importação da vacina Sputnik V; entenda as razões|language=pt-BR|work=BBC News Brasil|url=https://www.bbc.com/portuguese/brasil-56897420|access-date=2021-04-28|archive-date=28 April 2021|archive-url=https://web.archive.org/web/20210428115856/https://www.bbc.com/portuguese/brasil-56897420|url-status=live}}</ref><ref>{{Cite news|vauthors=Cunningham E, Dixon R|title=Brazil rejects Russia's Sputnik V coronavirus vaccine, citing safety concerns|language=en-US|newspaper=The Washington Post|url=https://www.washingtonpost.com/world/2021/04/27/sputnik-vaccine-brazil-russia-coronavirus/|access-date=2021-04-28|issn=0190-8286|archive-date=27 April 2021|archive-url=https://web.archive.org/web/20210427234007/https://www.washingtonpost.com/world/2021/04/27/sputnik-vaccine-brazil-russia-coronavirus/|url-status=live}}</ref> * the adenovirus carrier in all samples was actually able to replicate in spite of manufacturer's declaration it was incapacitated * the methodology used by Gamaleya to check immune system response was unreliable and documentation provided made its verification impossible * the procedure of registering adverse effects was insufficient * Anvisa delegation was also not allowed into the Gamaleya laboratory for inspection * all presented studies were performed on vaccine doses produced in laboratory, rather than in the manufacturing facility supplying vaccine for the mass market, which makes the results not representative * Anvisa found issues in one of the factories in Russia that could impact sterility of the doses.<ref name=":2" />

On 29 April 2021, the developers of Sputnik V said that Anvisa admitted not testing Sputnik V and that they would sue Anvisa in Brazil for defamation. At a press conference, Anvisa officials said that Gamaleya's own documents indicated multiple times the presence of replication-competent adenoviruses (RCAs) in ready vaccine batches and that the specifications accepted a level of RCAs 300 times greater than any other regulatory threshold. Anvisa presented the video of a meeting with representatives from Russia and Brazil where, when asked about the presence of RCAs, a representative from Russia reported problems with the cells and said that the vaccine could have been redeveloped, but it would take too long, so the developers instead chose to continue the research imposing an acceptable level of RCAs.<ref>{{cite news |vauthors=Osborn A, Paraguassu L |date=2021-04-29 |title=Russian vaccine developer to sue Brazilian regulator for defamation |work=Reuters |url=https://www.reuters.com/article/us-health-coronavirus-brazil-sputnik-idUSKBN2CG1ST |location=Moscow, Brasília |access-date=2021-04-29 |archive-date=29 April 2021 |archive-url=https://web.archive.org/web/20210429211523/https://www.reuters.com/article/us-health-coronavirus-brazil-sputnik-idUSKBN2CG1ST |url-status=live }}</ref><ref>{{cite news |vauthors=Paraguassu L, Brito R |date=2021-04-29 |title=Anvisa rebate "grave acusação" de fabricantes da Sputnik e divulga documentos e vídeo de reunião |trans-title=Anvisa counters Sputnik manufacturers' "serious accusation" and releases documents and meeting video |url=https://www.istoedinheiro.com.br/anvisa-rebate-grave-acusacao/ |language=pt-BR |agency=Reuters Brasil |publisher=Istoé Dinheiro |location=Brasilia |access-date=2021-04-29 |archive-date=29 April 2021 |archive-url=https://web.archive.org/web/20210429233337/https://www.istoedinheiro.com.br/anvisa-rebate-grave-acusacao/ |url-status=live }}</ref> Virologist Angela Rasmussen described this problem as a quality control issue that is not important for healthy people because adenoviruses are not important pathogens, but added that it could produce serious adverse effects in immunocompromised individuals.<ref>{{cite news |title=Brazil says Russian Covid vaccine carried live cold virus |url=https://www.france24.com/en/live-news/20210428-brazil-says-russian-covid-vaccine-carried-live-cold-virus |access-date=2021-04-30 |work=France 24 |agency=Agence France-Presse |date=2021-04-28 |location=Washington |archive-date=30 April 2021 |archive-url=https://web.archive.org/web/20210430164936/https://www.france24.com/en/live-news/20210428-brazil-says-russian-covid-vaccine-carried-live-cold-virus |url-status=live }}</ref> Medicinal chemist Derek Lowe commented that the presence of replicating adenoviruses is unlikely to cause any major problems, but it is a "completely unnecessary risk", that it certainly will harm some people, and that providing a product different from the one described in studies undermines the credibility of all manufacturing and quality control processes,<ref>{{cite web |vauthors=Lowe D |title=Brazil Rejects the Gamaleya Vaccine |url=https://www.science.org/content/blog-post/brazil-rejects-gamaleya-vaccine |website=In the Pipeline |publisher=Science Translational Medicine |access-date=2021-04-30 |date=2021-04-28 |archive-date=15 September 2022 |archive-url=https://web.archive.org/web/20220915130309/https://www.science.org/content/blog-post/brazil-rejects-gamaleya-vaccine |url-status=live }}</ref> adding that some posts on the official Sputnik V Twitter account constitute "aggressive political marketing" and some make invalid claims regarding the performance of competing vaccines, such as the Pfizer-BioNTech vaccine.<ref>{{cite web |vauthors=Lowe D |title=Russian Vaccine Behavior |url=https://www.science.org/content/blog-post/russian-vaccine-behavior |website=In the Pipeline |publisher=Science Translational Medicine |access-date=2021-04-30 |date=2021-04-28 |archive-date=14 April 2023 |archive-url=https://web.archive.org/web/20230414164151/https://www.science.org/content/blog-post/russian-vaccine-behavior |url-status=live }}</ref> Anvisa said that the import ban can be reversed if Gamaleya clarifies the issues. Adenovirus infections cause only mild colds in healthy individuals, but they can cause life-threatening illnesses in immunodeficient individuals.<ref name="sciencemag-anvisa-controversy">{{cite web |vauthors=Moutinho S, Wadman M |date=2021-04-30 |title=Is Russia's COVID-19 vaccine safe? Brazil's veto of Sputnik V sparks lawsuit threat and confusion |url=https://www.science.org/content/article/russias-covid-19-vaccine-safe-brazils-veto-sputnik-v-sparks-lawsuit-threat-and |access-date=2021-05-02 |publisher=Science |archive-date=29 June 2022 |archive-url=https://web.archive.org/web/20220629074752/https://www.science.org/content/article/russias-covid-19-vaccine-safe-brazils-veto-sputnik-v-sparks-lawsuit-threat-and |url-status=live }}</ref> The director of the Public Health Institute of Chile (ISP), Heriberto Garcia, said that the ISP would not necessarily reject the vaccine, even if it had replicating adenoviruses, because the risk of getting a common cold from the vaccine must be seen in light of the risk of contracting COVID-19 when not vaccinated. He also said that real-world data from Argentina and Mexico showed no adverse effects greater than those seen in people vaccinated with the Pfizer-BioNTech vaccine or CoronaVac.<ref>{{cite news |vauthors=Laing A |title=Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection |url=https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-chilean-regulator-sees-no-clouds-over-sputnik-vaccine-despite-2021-04-30/ |access-date=2021-05-03 |work=Reuters |date=2021-04-30 |archive-date=3 May 2021 |archive-url=https://web.archive.org/web/20210503211604/https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-chilean-regulator-sees-no-clouds-over-sputnik-vaccine-despite-2021-04-30/ |url-status=live }}</ref>

On 4 June, Anvisa approved exceptional imports of Sputnik V, restricting it mainly to healthy adults and limiting it to only 1% of the population of 6 importing states, in order to manage risks through control and supervision of side effects. Anvisa said that the concern with replicating viruses has not been fully resolved, but that additional documents received indicate a substantially reduced acceptable amount. The new parameter would be in an FDA manual, which was not found. Anvisa also said that impurity and quality controls are insufficient and that the manufacturing plants must undergo corrections to meet WHO quality standards.<ref name="reuters-brazil-importauth">{{cite news |vauthors=Mcgeever J, Paraguassu L |title=Brazil's Anvisa approves Russian Sputnik V vaccine, with conditions |url=https://www.reuters.com/world/americas/brazil-health-regulator-technical-staff-recommend-conditions-any-approval-2021-06-04/ |access-date=2021-06-05 |work=Reuters |date=2021-06-04 |archive-date=5 June 2021 |archive-url=https://web.archive.org/web/20210605123714/https://www.reuters.com/world/americas/brazil-health-regulator-technical-staff-recommend-conditions-any-approval-2021-06-04/ |url-status=live }}</ref><ref>{{cite news |vauthors=Alegretti L, Barifouse R |title=Covaxin e Sputnik V: O que muda na vacinação do Brasil com decisão da Anvisa |trans-title=Covaxin and Sputnik V: What changes in vaccination in Brazil after Anvisa's decision |url=https://www.bbc.com/portuguese/brasil-57358261 |access-date=2021-06-05 |work=BBC Brasil |date=2021-06-04 |language=Portuguese |archive-date=5 June 2021 |archive-url=https://web.archive.org/web/20210605134314/https://www.bbc.com/portuguese/brasil-57358261 |url-status=live }}</ref><ref>{{cite news |title=Anvisa aprova, com restrições, a importação excepcional de doses da Covaxin e Sputnik V |trans-title=Anvisa approves import of doses of Covaxin and Sputnik V, with restrictions |url=https://g1.globo.com/bemestar/vacina/noticia/2021/06/04/anvisa-covaxin-sputnik-v.ghtml |access-date=2021-06-04 |work=G1 |agency=Globo |date=2021-06-04 |language=Portuguese |archive-date=18 June 2021 |archive-url=https://web.archive.org/web/20210618004819/https://g1.globo.com/bemestar/vacina/noticia/2021/06/04/anvisa-covaxin-sputnik-v.ghtml |url-status=live }}</ref> As of 16 June, the same import conditions were extended to a total of 13 states.<ref>{{cite news |title=Anvisa autoriza importação excepcional da Sputnik V por mais 7 estados, também com restrições |trans-title=Anvisa authorizes exceptional import of Sputnik V for 7 more states, also with restrictions |url=https://g1.globo.com/bemestar/vacina/noticia/2021/06/16/anvisa-autoriza-importacao-excepcional-da-sputnik-v-por-mais-7-estados.ghtml |access-date=2021-06-16 |work=G1 |publisher=Globo |date=2021-06-16 |language=Portuguese |archive-date=16 June 2021 |archive-url=https://web.archive.org/web/20210616114320/https://g1.globo.com/bemestar/vacina/noticia/2021/06/16/anvisa-autoriza-importacao-excepcional-da-sputnik-v-por-mais-7-estados.ghtml |url-status=live }}</ref> On 5 August, the consortium of northeastern Brazilian states, corresponding to 7 of the 13 states, suspended the import of 37 million doses due to the restrictions imposed by Anvisa. These doses will supply Mexico, Argentina and Bolivia.<ref>{{cite news |title=Brazil's northeastern states drop plan to buy Russia's COVID vaccine |url=https://www.reuters.com/world/americas/brazils-northeastern-states-drop-plan-buy-russias-covid-vaccine-2021-08-05/ |access-date=5 August 2021 |work=Reuters |date=5 August 2021 |archive-date=5 August 2021 |archive-url=https://web.archive.org/web/20210805200542/https://www.reuters.com/world/americas/brazils-northeastern-states-drop-plan-buy-russias-covid-vaccine-2021-08-05/ |url-status=live }}</ref>

===Further development=== ====Heterologous prime-boost vaccination==== {{See also|COVID-19 vaccine clinical research#Heterologous prime-boost vaccination|Sputnik Light#Heterologous prime-boost vaccination}} On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the Oxford–AstraZeneca vaccine.<ref>{{cite web|url=https://rdif.ru/Eng_fullNews/6220/|title=RDIF, The Gamaleya National Center, AstraZeneca and R-Pharm sign an agreement to cooperate on COVID-19 vaccine development|date=21 December 2020|website=The Russian Direct Investment Fund|access-date=12 February 2021|archive-date=21 April 2021|archive-url=https://web.archive.org/web/20210421143602/https://rdif.ru/Eng_fullNews/6220/|url-status=live}}</ref> The study program will last 6 months in several countries, and it is planned to involve 100 volunteers in each study program. On 9 February 2021, the Ministry of Health of the Republic of Azerbaijan allowed clinical studies in the country for the combined use of the Oxford–AstraZeneca vaccine and Sputnik Light, stating that the trials would begin before the end of February 2021.<ref>{{cite web|url=http://sehiyye.gov.az/xeberler/3356-azrbaycan-dnyada-ilk-olaraq-sputnik-v-v-astrazeneca-irktlrinin-covid-19-a-qar-olan-vaksinlrin-birg-ttbiqi-tdqiqatna-icaz-verdi.html|title=Azerbaijan allowed for the first in the world to study a combination of "Sputnik V" vaccine and COVID-19 vaccine developed by "AstraZeneca" Company|date=9 February 2021|publisher=MoH of Azerbaijan|access-date=11 February 2021|archive-date=9 February 2021|archive-url=https://web.archive.org/web/20210209235328/http://sehiyye.gov.az/xeberler/3356-azrbaycan-dnyada-ilk-olaraq-sputnik-v-v-astrazeneca-irktlrinin-covid-19-a-qar-olan-vaksinlrin-birg-ttbiqi-tdqiqatna-icaz-verdi.html|url-status=live}}</ref><ref name=clinicaltrials-20210114>{{cite journal |url=https://clinicaltrials.gov/ct2/show/NCT04686773 |title=Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, Given in Combination With rAd26-S, Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for the Prevention of COVID-19 |id=NCT04686773 |website=ClinicalTrials.gov |publisher=U.S. National Library of Medicine |date=14 January 2021 |access-date=9 February 2021 |archive-date=11 June 2021 |archive-url=https://web.archive.org/web/20210611125810/https://clinicaltrials.gov/ct2/show/NCT04686773 |url-status=live }}</ref> On 20 February 2021, in the official Sputnik V Twitter account it was stated that clinical trials have already started.<ref>{{cite web |url=https://twitter.com/sputnikvaccine/status/1363034955006279682 |title=Sputnik V twitter account |date=20 February 2021 |access-date=13 April 2021 |archive-date=13 April 2021 |archive-url=https://web.archive.org/web/20210413184124/https://twitter.com/sputnikvaccine/status/1363034955006279682 |url-status=live }}</ref>

== Society and culture ==

=== Economics ===

==== In Russia ==== [[File:Вакцинация медицинских работников Москвы от COVID-19 (22).jpg|thumb|Medical worker in Moscow with the vaccine]] [[File:Gam-COVID-Vac 02.jpg|thumb|Vaccination of military personnel and civilian specialists of the Northern Fleet with the second component of the drug "Gam-COVID-Vac" ("Sputnik V")]] The vaccine is free of charge to users in Russia and Kazakhstan. The cost per dose would be less than US$10 (US$20 for the required two doses) on international markets, much less than the cost of mRNA vaccines from other manufacturers. Kirill Dmitriev, head of the fund, told reporters that over 1{{nbsp}}billion doses of the vaccine are expected to be produced in 2021 outside of Russia.<ref>{{cite news|vauthors=Litvinova D|date=24 November 2020|title=Russian virus vaccine to cost less than $10 per dose abroad|work=Associated Press|url=https://apnews.com/article/coronavirus-pandemic-russia-a781dda3087f453eef18c97082feedfb|access-date=6 December 2020|archive-date=24 November 2020|archive-url=https://web.archive.org/web/20201124182523/https://apnews.com/article/coronavirus-pandemic-russia-a781dda3087f453eef18c97082feedfb|url-status=live}}</ref><ref>{{Cite news|title=Russia's Sputnik COVID-19 vaccine to cost less than $20 per person internationally|url=https://www.theglobeandmail.com/world/article-russias-sputnik-covid-19-vaccine-to-cost-less-than-20-per-person/|date=2020-11-24|access-date=2020-11-28|work=The Globe and Mail|vauthors=Osborn A, Nikolskaya P|archive-date=25 November 2020|archive-url=https://web.archive.org/web/20201125164117/https://www.theglobeandmail.com/world/article-russias-sputnik-covid-19-vaccine-to-cost-less-than-20-per-person/|url-status=live}}</ref>

The head of the Gamaleya Research Institute Alexander Ginzburg estimated that it would take 9–12 months to vaccinate the vast majority of the Russian population, assuming in-country resources were adequate.<ref>{{cite web|title=Центр Гамалеи назвал сроки вакцинации большей части населения России|url=https://www.rbc.ru/rbcfreenews/5f5238ec9a79478b506f90b5|publisher=RBK|date=4 September 2020|access-date=2020-09-06|archive-date=6 September 2020|archive-url=https://web.archive.org/web/20200906154308/https://www.rbc.ru/rbcfreenews/5f5238ec9a79478b506f90b5|url-status=live}}</ref><ref name="reuters-freeze-drying">{{cite news|vauthors=Sagdiev R, Ivanova P, Nikolskaya P, Swift R, Smout A|date=17 November 2020|title=Russia focuses on freeze-dried vaccine doses as transport fix|work=Reuters|location=Moscow|veditors=Mason J, Macfie N|url=https://www.reuters.com/article/health-coronavirus-russia-vaccine-transp/rpt-exclusive-russia-focuses-on-freeze-dried-vaccine-doses-as-transport-fix-idUSL1N2I30ML|access-date=20 November 2020|archive-date=26 January 2021|archive-url=https://web.archive.org/web/20210126131524/https://www.reuters.com/article/health-coronavirus-russia-vaccine-transp/rpt-exclusive-russia-focuses-on-freeze-dried-vaccine-doses-as-transport-fix-idUSL1N2I30ML|url-status=live}}</ref>

The commercial release of the Gam-COVID-Vac was first scheduled for September 2020. In October, Mikhail Murashko said that the Gam-COVID-Vac would be free for all Russian citizens after the launching of mass production.<ref>{{Cite web |language=ru |url=https://www.rbc.ru/rbcfreenews/5f92fe089a79477bc07b969b |title=Минздрав пообещал россиянам бесплатную вакцинацию от COVID-19 |trans-title=Ministry of Health promised Russians free vaccination against COVID-19 |website=RBC.ru |date=23 October 2020 |access-date=2020-10-23 |archive-date=27 October 2020 |archive-url=https://web.archive.org/web/20201027005226/https://www.rbc.ru/rbcfreenews/5f92fe089a79477bc07b969b |url-status=live }}</ref><ref>{{cite web |title=В будущем вакцинация от COVID-19 будет проходить бесплатно |trans-title=In the future, vaccination against COVID-19 will be free of charge |url=https://rg.ru/2020/10/07/v-budushchem-vakcinaciia-ot-covid-19-budet-prohodit-besplatno.html |website=Russian Newspaper |date=11 October 2020 |access-date=2020-10-23 |language=ru |archive-date=26 October 2020 |archive-url=https://web.archive.org/web/20201026100840/https://rg.ru/2020/10/07/v-budushchem-vakcinaciia-ot-covid-19-budet-prohodit-besplatno.html |url-status=live }}</ref> Later on, the Russian Ministry of Health registered the maximum ex-factory price equal to 1,942 rubles for two components and included it into The National List of Essential medicines.<ref name="RIA">{{cite web |url = https://ria.ru/20201205/vaktsina-1587819818.html |title = Минздрав зарегистрировал предельную отпускную цену на вакцину "Спутник V" |trans-title = The Ministry of Health registered the maximum selling price for the Sputnik V vaccine |date = 5 December 2020 |publisher = RIA |access-date = 2020-09-21 |language = ru |archive-date = 6 December 2020 |archive-url = https://web.archive.org/web/20201206091347/https://ria.ru/20201205/vaktsina-1587819818.html |url-status = live }}</ref> There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.<ref name="RIA"/>

In the beginning of December 2020, Russian authorities announced the start of a large-scale free of charge vaccination with Gam-COVID-Vac for Russian citizens: the immunization program was launched on 5 December 2020 (with 70 medical centers in Moscow providing vaccinations).<ref name="bbc_05_12_2020">{{Cite news|url=https://www.bbc.com/news/world-europe-55198166|title=Covid: Russia begins vaccinations in Moscow|work=BBC|date=5 December 2020|access-date=2020-12-11|archive-date=1 June 2022|archive-url=https://web.archive.org/web/20220601084944/https://www.bbc.com/news/world-europe-55198166|url-status=live}}</ref>

Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease.<ref name="reuters.com">{{cite news|vauthors=Soldatkin V, Oziel C|date=5 December 2020|title=Moscow rolls out Sputnik V COVID-19 vaccine to most exposed groups|work=Reuters|veditors=Char P|url=https://www.reuters.com/article/us-health-coronavirus-russia-vaccination/moscow-rolls-out-sputnik-v-covid-19-vaccine-to-most-exposed-groups-idUSKBN28F09O|access-date=6 December 2020|archive-date=6 December 2020|archive-url=https://web.archive.org/web/20201206192621/https://www.reuters.com/article/us-health-coronavirus-russia-vaccination/moscow-rolls-out-sputnik-v-covid-19-vaccine-to-most-exposed-groups-idUSKBN28F09O|url-status=live}}</ref> Initially the vaccine was only offered to people over 60 years of age, later this restriction was lifted.<ref>{{cite news |title=Russia approves Sputnik V COVID-19 vaccine for people over 60: media |url=https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russia-approves-sputnik-v-covid-19-vaccine-for-people-over-60-media-idUSKBN29005A |work=Reuters |date=26 December 2020 |access-date=20 January 2021 |archive-date=28 January 2021 |archive-url=https://web.archive.org/web/20210128154250/https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russia-approves-sputnik-v-covid-19-vaccine-for-people-over-60-media-idUSKBN29005A |url-status=live }}</ref>

Potential recipients were notified via text messaging, which said "You are working at an educational institution and have top-priority for the COVID-19 vaccine, free of charge". Patients were asked a few general health questions before receiving the vaccine.<ref>{{cite news |title=Covid: Russia begins vaccinations in Moscow |url=https://www.bbc.com/news/world-europe-55198166 |work=BBC News |date=5 December 2020 |access-date=6 December 2020 |archive-date=1 June 2022 |archive-url=https://web.archive.org/web/20220601084944/https://www.bbc.com/news/world-europe-55198166 |url-status=live }}</ref><ref>{{cite news|date=5 December 2020|title=Moscow delivers Russia's Sputnik V coronavirus vaccine to clinics|work=The Guardian|agency=Reuters|url=https://www.theguardian.com/world/2020/dec/05/coronavirus-moscow-delivers-sputnik-v-vaccine-clinics-russia|access-date=6 December 2020|archive-date=6 December 2020|archive-url=https://web.archive.org/web/20201206225005/https://www.theguardian.com/world/2020/dec/05/coronavirus-moscow-delivers-sputnik-v-vaccine-clinics-russia|url-status=live}}</ref><ref>{{cite news|date=5 December 2020|title=Coronavirus: Russia rolls out COVID vaccination in Moscow|work=Deutsche Welle|url=https://www.dw.com/en/coronavirus-russia-rolls-out-covid-vaccination-in-moscow/a-55831123|access-date=6 December 2020|archive-date=13 April 2022|archive-url=https://web.archive.org/web/20220413235330/https://www.dw.com/en/coronavirus-russia-rolls-out-covid-vaccination-in-moscow/a-55831123|url-status=live}}</ref> People with certain underlying health conditions, pregnant women, and those who have had a respiratory illness for the past two weeks were barred from vaccination.<ref name="reuters.com"/> The vaccine vial was removed from medical centre's freezer about 15 minutes before use.

In early December 2020, the Minister of Health, Mikhail Murashko, said that Russia had already vaccinated more than 100,000 high-risk people.<ref>{{Cite news|title=Putin orders Russia to begin a large-scale voluntary COVID-19 vaccination program next week|url=https://www.theglobeandmail.com/world/article-putin-orders-russian-authorities-to-begin-mass-voluntary-covid-1//|date=2020-12-02|access-date=2020-12-03|work=The Globe and Mail|vauthors=Marrow A, Ostroukh A|archive-date=4 December 2020|archive-url=https://web.archive.org/web/20201204002542/https://www.theglobeandmail.com/world/article-putin-orders-russian-authorities-to-begin-mass-voluntary-covid-1/|url-status=live}}</ref> Forty thousand of those were volunteers in Sputnik V's Phase 3 trials, another 60,000 nurses and doctors had also taken the vaccine.<ref>{{cite news |title=COVID-19: Moscow opens Sputnik V clinics – but 100,000 have already had it |url=https://news.sky.com/story/covid-19-moscow-vaccine-launch-is-more-of-a-pr-event-100-000-have-already-had-it-12151854 |work=Sky News |access-date=6 December 2020 |archive-date=6 December 2020 |archive-url=https://web.archive.org/web/20201206114253/https://news.sky.com/story/covid-19-moscow-vaccine-launch-is-more-of-a-pr-event-100-000-have-already-had-it-12151854 |url-status=live }}</ref> The head of the Russian Direct Investment Fund, Kirill Dmitriev, said in an interview with the BBC that Russian medics expected to give about 2{{nbsp}}million people coronavirus vaccinations in December 2020.<ref>{{cite web |url = https://www.theguardian.pe.ca/news/world/russia-to-vaccinate-two-million-against-covid-19-in-dec-rdif-head-to-bbc-527563/ |title = Russia to vaccinate two million against COVID-19 in Dec – RDIF head to BBC |date = 4 December 2020 |agency = Reuters |access-date = 2020-09-21 |archive-date = 9 February 2021 |archive-url = https://web.archive.org/web/20210209013248/https://www.theguardian.pe.ca/news/world/russia-to-vaccinate-two-million-against-covid-19-in-dec-rdif-head-to-bbc-527563/ |url-status = live }}</ref>

Up to the beginning of December 2020, ''Generium'' (which is supervised by Pharmstandard) and ''Binnopharm'' (which is supervised by AFK Sistema) companies produced Gam-COVID-Vac on a large scale.

On 10 December, Deputy Prime Minister Tatyana Golikova announced that approximately 6.9{{nbsp}}million doses of the Sputnik V vaccine would enter civilian circulation in Russia before the end of February 2021.<ref>{{cite web |url = https://tass.com/economy/1233811 |title = About 6.9 mln doses of Sputnik V vaccine to enter circulation in Russia by end of February |date = 10 December 2020 |publisher = TASS |access-date = 2020-09-21 |archive-date = 13 December 2020 |archive-url = https://web.archive.org/web/20201213234842/https://tass.com/economy/1233811 |url-status = live }}</ref> Moscow Mayor Sergei Sobyanin announced that the newly opened Moscow-based "R-Pharm" will become a leading manufacturer of Russia's Sputnik V coronavirus vaccine. Working at full capacity, the factory will produce up to 10{{nbsp}}million doses a month.<ref>{{cite web |url = https://www.themoscowtimes.com/2020/12/22/coronavirus-in-russia-the-latest-news-dec-22-a69117 |title = Coronavirus in Russia: The Latest News |date = 22 December 2020 |publisher = The Moscow Times |access-date = 2020-09-21 |archive-date = 22 December 2020 |archive-url = https://web.archive.org/web/20201222145227/https://www.themoscowtimes.com/2020/12/22/coronavirus-in-russia-the-latest-news-dec-22-a69117 |url-status = live }}</ref>

In May 2021 Sergei Sobyanin complained that only 1.3 million Moscow residents out of 12 million had received the first dose (10.2%). Only 9.5% of Russians had received a vaccine.<ref>{{Cite web|title=Собянин заявил о минимальной доле привитых в Москве в сравнении с Европой|url=https://www.rbc.ru/society/21/05/2021/60a74ebb9a7947639d69ecaa|access-date=2021-05-25|website=РБК|date=21 May 2021|language=ru|archive-date=25 May 2021|archive-url=https://web.archive.org/web/20210525125011/https://www.rbc.ru/society/21/05/2021/60a74ebb9a7947639d69ecaa|url-status=live}}</ref> Forbes Russia established that Russia committed to export 205 millions of doses of "Sputnik V" to other countries, and as of 16 May.3 millions (8%) were so far delivered.<ref>{{Cite web|title=Дипломатический иммунитет: кто и в каком количестве покупает российскую вакцину|url=https://www.forbes.ru/biznes/429873-diplomaticheskiy-immunitet-kto-i-v-kakom-kolichestve-pokupaet-rossiyskuyu-vakcinu|access-date=2021-05-25|website=Forbes.ru|date=25 May 2021|language=ru|archive-date=25 May 2021|archive-url=https://web.archive.org/web/20210525125008/https://www.forbes.ru/biznes/429873-diplomaticheskiy-immunitet-kto-i-v-kakom-kolichestve-pokupaet-rossiyskuyu-vakcinu|url-status=live}}</ref> A survey found that 62% of the Russian population felt hesitant, with 55% not afraid of getting sick and some willing to wait for CoviVac.<ref name="guardian-hesitancy">{{cite news |vauthors=Roth A |title='I don't have a choice': Russians scramble to get Covid vaccine amid new restrictions |url=https://www.theguardian.com/world/2021/jun/26/i-dont-have-a-choice-russians-scramble-to-get-covid-vaccine-amid-new-restrictions |access-date=11 July 2021 |work=The Guardian |date=26 June 2021 |location=Moscow |archive-date=11 July 2021 |archive-url=https://web.archive.org/web/20210711020755/https://www.theguardian.com/world/2021/jun/26/i-dont-have-a-choice-russians-scramble-to-get-covid-vaccine-amid-new-restrictions |url-status=live }}</ref>

In June 2021, with the increase in Delta variant cases, several Russian city governments introduced strict measures to overcome vaccine hesitancy, such as requiring vaccine QR codes from customers in cafes.<ref name="guardian-hesitancy"/>

==== Outside of Russia ==== thumb|In dark green are the countries that approved Sputnik V vaccine against COVID-19. In light green are the countries that have shown interest in obtaining the vaccine. Light blue indicates current or future producers and dark blue the country origin of vaccine design (Russia). Russia is pursuing deals to supply its vaccine abroad.<ref>{{Cite news|date=2020-12-31|title=Putin Battles to Sell Russia's Vaccine in New Rift With West|work=Bloomberg.com|url=https://www.bloomberg.com/news/articles/2020-12-31/putin-battles-to-sell-russia-s-vaccine-in-new-rift-with-the-west|access-date=2021-03-03|archive-date=3 February 2021|archive-url=https://web.archive.org/web/20210203235649/https://www.bloomberg.com/news/articles/2020-12-31/putin-battles-to-sell-russia-s-vaccine-in-new-rift-with-the-west|url-status=live}}</ref>

According to the Russian Direct Investment Fund, they had received orders for more than 1.2{{nbsp}}billion doses of the vaccine as of December 2020. Over 50 countries had made requests for doses, with supplies for the global market being produced by partners in India, Brazil, China, South Korea, Hungary, and other countries.<ref>{{cite news |vauthors=Rodgers J |title=Facing Record COVID-19 Case Rise, Russia Rolls Out Sputnik V Vaccine |url=https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/ |work=Forbes |access-date=6 December 2020 |archive-date=7 December 2020 |archive-url=https://web.archive.org/web/20201207092511/https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/ |url-status=live }}</ref><ref>{{cite news|vauthors=Arkhipov I, Kravchenko S|date=2 December 2020|title=Putin Orders Start of Mass Covid-19 Shots Hours After U.K. News|work=Bloomberg News|url=https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots|access-date=6 December 2020|archive-date=3 December 2020|archive-url=https://web.archive.org/web/20201203071114/https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots|url-status=live}}</ref> In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.<ref>{{cite news |title=Russia Defends First Covid-19 Vaccine as Safe Amid Skepticism |url=https://www.bloomberg.com/news/articles/2020-08-12/russia-defends-first-covid-19-vaccine-as-safe-amid-skepticism |vauthors=Meyer H, Arkhipov I |work=Bloomberg News |access-date=12 August 2020 |archive-date=23 March 2022 |archive-url=https://web.archive.org/web/20220323175108/https://www.bloomberg.com/news/articles/2020-08-12/russia-defends-first-covid-19-vaccine-as-safe-amid-skepticism |url-status=live }}</ref>

The Israeli Hadassah Medical Center signed a commercial memorandum of understanding to obtain 1.5–3{{nbsp}}million doses.<ref>{{Cite news|title=Israel to receive Russia's 92% effective COVID vaccine|url=https://m.jpost.com/breaking-news/russias-sputnik-v-covid-19-vaccine-candidate-92-percent-effective-study-shows-648740/amp|date=2020-11-12|access-date=2020-11-19|work=The Jerusalem Post|vauthors=Jaffe-Hoffman M|archive-date=19 November 2020|archive-url=https://web.archive.org/web/20201119042415/https://m.jpost.com/breaking-news/russias-sputnik-v-covid-19-vaccine-candidate-92-percent-effective-study-shows-648740/amp|url-status=live}}</ref>

Argentina agreed to buy 25{{nbsp}}million doses of Russia's COVID-19 vaccine, subject to its clearing clinical trials;<ref>{{cite news |title=Argentina agrees to buy 25{{nbsp}}million doses of Russia's COVID-19 vaccine |url=https://www.batimes.com.ar/news/argentina/argentina-agrees-to-buy-25-million-doses-of-russias-covid-19-vaccine.phtml |work=www.batimes.com.ar |date=3 November 2020 |access-date=6 December 2020 |archive-date=4 November 2020 |archive-url=https://web.archive.org/web/20201104221548/https://www.batimes.com.ar/news/argentina/argentina-agrees-to-buy-25-million-doses-of-russias-covid-19-vaccine.phtml |url-status=live }}</ref> the vaccine was registered and approved in Argentina in late December 2020.<ref>{{cite news |title=Argentina Approves Russian Vaccine With Plane Waiting in Moscow |url=https://www.bloomberg.com/news/articles/2020-12-23/argentina-approves-russian-vaccine-with-plane-awaiting-in-moscow |website=Bloomberg.com |date=23 December 2020 |access-date=23 December 2020 |archive-date=23 December 2020 |archive-url=https://web.archive.org/web/20201223230932/https://www.bloomberg.com/news/articles/2020-12-23/argentina-approves-russian-vaccine-with-plane-awaiting-in-moscow |url-status=live }}</ref> The Brazilian state of Bahia signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and planned to buy 50{{nbsp}}million doses to market in northeastern Brazil.<ref>{{cite news|vauthors=Boadle A|date=24 October 2020|title=Second Brazilian company to produce Russia's Sputnik V COVID-19 vaccine|work=Reuters|veditors=Wallis D|url=https://www.reuters.com/article/us-health-coronavirus-brazil-sputnik-idUSKBN2782VS|access-date=6 December 2020|archive-date=1 November 2020|archive-url=https://web.archive.org/web/20201101140626/https://www.reuters.com/article/us-health-coronavirus-brazil-sputnik-idUSKBN2782VS|url-status=live}}</ref>

On 21 January 2021, Argentine president Alberto Fernández became the first Latin American leader to be inoculated with Sputnik V, shortly after it was approved for use in the country.<ref>{{cite news |title=Argentina's president sits for Russian Covid jab |url=https://www.france24.com/en/live-news/20210121-argentina-s-president-sits-for-russian-covid-jab |work=France 24 |date=21 January 2021 |access-date=23 January 2021 |archive-date=6 March 2021 |archive-url=https://web.archive.org/web/20210306122407/https://www.france24.com/en/live-news/20210121-argentina-s-president-sits-for-russian-covid-jab |url-status=live }}</ref><ref>{{cite news |vauthors=Centenera M |title=Alberto Fernández, primer presidente de América Latina en vacunarse contra la covid-19 (in Spanish) |url=https://elpais.com/internacional/2021-01-21/alberto-fernandez-recibe-la-primera-dosis-de-la-vacuna-rusa-contra-la-covid-19.html |work=El País |date=21 January 2021 |language=es |access-date=23 January 2021 |archive-date=6 April 2023 |archive-url=https://web.archive.org/web/20230406034437/https://elpais.com/internacional/2021-01-21/alberto-fernandez-recibe-la-primera-dosis-de-la-vacuna-rusa-contra-la-covid-19.html |url-status=live }}</ref> Two months after being vaccinated he developed fever and headache, and tested positive for COVID-19.<ref>{{Cite news |title=Argentina's President tests positive for Covid-19 after vaccine |vauthors=Rebaza C, Timm-Garcia J, Hu C |work=CNN |date=4 April 2021 |url=https://edition.cnn.com/2021/04/04/americas/argentina-alberto-fernndez-covid-19-sputnik-vaccine-intl-latam/index.html |access-date=17 April 2021 |archive-date=17 April 2021 |archive-url=https://web.archive.org/web/20210417144904/https://edition.cnn.com/2021/04/04/americas/argentina-alberto-fernndez-covid-19-sputnik-vaccine-intl-latam/index.html |url-status=live }}</ref> He was asymptomatic ten days later, was discharged from medical treatment subject to medical follow-up as usual for former COVID-19 patients, and resumed his normal activities.<ref>{{Cite news|title=Alberto Fernández recibe el alta por COVID y retoma sus actividades|language=es|trans-title=Alberto Fernández is discharged from treatment for COVID and resumes his activities|work=Perfil|date=13 April 2021|url=https://www.perfil.com/noticias/politica/alberto-fernandez-recibe-alta-por-covid-y-retoma-actividades.phtml|access-date=18 April 2021|archive-date=18 April 2021|archive-url=https://web.archive.org/web/20210418010453/https://www.perfil.com/noticias/politica/alberto-fernandez-recibe-alta-por-covid-y-retoma-actividades.phtml|url-status=live}}</ref>

According to ''The New York Times'' sources, in February 2021, Israel agreed to finance a supply of the Sputnik V vaccine to Syria in order to secure the release of an Israeli civilian held in Syria.<ref>{{Cite news| vauthors = Kingsley P, Bergman R, Kramer AE |date=2021-02-21|title=Israel Secretly Agrees to Fund Vaccines for Syria as Part of Prisoner Swap|work=The New York Times|url=https://www.nytimes.com/2021/02/20/world/middleeast/israel-syria-prisoner-swap-vaccines.html |archive-url=https://ghostarchive.org/archive/20211228/https://www.nytimes.com/2021/02/20/world/middleeast/israel-syria-prisoner-swap-vaccines.html |archive-date=2021-12-28 |url-access=limited|access-date=2021-03-03|issn=0362-4331| url-status=live }}</ref>

Due to the delay in shipping of doses from Italy and the European Union, San Marino imported doses of the Sputnik V vaccine (not approved by the EMA) and started a mass vaccination on 28 February of its healthcare workers.<ref>{{Cite news|title=Vaccino Sputnik, a San Marino 400 dosi al giorno dal 1 marzo: "Sicurezza? Confortati dagli studi. Per ora lo diamo solo ai nostri cittadini|url=https://www.ilfattoquotidiano.it/2021/02/28/vaccino-sputnik-a-san-marino-400-dosi-al-giorno-dal-1-marzo-sicurezza-confortati-dagli-studi-per-ora-lo-diamo-solo-ai-nostri-cittadini/6116063/|language=it|access-date=1 March 2021|publisher=Il Fatto Quotidiano|vauthors=Camparsi ML|archive-date=28 February 2021|archive-url=https://web.archive.org/web/20210228115025/https://www.ilfattoquotidiano.it/2021/02/28/vaccino-sputnik-a-san-marino-400-dosi-al-giorno-dal-1-marzo-sicurezza-confortati-dagli-studi-per-ora-lo-diamo-solo-ai-nostri-cittadini/6116063/|url-status=live}}</ref>

14 April 2021, Armenia agreed with Russia on purchase of 1 million doses of coronavirus vaccines Sputnik V. This was the decision of Armenian health minister Anahit Avanesyan. The Armenian authorities have begun negotiations with Russia on the production of the Sputnik V coronavirus vaccine. Head of the Armenian Ministry of Health Anahit Avanesyan stated this at a press conference on 12 March 2021.<ref>{{Cite news|title=Армения приобретет миллион доз "Спутник V"|url=https://rg.ru/2021/04/14/armeniia-priobretet-million-doz-sputnik-v.html|work=rg.ru|date=2021-04-14|access-date=13 May 2021|archive-date=13 May 2021|archive-url=https://web.archive.org/web/20210513045531/https://rg.ru/2021/04/14/armeniia-priobretet-million-doz-sputnik-v.html|url-status=live}}</ref>

==== Public opinion polls ==== An opinion poll of Canadians conducted by Léger in August 2020 found that a majority (68%) would not take the Russian vaccine if offered a free dose, compared to 14% who said they would take it. When Americans were asked the same question, 59% would not take the Russian vaccine if offered a free dose, compared to 24% who said they would take it.<ref>{{cite web |vauthors=Cyr E |title=Leger's Weekly Survey |url=https://leger360.com/wp-content/uploads/2020/08/Legers-Weekly-Survey-august-24th-2020.pdf |website=leger360.com |access-date=5 September 2020 |date=24 August 2020 |archive-date=5 September 2020 |archive-url=https://web.archive.org/web/20200905010710/https://leger360.com/wp-content/uploads/2020/08/Legers-Weekly-Survey-august-24th-2020.pdf }}</ref><ref>{{Cite web|url=https://projects.fivethirtyeight.com/polls/20200824_National.pdf|title=Leger's Weekly Survey on Russian vaccine; saved copy on 5 38.com|access-date=25 February 2021|archive-date=28 August 2020|archive-url=https://web.archive.org/web/20200828073117/https://projects.fivethirtyeight.com/polls/20200824_National.pdf}}</ref> In June 2021, according to a poll conducted by {{interlanguage link|Ost-Ausschuss der Deutschen Wirtschaft|de}} (''German Eastern Business Association''), a majority (60%) of Germans would use the Russian vaccine Sputnik V if they had the opportunity to do so. With 71% approval, the values in East Germany are significantly higher, but with 58% of the respondents there is also a solid majority in West Germany. 38% of respondents, on the other hand, would not want to use Sputnik V.<ref>{{cite news|date=2 June 2021|title=Klare Mehrheit wünscht engere Beziehungen zu Russland|work=Ost-Ausschuss der Deutschen Wirtschaft|url=https://www.ost-ausschuss.de/de/PM%20Forsa%20Gesamt|access-date=7 July 2021|archive-date=9 July 2021|archive-url=https://web.archive.org/web/20210709184639/https://www.ost-ausschuss.de/de/PM%20Forsa%20Gesamt|url-status=live}}</ref>

In July 2020, opinion polls suggested around 90% of the Russian population had doubts about the vaccine but by September this had dropped to around half the Russian population.<ref>{{cite news|date=6 September 2020|title=Putin's vaccine meets opposition from frontline workers in Russia|work=CNN|url=https://www.cnn.com/2020/09/06/europe/russia-vaccine-putin-opposition-intl/|access-date=6 September 2020|vauthors=Ullah Z, Chernova A|archive-date=7 September 2020|archive-url=https://web.archive.org/web/20200907082126/https://www.cnn.com/2020/09/06/europe/russia-vaccine-putin-opposition-intl/|url-status=live}}</ref> In May 2021, the Levada Center released a poll of 1,614 respondents from 50 regions which showed that 26% of Russians were prepared to be vaccinated with Sputnik V, while 62% were not prepared to be vaccinated. Ten percent of respondents had already been vaccinated.<ref>{{cite news|date=12 May 2021|title=Majority of Russians Still Not Ready to Get Sputnik Vaccine – Poll|work=The Moscow Times|url=https://www.themoscowtimes.com/2021/05/12/majority-of-russians-still-not-ready-to-get-sputnik-vaccine-poll-a73861|access-date=2 July 2021|archive-date=9 July 2021|archive-url=https://web.archive.org/web/20210709182609/https://www.themoscowtimes.com/2021/05/12/majority-of-russians-still-not-ready-to-get-sputnik-vaccine-poll-a73861|url-status=live}}</ref>

=== Resale controversy === Under a resale arrangement, the Russian Direct Investment Fund (RDIF) offered Abu Dhabi-based firm, Aurugulf Health Investments the exclusive rights to sell the Sputnik V coronavirus vaccine. According to media reports, the vaccine was intended to be sold to a host of countries at huge premiums. As per documents reviewed by the Moscow Times, Emirati Sheikh Ahmed Dalmook al-Maktoum, a Dubai royal, worked as the middleman for reselling millions of Sputnik V vaccine doses to countries in dire need of COVID-19 vaccine at a higher premium. Corporate registry data showed that one of the two entities controlling Aurugulf is Royal Group, a conglomerate headed by UAE national security advisor, Sheikh Tahnoon bin Zayed al-Nahyan. Acquired documents, interviews with officials and buyer data showed that countries like Pakistan, Guyana, which were on the receiving end of the vaccine from the UAE, were coerced to pay more than double the price advertised by Russia.<ref>{{cite web|url=https://www.themoscowtimes.com/2021/07/09/a-royal-mark-up-how-an-emirati-sheikh-resells-millions-of-russian-vaccines-to-the-developing-world-a74461|title=A Royal Mark Up: How an Emirati Sheikh Resells Millions of Russian Vaccines to the Developing World|access-date=10 July 2021|website=The Moscow Times|date=9 July 2021|archive-date=10 July 2021|archive-url=https://web.archive.org/web/20210710091447/https://www.themoscowtimes.com/2021/07/09/a-royal-mark-up-how-an-emirati-sheikh-resells-millions-of-russian-vaccines-to-the-developing-world-a74461|url-status=live}}</ref> The same deal was further used for reselling 1 million Sputnik V vaccine doses by the Emirati royal Sheikh Ahmed Dalmook al-Maktoum to Kenya for huge mark-ups. However, the deal eventually failed as Nairobi learnt of the first shipment consisting of 75,000 doses not coming directly from Russia.<ref>{{cite web|url=https://www.themoscowtimes.com/2021/07/19/kenyas-failed-sputnik-v-deal-used-emirati-resale-scheme-a74554|title=Kenya's Failed Sputnik V Deal Used Emirati Resale Scheme|access-date=19 July 2021|website=The Moscow Times|date=19 July 2021|archive-date=19 July 2021|archive-url=https://web.archive.org/web/20210719101624/https://www.themoscowtimes.com/2021/07/19/kenyas-failed-sputnik-v-deal-used-emirati-resale-scheme-a74554|url-status=live}}</ref>

===Scientific assessment=== On 11 August 2020, a World Health Organization (WHO) spokesperson said "prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data".<ref name=lovelace/> A WHO assistant director said, "You cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages".<ref>{{cite news|vauthors= Nebehay S|date= 11 August 2020|title= WHO says discussing new COVID-19 vaccine with Russia|work= Reuters|location= Geneva|veditors= Shields M|url= https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-who/who-says-discussing-new-covid-19-vaccine-with-russia-idUSKCN2571BC|access-date= 11 August 2020|archive-date= 11 August 2020|archive-url= https://web.archive.org/web/20200811101341/https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-who/who-says-discussing-new-covid-19-vaccine-with-russia-idUSKCN2571BC|url-status= live}}</ref>

Francois Balloux, a geneticist at University College London, called the Russian government's approval of Gam-COVID-Vac a "reckless and foolish decision".<ref name=nature/> Professor Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia, characterized the announcement as a "political stunt", and stated that the untested vaccine could be very harmful.<ref name=lovelace/>

Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said "we can be cautiously optimistic that SARS-CoV2 vaccines targeting the spike protein are effective". Moreover, as the Sputnik antigen is delivered via a different modality, namely using a disabled Adenovirus rather than formulated RNA, this provides flexibility in terms of perhaps one or other method providing better responses in certain age-groups, ethnicities, etc., plus the storage of this vaccine ought to be more straightforward.<ref>{{cite web |url=https://www.reuters.com/article/health-coronavirus-vaccine-russia-idUKL1N2HX0MD |title=Instant view-Russia says its Sputnik V COVID-19 vaccine is 92% effective |website=reuters.com |date=2020-11-11 |access-date=12 April 2023 |archive-date=3 December 2021 |archive-url=https://web.archive.org/web/20211203213735/https://www.reuters.com/article/health-coronavirus-vaccine-russia-idUKL1N2HX0MD |url-status=live }}</ref>

"There is a huge risk that confidence in vaccines would be damaged by a vaccine that received approval and was then shown to be harmful", said immunologist Peter Openshaw.<ref name="burki" />

Ian Jones, a professor of virology at the University of Reading, and Polly Roy, professor and Chair of Virology at The London School of Hygiene and Tropical Medicine, commenting on phase III results published in ''The Lancet'' in February 2021, said "The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19."<ref>{{cite journal | vauthors = Jones I, Roy P | title = Sputnik V COVID-19 vaccine candidate appears safe and effective | language = English | journal = The Lancet | volume = 397 | issue = 10275 | pages = 642–643 | date = February 2021 | pmid = 33545098 | pmc = 7906719 | doi = 10.1016/S0140-6736(21)00191-4 | doi-access = free }}</ref>

On 12 May 2021, a group of biostatisticians published an article in ''The Lancet'' about data discrepancies and substandard reporting of interim data of the Sputnik V phase-III trial. According to the article, the lack of transparency of the trial results raises serious concerns. Data inconsistencies were found, including a very low probability of homogeneity of vaccine efficacy across age groups.<ref name="bucci-discrepancies">{{cite journal | vauthors = Bucci EM, Berkhof J, Gillibert A, Gopalakrishna G, Calogero RA, Bouter LM, Andreev K, Naudet F, Vlassov V | title = Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial | journal = Lancet | volume = 397 | issue = 10288 | pages = 1881–1883 | date = May 2021 | pmid = 33991475 | doi = 10.1016/S0140-6736(21)00899-0 | pmc = 9751705 | doi-access = free }}</ref>

Two preliminary studies, one from Argentina and one from San Marino, found mostly mild adverse events and no vaccine-associated deaths.<ref name="nature-emerging-evidence"/> Another study carried out in San Marino has concluded a high tolerability profile in the population aged ≥60 years in terms of short-term adverse events following immunization.<ref>{{cite journal | vauthors = Montalti M, Soldà G, Di Valerio Z, Salussolia A, Lenzi J, Forcellini M, Barvas E, Guttmann S, Messina R, Poluzzi E, Raschi E, Riccardi R, Fantini MP, La Fauci G, Gori D | title = ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance | language = English | journal = eClinicalMedicine | volume = 38 | article-number = 101027 | date = August 2021 | pmid = 34505029 | pmc = 8413252 | doi = 10.1016/j.eclinm.2021.101027 | doi-access = free }}</ref>

An article published by the journal ''Nature'' on 6 July 2021 cited data released by the United Arab Emirates on some 81,000 individuals who had received Sputnik V, according to which the vaccine demonstrated an efficacy of 97.8% in preventing symptomatic COVID-19, and 100% efficacy in preventing severe complications. The figures echoed similar findings from unpublished data on 3.8 million Russians, according to which Sputnik V demonstrated an efficacy of 97.7%.<ref>Nogrady B, "[https://www.nature.com/articles/d41586-021-01813-2 Mounting evidence suggests Sputnik COVID vaccine is safe and effective]" {{Webarchive|url=https://web.archive.org/web/20210829150648/https://www.nature.com/articles/d41586-021-01813-2 |date=29 August 2021 }} ''Nature'', 595, 339–340 (2021)</ref>

A study published by the ''Journal of Medical Internet Research'' analyzed the dataset consisted of 11,515 self-reported Sputnik V vaccine adverse events posted on Telegram. Telegram users complained mostly about pain, fever, fatigue, and headache.<ref name=jmir>Jarynowski A, Semenov A, Kamiński M, Belik V (18 May 2021) [https://www.jmir.org/2021/11/e30529 Mild Adverse Events of Sputnik V Vaccine in Russia: Social Media Content Analysis of Telegram via Deep Learning.] {{Webarchive|url=https://web.archive.org/web/20211217101325/https://www.jmir.org/2021/11/e30529 |date=17 December 2021 }}''Journal of Medical Internet Research'', 23(11):e30529</ref>

==See also== * List of Russian drugs

== References == {{Reflist|refs=

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== Further reading == {{refbegin}} * {{cite news | title=How Gamaleya's Vaccine Works | website=The New York Times | date=7 January 2021 | url=https://www.nytimes.com/interactive/2021/health/gamaleya-covid-19-vaccine.html | vauthors=Corum J, Zimmer C | access-date=10 May 2021 | archive-date=20 April 2021 | archive-url=https://web.archive.org/web/20210420022117/https://www.nytimes.com/interactive/2021/health/gamaleya-covid-19-vaccine.html | url-status=live }} {{refend}}

== External links == {{scholia}} {{Commons category}} * {{Official website}}

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{{DEFAULTSORT:Sputnik V Covid-19 Vaccine}} Category:Adenoviridae Category:Gamaleya Research Institute of Epidemiology and Microbiology Category:Medical controversies in Russia Category:Products introduced in 2020 Category:Russian COVID-19 vaccines Category:Science and technology in Russia Category:Vaccine controversies Category:Viral vector vaccines