FDA: Approval of COVID-19 vaccine possible in April 2021

FDA: Approval of COVID-19 vaccine possible in April 2021
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The Philippines’ Food and Drug Administration (FDA) announced the possibility of approving a COVID-19 vaccine in April 2021.

According to the FDA, they may be able to approve a COVID-19 vaccine for commercial use in the country in April 2021 but this is considered the “best case scenario.”

In an online forum held on Friday, Director General said: “The best case scenario, if clinical trials are completed by December or January, and a company would file an application with FDA, it’s possible that by April, 2021, we will have an approved vaccine.”

He elaborated: “Talagang best case scenario yun (That’s definitely the best case scenario), meaning yung three to six months [of clinical trials], magiging three months (will be three months); assuming that they will complete all their analysis and submit immediately to FDA.”

The chief also pointed out how approval will mostly depend on the completion of the phase 3 clinical trials of the vaccine candidates.

Domingo noted: “Once completed, they can start the registration process with the FDA. This is of course not limited to vaccines that will undergo phase 3 clinical trials here. It is possible that some vaccines will not go to the Philippines for phase 3 but will also register. At the earliest, ang nakikita natin na merong may matatapos na (what we expect the completion of) phase 3 clinical trial is December this year.”

“That means, there’s a possibility that by the end of the year or toward the first quarter next year, we already have applicants for registration. Like I said, we will give it about 45 to 60 days, depending of course on the approval that they get from their own country or WHO (World Health Organization),” he continued.

Department of Science and Technology (DOST) Secretary Fortunato Dela Pena added that the the list of vaccines and protocols for the Solidarity trial for Vaccines may be released by the World Health Organization (WHO) by next month.

Dela Pena explained: “Vaccine recipients under the will be recruited from five to 10 barangays reporting high COVID cases. This is important because we want to test for the efficacy of the vaccine and we will do it in places where there is a high occurrence or attack rate.”