DOH: Pfizer won’t hold clinical trials for COVID-19 vaccine in Philippines

CEBU, Philippines —  American pharmaceutical firm Pfizer has no plans of conducting clinical trials of its COVID-19 vaccine candidate in the Philippines, the Department of Health said yesterday.

In a briefing, Health Undersecretary Maria Rosario Vergeire said there were no commitments yet made during the government’s meeting with the US drug maker last Friday.

“We just had to explain to them our regulatory processes,” Vergeire said.

“They gave information that they won’t conduct clinical trials in the Philippines because they are well advanced already with their Phase 3 clinical trials,” she said, adding government officials were told that the Phase 3 clinical trials of Pfizer’s candidate vaccine may be done by October.

The health official said most of the discussions during the meeting focused on pre-ordering of the potential vaccines and the Confidential Disclosure Agreement. A CDA contains the agreement between the vaccine manufacturer and the Philippines and details about the products.

Phase 3 clinical trials are large-scale testing on thousands of people to check the safety and efficacy of vaccines. It is an essential phase before receiving regulatory approval.

The government previously said the Philippines was scheduled to start the clinical trials of Sputnik V, Russia’s coronavirus vaccine, in October. Negotiations with Russia are still ongoing, with the Philippines’ vaccine expert panel seeking clarifications on the documents submitted by Moscow.

Meanwhile, five hospitals have been identified as sites for the planned clinical trials of the vaccine candidate produced by Sinovac Biotech Ltd although talks with the Chinese vaccine manufacturer are still on track.

Vergeire said discussions with other vaccine developers continue as the country seeks to source COVID-19 vaccines to fight Southeast Asia’s worst outbreak.

She said the Department of Science and Technology has a scheduled meeting with CSL, which is developing a coronavirus vaccine with the University of Queensland in Australia. The University of Queensland is currently undertaking a Phase 1 clinical evaluation of its vaccine candidate.

Vergeire also said the CDA of Moderna—the first company in the US to conduct a Phase 3 clinical study of a potential COVID-19 vaccine—is being studied.

“Once these CDAs are finalized, we can move forward for further meetings to finalize our agreement with them,” she said.

The country’s confirmed coronavirus cases reached over 237,000 as of Sunday. — Philstar.com (FREEMAN)