FDA seeks Duterte OK for emergency use of COVID-19 vaccines

FILE PHOTO: Small bottles labelled with “Vaccine” stickers stand near a medical syringe in front of displayed “Coronavirus COVID-19” words in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration

MANILA, Philippines — Health authorities are seeking the approval of President Rodrigo Duterte to allow the Food and Drug Administration (FDA) to grant emergency use authorization (EUA) to coronavirus vaccines that will be made available in the country.

In a televised press briefing Thursday, FDA Director-General Eric Domingo said Duterte has a “positive response” to the request.

“Once mabigyan tayo ng authority na magbigay ng EUA, hopefully meron din po mag-apply sa atin na nakaapprove na po sa ibang bansa,” Domingo said.

The COVID-19 vaccines of China’s Sinovac Biotech and Russia’s Gamaleya Research Institute have already secured EUA from their respective governments.

But Domingo said the vaccines need to secure EUA from the FDA of the Philippines as well for them to be able to be used in the country.

“Hindi po automatic iyon kasi unang-una iyong EUA po particular sa kanilang bansa so mag-aaply pa po sila dito ng EUA,” he said.

He further assured that only those vaccines that will be proven to have high efficacy and minimal side effects will be given EUA in the country.

In a meeting in Malacañang on Tuesday night, Health Secretary Francisco Duque III asked the President to grant FDA with EUA, saying that it would also “cut the red tape.”

“We are respectfully requesting that you consider the issuance of an executive order for FDA to grant an Emergency Use Authorization for the various vaccines that will — will enter the country and for which applications are to be filed,” Duque told Duterte.

Duque said that the EO will help cut the processing time for approval of COVID-19 vaccines from six months to just about 21 days.

Over a hundred COVID-19 vaccines are currently being developed worldwide but not one has yet to reach the stage where it is considered safe for mass inoculation.

In the Philippines, Sinovac is currently seeking approval from the FDA to conduct Phase 3 of its trials in the country.

Sinovac is the first drugmaker to get past the Philippine vaccine expert panel’s initial evaluation. The panel is also evaluating the COVID-19 vaccines of Gamaleya’s Sputnik-V and Johnson & Johnson’s Janssen subsidiary for late-stage trials.

Meanwhile, talks with US drugmakers Pfizer and Moderna are also ongoing according to the DOH.

EDV