COVID-19 vaccine approval possible in April, 2021 — FDA

Published September 25, 2020, 2:11 PM

by Analou de Vera

The Food and Drug Administration (FDA) said the possibility of approving a COVID-19 vaccine for commercial use in the country may happen in April, 2021, which is considered as the “best case scenario.”

(Joe Raedle/Getty Images/AFP / MANILA BULLETIN)

“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,” said FDA Director General Rolando Enrique Domingo in an online forum on Friday.

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

Domingo noted that the approval of a vaccine really depends on the completion of the phase 3 clinical trials.

“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 phase 3 clinical trial is December this year,” said the FDA chief.

“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 added.

WHO Solidarity trial for Vaccines

Department of Science and Technology (DOST) Secretary Fortunato Dela Pena said that the WHO may release the list of vaccines and protocols for the Solidarity trial for Vaccines by next month.

“Vaccine recipients under the WHO solidarity trial 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,” said Dela Pena.

He added that the solidarity vaccine trials will be “led by the Philippine General Hospital as the main implementer and there are 12 hospitals that have been chosen as trial sites” for this initiative.

“We are now in the process of finalizing the memorandum of agreement between the DOST and DILG because this is very important in the conduct and in the implementation of the zoning guidelines,” he added.

Negotiations with vaccine developers

On top of the WHO Solidarity Trial, the country is also having discussions with other international vaccine developers, said Dela Pena.

The DOST chief said that the government is currently having negotiations with 17 vaccine developers from China, the United States of America, Taiwan, Japan, Australia, Russia, and India.

“We’re approaching these countries to find out what is the status of their vaccine and whether they are willing to enter into a partnership with us in one form or another either through trials or through manufacture in our country,” he said.

Out of the 17, six have already signed “confidentiality disclosure agreements (CDA).”

“Meaning to say, because of their interest to do the clinical trials in the Philippines, they are willing to show us their data and information on the results of their trials in their country, particularly in the phases that they completed,” said Dela Pena.

 
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