FDA: 7 COVID-19 vax brands approved for emergency use in PH

By Ma. Teresa Montemayor/PNA

MANILA – Food and Drug Administration (FDA) Director-General Eric Domingo on Monday (May 10) said the Philippines has the second most number of authorized vaccines for use against COVID-19.

“Since last week po, we already have seven vaccines that we have given emergency use authorization (EUA),” Domingo said in a meeting with President Rodrigo Duterte.

“Iyong mga ibang country po, usually a little less, but…mayroong tina-target po na dalawa sila [National Task Force Against COVID-19 Sec. Carlito Galvez Jr.] to come into the country aside from the seven that are already authorized.”

 Domingo reported there are 111 vaccine candidates worldwide undergoing clinical trials on humans – Phases 1, 2, and 3 – and of these, 14 are already being used in different countries.

So far, the FDA has granted EUAs to the COVID-19 vaccines from AstraZeneca, Sinovac, Gamaleya Institute, Johnson & Johnson, Bharat Biotech, Pfizer-BioNTech, and Moderna, following Executive Order No. 121 signed by the President on Dec. 1, 2020.

The FDA observes two conditions in granting a EUA to COVID-19 vaccines — the presence of enough evidence showing the vaccine may be able to prevent COVID-19, and safety for use, which means its known and potential benefits outweigh the risks.

“Iyon pong Bharat Biotech, ito po ‘yong isang Indian vaccine na hinihintay pa po natin ‘yong good manufacturing practice certificate niyan bago makapag-import sa Pilipinas,” Domingo said.

As for Sinopharm’s COVID-19 vaccine, the FDA has requested pertinent clinical trial data and the information from the World Health Organization (WHO) which included the vaccine in its emergency use listing so that the country’s vaccine expert panel can conduct a quick review.

“The Strategic Advisory Group of Experts of WHO completed the review of the vaccine of Sinopharm. In fact, they also did inspections of the factory to make sure that it follows good manufacturing practice. And it was found to have efficacy in preventing symptomatic and hospitalized disease at an estimated 79 percent among all age groups,” Domingo added. (PNA) -jlo

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