Only Pfizer’s Covid-19 vaccine has applied for EUA: FDA

By Ma. Teresa Montemayor

December 29, 2020, 4:35 pm

<p>Food and Drug Administration Director General Eric Domingo <em>(screenshot)</em></p>

Food and Drug Administration Director General Eric Domingo (screenshot)

MANILA – Food and Drug Administration (FDA) Director General Eric Domingo said Tuesday the only application for Emergency Use Authorization (EUA) it has received so far was for the Pfizer’s vaccine for the coronavirus disease 2019 (Covid-19).

"This (application) was submitted to us late in the afternoon of December 23. This was submitted online to the FDA and we have downloaded their submissions yesterday, and have distributed them to the reviewers and regulators," Domingo said in an online media briefing.

He said the evaluation, which he hopes to be completed within two weeks, would focus on both the regulatory side for the quality of the vaccine and the clinical trial for its efficacy and safety.

"Of course, that doesn't include the possibility that we'll still be requesting documents for their application. But as far as I can see, almost all our requirements are included in their submission. We just have to go through it," Domingo said, adding that other vaccine manufacturers could be ready for their EUA application by January 2021.

He said the FDA has already received three applications for the vaccine clinical trials to be held in the country.

"Yesterday, we already approved one and this is the clinical trial of Janssen (of Johnson & Johnson). This has been given the go signal by FDA and maybe, they will already start with the clinical after the New Year," Domingo said.

He said the application of China's Clover Biopharmaceuticals is still pending as the FDA is "waiting for some documentation from the proponent for the completion of requirements.”

China’s Sinovac, he said, has requested some changes in their protocol or research design so it was returned to the reviewers for final clearance.

On Monday, Domingo ordered the FDA Regulatory Enforcement Unit to look into reports that certain individuals in the country have received shots of vaccines against Covid-19.

"We want to know the status of the vaccination and which vaccines were used. But of course, that will probably take a few days, so we can't give you updates yet," he said. (PNA)