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

Friday, September 25th, 2020. Filed under: News

MANILA, Sept 25 (Mabuhay) — 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.

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.  (MNS)

ALSO READ: Avigan trial still awaiting finalization of legal documents –DOH

Related posts

Iloilo placed under MECQ from Sept. 25-Oct. 9DILG chief to meet with Metro mayors on fate of GCQNCR is flattening COVID-19 curve –UP expertAreas with zero COVID-19 transmission should be classified under new normal — RoquePH Covid-19 case count up by 3,475; recoveries now over 230KPH Covid-19 cases rise by 3,311; recoveries now 229,865Palace appeals to public: Give ‘staycations’ amid COVID-19 crisis a chancePH Covid-19 cases rise to 265,888; recoveries now 207,504Palace appeals to public: Give ‘staycations’ amid COVID-19 crisis a chancePhilippines logs 3,372 more COVID-19 cases; total at 261,21618,065 new Covid-19 recoveries bring total to over 273KPH Covid-19 recoveries climb to 254,223; active cases now 54,294PH Covid-19 recoveries now 253K, active cases rise to 52,702MGCQ status for Metro Manila in November not impossible — PalaceCovid-19 cases drop due to ‘One Hospital, Oplan Kalinga’Easing NCR GCQ may lead to COVID-19 surge around Christmas, experts sayPalace says worst of Covid-19 is overPhilippines’ COVID-19 cases top 245,000 with 3,176 new infectionsPhilippines allows use of antigen test to detect COVID-19Christmas parties prohibited in Metro Manila, Philippines’ GCQ areas