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Manila Bulletin devider Philippines devider National devider COVID-19 vaccines expected to get full authorization from PH FDA by 2022

COVID-19 vaccines expected to get full authorization from PH FDA by 2022

Published Nov 18, 2021 12:44 pm

Food and Drug Administration

The Food and Drug Administration (FDA) said that some coronavirus disease (COVID-19) vaccines may be granted a full authorization by next year.

This was the prediction of FDA Director-General Rolando Enrique Domingo as several vaccine developers are expected to finish the clinical trials of their respective vaccines this year.

“I believe--- my prediction is early next year, by the first quarter. Not only Pfizer, maybe several of the existing vaccines will get full approval for marketing authorization. I hope next year, it will be available in the private sector,” said Domingo in an interview over ABS-CBN News Channel on Thursday, Nov. 18.

Domingo said that his agency is “really eagerly awaiting” for vaccine developers to submit their data for full authorization.

“I believe that towards the end of this year, the clinical trials will end. They would have completed their clinical trials,” he said.

“Once they consolidate all of that data, most of these vaccines will probably start applying, not just in Philippine FDA but all FDAs all over the world,” he added.

All COVID-19 vaccines that are being used currently in the Philippines are under emergency use authorization (EUA). Under this set up, only the government can procure these vaccines. If a vaccine is granted a full authorization or a Certificate of Product Registration (CPR), then they can be sold commercially.

The vaccines that were granted EUA in the Philippines include Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik V, Janssen, Covaxin, Moderna, Sinopharm, and Covovax.

In the United States, its FDA granted full approval to Pfizer- BioNTech’s COVID-19 vaccine last August. The vaccine makers have yet to submit an application for full approval to the Philippine FDA, said Domingo.

“They (Pfizer-BioNTech) haven’t applied anywhere else other than the US at this time. We did ask them and they said they were completing all of their documents and requirements,” said the FDA chief.

“If they do apply here, it’s not going to take long. Kaya lang (However), they haven’t applied yet. It’s probably also because the company is not yet ready to supply... baka nagko-concentrate sila sa (maybe they are concentrating in) one market at this time,” he added.

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