FDA: Phase IV trials still required for COVID-19 vaccines

On Monday, the FDA clarified that even with a waiver under the Bayanihan Act, Phase IV trials for COVID-19 vaccines will still continue as part of post-registration processes.

Health Undersecretary Eric Domingo stated that while incomplete Phase IV trials do not prevent public vaccination studies, full approval requires completion of these trials which can take up to two years.

Philippine Foundation for Vaccination president Dr. Liza Gonzales said health workers and frontliners will be prioritized in clinical vaccine trials once they begin.

As of Friday, the FDA has yet to receive any applications for COVID-19 vaccine clinical trials in the Philippines.

Dr. Jesusa Cirunay from the FDA's Center for Drug Regulation and Research stated that while normal approval takes 45 to 60 days, this can be expedited for COVID-19 vaccines if complete documents are submitted.

Phase IV trial approvals typically take around 70 to 90 working days but can also be expedited.