FDA: EUA for AztraZeneca jab may be out by end-January

FILE PHOTO: A test tube labeled with the Vaccine is seen in front of the AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic

MANILA, Philippines — The Food and Drug Administration (FDA) aims to finish its evaluation of British drugmaker AztraZeneca’s emergency use authorization (EUA) application and decide by the end of January, its chief said Friday.

FDA Director-General Eric Domingo said AztraZeneca has yet to submit additional requirements and clarify questions raised by the country’s vaccine experts panel regarding its Covid-19 jab.

“Basta sumagot sila sa kanilang mga requirement at mga katanungan sa kanila siguro po mga 10 days kaya na ‘yan, one week, seven to 10 days,” he said during the resumption of the Senate inquiry on the government’s Covid-19 vaccination program.

(As long as they comply with the requirements and clarify the questions posed before them, maybe 10 days, the evaluation could be finished.)

“’Yung AztraZeneca, end of January po ang target,” Domingo added.

The FDA has so far granted a EUA to Pfizer-BioNTech’s Covid-19 vaccine.

Meanwhile, the decision on EUA applications of Russia’s Gamaleya and China’s Sinovac is expected to be out before the end of February.

Domingo said Sinovac has recently submitted to FDA the results of its clinical trials.

Another drugmaker, Bharat Biotech from India, has likewise applied for a EUA for its Covid-19 vaccine. However, Domingo said the drug manufacturer’s clinical trials have no results yet.

US drug manufacturer Moderna has also expressed their intent to “soon” apply for a EUA in the Philippines as it has already discussed with the FDA the process and requirements for an application.

Serum Institute of India will also apply for a EUA in the country once it gets enough data on its Phase 3 trial of the Novovax vaccine, Domingo said.

By March, the country would have an “initial few hundred thousands” of Covid-19 vaccines from different brands, vaccine czar Carlito Galvez Jr. said in the same hearing.

According to him, the Philippines will be securing 148 million doses of Covid-19 vaccines from different drugmakers including Pfizer-BioNTech, Sinovac, AztraZeneca, Novovax, Johnson and Johnson, Gamaleya, and Bharat BioTech.

KGA