DOH: Duterte order needed for emergency use of COVID-19 vaccines

The Department of Health (DOH) said an executive order is needed to grant emergency use authorization (EUA) to the Food and Drug Administration (FDA) to hasten the approval of coronavirus vaccines that will enter the country.

In a virtual press briefing on Wednesday, November 18, Health Undersecretary Maria Rosario Vergeire stressed the need for the FDA to have EUA especially in this time of pandemic.

"Kaya hinihingi natin sa Presidente na bigyan ng authority ang FDA na magkaroon nito dahil sa mga batas natin ay hindi tayo maaring magbigay nito," Vergeire said. (That's why we're requesting for the President to give FDA the authority, because our laws don't allow [the DOH] to do so.)

An EUA will speed up the processing time for approval of COVID-19 vaccines that will enter the country – from 6 months to 21 days.

In a cabinet meeting with President Rodrigo Duterte on Tuesday night, Health Secretary Francisco Duque III requested the Chief Executive to grant FDA with EUA as 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 (EUA) for the various vaccines that will enter the country and for which applications are to be filed," Duque said.

'Expedited process'

During Wednesday's briefing, Vergeire explained that the expedited process would not sacrifice thorough evaluation of the vaccines, as the FDA would still continue monitoring them even if they are already registered.

"We have the vaccine expert panel at the start, and the FDA would continuously monitor this technology kahit nabigyan na nila ng rehistro sa ating bansa (even though they are already registered in our country)," she explained.

Vergeire pointed out that while vaccine development usually has 4 phases of clinical trials, countries around the world reduced the process to just 3 phases due to the urgency of the pandemic situation.

"[However], we are not removing phase 4, because we are also doing that even though we already procured [the vaccines]," she added.

Vergeire also assured the public that the Philippine government can still procure COVID-19 vaccines from companies like Moderna, which did not hold clinical trials in the country.

She added that if the country's vaccine expert panel is able to evaluate a vaccine and get FDA approval, "then we can readily procure these sets of vaccines."

Out of the 17 vaccines being developed around the world, 9 are currently undergoing the 3rd phase of trials, with Pfizer and Moderna reporting promising results. – Rappler.com

Bonz Magsambol

Bonz Magsambol is a multimedia reporter for Rappler, covering health, education, and social welfare. He first joined Rappler as a social media producer in 2016.

image