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FDA yet to receive any application for phase 3 trial of COVID-19 vaccine

The Food and Drug Administration (FDA) has not yet received any applications from COVID-19 vaccine manufacturers to hold phase 3 trials in the Philippines, FDA Director General Eric Domingo said Thursday.

According to a Raffy Tima’s report on “24 Oras,” Russia’s Sputnik V vaccine and the one being developed by Johnson and Johnson have not yet reached the FDA.

“Wala pang umaabot sa FDA na application for a clinical trial for a COVID-19 vaccine. They are still with the vaccine expert panel. I think they are still completing documents. So officially, wala pang na-e-endorse sa FDA,” Domingo said.

The COVID-19 vaccine of Chinese firm Sinovac, meanwhile, has not yet reached the vaccine review panel.

“Kung dumating ngayon ‘yung mga applications ta’s ma-vet at saka ma-clear ng expert panel natin, their target is at the very earliest, by end of October, mag-start ng clinical trials,” Domingo said.

Phase 3 is the longest part of vaccine development that typically takes five to six months and involves thousands of people.

However, passing phase 3 is not a guarantee that a vaccine is effective.

“Kailangan, of course, wala tayong safety issue and second is the efficiency. Kasi kung ma-register siya pero ‘yung effectiveness naman niya, ang immunogenicity is 20 o 30 percent lang, masyadong mababa naman ‘yun to be an effective vaccine,” Domingo explained.

The FDA chief added that it is likely that a COVID-19 vaccine will be rolled out mid-2021 in the Philippines at the rate the process is going.

Domingo said this is still quicker than the normal vaccine development period of five to ten years.

The Philippines has 296,755 COVID-19 cases as of Thursday afternoon.  — Julia Mari Ornedo/BM, GMA News