FDA still processing Sinovac's EUA application: DOH

By Ma. Teresa Montemayor

February 8, 2021, 9:47 pm

MANILA – Sinovac Biotech's bid for the emergency use application (EUA) of its Covid-19 vaccine in the Philippines, CoronaVac, is still being processed by the Food and Drug Administration (FDA), Department of Health (DOH) Undersecretary Maria Rosario Vergeire said on Monday.

In an online media briefing, Vergeire also reported that the independent clinical trials of Sinovac Biotech, Clover Biopharmaceutical and Johnson and Johnson Janssen pharmaceutical are still in site initiation phase or site selection and its readiness to enroll subjects.

"We continue to coordinate with the Department of Science and Technology and Task Group of Vaccine Evaluation and Selection, so we can get additional information on these clinical trials," Vergeire said.

Last week, Vaccine czar Carlito Galvez Jr. said 500,000 free doses of CoronaVac can be shipped to the country anytime as soon as FDA grants the EUA.

As to the Avigan trial last January 28, Vergeire said a total of 37 patients enrolled in the trial with 25 already finished treatment, six are currently still in the course of the medicines, four have withdrawn, four stopped with the study.

"As for the WHO (World Health Organization) solidarity trial, we had a meeting with them and they committed to us, by the second week of February, they can already provide us with the protocol, contract agreement and the other details for the solidarity trial. So up until then, that's the only time we can give information because they've requested from us that they will be the one to announce all the details when this WHO trial starts," she added.

To date, the FDA has granted EUA only to AstraZeneca's Covid-19 vaccine and Pfizer-BioNTech’s Covid-19 vaccine.

National Policy Against Covid-19 chief implementer Secretary Carlito Galvez Jr. earlier said some 117,000 doses of Covid-19 vaccines produced by Pfizer pharmaceutical company will be the first to arrive and these will be delivered in one tranche.

He said it would be followed by the arrival of around 5,500,000 to 9,290,400 doses of AstraZeneca vaccines to be delivered on the first and second quarter of this year. (PNA)

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