The Russian vaccine Gam-COVID-Vac, also known as Sputnik V, is 91.6 % effective against symptomatic COVID-19, a phase III trial has shown. The preliminary results of this crucial final round of testing were published in the prestigious medical journal The Lancet on Tuesday.
The findings are based on data from nearly 20,000 people who participated in the study in 25 hospitals and clinics in Moscow from September through November 202
Researchers at Russia’s Gamaleya National Research Centre for Epidemiology and Microbiology, where Sputnik V was developed, say they are happy with the results. «Our interim analysis of the randomized, controlled, phase III trial of Gam-COVID-Vac in Russia has shown high efficacy, immunogenicity and a good tolerability profile in participants aged 18 years or older,» says Gamaleya’s Dr. Inna V Dolzhikova, co-lead author of the study published in The Lancet. The researchers found no serious negative consequences of vaccination. Reported side effects included flu-like symptoms and pain at the injection site.
Sputnik V was the first coronavirus vaccine to be released worldwide. Russia’s move to start using it on a mass scale last year, before all the trials were completed and results analyzed, has been criticized by the international community. Another point of contention: The Gamaleya research center did not just develop the vaccine but was also in charge of authorizing its use in Russia. In the EU or the US, authorization is handled not by the companies who develop the serum, but by separate entities like the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA).
The release of the phase III results is likely to increase confidence in the Russian vaccine.
«The development of the Sputnik V vaccine has been criticized 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,» Professor Ian Jones, University of Reading, and Professor Polly Roy, London School of Hygiene & Tropical Medicine, who were not involved in the study, wrote in a comment about the new findings.
Good results with the elderly as well: The most recent Sputnik V trial included 2,144 participants over 60 years of age, and the vaccine efficacy in this group was 91.8 %. A British coronavirus vaccine developed by AstraZeneca had been criticized for not testing a sufficient number of people from this risk group.