FDA OKs emergency use authorization for AstraZeneca vaccine

The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the COVID-19 vaccine developed by British drugmaker AstraZeneca.

"After a thorough review of the currently available data by our medical and regulatory experts, the FDA is granting an emergency use authorization to the COVID-19 vaccine AstraZeneca," said FDA Director General Rolando Enrique Domingo in a public press briefing.

"It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risk. The interim data from the ongoing Phase 3 trials when taken to its entirety show that the vaccine has an efficacy of 70 percent after the first dose," he added.

AstraZeneca's vaccine was the second to be approved for emergency use in the Philippines. The first was that developed by Pfizer-BioNTech. The FDA's approval comes three weeks after AstraZeneca submitted its application for an EUA.

Domingo said that the adverse events reported when given an AstraZeneca vaccine are "mostly mild to moderate (which is) similar to common vaccine reactions."

"Ang nakitang adverse events nya are all very mild, very similar to getting flu injections. Ang karamihan ‘yung pananakit doon sa lugar ng injection, konting sinat, konting sakit ng ulo that are all transient and easily manage (The adverse events that were observed were all very mild, very similar to getting flu injections. Mostly, a pain in the injection site, a slight fever, a slight headache – that are all transient and can easily be managed)," he said.

"The company AstraZeneca will be working with the Department of Health, FDA, and of course the surveillance system that is being setup by the vaccination program to assure all adverse events are reported so we can monitor them very closely," he added.

This vaccine is authorized for use in people 18 years and older.

"The COVID-19 vaccine AstraZeneca shall only be administered by vaccine providers designated by the DoH at gagamitin lang kontra sa COVID-19, wala po syang ibang indication (and will only be used against COVID-19, it has no other indication)," said Domingo.

Domingo added that it can be kept at a regular refrigerator temperature.

“The advantage of this vaccine is that it is stored in two to eight degrees so it is not delicate and it is easy to transport and store,” he said.

Domingo noted that AstraZeneca vaccines cannot be sold commercially.

"We have to clarify that the EUA is not a marketing authorization, it is not a certificate of product registration. Therefore the EUA cannot be used as an authorization to market the vaccine commercially," he said.

“The AstraZeneca (company) shall supply the COVID-19 vaccine only to emergency responders. So maari po silang magbenta sa Department of Health or the National Task Force (NTF) or whoever the DoH or the NTF designate as authorize to procure COVID-19 vaccines such as LGUs (local government units), public and private hospitals, and other partners of DoH and NTF," he added.

Domingo said that the “validity of the EUA is only within the duration of the declared public health emergency due to COVID-19 or upon marketing authorization.”

He said that the FDA is still reviewing the EUA applications of Russia's Gamaleya Research Institute, China's Sinovac Biotech, and India's Bharat Biotech.