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Russian President Vladimir Putin on Wednesday announced the second dubious approval of a COVID-19 vaccine that has not been evaluated in clinical trials.
The vaccine, dubbed EpiVacCorona, is said to be a synthetic peptide-based vaccine, which uses fragments of the pandemic virus SARS-CoV-2 to spur protective immune responses in those vaccinated. It was developed by Vector State Virology and Biotechnology Center, a former Soviet bioweapons research lab.
Like the first Russian-approved vaccine, whether EpiVacCorona is actually safe and effective is completely unknown. In a televised news conference, Putin said that early trials involving 100 people were successful. But researchers have not published any safety or efficacy data from those trials. Russian health officials have said they are still reviewing the vaccine for “safety and quality” but declined to provide any additional information on the vaccine, data, or approval process.
Moreover, EpiVacCorona has not yet entered larger clinical trials necessary to determine safety and efficacy. Generally, data from late-stage clinical trials (Phase III trials) are required for standard regulatory approval. Those trials tend to involve tens of thousands of participants, who are closely followed for months to assess how effective the vaccine is at preventing infection and to monitor for rare side-effects.
Still, Putin touted the new vaccine in the news conference, revealing that Deputy Prime Minister Tatyana Golikova and the head of Russia’s consumer safety watchdog Anna Popova have both been given doses of EpiVacCorona 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. That vaccine was also approved without published data after being tested in only 76 people. Early trial results have since been released on the vaccine, but researchers quickly noted oddities in the data. Sputnik V is now in large Phase III trials.
And, like EpiVacCorona, Putin announced the approval of Sputnik V while noting early, high-profile vaccinations. Putin revealed that one of his own daughters had received a dose of the vaccine.