The Food and Drug Administration (FDA) announced Friday that it granted an Emergency Use Authorization (EUA) to the Sputnik V Gam-Cov-Vac COVID-19 vaccine manufactured by Russian drugmaker Gamaleya Research Institute.
“Today, we would like to announce that after a rigorous and thorough review by the regulatory and medical experts of the currently available published and unpublished data, the FDA is granting emergency use authorization to the Sputnik V Gam-Cov-Vac COVID-19 vaccine manufactured by Gamaleya National Center of Epidemiology and Microbiology,” said FDA Director General Rolando Enrique Domingo in a press briefing.
Domingo said it was “reasonable to believe” that the Sputnik V vaccine is effective to prevent COVID-19 based on the totality of evidence available to date, including “data from adequate and well-known controlled trials.”
Domingo said the interim data on the ongoing Phase 3 trials of the Russia’s vaccine showed that it has an “an overall efficacy of 91.6 percent in preventing COVID-19 and the efficacy rate is consistent to all age groups aged 18 and older.”
“The adverse events reported were mostly mild and transient similar to common vaccine reactions. No specific safety concerns were identified,” he said.
Domingo said the vaccine requires two doses, three weeks apart.
“The known and potential benefits of the Gamaleya Sputnik V vaccine, when used to prevent COVID-19, outweigh the known and potential risks,” he said.
Domingo, meanwhile, noted that the EUA is not a marketing authorization.
“We have not issued any Certificate of Product Registration for any COVID-19 vaccine, so no COVID-19 vaccine can be sold in the market commercially. Hence, this EUA cannot be used as an authorization to market the vaccine commercially,” he said.
Aside from Gamaleya, the FDA had granted EUA for the COVID-19 vaccines developed by American drugmaker Pfizer, British firm AstraZeneca, and China’s Sinovac Biotech.