PH okays emergency use of Pfizer COVID-19 vaccine

BY ANALOU DE VERA

The Food and Drug Administration (FDA) announced Thursday that it has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in the country.

“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine,” said FDA Director-General Rolando Enrique Domingo.

“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,” he added.

“Evaluation was based on current available data. The assessment ensured that the benefits outweigh the known and potential risks of the product,” he said.

The FDA approval comes three weeks after the US-based pharmaceutical company applied for an EUA in the Philippines last Dec. 23.

The EUA allows the use of Pfizer vaccine through the conduct of a national immunization program.

“The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially,” Domingo said.

The FDA chief said that “adverse events following immunization” shall be closely monitored.

“The roll out of the vaccine and use in more than five million worldwide has identified severe allergic reaction in a few individuals. Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond,” said Domingo.

“Reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented,” he added.

Domingo said that the FDA will “ensure that Filipinos can have access to vaccines that hold greater benefits and outweighs the risk and possible adverse effects” during this pandemic.

“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,” he said.