The Food and Drug Administration (FDA) on Thursday granted emergency use authorization (EUA) to Pfizer-BioNTech’s coronavirus disease 2019 (Covid-19) vaccine (BNT162b2) after actual review by the country’s medical and regulatory experts.
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known potential risks. The interim data from the ongoing Phase 3 trial shows that the vaccine has an efficacy of 95 percent in the study population and at least 92 percent among all racial groups,” FDA Director General, Dr. Eric Domingo said in an online press briefing.
Domingo noted that the adverse events reported in some countries that have rolled-out vaccinations are transient and are mostly mild to moderate, similar to common vaccine reactions. He said following immunization, the adverse events will be closely monitored.
The vaccine’s rollout and use in more than 5 million people worldwide have identified severe allergic reaction in a few individuals.
Domingo said vaccinations must be done by health professionals who are trained to recognize and manage such adverse reactions and should have resources at hand to adequately respond.
Domingo clarified that the EUA granted to the vaccine is not a marketing authorization or a Certificate of Product Registration, as stated under executive order no. 121.
“Hence, it cannot be used as an authorization to market the vaccine commercially. Hindi pa po siya maaaring ibenta sa mga botika o sa mga doktor o maibebenta din directly sa pasyente (It cannot be sold in drugstores or to doctors or to patients directly),” Domingo said.
He added that Pfizer Inc. would supply the vaccine only to emergency response stakeholders consistent with the terms and conditions of the EUA or their designees authorized to procure the vaccine in line with the Covid-19 vaccination program.
Vaccine czar Carlito Galvez said Wednesday that Pfizer may be the first Covid-19 vaccine to enter the country through the COVAX Facility which is an international platform aiming for equitable access to vaccines.
“The development of these vaccines is still ongoing. We will keep track of the progress and FDA will provide our public with the correct information on the authorized products for transparency, to aid the decision making of Filipinos,” Domingo said.
As for the EUA application of AstraZeneca, Domingo said it is still in the middle of the evaluation process as experts are waiting for some clarifications from the pharmaceutical firm.
“We hope to finish the evaluation within 21 days kasi ang AstraZeneca may EUA naman (because Astrazeneca has EUA) from the United Kingdom,” he said.
“‘Yung sa Gamaleya and ‘yung sa Sinovac talagang (Those for Gamaleya and Sinvoac) they’re still pending some documents and some requirements,” he added.
An EUA would be granted only if data on controlled trials show that the benefits of the vaccine or treatment outweigh the risks it poses. Domingo said. CURRENTPH