FDA: COVID-19 vaccines need to undergo Phase IV trials

The Food and Drug Administration (FDA) clarified Monday the COVID-19 vaccines would still need to complete its Phase IV trials.

FDA general director Health Undersecretary Eric Domingo explained in an interview on Dobol B sa News TV that the waiver of Phase IV trials included in the proposed Bayanihan to Recover as One Act only address 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.

(Even though Phase IV is not yet complete, it can be studied if it can be used for here in our public vaccination.)

The Universal Health Care Law mandates vaccines to complete Phase IV trials first before it would be approved for public vaccination. Domingo said Phase IV trials could last up to two years.

But with the waiver under the Bayanihan 2, the FDA chief said the Health Technology Assessment Council of the Department of Health could study the vaccines for mass after Phase III.

Domingo said the DFA registers all vaccines that finished the Phase III. He added Phase I to Phase III already established the safety and efficacy of the vaccines.

He said Phase IV trials include post-marketing monitoring wherein the FDA would be monitoring the vaccine’s possible side effects.

Also read: FDA: No one applied for COVID-19 vaccine trial yet

FDA: COVID-19 vaccines need to undergo Phase IV trials

supported on Friday 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.

Senator Sonny Angara also said Bayanihan to Recover as One Act or Bayanihan 2 has a provision which would ease the procurement COVID-19 vaccines.

“Sa kasalukuyang batas, sa Universal Health Care, kailangan hanggang Stage 4 trial. Medyo matagal ‘yun. So dito inilagay natin kahit wala pa ‘yung Stage 4 trials for the duration of COVID-19, basta na-certify na ng World Health Organization, puwede na mag-advance procurement,” Angara told reporters in an online interview.

“Kasi alam natin agawan’ yan eh pagdating ng panahon magkakaroon ng pila for the vaccine… Ginawa natin’ yun para hindi tali ang kamay ng ating gobyerno, para mauna dito sa vaccine,” he added.