FDA sees COVID-19 vaccine in Philippine by April 2021

MANILA, Philippines — The Food and Drug Administration (FDA) assured the public yesterday that caution will be strictly observed in registering vaccines and approving clinical trials for vaccines against coronavirus disease, saying that safety is the government’s utmost priority.

Under the best scenario, the FDA also said a vaccine may be approved for use in the Philippines by April 2021.

FDA director general Eric Domingo said the agency has “very strict protocols when it comes to human trials, especially for a vaccine not yet existing.”

“Healthy people will be vaccinated by a vaccine that we are not yet certain (of the effects). We are very strict on this,” he noted when asked in a press briefing about local government units which intend to do their own clinical trials of anti-COVID vaccines.

Domingo maintained that a vaccine cannot be used in the country if it is not registered with the FDA. He said even clinical trials need the approval of the agency.

He said as a policy, all clinical trials must go through the sub-technical working group of the Inter-Agency Task Force and they must be endorsed by the Vaccine Expert Panel to the FDA. So far, he said the FDA has not received any application to register a vaccine.

“It really depends when they complete the Phase 3 clinical trials. Once completed, they can start the registration process with FDA. This is, of course, not limited to vaccines that will undergo Phase 3 clinical trials here,” he claimed.

Vaccines that do not undergo such trial in the country must also be registered with the FDA.

The FDA expects that there are vaccines that will have completed the Phase 3 trials by December. This means there is a possibility that by the end of the year or towards the first quarter of 2021, there would be a vaccine for registration.

“We will give it about 45-60 days, depending of course on the approval that they get from their own country or the World Health Organization… Meaning, the best scenario…. it’s possible that by April 2021, we will have an approved vaccine,” he said.