Novavax Already Signifies Intention To Apply For EUA In PH — FDA

Novavax had already signified its intention to apply for EUA in the Philippines, according to FDA.

The Food and Drug Administration (FDA) on Monday said that Novavax had already signified its intention to apply for emergency use authorization (EUA) in the Philippines.

Novavax To Apply For EUA
Photo source: Gavi

In a meeting with President Rodrigo Duterte last June 14, FDA Director-General Eric Domingo said that Novavax had already sent some of the clinical trial results to the FDA.

Novavax already wrote the other day signifying their intention to apply for emergency use authorization. In fact, they already sent some of the clinical trial results to us,” Domingo said.

Domingo also said that it was currently being studied by experts although it had yet to officially apply for an EUA in the Philippines. According to Domingo, Novavax may apply by July or August this year.

READ ALSO: DFA: China To “Prioritize” PH On COVID-19 Vaccine Delivery

It was last week when Domingo said that the Food and Drug Administration had approved for emergency use the COVID-19 vaccine Sinopharm.

In the past, the Food and Drug Administration also granted an emergency use authorization to Pfizer-BioNTech COVID-19 vaccine, Sputnik V COVID-19 vaccine, AstraZeneca COVID-19 vaccine, and Sinovac COVID-19 vaccine to name a few.

Meanwhile, the Department of Health (DOH) said that COVID-19 vaccines must secure “Certificates of Product Registration (CPR)” from the Food and Drug Administration before they’re allowed to be made commercially available in the Philippines.

Vaccine manufacturers may submit an application for CPR once they have finished all the clinical trial phases. Once they have a CPR already, it can already be made available commercially,” Health Undersecretary Maria Rosario Vergeire said in a virtual forum.

For more news and updates, you may feel free to visit this site more often. You may also visit Newspapers.ph via our official Facebook page and YouTube channel.

Leave a Comment