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. 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. This vaccine was given the
trade name "Sputnik V", after
the world's first artificial satellite. 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. On 26 August, certificate No. ЛП-006423 (
LP-006423) was issued for the lyophilized formulation "Gam-COVID-Vac-Lyo".
Clinical trials Phase I–II A phase I safety trial began on 18 June 2020. 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.
Phase III 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. 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. In 2020–2021, phase III clinical studies were also being conducted in Belarus, UAE, India, Kazakhstan and Venezuela. On 13 April 2021, India's health ministry said its drug regulator had found that safety and immunogenicity data from a local trial of Sputnik V coronavirus vaccine was comparable to that of a late-stage trial done in Russia.
Variants In May 2021, a study by researchers of the
National University of Córdoba, Argentina, found that the vaccine produced antibodies capable of
neutralizing the
Gamma variant. 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. 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).
Authorizations 's meeting with government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered
vaccine against COVID-19 As of December 2020, Belarus and Argentina granted
emergency use authorization for the
vector-based vaccine. 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. On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF. 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. On 4 March 2021, the
Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V. 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. As of June 2021, Sputnik V is under rolling review process by EMA, but the marketing authorisation application was not submitted yet. Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories, 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. The Czech Republic was also considering buying Sputnik V, and Prime Minister
Andrej Babis dismissed the Minister of Health,
Jan Blatný, who was a loud opponent to the use of Sputnik V. 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. 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. 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". 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 20million doses of the vaccine. On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data. As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization. On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use. On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use.
Slovakia On 1 March 2021, Slovakia bought 2million 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 1million doses were set to arrive in May and June. 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. The Slovak State Institute for Drug Control stated that Sputnik V has not yet been approved for use, as the first 200,000 doses received on 31 March were different from the product currently being reviewed by the
European Medicines Agency as well as from the vaccine used in studies published in
The Lancet. The producers have failed to reply to requests for documentation, and approximately 80% of the data was not supplied even after repeated requests. Due to the inconsistencies, it was not possible to review the safety and efficacy of the vaccine. The Russian Direct Investment Fund replied that the Slovak laboratory which tested the vaccine was not certified by the EMA. Slovak Prime Minister
Igor Matovič resigned on 30 March, due to the political crisis started by the order of the Sputnik V vaccine. On 6 April 2021, the RDIF asked to return the delivered first batch of the vaccine due to "multiple contract violations". On 29 April 2021, the Slovak Ministry of Health published the Sputnik V contract. According to the contract, the RDIF as a seller is not liable for any
adverse events following administering of the vaccine, nor its effectiveness. According to the Slovak lawyers, the contract is explicitly disadvantageous for Slovakia. 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". RDIF threatened the newspaper with legal action if they didn't comply with the demand by 9 May. The newspaper's editors refused. the Slovak government approved the vaccine, and announced that vaccination with Sputnik V would begin in June 2021, despite the negative review by Slovakia's drug regulator. Vaccinations started on 7 June, but without significant interest in the Sputnik V vaccine. Slovakia had no plans to order new batches 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. Temporary government approval for Sputnik V expired on 31 August 2021. In total, 18,500 people have been vaccinated. The purchase of Sputnik V, which led to a political crisis and contributed to a fall of
Igor Matovič's Cabinet was investigated by
Slovak Police Force with the investigation levered against
Marek Krajčí. No violation of the law was found in October 2022.
Brazil On 26 April 2021, the
Brazilian health regulator Anvisa rejected the use of Sputnik V, alleging a lack of consistent and reliable data and the presence of replicating adenovirus in the vaccine. RDIF and Sputnik V's official Twitter account said the decision may be politically motivated, pointing to a report by the United States government stating that the Office of Global Affairs persuaded Brazil to reject the vaccine. Several Brazilian states in the North and Northeast regions had already signed contracts for the acquisition of more than 30 million doses. Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation: • 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. 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. 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, 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. 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. 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. On 4 June, Anvisa approved exceptional imports of Sputnik V, restricting it mainly to healthy adults and limiting it to only 1% of the population of 6 importing states, in order to manage risks through control and supervision of side effects. Anvisa said that the concern with replicating viruses has not been fully resolved, but that additional documents received indicate a substantially reduced acceptable amount. The new parameter would be in an FDA manual, which was not found. Anvisa also said that impurity and quality controls are insufficient and that the manufacturing plants must undergo corrections to meet WHO quality standards. As of 16 June, the same import conditions were extended to a total of 13 states. On 5 August, the consortium of northeastern Brazilian states, corresponding to 7 of the 13 states, suspended the import of 37 million doses due to the restrictions imposed by Anvisa. These doses will supply Mexico, Argentina and Bolivia.
Further development 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. 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. On 20 February 2021, in the official Sputnik V
Twitter account it was stated that clinical trials have already started. == Society and culture ==