DOH waives Phase 4 clinical trials for COVID-19 drugs, vaccines

The Department of Health (DOH) said on Friday that it will do away with the fourth and final phase requirement of clinical trials for coronavirus disease (COVID-19) drugs and vaccines in a bid to accelerate the national response to the pandemic.

In a statement, the health department said they made this recommendation while in discussions with the Health Technology Assessment Council, Food and Drug Administration (FDA), and Philippine Medical Association (PMA).

The fourth phase of clinical trials require further testing of a drug or vaccine in a bigger population, that could possibly take years after approval.

“This recommendation is also not without historical precedent,” the DOH said in its statement.

“Accelerated clinical trials and regulatory approvals in response to threats such as Ebola and Meningitis contributed to mitigating the spread of Ebola and decline in the incidence of Meningitis in the

sub-Saharan belt,” it added.

The statement was made after a provision in the Bayanihan to Recover as One Bill or Bayanihan 2 stated that the Phase 4 trial requirement for clinical trials will be waived for any drug or vaccine under the Universal Health Care Act.

Instead of the fourth phase of the clinical trials, the health department said it will conduct safety and effectiveness surveillance and keep a database of recipients of the drugs or vaccines, who will be informed of the risks and benefits of the vaccination.

Clinical trials for COVID-19 drugs and vaccines in the country may begin by the fourth quarter of 2020, while the distribution of approved vaccines to the public may start by the second quarter of 2021, the Department of Science and Technology (DOST) had earlier said.

Avigan, a Japanese anti-flu drug, started clinical trials in the Philippines on Monday, Aug. 17. Clinical trials for Remdesivir, an anti-viral drug, is also ongoing through the World Health Organization-led Solidarity Trial.