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FDA: Full jabs approval set next year



The Philippine Food and Drug Administration (FDA) on Thursday said that the public will soon have direct access to several coronavirus disease 2019 (Covid-19) vaccines as early as the first quarter of 2022.

FDA director general Eric Domingo said that the country’s regulatory body is expecting to give full approval on several Covid-19 vaccine brands that will allow them to distribute and sell in the market.

“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,” Domingo said.

The statement came after the United States-FDA gave full approval to Pfizer-BioNTech’s Covid-19 vaccine in August and Domingo noted that they have already asked Pfizer to submit an application for full approval, but the American vaccine manufacturer said it was still completing their requirements.

“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,” Domingo said.

“If they do apply here, it’s not going to take long. However, they haven’t applied yet. It’s probably also because the company is not yet ready to supply,” he added.

Domingo also revealed that none of the vaccine manufacturers who initially received emergency use authorization (EUA) has applied for the full approval permit.

“I believe that towards the end of this year, the clinical trials will end. They would have completed their clinical trials,” Domingo said. “Once they consolidate all of that data, most of these vaccines will probably start applying, not just in Philippine FDA but all FDA all over the world.”

So far, the FDA has granted EUA to nine vaccine brands such as Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik V, Janssen, Covaxin, Moderna, Sinopharm and Covovax.

Under the EUA, vaccine manufacturers are only allowed to transact with the government.

Previously, Domingo explained that a vaccine manufacturer must complete Phase 3 of its clinical trial before they can acquire a Certificate of Product Registration (CPR).

A CPR is a permit issued by the FDA for a product before it can be distributed and sold in the market.

The FDA chief also added that aside from completing the Phase 3 clinical trial, safety data must be presented along with efficacy data to the regulatory body.