COVID-19 vaccine to undergo Phase 4 clinical trials–FDA
CALOOCAN CITY, Aug. 26 (PIA) — The Food and Drugs Administration (FDA) on Tuesday clarified that the COVID-19 vaccine would still undergo Phase 4 of clinical trials even if the government has allowed its procurement without completing Phase 4.
In a report by PTV News, FDA Director-General Eric Domingo said the process might take up to 2 years if the government will wait for the Phase 4 trial to be completed before purchasing the vaccine.
The FDA has a vaccine expert panel to screen possible COVID-19 vaccines that will undergo clinical trials in the Philippines.
“Pero as of now, sa FDA, wala pa namang nag-a-apply sa amin for a clinical trial at definitely wala pa rin for registration,” Domingo added.
To recall, the anti-viral drug, Avigan, donated by Japan earlier this month has not yet started its clinical trial in the country.
Department of Health (DOH) Undersecretary Maria Rosario Vergeire, for her part, explained that the “accelerated process” of a clinical trial has been done before by other countries particularly during the Ebola virus outbreak. However, safeguards must still be present.
Undersecretary Vergeire added that a pilot area will be available where the distribution of vaccine will begin. (PIA NCR)