No adverse events reported in Phase 3 trials that involved 36,000 volunteers, says its Health Ministry
- Russia’s Sputnik V vaccine has proven to be “92% efficacious” among a group of volunteers who are part of Phase 3 trials to test the vaccine, the Russian Health Ministry said in a statement
- The results were based on an analysis of 20 participants in the trial who were confirmed COVID-19 positive. The trials consist of 20,000 people who got one dose of the vaccine, and 16,000 who got two, 14 days apart. The efficacy percentage means that when cases were split among the placebo group and vaccinated group, 92% of those who were vaccinated were safe.
- This is close to the efficacy percentage claimed by Pfizer on Monday that said its RNA vaccine was 90% efficacious, though that relied on a larger COVID-19-positive volunteer set of 94.
- The Russian trials are ongoing in multiple countries, and a Phase 2/3 trial that tests for a immune reaction in a limited number of people is going on in India too. Hyderabad-based Dr. Reddy’s Laboratories is a partner of the Russian organisation, Gamaleya Research Foundation, that has developed Sputnik V.
- The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks. Thanks to the production scale-up at new manufacturing sites, Sputnik V vaccine will soon be available for a wider population. This will break the current trend and lead to an eventual decrease in COVID-19 infection rates, first in Russia, then globally.
- As with Pfizer’s, the preliminary report of Sputnik V’s efficacy is yet to be published in a peer-reviewed medical journal. The latter has also not yet been evaluated by an independent board of medical experts, the Russian Health Ministry statement indicated.
- Because Sputnik V has emergency authorisation from medical authorities in Russia, it had also been administered to a section of the population such as doctors and medical workers. Apart from the trial participants, the effects of vaccination were also observed in 10,000 volunteers representing medics and other high-risk groups under the civil use of the vaccine out of clinical trials also confirmed the vaccine’s efficacy rate of over 90 percent.
- Results from Pfizer+BioNTech opens the closed door to vaccine availability a little. One can legitimately expect more good news from more vaccines and expect that the door will open even more. Even after these and other licences were available, only limited doses would be available in the early days and would be administered according to “priorities already set”.
- However, the data so far available for the Pfizer vaccine did not indicate if it was effective at preventing disease transmission or was only good enough to protect from severe disease. There was also no evidence disclosed on whether it protected older (and more vulnerable) people.