COVID vaccine applications for commercial distribution possible by 2021: FDA


Posted at May 06 2021 11:47 AM | Updated as of May 06 2021 12:01 PM

COVID vaccine applications for commercial distribution possible by 2021: FDA 1
Medical workers receive their first dose of the Sputnik V COVID-19 vaccine at the Sta. Ana Hospital in Manila on May 4, 2021, as the Russian vaccine rolls out in five cities in Metro Manila. Mark Demayo, ABS-CBN News

MANILA - Applications for the commercial distribution of COVID-19 vaccines could come as early as next year, the Food and Drug Administration said Thursday.

The Philippines has so far only granted emergency use authorization (EUA) to vaccine candidates of 7 drugmakers: Pfizer-BioNTech, Oxford-AstraZeneca, Gamaleya Institute, Sinovac Biotech, Johnson & Johnson, and Bharat Biotech, and Moderna.

"Before you get a certificate of product registration (CPR) you have to complete your phase 3 trial. Personally I expect the earliest mag a-apply for CPR is late this year or early next year," FDA director-general Eric Domingo told ANC's Headstart.

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The agency had also granted compassionate special permit (CSP) for the use of Sinopharm's COVID-19 jab on President Rodrigo Duterte's close-in security detail.

Duterte earlier this week was vaccinated with the Chinese vaccine, which he has since ordered to be pulled out of the country, Domingo said.

"The President accepted there was a lapse. Pinatanggal niya na lahat ng Sinopharm na nandito sa Pilipinas," he said.

(He has ordered the removal of all Sinopharm vaccines here in the Philippines.)

"I think yesterday we were very successfully able to explain to the President the situation. And as you can see the President is maybe willing to rectify once he realize there was a problem using a vaccine that is under CSP instead of using a vaccine under EUA."

The FDA has asked the Presidential Security Group to submit a report on how many doses were brought in the country, how many were used, the list of persons inoculated, and side effects or outcomes monitored, Domingo said.

The Philippines is aiming to inoculate 50 to 70 million of its population against COVID-19 by yearend to achieve herd immunity. As of Tuesday, it has administered 2.065 million doses of COVID-19 vaccine.