MANILA, Philippines — If everything goes according to schedule, the Food and Drug Administration (FDA) said a COVID-19 vaccine might be available in the country as early as April next year.
But FDA Director General Eric Domingo pointed out that this timetable rests entirely on manufacturers being able to complete clinical trials and analysis of results of their vaccine this year and their prompt submission of requirements for product evaluation and registration.
“At the earliest, we believe that [they] would be able to complete their Phase 3 clinical trials in December. That means there’s a possibility that by the end of the year or toward the first quarter of next year, we already have applicants for registration,” Domingo told reporters on Friday.
Once the clinical data and registration requirements are submitted to the FDA, it will take around 45 to 60 days for the agency to process the registration.
Domingo said only applications from those that completed their Phase 3 trials and have complete documents and dossiers would be processed.
“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,” Domingo said.