By Alejandra Pousa, 01/05/21
Approved for use in a number of countries and currently under review by the EMA (European Medicines Agency), Gamalayeva's Sputnik V vaccine remains controversial.
Beyond Putin's propaganda, Russia has not provided reliable data to an independent drug testing authority (phases 1 and 2 trials - partial results for safety, long term safety and immunogenicity). Those studies were conducted on 38 participants each. A phase 3 randomized, double blind, placebo controlled clinical trial involving 2,000 participants is taking place in Venezuela but will be completed by December 2021. The last peer reviewed study on 20,000 participants was published by The Lancet in February finding the vaccine a 91.2% effective.
Under review from the EMA since April, it is not clear when the decision of recommending Sputnik or not will be made because of alleged ethical questions and the lack of essential data.
The Czech Republic, Germany and Austria are trying to secure doses but will not use them until EMA gives them the go ahead. Hungary and Slovakia have already approved it for emergency use but it was only in Hungary where inoculations with it were made. Serbia has used it extensively with good results. Italy is considering producing it locally. As for the rest of the world, 60 countries have accepted it. Interestingly enough, Russia has so far a low vaccination rate, 19 million doses of Sputnik for a population of 144 million.
Political weapon or not, what we do know about it is that it uses two different types of inactive harmless viruses in two different doses in order to prevent the second shot from neutralizing the effect produced with the first one, thus having a booster reaction. As for side effects, neither of the papers published by the Lancet present evidence of them.
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