FDA inspection of Russian vaccine facility off as Gamaleya Institute files documents

Kristine Sabillo, ABS-CBN News

Posted at Mar 17 2021 08:06 PM

MANILA — The Food and Drug Administration on Wednesday confirmed that its inspectors would no longer visit Russia to check on the manufacturing facility of Gamaleya Institute’s Sputnik V COVID-19 vaccine. 

“The inspection trip to Russia did not push through because last Friday the applicant submitted the required documents and those are being reviewed,” FDA Director General Eric Domingo said in a text message to ABS-CBN News.

Domingo said this after another FDA official on Saturday said that the Russian-funded Gamaleya Institute had submitted all of its documents required for its emergency use authorization (EUA) application.

COVID-19 vaccines under development are required to secure an EUA before they can be used for a country’s immunization program. 

On Saturday, the FDA official had said they would still evaluate if the inspection is needed.

Domingo previously explained that every company applying for an EUA is required to submit a Certificate of Good Manufacturing Practice.

Domingo did not say when they would finish the evaluation.

Currently, only Pfizer, AstraZeneca and Sinovac have EUAs in the Philippines. Besides Gamaleya, also awaiting an EUA is India’s Bharat Biotech. Chinese government-owned Sinopharm also applied but has not submitted enough documents.

As of Tuesday, more than 240,000 health workers have been vaccinated against COVID-19 using AstraZeneca and Sinovac doses. This is out of the more than 1.1 million doses that the country has received so far.

The Philippines previously said it plans to buy 20 million doses of Sputnik V vaccines from Russia.

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