DOH backs waiver of Phase 4 trials for COVID-19 vaccine, meds
The Department of Health (DOH) on Friday recommended several safeguards for the COVID-19 vaccination program after it agreed with the waiver of Phase 4 trials of vaccines and drugs for the novel disease.
Sought for comment on the provision doing away with Phase 4 clinical trials for COVID-19 vaccines under the Bayanihan 2 bill, the DOH said it supports the move as it was also recommended by the Health Technology Assessment Council, Food and Drug Administration, and the Philippine Medical Association.
"The advantage of waiving this provision is that we can accelerate our national response to the pandemic in terms of vaccine distribution," it said in a written response to reporters.
The waiver of Phase 4 trials has "historical precedent," according to the DOH, as it claimed that accelerated clinical trials and regulatory approvals led to the mitigation of Ebola and decreased incidence of Meningitis in the sub-Saharan belt.
The DOH recommends the following safeguards in lieu of Phase 4 clinical trials mandated by the Universal Health Care Law, provided that the COVID-19 medicine or vaccine is approved by the World Health Organization and other internationally recognized health agencies:
- 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; and
- Pilot implementation and community engagement activities before mass rollout.
President Rodrigo Duterte is pinning his hopes on the commitment of China and Russia to make their COVID-19 vaccines available in the Philippines, though these would not be for free.
Around 1,000 Filipinos are being eyed to be included for the Phase 3 clinical trials of Russia's Sputnik V but the FDA said it has yet to receive an application as of Friday. — DVM, GMA News