AstraZeneca, Pfizer, Sinovac looking to apply for EUA in Philippines —FDA

Pharmaceutical companies AstraZeneca, Pfizer, and Sinovac are looking to apply for emergency use authorization (EUA) for their COVID-19 vaccine candidates in the Philippines, an official said Tuesday.

Food and Drug Administration (FDA) Director General Eric Domingo said the three companies have reached out to the Philippines about getting emergency use approval.

"Most of them naman talagang naghihintay na rin ng EUA guidelines natin, I think they will be applying soon," Domingo said at a Malacañang briefing.

Earlier this month, President Rodrigo Duterte allowed the FDA to issue an EUA for COVID-19 drugs and vaccines.

Officials earlier said an EUA will reduce the processing time for the approval of the vaccines for local use from six months to 21 days.

According to an executive order by Duterte, an EUA may be issued if data from clinical trials show it is reasonable to believe the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19, and that its known benefits outweigh potential risks, among other conditions.

An EUA will be valid only during the declared COVID-19 public health emergency but the FDA director general could revisit or revoke it “to protect the general public health and safety,” according to the EO.

Domingo last week said only drug manufacturers and the government can request the FDA for an EUA for vaccines still in development. He stressed that an EUA is not does not mean the vaccine is ready for commercial use.

One of the companies, AstraZeneca, recently withdrew its application to conduct clinical trials in the Philippines. Domingo said AstraZeneca may still supply vaccines in the country once it gets government approval.

Pfizer will not conduct trials in the country, the Department of Health said in September. Sinovac has a pending application.

Britain was the first country in the world to approve the Pfizer-BioNTech COVID-19 vaccine for use. A 90-year-old woman was the first to get the vaccine. — BM, GMA News