FDA: Sputnik V vaccine thoroughly reviewed by experts before EUA grant

Philippine experts have thoroughly reviewed Sputnik V, the coronavirus vaccine developed by Russia’s Gamaleya Institute, before it was granted an emergency use authorization (EUA), Food and Drug Administration (FDA) chief Eric Domingo said Thursday.

The Russian vaccine recently came under scrutiny after Brazilian authorities recommended against it over “critical issues” on its effectiveness and safety.

The FDA issued an EUA for Sputnik V in March.

Domingo assured the public that the Gamaleya Institute “satisfied” requirements concerning Sputnik V’s safety and efficacy.

“If you remember, if you look at our timeline, it took us the longest probably to check the Russian vaccine because we really required and asked for all of the documents regarding safety and efficacy and of course the quality of the product,” Domingo told ANC.

“We were satisfied in the end after so many exchanges of emails and communication… and that is why our experts deemed that the benefit of using the vaccine is really way more than the possible risk associated with it,” he added.

Domingo also said Sputnik V’s clinical trial data was published in a respected peer-reviewed journal “and that was enough for our experts to say that it is a good vaccine to use.”

Vaccine czar Secretary Carlito Galvez Jr. said Philippine authorities would rely on official reports and not just news articles in deciding whether to reevaluate the jab. 

The Philippines has received over 3.5 million doses of the AstraZeneca and Sinovac vaccines. More than 1.5 million individuals have been inoculated as of April 27. --NB, GMA News