FDA cancels inspection trip to Russia as Gamaleya submits EUA documents

MANILA, Philippines — The Food and Drug Administration (FDA) has canceled its inspection trip to Russia after the Gamaleya Research Institute submitted the required documents to secure an emergency use authorization (EUA) in the Philippines for its Sputnik V COVID-19 vaccine.

FDA Director-General Eric Domingo said a team from the drug regulator was supposed to fly to Russia this week to inspect the factory of Gamaleya Research Institute. Gamaleya earlier invited the FDA to visit its factory instead of submitting a Certificate of Good Manufacturing Practice, two months after applying for a EUA.

“The inspection trip to Russia did not push through because last Friday the applicant submitted the required documents and those are being reviewed,” Domingo told INQUIRER.net in a text message on Wednesday.

In November last year, Russia said its Sputnik V vaccine is 92 percent effective at protecting people from COVID-19 based on interim trial results.

Vaccine czar Carlito Galvez Jr. earlier said the EUA application of Gamaleya for its COVID-19 vaccine is now on its “advance stage.” 

So far, only US drugmaker Pfizer, British-Swede firm AstraZeneca, and China’s Sinovac Biotech have secured EUA in the Philippines.

Aside from the Gamaleya Research Institute, China’s Sinopharm and India’s Bharat Biotech also have pending EUA applications before the FDA.

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