Gov’t prepares for phase 3 of COVID-19 vaccine trials

MANILA, Philippines — Government agencies are preparing for Phase 3 of the trials of candidate vaccines for COVID-19, which begins in November, according to the Department of Health (DOH).

The initiative is being led by Inter-Agency Task Force’s Subtechnical Working Group (TWG) on COVID-19 Vaccine Development, with the Department of Science and Technology (DOST) as its chair.

Health Undersecretary Maria Rosario Vergeire earlier said three vaccine developers had sent applications for Phase 3 clinical trials of their candidate vaccines in the country.

These are Russia’s Gamaleya Research Institute, Johnson & Johnson’s Janssen Pharmaceuticals and China’s Sinovac Biotech.

Gamaleya manufactures Sputnik V, the first registered COVID-19 vaccine in Russia.

The Philippines is also participating in the solidarity vaccine trials led by the World Health Organization.

The DOST said it had selected 12 hospitals in Metro Manila, Cavite, Cebu City and Davao City as trial sites.

A data and safety monitoring committee was formed by the DOST to ensure the safety of the human participants in clinical trials.

The government is optimistic that a vaccine would be ready by the first or second quarter of next year.

All the clinical trials to be conducted in the country for the development of the vaccines will go through a clear set of processes to ensure that these will be safe and effective, according to the DOST.

Science Secretary Fortunato de la Peña assured the public that any clinical trial would “go through a rigorous review to make sure that the potential vaccines to be injected on people have been concluded to be safe even in the first and second phase of the clinical trial.”

Six pharmaceutical companies have signed a confidentiality disclosure agreement that would let the Philippines’ vaccine experts panel to review the results of their respective Phase 1 and Phase 2 trials, Vergeire said.

According to the DOH, all applications for clinical trials to be conducted in the country are submitted to the sub-TWG for Vaccine Development and pertinent documents are reviewed by the Vaccine Expert Panel and the Ethics Review Committees.

“These bodies are composed of vaccine experts, technical experts, and scientists who will identify, evaluate, and recommend possible vaccine candidates for the Philippines,” the DOH said.