FDA clarifies COVID-19 vaccines would still undergo Phase IV trials

The Food and Drug Administration (FDA) on Monday clarified the Phase IV trials for COVID-19 vaccines will continue as part of the post-registration process.

Interviewed on Dobol B sa News TV, FDA general director Health Undersecretary Eric Domingo explained that the waiver of Phase IV trials under the proposed Bayanihan to Recover as One Act only covers public vaccination.

"Ang sinabi po kahit hindi pa kumpleto 'yung Phase IV, puwede na pong pag-aralan kung maaari itong gamitin sa pagpapabakuna dito sa ating public vaccination,” Domingo said.

Under the Universal Health Care Law, a vaccine should complete the Phase IV trials to get approval for public vaccination. Phase IV trials could take up to two years, Domingo said.

With the waiver, the FDA chief said the Health Technology Assessment Council of the Department of Health will be able to study the vaccines for mass vaccination after Phase III.

He said FDA registers all vaccines that completed the Phase III. He explained that Phase I to III trials already established the safety and efficacy of the vaccines.

Domingo said Phase IV trials involve post-marketing monitoring. During Phase IV trials, he said the FDA will monitor the possible side effects, which are very rare.

On Friday, the DOH backed the waiver of Phase IV trials but with the following safeguards:

• safety and effectiveness surveillance following WHO recommendations
• database of recipients of the drugs/vaccines
• transparent and effective risk communication on the benefits and risks of interventions against COVID-19
• informed consent and assent to recipients of drugs, vaccines, and other interventions for COVID-19
• pilot implementation and community engagement activities before mass rollout.

—AOL, GMA News