FDA: EUA to enable arrival of COVID-19 vaccines in PH before Q2 2021

MANILA, Philippines — The Food and Drug Administration (FDA) said Friday that the availability of the COVID-19 vaccines in the country before the second quarter of 2021 would only be possible if President Rodrigo Duterte lets the agency issue the emergency use authorization (EUA) for it.

FDA Director-General Eric Domingo said in an online press briefing that EUA could expedite the procurement of COVID-19 vaccines.

“Yes, I would think so, once we have the EUA mechanism in place,” he said when asked if EUA could make possible the arrival of the vaccines by the second quarter of next year.

Health authorities have sought the approval of Duterte to allow the FDA to grant EUAs to vaccines that will be made available in the country.

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

Palace spokesman Harry Roque later said that Duterte approved “in principle” the executive order that would allow the FDA to grant EUA to COVID-19 vaccines.

With the EUA, the FDA is seen to shorten its process of approving COVID-19 vaccines from six months to just 21 days, according to Domingo. Also, the FDA’s issuance of EUA to COVID-19 vaccines means the agency recognizes the vaccines’ approval by regulatory bodies overseas.

Pharmaceutical companies Pfizer and Moderna, which vaccines have reportedly shown to have high effectivity against COVID-19, separately announced plans to apply for EUA in the US-FDA soon.

“Once nakakuha na sila ng EUA for example sa US FDA, mas mapapabilis talaga ‘yung proseso (it will really speed up the process). And we will be able to take a look at evaluations that are done by these reliable regulatory agencies, that will hasten the process of having them available here,” Domingo explained.

KGA