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MANILA — The Department of Health on Wednesday said an executive order granting emergency use powers to the Food and Drug Administration (FDA) is necessary to speed up the approval of COVID-19 vaccines entering the country.

Health Undersecretary Maria Rosario Vergeire during a virtual forum pointed out that Republic Act 9711 or the FDA Act does not mandate the regulatory body to give emergency use authority for products even during a pandemic.

“Kaya po, hinihingi natin sa Presidente na bigyan ng authority ang FDA na magkaroon nito dahil sa mga batas natin, hindi tayo maaari na makapagbigay nito,” she said.

(This is why we are asking the President to give FDA the authority because in our laws, we cannot provide for this.)

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Vergeire said this a day after Health Secretary Francisco Duque III asked President Rodrigo Duterte for an executive order on the matter.

“We are respectfully requesting that you consider the issuance of an executive order for FDA to grant an Emergency Use Authorization (EUA) for the various vaccines that will enter the country and for which applications are to be filed,” Duque told Duterte during a meeting on Tuesday night.

Duque said the EUA would “cut the red tape” and the processing time from 6 months to just about 21 days.

He also explained that an EUA would allow the FDA to use the evaluation of other national regulatory authorities in considering the application of vaccine developers.

Vergeire pointed out that the FDA needs a policy basis for it to issue an EUA, although the Bayanihan 2 Act already allows vaccines under development to enter the country.

While vaccines regularly have to pass 4 phases of clinical trials, countries around the world are now allowing public use after Phase 3 because of the emergency situation brought about by the COVID-19 pandemic.

Vergeire also pointed out that Phase 4 trials, which looks into side effects of a vaccine on larger populations, will still be done, although procurement is allowed already after Phase 3.

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She pointed out that before the pandemic, the regulatory process of the FDA can last to about 270 days to a year.

She said that even if the process is expedited to just 21 days, they have safeguards in place, such as the pre-screening by an expert panel.

Vaccine czar Secretary Carlito Galvez supported the DOH’s request for an EO. He said of the 17 possible vaccines from other countries, 9 are already in Phase 3. Three of those might undergo clinical trials in December and January, he said.

Galvez said the private sector already raised money to help in vaccine procurement.

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He asked Duterte to undergo “Advance Market Commitment” for the purchase of vaccines through the World Bank and the Asian Development Bank as finance managers.

“At the same time, we have also to have various modes of financing including Private-Public Tripartite Agreement without the cost with the government. So the private sector will finance it by buying directly to the vaccine company but with ano --- with the regulation that the DOH will be the one who will know, who will decide where the vaccine will be given,” Galvez said.

— With a report from Joyce Balancio, ABS-CBN News