Science reported a review of the new vaccine by the Gamaleya National Center of Epidemiology and Microbiology in Moscow involved just 20 COVID-19 cases — far too few for the claim of 92% efficacy for the “Sputnik V” vaccine to be convincing.
Pfizer and BioNTech analyzed 94 cases to make their efficacy claim, and other vaccine makers plan to wait for at least 50 or more COVID-19 cases to accumulate in a trial to assess a candidate’s worth, Science reported.
“It’s very difficult to explain [the Gamaleya] announcement,” Svetlana Zavidova, a Moscow-based lawyer who heads Russia’s Association of Clinical Trials Organizations, told Science.
“I’m afraid they looked at the results of Pfizer and added 2%.”
The claims don’t pass “the smell test,” Wayne Koff, who heads the nonprofit Human Vaccines Project, told Science.
The Food and Drug Administration “wouldn’t have accepted a report on 20 cases,” John Moore, a vaccine researcher at Weill Cornell Medical College, added, calling the announcement “Putinology,” referring to the Russian president, Science reported.
“Why is Russia doing this?” he asked. “It’s the international vaccine race. They want to be seen to be keeping up with their competitors in other countries. It’s clearly a rushed out announcement. But it doesn’t mean it’s wrong.”
One month before Sputnik V’s efficacy trial launched in September, the Gamaleya vaccine received a highly controversial approval from Russian regulatory authorities, Science reported.
Koff, who for many years headed the AIDS vaccine division of the U.S. National Institutes of Health, told Science the efficacy claim for the Russia vaccine is an “interesting observation,” though one that is hard to evaluate because Gamaleya, like Pfizer and BioNTech, offered scant data.
According to Science, Pfizer and BioNTech and other companies have made their trial protocols public, but Gamaleya has not. Zavidova noted that she learned more about the details of Gamaleya’s study on a clinical trials website maintained by NIH than she did on a similar registry in Russia, which has “only the name of this protocol without any details.”
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