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Sputnik V COVID-19 vaccine

December 28, 2023

"Sputnik V" redirects here. For the Soviet satellite known as Sputnik 5, see Korabl-Sputnik 2.

Sputnik V (Russian: Спутник V, the brand name from RDIF) or Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced[3]) 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.[4][5]

Sputnik V COVID-19 vaccine
Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade names
  • Sputnik V[1]
  • Спутник V
Other names
  • Gam-COVID-Vac
  • Гам-КОВИД-Вак
License data
  • EU EMA: by INN
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
  • BR: Exceptional import[2]
  • RU: Registered on 11 August 2020
Full list of Sputnik V vaccine authorizations
Identifiers
DrugBank
  • DB15848

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.[6] 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.[4][5][7][8][9] 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.[10]

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.[11] However, as of April 2022 less than 2.5% of the people vaccinated worldwide have taken a Sputnik V dose.[12] In early 2022, as a result of the 2022 Russian invasion of Ukraine, the United States and other countries placed RDIF on the list of sanctioned Russian entities and people,[13][14] significantly reducing Sputnik V's future commercial prospects.[13][12]

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 (Russian: Гам-КОВИД-Вак-Лио, no data on use), Sputnik Light (Russian: Спутник Лайт, used for revaccination, as well as vaccination of foreigners in Russia), Gam-COVID-Vac-M (Russian: Гам-КОВИД-Вак-М, for vaccination of adolescents 12–17 years old[15]).

Medical uses edit

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 −18 °C or 0 °F or lower, and as a freeze-dried (lyophlilized) powder, "Gam-COVID-Vac-Lyo", which can be stored at 2–8 °C or 36–46 °F. The freeze-dried powder must be reconstituted with sterile water before use.[16] 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.[17][18]

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.[19][20][21] 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.[22]

On August 11, 2021, the developers of the Sputnik V vaccine offered its 'Sputnik Light' (Ad26) vaccine to Pfizer for trial against the Delta variant.[23][24]

Effectiveness edit

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.[25][26] A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[27] Effectiveness is generally expected to slowly decrease over time.[28]

On 25 August, a preliminary version of a case-control study indicated an unadjusted effectiveness[25][26] 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.[A]

A large-scale study in Buenos Aires from December 29, 2020, to May 15, 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 98% (95% CI, 95–99%) 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.[10]

Initial effectiveness by variant
Doses Severity of illness Delta Alpha
1 Symptomatic Not reported Not reported
Hospitalization 35% (−21 to 65%)[A] Not reported
2 Asymptomatic Not reported 86% (84–87%)[B]
Symptomatic Not reported Not reported
Hospitalization 81% (68–88%)[C][A] Not reported
Death Not reported 98% (96–99%)[B]
  1. ^ a b c Case-control study with 13,894 participants from 3 July 2021 to 9 August 2021 in Saint Petersburg. The study awaits peer review.[29][30][may be outdated as of December 2021]
  2. ^ a b 22 January to 10 June 2021 in Hungary.[31]
  3. ^ 14 to 55 days after the second dose, higher in women, 84% (66–92%), than in men, 76% (51–88%). Increases to 85% (72–92%) 56 days or more after the second dose.

A large-scale study was conducted in Mexico.[32] The study compared 793,487 adults vaccinated with different vaccines with 4,792,338 unvaccinated adults between December 24, 2020, and September 27, 2021.The results were as follows:

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 edit

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 91.6% (95% CI, 85.6–95.2%) after the second dose for all age groups, with no unusual side effects.[33] For the age group of 60 years and older, the reported efficacy was 91.8%.[34] 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 data discrepancies, substandard reporting, apparent errors and numerical inconsistencies and a very unlikely homogeneity in vaccine efficacy across age groups.[35]

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".[36]

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.[37] 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.[38][39]

Adverse effects edit

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, and Pfizer, evidence does not suggest a risk of vaccine-induced immune thrombotic thrombocytopenia.[40] Although 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.[41]

Pharmacology edit

 
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.[6][19][42] Adenoviral vectors[43][44] 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[45][46] 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[46] and Gam-COVID-Vac vaccines the producer cells for the production of non-replicating adenoviral vectors were obtained from the HEK 293 cell line.[47] Each dose of Gam-COVID-Vac contains (1.0 ± 0.5) × 1011 virus particles.[34]

Both Ad26 and Ad5 were modified to remove the E1 gene to prevent replication outside the HEK 293 cells.[48] 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.[49][50] However, although rare, homologous recombination between the inserted cellular sequence and the vector sequence can restore the replication capacity to the vector,[51] with less than 100 replicating adenovirus particles per dose of the vaccine.[48]

Chemistry edit

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two doses.[52][53]

No adjuvants[54] and no other components or ingredients should be included in the vaccine.[1]

Manufacturing edit

 
Pharmaceutical company União Quimica started production of Sputnik V in Brazil in January 2021[citation needed]

Large quantities of both adenoviruses are produced by HEK 293 cells that have the E1 gene necessary for viral replication.[49][50][51] Rarely, Ad5 can acquire the E1 gene from the HEK 293 cells, restoring its ability to replicate.[51] 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.[48]

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.[6]

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 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 million doses.[55][56]

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 million doses will have been manufactured in Russia, less than 5% of which will have been exported.[57]

An agreement for the production of over 100 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.[58] The RDIF announced plans to sell 100 million doses to India, 35 million to Uzbekistan, and 32 million to Mexico, as well as 25 million each to Nepal and Egypt.[59] In India, the first dose of Sputnik V vaccine was administered on 14 May 2021 at Hyderabad.[60] Argentina became the first Latin American country to produce it.[61] Large-scale production started in June 2021.[62] As of 31 December 2021 277 million doses were manufactured, mostly (265 million) in Russia.[63]

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.[13][14] The European Union, Ukraine, United Kingdom and Australia followed later in February and in March.[64] This significantly reduces vaccine's future commercial prospects.[13][12]

History edit

 
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]

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.[65][66] This vaccine was given the trade name "Sputnik V", after the world's first artificial satellite.[5][8][67]

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.[4] 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.[5] 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.[68][69] On 26 August, certificate No. ЛП-006423 (LP-006423) was issued for the lyophilized formulation "Gam-COVID-Vac-Lyo".[4][5][8][70][6]

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.[71]

Clinical trials edit

Phase I–II edit

A phase I safety trial began on 18 June 2020.[4] 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.[6] 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,[72] 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.[73]

Phase III edit

 
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.[74]

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.[75] In 2020–2021, phase III clinical studies were also being conducted in Belarus,[76] UAE,[77] India,[78] Kazakhstan[79] and Venezuela.[80]

On April 13, 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.[81]

Variants edit

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.[82]

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.[83]

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).[84]

Authorizations edit

  Full authorization
  Emergency authorization
  Authorization expired
  Allowed for travel
  Rejected
See also: List of COVID-19 vaccine authorizations § Sputnik V
 
President Putin's meeting with government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered vaccine against COVID-19.[4][5]

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.[85]

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.[86] 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.[87][88][89][90][91]

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.[92] 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.[93] On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.[94] The EU applicant is R-Pharm Germany GmbH.[94] 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.[95] As of June 2021, Sputnik V is under rolling review process by EMA, but the marketing authorisation application was not submitted yet.[96]

Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,[58] and Mexico.[97]

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.[98][99]

The Czech Republic is 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.[100][101][102]

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.[103] 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.[104]

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".[105]

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 million doses of the vaccine.[106][107]

On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data.[108][109]

As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization.[110]

On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use.[111]

On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use.[112][113]

Slovakia edit

On 1 March 2021, Slovakia bought 2 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 million doses were set to arrive in May and June.[114]

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.[115] 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 the 31st of March were different from the product currently being reviewed by the EMA 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.[116][117] Russian Direct Investment Fund replied that Slovakian laboratory which tested the vaccine was not certified by the EU.

Slovak Prime Minister Igor Matovič resigned on 30 March, due to the political crisis started by the order of the Sputnik V vaccine.[118] On 6 April 2021, the RDIF asked to return the delivered first batch of the vaccine due to "multiple contract violations".[116][119]

On 29 April 2021, the Slovak Ministry of Health published the Sputnik V contract.[120] According to the contract, the RDIF as a seller is not liable for any adverse events following administering of the vaccine, nor its effectiveness.[120][121] According to the Slovak lawyers, the contract is explicitly disadvantageous for Slovakia.[121][122]

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".[123][124] RDIF threatened the newspaper with legal action if they didn't comply with the demand by 9 May.[125] The newspaper's editors refused.[125]

After the samples were sent to the EU-certified laboratory in Hungary and it was stated that "the results were satisfactory",[126] the Slovakian 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.[127][128] Vaccinations started on 7 June,[129] but without significant interest in the Sputnik V vaccine.[130][131] Slovakia has no plans to order new batches[130] and plans to sell or donate unused vaccines to Balkans countries.[132] 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.[133] Temporary government approval for Sputnik V expired on 31 August 2021.[134][135] In total, 18,500 people have been vaccinated.[136]

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.[137]

Brazil edit

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 recent report by the United States government that tried to persuade Brazil to reject the vaccine. Several Brazilian states in the North and Northeast regions had already signed contracts for the acquisition of more than 30 million doses.[138][139][140] Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation:[141][142][143]

  • 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.[142]

On April 29, 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.[144][145] 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.[146] 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,[147] 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.[148] 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.[48] 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.[149]

On June 4, 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.[2][150][151] As of 16 June, the same import conditions were extended to a total of 13 states.[152] On August 5, 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.[153]

Further development edit

Heterologous prime-boost vaccination edit

See also: COVID-19 vaccine clinical research § Heterologous prime-boost vaccination, and 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.[154] 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.[155][156] On February 20, 2021, in the official Sputnik V Twitter account it was stated that clinical trials have already started.[157]

Society and culture edit

Economics edit

In Russia edit

 
Medical worker in Moscow with the vaccine
 
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 billion doses of the vaccine are expected to be produced in 2021 outside of Russia.[158][159]

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.[160][161]

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.[162][163] 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.[164] There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.[164]

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).[165]

Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease.[166] Initially the vaccine was only offered to people over 60 years of age, later this restriction was lifted.[167]

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.[168][169][170] 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.[166] 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.[171] Forty thousand of those were volunteers in Sputnik V's Phase 3 trials, another 60,000 nurses and doctors had also taken the vaccine.[172] 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 million people coronavirus vaccinations in December 2020.[173]

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 million doses of the Sputnik V vaccine would enter civilian circulation in Russia before the end of February 2021.[174] 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 million doses a month.[175]


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.[176] Forbes Russia established that Russia committed to export 205 millions of doses of "Sputnik V" to other countries, and as of May 16.3 millions (8%) were so far delivered.[177] 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.[178]

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.[178]


Outside of Russia edit

 
In dark green are the countries that approved Sputnik V vaccine against COVID-19 (w/disputed Crimea). 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.[179]

According to the Russian Direct Investment Fund, they had received orders for more than 1.2 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.[180][181] In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.[182]

The Israeli Hadassah Medical Center signed a commercial memorandum of understanding to obtain 1.5–3 million doses.[183]

Argentina agreed to buy 25 million doses of Russia's COVID-19 vaccine, subject to its clearing clinical trials;[184] the vaccine was registered and approved in Argentina in late December 2020.[185] The Brazilian state of Bahia signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and planned to buy 50 million doses to market in northeastern Brazil.[186]

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.[187][188] Two months after being vaccinated he developed fever and headache, and tested positive for COVID-19.[189] 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.[190]

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.[191]

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.[192]

April 14, 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 March 12, 2021.[193]


Public opinion polls edit

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.[194][195] In June 2021, according to a poll conducted by 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.[196]

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.[197] 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.[198]


Resale controversy edit

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.[199] 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.[200]

Scientific assessment edit

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".[9] 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".[201]

Francois Balloux, a geneticist at University College London, called the Russian government's approval of Gam-COVID-Vac a "reckless and foolish decision".[4] 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.[9]

Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said "that 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.[202]

"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.[8]

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."[203]

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.[35]

Two preliminary studies, one from Argentina and one from San Marino, found mostly mild adverse events and no vaccine-associated deaths.[40] 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.[204]

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%.[205]

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.[206]

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  124. ^ . Archived from the original on 11 May 2021. 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.
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Further reading edit

External links edit

 
Scholia has a profile for Gam-COVID-Vac (Q98270627).
 
Wikimedia Commons has media related to Sputnik V.
  • Official website  

December 28, 2023
sputnik, covid, vaccine, sputnik, redirects, here, soviet, satellite, known, sputnik, korabl, sputnik, sputnik, russian, Спутник, brand, name, from, rdif, covid, russian, Гам, КОВИД, Вак, name, under, which, legally, registered, produced, adenovirus, viral, ve. Sputnik V redirects here For the Soviet satellite known as Sputnik 5 see Korabl Sputnik 2 Sputnik V Russian Sputnik V the brand name from RDIF or Gam COVID Vac Russian Gam KOVID Vak the name under which it is legally registered and produced 3 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 4 5 Sputnik V COVID 19 vaccineRussian Ministry of Health image of Gam COVID Vac vialsVaccine descriptionTargetSARS CoV 2Vaccine typeViral vectorClinical dataTrade namesSputnik V 1 Sputnik VOther namesGam COVID VacGam KOVID VakLicense dataEU EMA by INNRoutes ofadministrationIntramuscularATC codeJ07BN02 WHO Legal statusLegal statusBR Exceptional import 2 RU Registered on 11 August 2020Full list of Sputnik V vaccine authorizationsIdentifiersDrugBankDB15848Gam 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 6 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 4 5 7 8 9 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 10 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 11 However as of April 2022 less than 2 5 of the people vaccinated worldwide have taken a Sputnik V dose 12 In early 2022 as a result of the 2022 Russian invasion of Ukraine the United States and other countries placed RDIF on the list of sanctioned Russian entities and people 13 14 significantly reducing Sputnik V s future commercial prospects 13 12 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 Russian Gam KOVID Vak Lio no data on use Sputnik Light Russian Sputnik Lajt used for revaccination as well as vaccination of foreigners in Russia Gam COVID Vac M Russian Gam KOVID Vak M for vaccination of adolescents 12 17 years old 15 Contents 1 Medical uses 1 1 Effectiveness 1 2 Efficacy 2 Adverse effects 3 Pharmacology 4 Chemistry 5 Manufacturing 6 History 6 1 Clinical trials 6 1 1 Phase I II 6 1 2 Phase III 6 1 3 Variants 6 2 Authorizations 6 2 1 Slovakia 6 2 2 Brazil 6 3 Further development 6 3 1 Heterologous prime boost vaccination 7 Society and culture 7 1 Economics 7 1 1 In Russia 7 1 2 Outside of Russia 7 1 3 Public opinion polls 7 2 Resale controversy 7 3 Scientific assessment 8 References 9 Further reading 10 External linksMedical uses editThe 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 18 C or 0 F or lower and as a freeze dried lyophlilized powder Gam COVID Vac Lyo which can be stored at 2 8 C or 36 46 F The freeze dried powder must be reconstituted with sterile water before use 16 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 17 18 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 19 20 21 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 22 On August 11 2021 the developers of the Sputnik V vaccine offered its Sputnik Light Ad26 vaccine to Pfizer for trial against the Delta variant 23 24 Effectiveness edit 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 25 26 A vaccine is generally considered effective if the estimate is 50 with a gt 30 lower limit of the 95 confidence interval 27 Effectiveness is generally expected to slowly decrease over time 28 On 25 August a preliminary version of a case control study indicated an unadjusted effectiveness 25 26 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 A A large scale study in Buenos Aires from December 29 2020 to May 15 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 98 95 CI 95 99 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 10 Initial effectiveness by variant Doses Severity of illness Delta Alpha1 Symptomatic Not reported Not reportedHospitalization 35 21 to 65 A Not reported2 Asymptomatic Not reported 86 84 87 B Symptomatic Not reported Not reportedHospitalization 81 68 88 C A Not reportedDeath Not reported 98 96 99 B a b c Case control study with 13 894 participants from 3 July 2021 to 9 August 2021 in Saint Petersburg The study awaits peer review 29 30 may be outdated as of December 2021 a b 22 January to 10 June 2021 in Hungary 31 14 to 55 days after the second dose higher in women 84 66 92 than in men 76 51 88 Increases to 85 72 92 56 days or more after the second dose A large scale study was conducted in Mexico 32 The study compared 793 487 adults vaccinated with different vaccines with 4 792 338 unvaccinated adults between December 24 2020 and September 27 2021 The results were as follows Effectiveness of vaccines in Mexico 2021 Vaccine Incidental infection effectiveness Hospitalization effectiveness Mortality effectivenessSpikevax 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 edit 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 91 6 95 CI 85 6 95 2 after the second dose for all age groups with no unusual side effects 33 For the age group of 60 years and older the reported efficacy was 91 8 34 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 data discrepancies substandard reporting apparent errors and numerical inconsistencies and a very unlikely homogeneity in vaccine efficacy across age groups 35 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 36 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 37 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 38 39 Adverse effects editSide 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 and Pfizer evidence does not suggest a risk of vaccine induced immune thrombotic thrombocytopenia 40 Although 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 41 Pharmacology edit nbsp 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 6 19 42 Adenoviral vectors 43 44 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 45 46 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 46 and Gam COVID Vac vaccines the producer cells for the production of non replicating adenoviral vectors were obtained from the HEK 293 cell line 47 Each dose of Gam COVID Vac contains 1 0 0 5 1011 virus particles 34 Both Ad26 and Ad5 were modified to remove the E1 gene to prevent replication outside the HEK 293 cells 48 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 49 50 However although rare homologous recombination between the inserted cellular sequence and the vector sequence can restore the replication capacity to the vector 51 with less than 100 replicating adenovirus particles per dose of the vaccine 48 Chemistry editThe other ingredients excipients are the same both quantitatively and qualitatively in the two doses 52 53 Tris hydroxymethyl aminomethane buffer Sodium chloride salt Sucrose sugar Magnesium chloride hexahydrate Disodium EDTA dihydrate a chelation ligand sequestrant Polysorbate 80 Ethanol 95 WaterNo adjuvants 54 and no other components or ingredients should be included in the vaccine 1 Manufacturing edit nbsp Pharmaceutical company Uniao Quimica started production of Sputnik V in Brazil in January 2021 citation needed Large quantities of both adenoviruses are produced by HEK 293 cells that have the E1 gene necessary for viral replication 49 50 51 Rarely Ad5 can acquire the E1 gene from the HEK 293 cells restoring its ability to replicate 51 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 48 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 6 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 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 million doses 55 56 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 million doses will have been manufactured in Russia less than 5 of which will have been exported 57 An agreement for the production of over 100 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 58 The RDIF announced plans to sell 100 million doses to India 35 million to Uzbekistan and 32 million to Mexico as well as 25 million each to Nepal and Egypt 59 In India the first dose of Sputnik V vaccine was administered on 14 May 2021 at Hyderabad 60 Argentina became the first Latin American country to produce it 61 Large scale production started in June 2021 62 As of 31 December 2021 277 million doses were manufactured mostly 265 million in Russia 63 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 13 14 The European Union Ukraine United Kingdom and Australia followed later in February and in March 64 This significantly reduces vaccine s future commercial prospects 13 12 History edit nbsp Package and Vial for the first doseThe 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 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 65 66 This vaccine was given the trade name Sputnik V after the world s first artificial satellite 5 8 67 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 4 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 5 The license under register number No LP 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 68 69 On 26 August certificate No LP 006423 LP 006423 was issued for the lyophilized formulation Gam COVID Vac Lyo 4 5 8 70 6 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 71 Clinical trials edit Phase I II edit A phase I safety trial began on 18 June 2020 4 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 6 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 72 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 73 Phase III edit nbsp Sputnik V efficacy for different conditions The error bars indicate the confidence interval containing the efficacy with 95 probabilityIn 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 74 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 75 In 2020 2021 phase III clinical studies were also being conducted in Belarus 76 UAE 77 India 78 Kazakhstan 79 and Venezuela 80 On April 13 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 81 Variants edit In May 2021 a study by researchers of the National University of Cordoba Argentina found that the vaccine produced antibodies capable of neutralizing the Gamma variant 82 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 83 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 84 Authorizations edit Graphs are unavailable due to technical issues There is more info on Phabricator and on MediaWiki org Full authorization Emergency authorization Authorization expired Allowed for travel RejectedSee also List of COVID 19 vaccine authorizations Sputnik V nbsp President Putin s meeting with government members on 11 August 2020 via videoconference at which he announced a conditionally registered vaccine against COVID 19 4 5 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 85 As of December 2020 Belarus and Argentina granted emergency use authorization for the vector based vaccine 86 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 87 88 89 90 91 On 19 January 2021 the Russian authorities applied for the registration of Sputnik V in the European Union according to the RDIF 92 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 93 On 4 March 2021 the Committee for Medicinal Products for Human Use CHMP of the EMA started a rolling review of Sputnik V 94 The EU applicant is R Pharm Germany GmbH 94 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 95 As of June 2021 Sputnik V is under rolling review process by EMA but the marketing authorisation application was not submitted yet 96 Emergency use has also been authorized in Algeria Bolivia Serbia the Palestinian territories 58 and Mexico 97 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 98 99 The Czech Republic is also considering buying Sputnik V and Prime Minister Andrej Babis dismissed the minister of health Jan Blatny who was a loud opponent to the use of Sputnik V 100 101 102 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 103 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 104 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 105 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 million doses of the vaccine 106 107 On 12 April 2021 India approved the use of Sputnik V vaccine for emergency use against COVID 19 based on strong immunogenicity data 108 109 As of 12 April 2021 62 countries had granted Sputnik V emergency use authorization 110 On 27 April 2021 Bangladesh approved the use of Sputnik V vaccine for emergency use 111 On 30 April 2021 Turkey and Albania approved the use of Sputnik V vaccine for emergency use 112 113 Slovakia edit On 1 March 2021 Slovakia bought 2 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 million doses were set to arrive in May and June 114 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 115 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 the 31st of March were different from the product currently being reviewed by the EMA 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 116 117 Russian Direct Investment Fund replied that Slovakian laboratory which tested the vaccine was not certified by the EU Slovak Prime Minister Igor Matovic resigned on 30 March due to the political crisis started by the order of the Sputnik V vaccine 118 On 6 April 2021 the RDIF asked to return the delivered first batch of the vaccine due to multiple contract violations 116 119 On 29 April 2021 the Slovak Ministry of Health published the Sputnik V contract 120 According to the contract the RDIF as a seller is not liable for any adverse events following administering of the vaccine nor its effectiveness 120 121 According to the Slovak lawyers the contract is explicitly disadvantageous for Slovakia 121 122 On 8 May 2021 the Russian Direct Investment Fund sent a letter to the Dennik N newspaper requesting the removal of the statements of the drug regulator calling them unsubstantiated and false and fake news 123 124 RDIF threatened the newspaper with legal action if they didn t comply with the demand by 9 May 125 The newspaper s editors refused 125 After the samples were sent to the EU certified laboratory in Hungary and it was stated that the results were satisfactory 126 the Slovakian 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 127 128 Vaccinations started on 7 June 129 but without significant interest in the Sputnik V vaccine 130 131 Slovakia has no plans to order new batches 130 and plans to sell or donate unused vaccines to Balkans countries 132 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 133 Temporary government approval for Sputnik V expired on 31 August 2021 134 135 In total 18 500 people have been vaccinated 136 Purchase of Sputnik V which led to a political crisis and contributed to a fall of Igor Matovic s Cabinet was investigated by Slovak Police Force with the investigation levered against Marek Krajci No violation of the law was found in October 2022 137 Brazil edit 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 recent report by the United States government that tried to persuade Brazil to reject the vaccine Several Brazilian states in the North and Northeast regions had already signed contracts for the acquisition of more than 30 million doses 138 139 140 Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation 141 142 143 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 142 On April 29 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 144 145 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 146 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 147 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 148 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 48 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 149 On June 4 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 2 150 151 As of 16 June the same import conditions were extended to a total of 13 states 152 On August 5 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 153 Further development edit Heterologous prime boost vaccination edit See also COVID 19 vaccine clinical research Heterologous prime boost vaccination and 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 154 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 155 156 On February 20 2021 in the official Sputnik V Twitter account it was stated that clinical trials have already started 157 Society and culture editEconomics edit In Russia edit nbsp Medical worker in Moscow with the vaccine nbsp 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 billion doses of the vaccine are expected to be produced in 2021 outside of Russia 158 159 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 160 161 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 162 163 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 164 There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia 164 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 165 Doctors and other medical workers teachers and social workers were given priority due to their highest risk of exposure to the disease 166 Initially the vaccine was only offered to people over 60 years of age later this restriction was lifted 167 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 168 169 170 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 166 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 171 Forty thousand of those were volunteers in Sputnik V s Phase 3 trials another 60 000 nurses and doctors had also taken the vaccine 172 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 million people coronavirus vaccinations in December 2020 173 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 million doses of the Sputnik V vaccine would enter civilian circulation in Russia before the end of February 2021 174 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 million doses a month 175 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 176 Forbes Russia established that Russia committed to export 205 millions of doses of Sputnik V to other countries and as of May 16 3 millions 8 were so far delivered 177 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 178 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 178 Outside of Russia edit nbsp In dark green are the countries that approved Sputnik V vaccine against COVID 19 w disputed Crimea 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 179 According to the Russian Direct Investment Fund they had received orders for more than 1 2 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 180 181 In August 2020 according to the Russian authorities there were at least 20 countries that wanted to obtain the vaccine 182 The Israeli Hadassah Medical Center signed a commercial memorandum of understanding to obtain 1 5 3 million doses 183 Argentina agreed to buy 25 million doses of Russia s COVID 19 vaccine subject to its clearing clinical trials 184 the vaccine was registered and approved in Argentina in late December 2020 185 The Brazilian state of Bahia signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and planned to buy 50 million doses to market in northeastern Brazil 186 On 21 January 2021 Argentine president Alberto Fernandez became the first Latin American leader to be inoculated with Sputnik V shortly after it was approved for use in the country 187 188 Two months after being vaccinated he developed fever and headache and tested positive for COVID 19 189 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 190 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 191 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 192 April 14 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 March 12 2021 193 Public opinion polls edit An opinion poll of Canadians conducted by Leger 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 194 195 In June 2021 according to a poll conducted by 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 196 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 197 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 198 Resale controversy edit 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 199 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 200 Scientific assessment edit 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 9 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 201 Francois Balloux a geneticist at University College London called the Russian government s approval of Gam COVID Vac a reckless and foolish decision 4 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 9 Stephen Griffin Associate Professor in the School of Medicine University of Leeds said that 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 202 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 8 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 19 203 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 35 Two preliminary studies one from Argentina and one from San Marino found mostly mild adverse events and no vaccine associated deaths 40 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 204 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 7 205 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 206 References edit a b Sputnik V Russian drug reference Medum ru a b Mcgeever J Paraguassu L 4 June 2021 Brazil s Anvisa approves Russian Sputnik V vaccine with conditions Reuters Retrieved 5 June 2021 Gosudarstvennyj reestr lekarstvennyh sredstv grls rosminzdrav ru a b c d e f g Callaway E August 2020 Russia s fast track coronavirus vaccine draws outrage over safety Nature 584 7821 334 335 doi 10 1038 d41586 020 02386 2 PMID 32782400 S2CID 221107555 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 a b c d e f Cohen J 11 August 2020 Russia s approval of a COVID 19 vaccine is less than meets the press release Science Retrieved 13 August 2020 a b c d e Logunov DY Dolzhikova IV Zubkova OV Tukhvatullin AI Shcheblyakov DV Dzharullaeva AS et al September 2020 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 Lancet 396 10255 887 897 doi 10 1016 S0140 6736 20 31866 3 PMC 7471804 PMID 32896291 Mahase E August 2020 Covid 19 Russia approves vaccine without large scale testing or published results BMJ 370 m3205 doi 10 1136 bmj m3205 PMID 32816758 a b c d Burki TK November 2020 The Russian vaccine for COVID 19 The Lancet Respiratory Medicine 8 11 e85 e86 doi 10 1016 S2213 2600 20 30402 1 PMC 7837053 PMID 32896274 a b c Berkeley Jr L 11 August 2020 Scientists worry whether Russia s Sputnik V coronavirus vaccine is safe and effective CNBC Retrieved 11 August 2020 a b Macchia A Ferrante D Angeleri P Biscayart C Mariani J Esteban S et al October 2021 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 JAMA Network Open 4 10 e2130800 doi 10 1001 jamanetworkopen 2021 30800 PMC 8556631 PMID 34714342 Russia expects WHO approval of Sputnik V vaccine by end of 2021 RDIF a b c Hoffman M 9 April 2022 How Russia s Ukraine invasion doomed the Sputnik V coronavirus vaccine The Washington Post Retrieved 3 May 2022 a b c d Webster P March 2022 Russian COVID 19 vaccine in jeopardy after Ukraine invasion Nature Medicine d41591 022 00042 y doi 10 1038 d41591 022 00042 y PMID 35293390 S2CID 247475281 a b Treasury Prohibits Transactions with Central Bank of Russia and Imposes Sanctions on Key Sources of Russia s Wealth U S Department of the Treasury Retrieved 25 April 2022 According to 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ZDRAVOOHRANENIYa ROSSIJSKOJ FEDERACII Pushparajah D Jimenez S Wong S Alattas H Nafissi N Slavcev RA March 2021 Advances in gene based vaccine platforms to address the COVID 19 pandemic Advanced Drug Delivery Reviews Elsevier 170 113 141 doi 10 1016 j addr 2021 01 003 PMC 7789827 PMID 33422546 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 Golikova nazvala sroki vypuska pervyh partij vakcin NIC Gamalei i Vektora Golikova announced the timing of the release of the first batches of vaccines of the Research Center of Gamaleya and Vector in Russian Interfax 29 July 2020 Zapusheno proizvodstvo rossijskoj antikoronavirusnoj vakciny Production of Russian anti coronavirus vaccine launched in Russian Vesti 15 August 2020 Retrieved 21 September 2020 Foy H Seddon M Sciorilli SB 10 March 2021 Russia seeks to make Sputnik V in Italy as overseas demand surges Financial Times Retrieved 10 March 2021 a b Ahmed A Kumar AM 11 January 2021 Russia s Sputnik V vaccine found safe in India mid stage trial Dr Reddy s Reuters Retrieved 26 January 2021 More Countries Line Up for Russia s Sputnik V Coronavirus Vaccine The Moscow Times 13 November 2020 Dr Reddy s Laboratories launches Sputnik V COVID 19 vaccine in India at Rs 995 per dose Firstpost 14 May 2021 Retrieved 14 May 2021 In Latin American first Argentina to produce Russia s Sputnik V vaccine France 24 20 April 2021 Retrieved 2 July 2021 Laboratorios Richmond set to begin manufacturing Sputnik V second doses Buenos Aires Times 30 June 2021 Retrieved 2 July 2021 COVID 19 vaccine production to December 31st 2021 Global Commission for Post Pandemic Policy 12 January 2022 Retrieved 19 September 2021 RUSSIAN DIRECT INVESTMENT FUND opensanctions org June 2011 Retrieved 25 April 2022 Russia plans to start producing coronavirus vaccine in September 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Retrieved 21 September 2020 Coronavirus Putin says vaccine has been approved for use BBC 11 August 2020 Retrieved 11 August 2020 Ivanova P 12 June 2021 Russia tests COVID 19 vaccine as nasal spray for children Reuters Moscow Retrieved 11 July 2021 Ellyatt H 10 September 2020 Scientists question strange data in Russian coronavirus vaccine trial after unlikely patterns CNBC Retrieved 10 September 2020 Logunov DY Dolzhikova IV Tukhvatullin AI Shcheblyakov DV October 2020 Safety and efficacy of the Russian COVID 19 vaccine more information needed Authors reply Lancet 396 10256 e54 e55 doi 10 1016 S0140 6736 20 31970 X PMC 7503057 PMID 32971043 S2CID 221805026 Hadassah bringing 1 5 million doses of Russian COVID 19 vaccine to Israel The Jerusalem Post JPost com Retrieved 19 November 2020 Clinical Trial of Efficacy Safety and Immunogenicity of Gam COVID Vac Vaccine Against COVID 19 National Library of Medicine Retrieved 28 September 2020 Clinical Trial of Efficacy Safety and Immunogenicity of Gam COVID Vac Vaccine Against COVID 19 in Belarus clinicaltrials gov December 2020 Retrieved 14 January 2021 UAE volunteers receive Russian Covid 19 vaccine Khaleej Times 10 January 2021 Bharadwaj S 15 January 2021 Dr Reddy s gets DCGI nod for Covid 19 vaccine Sputnik V Phase III trials The Times Of India Study of Sputnik V COVID 19 Vaccination in Adults in Kazakhstan Clinical trial number NCT04642339 for Clinical Trial of the Immunogenicity Safety and Efficacy of the Gam COVID Vac Vaccine Against COVID 19 in Venezuela at ClinicalTrials gov India says its safety study of Sputnik V vaccine comparable to Russian trial Reuters 13 April 2021 Rodriguez R Caeiro JP Juri H Pizzi R Gallego S Blanco S et al 25 May 2021 Evaluacion de la respuesta de anticuerpos neutralizantes a la vacuna Sputnik V en una cohorte en Cordoba y evaluacion de las propiedades neutralizantes de anticuerpos naturales y vacunales frente a la variante Manaos 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 Technical report in Spanish National University of Cordoba Retrieved 22 June 2021 Coronavirus la vacuna Sputnik V genera anticuerpos para las variantes que circulan en el pais Coronavirus the Sputnik V vaccine generates antibodies for the variants that circulate in the country La Nacion in Spanish 30 June 2021 Retrieved 11 July 2021 Ikegame S Siddiquey MN Hung CT Haas G Brambilla L Oguntuyo KY et al July 2021 Neutralizing activity of Sputnik V vaccine sera against SARS CoV 2 variants Nature Communications 12 1 4598 Bibcode 2021NatCo 12 4598I doi 10 1038 s41467 021 24909 9 PMC 8313705 PMID 34312390 Mullin J Malnick E 1 August 2020 Britain unlikely to use Russia s untrustworthy Covid vaccine The Telegraph Archived from the original on 19 August 2020 Retrieved 6 September 2020 Belarus registers Sputnik V vaccine in first outside Russia RDIF 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Retrieved 16 June 2021 COVID 19 vaccines European Medicines Agency 17 February 2021 Retrieved 16 June 2021 Da la Cofepris autorizacion para que la vacuna Sputnik V se aplique en Mexico Diario de Yucatan in Spanish 2 February 2021 Archived from the original on 21 April 2021 Retrieved 3 February 2021 Iran approves Russia s Sputnik V COVID 19 vaccine Al Jazeera Iran approves Russian coronavirus vaccine Sputnik V Reuters 26 January 2021 Czech Republic turns to Russian vaccine amid soaring COVID cases Al Jazeera 28 February 2021 Retrieved 1 March 2021 Muller R Hovet J 7 April 2021 Czech PM names fourth health minister amid Sputnik vaccine strife Reuters Retrieved 8 April 2021 Snajdrova T Arenberger ma zaznamy ve slozkach StB Byl jsem clen KSC spolupracovnik StB ne brani se novy ministr 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 Refresher in Czech Retrieved 8 April 2021 EMA starts rolling review of the Sputnik V COVID 19 vaccine www ema europa eu 4 March 2021 EU medical official warns of Sputnik jab Russian roulette www france24 com 8 March 2021 German leaders urge quick EU approval of Russia s Sputnik V jab thelocal de Retrieved 20 March 2021 Philippines grants emergency authorization for Russia s Sputnik V vaccine ABS CBN News 19 March 2021 Retrieved 19 March 2021 Russia s Sputnik V approved for emergency use in PH CNN Philippines 19 March 2021 Retrieved 19 March 2021 Russia s Covid vaccine Sputnik V gets nod from expert panel for emergency use in India Report The Indian Express 12 April 2021 Das KN 12 April 2021 Indian panel gives emergency approval for Russia s Sputnik V vaccine sources Reuters Sputnik V Vaccine Authorized in India sputnikvaccine com 12 April 2021 Retrieved 12 April 2021 Bangladesh approves emergency use of Russian vaccine Sputnik V New Age 27 April 2021 Retrieved 27 April 2021 Turkey OKs emergency use of Sputnik V vaccine Anadolu Agency Retrieved 30 April 2021 Russian Direct Investment Fund rdif ru Retrieved 7 May 2021 Sputnik V vaccines landed in Slovakia The Slovak Spectator 1 March 2021 Retrieved 2 March 2021 Higgins A 8 April 2021 Slovakia Claims a Bait and Switch With the Russian Vaccines it Ordered The New York Times ISSN 0362 4331 Archived from the original on 28 December 2021 Retrieved 11 April 2021 a b Russia calls on Slovakia to return Sputnik V doses after dispute Reuters 8 April 2021 Retrieved 12 April 2021 Vyrobca Sputnika V nedodal kontrolorom vacsinu potrebnych dat domov sme sk in Slovak 8 April 2021 Retrieved 12 April 2021 Slovak Regulator Says Sputnik V It Got Differs From Vaccine In Reviews Radio Free Europe Radio Liberty 8 April 2021 Retrieved 8 April 2021 Russian Direct Investment Fund asks Slovakia to return batch of Sputnik V vaccines meduza io 8 April 2021 Retrieved 12 April 2021 a b 964 2021 Centralny register zmluv www crz gov sk Retrieved 11 May 2021 a b Osvaldova L 30 April 2021 Zmluva o nakupe Sputnika je nevyhodna a moze vojst do dejin ako dalsi amatersky pocin hovoria pravnici Dennik N in Slovak Retrieved 11 May 2021 Vyhody jen pro Rusko lzi Matovice Slovaci znaji obsah smlouvy o Sputniku iDNES cz 30 April 2021 Retrieved 11 May 2021 Matovic oznamuje ockovanie Sputnikom Lengvarsky o tom nevie Matovic announces vaccination with Sputnik Lengvarsky is unaware Dennik N in Slovak List RDIF Denniku N Archived from the original on 11 May 2021 On the 8th of April Dennik N published an article by Veronika Folentova entitled Co pise v stanovisku statny ustav o Sputniku Vakciny v roznych krajinach spaja len nazov 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 lt gt 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 lt gt 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 a b Dennik N Rejects Russia s Demand to Withdraw Story on Sputnik Vaccine Dennik N Archived from the original on 11 May 2021 Slovak health ministry says Sputnik V doses tested in Hungary satisfactory Reuters 9 May 2021 Retrieved 26 May 2021 Hopkova D 12 May 2021 Koronavirus Sputnikom V by sa mohlo na Slovensku ockovat od juna Aktuality sk in Slovak Retrieved 26 May 2021 Slovakia could start giving Sputnik shots in June minister says Reuters 12 May 2021 Retrieved 26 May 2021 Teraz sk 5 June 2021 Ockovanie vakcinou Sputnik V sa spusta v krajoch postupne TERAZ sk in Slovak Retrieved 16 June 2021 a b Slovakia has no plans to receive new batches of Sputnik V vaccine minister TASS Retrieved 16 June 2021 Teraz sk 8 June 2021 Na vakcinu Sputnik V aktualne caka 4423 ľudi TERAZ sk in Slovak Retrieved 16 June 2021 Teraz sk 16 June 2021 Lengvarsky Zvysne davky Sputniku V by SR mohla predat ci darovat TERAZ sk in Slovak Retrieved 16 June 2021 Slovakia sells most Sputnik V vaccine doses back to Russia Reuters 2 July 2021 Retrieved 8 July 2021 Povolenie na terapeuticke pouzitie neregistrovaneho lieku PDF 1 March 2021 Retrieved 8 July 2021 Zmatky s vakcinami pokracuju Aky Sputnik mame v skladoch Pravda sk in Slovak 14 April 2021 Retrieved 8 July 2021 After low demand Slovakia delivers its last doses of Sputnik V euronews 1 September 2021 Retrieved 2 September 2021 Kauzu Sputnik V po ktorej padla Matovicova vlada policia uzavrela Dennik Standard in Slovak Retrieved 11 October 2022 COVID Brazil regulator rejects Russia s Sputnik vaccine Deutsche Welle Reuters 27 April 2021 Retrieved 27 April 2021 Brito R Ivanova P 27 April 2021 Brazil health regulator rejects Russia s Sputnik vaccine Reuters Retrieved 27 April 2021 Russia says Brazil refusal to import Sputnik V Political Al Jazeera 27 April 2021 Retrieved 27 April 2021 Brito R 26 April 2021 Brazil health regulator rejects Russia s Sputnik vaccine Coronavirus Retrieved 28 April 2021 a b Anvisa nega pedido de importacao da vacina Sputnik V entenda as razoes BBC News Brasil in Brazilian Portuguese Retrieved 28 April 2021 Cunningham E Dixon R Brazil rejects Russia s Sputnik V coronavirus vaccine citing safety concerns The Washington Post ISSN 0190 8286 Retrieved 28 April 2021 Osborn A Paraguassu L 29 April 2021 Russian vaccine developer to sue Brazilian regulator for defamation Reuters Moscow Brasilia Retrieved 29 April 2021 Paraguassu L Brito R 29 April 2021 Anvisa rebate grave acusacao de fabricantes da Sputnik e divulga documentos e video de reuniao Anvisa counters Sputnik manufacturers serious accusation and releases documents and meeting video in Brazilian Portuguese Brasilia Istoe Dinheiro Reuters Brasil Retrieved 29 April 2021 Brazil says Russian Covid vaccine carried live cold virus France 24 Washington Agence France Presse 28 April 2021 Retrieved 30 April 2021 Lowe D 28 April 2021 Brazil Rejects the Gamaleya Vaccine In the Pipeline Science Translational Medicine Retrieved 30 April 2021 Lowe D 28 April 2021 Russian Vaccine Behavior In the Pipeline Science Translational Medicine Retrieved 30 April 2021 Laing A 30 April 2021 Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection Reuters Retrieved 3 May 2021 Alegretti L Barifouse R 4 June 2021 Covaxin e Sputnik V O que muda na vacinacao do Brasil com decisao da Anvisa Covaxin and Sputnik V What changes in vaccination in Brazil after Anvisa s decision BBC Brasil in Portuguese Retrieved 5 June 2021 Anvisa aprova com restricoes a importacao excepcional de doses da Covaxin e Sputnik V Anvisa approves import of doses of Covaxin and Sputnik V with restrictions G1 in Portuguese Globo 4 June 2021 Retrieved 4 June 2021 Anvisa autoriza importacao excepcional da Sputnik V por mais 7 estados tambem com restricoes Anvisa authorizes exceptional import of Sputnik V for 7 more states also with restrictions G1 in Portuguese Globo 16 June 2021 Retrieved 16 June 2021 Brazil s northeastern states drop plan to buy Russia s COVID vaccine Reuters 5 August 2021 Retrieved 5 August 2021 RDIF The Gamaleya National Center AstraZeneca and R Pharm sign an agreement to cooperate on COVID 19 vaccine development The Russian Direct Investment Fund 21 December 2020 Azerbaijan allowed for the first in the world to study a combination of Sputnik V vaccine and COVID 19 vaccine developed by AstraZeneca Company MoH of Azerbaijan 9 February 2021 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 ClinicalTrials gov U S National Library of Medicine 14 January 2021 NCT04686773 Retrieved 9 February 2021 Sputnik V twitter account 20 February 2021 Litvinova D 24 November 2020 Russian virus vaccine to cost less than 10 per dose abroad Associated Press Osborn A Nikolskaya P 24 November 2020 Russia s Sputnik COVID 19 vaccine to cost less than 20 per person internationally The Globe and Mail Retrieved 28 November 2020 Centr Gamalei nazval sroki vakcinacii bolshej chasti naseleniya Rossii RBK 4 September 2020 Retrieved 6 September 2020 Sagdiev R Ivanova P Nikolskaya P Swift R Smout A 17 November 2020 Mason J Macfie N eds Russia focuses on freeze dried vaccine doses as transport fix Reuters Moscow Retrieved 20 November 2020 Minzdrav poobeshal rossiyanam besplatnuyu vakcinaciyu ot COVID 19 Ministry of Health promised Russians free vaccination against COVID 19 RBC ru in Russian 23 October 2020 Retrieved 23 October 2020 V budushem vakcinaciya ot COVID 19 budet prohodit besplatno In the future vaccination against COVID 19 will be free of charge Russian Newspaper in Russian 11 October 2020 Retrieved 23 October 2020 a b Minzdrav zaregistriroval predelnuyu otpusknuyu cenu na vakcinu Sputnik V The Ministry of Health registered the maximum selling price for the Sputnik V vaccine in Russian RIA 5 December 2020 Retrieved 21 September 2020 Covid Russia begins vaccinations in Moscow BBC 5 December 2020 Retrieved 11 December 2020 a b Soldatkin V Oziel C 5 December 2020 Char P ed Moscow rolls out Sputnik V COVID 19 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The Moscow Times 9 July 2021 Retrieved 10 July 2021 Kenya s Failed Sputnik V Deal Used Emirati Resale Scheme The Moscow Times 19 July 2021 Retrieved 19 July 2021 Nebehay S 11 August 2020 Shields M ed WHO says discussing new COVID 19 vaccine with Russia Reuters Geneva Retrieved 11 August 2020 Instant view Russia says its Sputnik V COVID 19 vaccine is 92 effective reuters com 11 November 2020 Retrieved 12 April 2023 Jones I Roy P February 2021 Sputnik V COVID 19 vaccine candidate appears safe and effective Lancet 397 10275 642 643 doi 10 1016 S0140 6736 21 00191 4 PMC 7906719 PMID 33545098 Montalti M Solda G Di Valerio Z Salussolia A Lenzi J Forcellini M et al August 2021 ROCCA observational study Early results on safety of Sputnik V vaccine Gam COVID Vac in the Republic of San Marino using active surveillance eClinicalMedicine 38 101027 doi 10 1016 j eclinm 2021 101027 PMC 8413252 PMID 34505029 Nogrady B Mounting evidence suggests Sputnik COVID vaccine is safe and effective Nature 595 339 340 2021 Jarynowski A Semenov A Kaminski M Belik V 18 May 2021 Mild Adverse Events of Sputnik V Vaccine in Russia Social Media Content Analysis of Telegram via Deep Learning Journal of Medical Internet Research 23 11 e30529Further reading editCorum J Zimmer C 7 January 2021 How Gamaleya s Vaccine Works The New York Times External links edit nbsp Scholia has a profile for Gam COVID Vac Q98270627 nbsp Wikimedia Commons has media related to Sputnik V Official website nbsp Portals nbsp Medicine nbsp Viruses nbsp COVID 19 Retrieved from https en wikipedia org w index php title Sputnik V COVID 19 vaccine amp oldid 1190534526, wikipedia, wiki, book, books, library,

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