Putin touts questionable second approval of unproven COVID-19 vaccine


Additionally, EpiVacCorona has not yet entered the larger clinical trials needed to determine safety and efficacy. In general, data from advanced stage clinical trials (phase III trials) are required for standard regulatory approval. These trials tend to involve tens of thousands of participants, who are followed closely for months to assess the vaccine’s effectiveness in preventing infections and to watch for rare side effects.

Still, Putin touted the new vaccine at the press conference, revealing that Deputy Prime Minister Tatyana Golikova and Russia’s Consumer Safety Oversight Chief Anna Popova both received doses of EpiVacCorona in as part of a clinical trial.

The dearth of data on EpiVacCorona echoes what was seen in August, when Russia approved its first COVID-19 vaccine, Sputnik V. This vaccine was also approved without published data after being tested on just 76 people. The first results of the trials have since been published on the vaccine, but researchers quickly noted quirks in the data. Sputnik V is currently in phase III of major trials.

And, like EpiVacCorona, Putin announced the approval of Sputnik V while noting early and high-profile vaccinations. Putin revealed that one of his own daughters received a dose of the vaccine.


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