07 July 2021

Sputnik V Nature

Nature: There is growing evidence of the safety and effectiveness of the Sputnik V vaccine

Alexander Ternavsky, Habr


The Russian vector vaccine against the coronavirus Sputnik V, also known as Gam-COVID-Vac, has not yet received approval from the World Health Organization and the European Medicines Agency (EMA). Despite this, she is receiving more and more approving publications in medical journals, according to an article in Nature (Bianca Nogrady, Mounting evidence suggests Sputnik COVID vaccine is safe and effective).

In particular, the scientific community began to provide data on the effectiveness of the vaccine. The fact is that the National Research Center for Epidemiology and Microbiology of Gamalei and the Russian Ministry of Health have repeatedly published press releases in which they provided data on effectiveness. For example, in February, organizations talked about 91.6% effectiveness for preventing symptoms of COVID-19 infection in their article for the Lancet magazine, and in April, the developer claimed 97.6%. Nevertheless, these data have been repeatedly criticized by the scientific community, since the full data on the tests have not been released, it does not inspire confidence in the drug.

Since then, 67 countries have approved and started using the vaccine, including Argentina, Hungary, Iran and Brazil. The UAE Ministry of Health reported 97.8% effectiveness among 81 thousand people who received both doses of the vaccine. A study by the Ministry of Health of Buenos Aires, the results of which have been published only as a preprint by this time, states that a single dose of the Sputnik Lite vaccine reduces the number of infections with obvious symptoms of COVID-19 by 78.6%, and the number of hospitalizations by 87.6%.

In addition, questions about the side effects of Sputnik V are gradually being removed. Unlike similar AstraZeneca and Johnson & Johnson vector vaccines, after which cases of thrombosis and other vascular diseases were detected, none of the countries that started using the Russian drug reported such side effects. In the Argentine and Brazilian studies, it is said that there were no deaths from side effects, and for the most part they were mild. A similar study was conducted in San Marino, and no serious consequences of the use of the Russian vaccine were also found there.

According to Alison Kelvin, a virologist at Dalhousie University in Halifax, Canada, scientists suggest that the occurrence of blood clotting disorders may indeed be associated with vector vaccines. However, it is not yet clear which of the components of the drugs causes thrombosis, respectively, there is no reliable information about whether these components are in the composition of the "Satellite". The virologist noted that the sample of the third phase of trials of 21,977 people is small, so far no serious side effects have been detected from the Russian drug, and given the increasing number of applications of Sputnik V, data on possible consequences will be received soon.

It is with an unclear situation with side effects that the unwillingness of WHO and EMA to issue a permit for the use of Sputnik V is connected, scientists believe. By this time, WHO has requested additional information about the trials from the Gamalea center, and is also conducting inspections at nine plants where the vaccine is produced. So far, only one production facility is of concern to the organization.

Meanwhile , Russian scientists accuse The EU is biased for refusing to register a Russian vaccine. Biotechnology researcher from Dmitry Kulish of the Skolkovo Institute of Science and Technology, who is not associated with the development of Sputnik, suggested that the EMA adheres to the position of "pro-Pfizer", which is why the Russian drug has not received approval. A representative of the agency in an interview with Nature dismissed this accusation, saying that all vaccines have the same requirements regardless of where they are produced.

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