The Food and Drugs Administration (FDA) has clarified that the Corona Virus Disease 2019 (COVID-19) vaccine will still undergo Phase 4 even if the government has allowed its procurement without completing Phase 4.
According to FDA Director-General Eric Domingo, 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 (As of now, there are no applicants for the clinical trial in the FDA and definitely none for registration).”
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 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.
Report from Sandra Samala
