Sunday, October 4, 2020

COVID-19 Vaccine Approval Possible in April, 2021 - FDA

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

FDA Director General Rolando Enrique Domingo in an online forum on Friday said that “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 also added, “Talagang best case scenario yun, meaning yung three to six months, magiging three months; assuming that they will complete all their analysis and submit immediately to FDA”.

Also, Domingo noted that the completion of the phase 3 clinical trials will be the bases on the approval of a vaccine.FDA chief said, “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”.

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

He also added, “Vaccine recipients under the WHO solidarity trial will be recruited from 5 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”.

Secretary Dela Pena also said that, “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”.

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