By NG Seruela
The Food and Drug Administration (FDA) reported that the American biotech company Novavax has submitted most of its requirements for its emergency use authorization (EUA) application following its application on Friday (Aug. 6).
In today’s (Aug. 9) Laging Handa, FDA Director-General Eric Domingo said the evaluation on the vaccine manufacturing side and safety and efficacy side of the Novavax vaccine has started. However, some requirements are still needed to be submitted by the company before the agency grants it an EUA.
“Karamihan naman po ng mga listahan natin na-submit na nila. Inuumpisahan na po natin iyong evaluation niyan both for the vaccine manufacturing side at saka po doon sa safety and efficacy side. Pero mayroon pa po silang mga kulang na mga requirements na kailangan i-submit natin bago po tayo makagawa ng desisyon dito,” he said.
The FDA chief shared that the maximum days before they announce their decision is 21 days, provided that the company has given its complete requirements.
“Usually naman po basta complete ang requirements it takes us 21 days ‘no, iyon ang maximum na sini-set natin. So, basta po iyong pinakamaagang makumpleto naman nila ang kanilang mga requirements, mas mapapabilis po ang kanilang evaluation,” he said.
Domingo clarified that the Novavax application is for individuals aged 18 and above. He added that its efficacy is “very similar” to the existing vaccines that is around 80 to 90%. However, it is still being evaluated by the country’s vaccine expert panel. -rir
