DOH: COVID-19 vaccine phase 3 trials in PH to start in November

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The country may begin conducting COVID-19 vaccine trials by next month, the Department of Health said Saturday. (FILE PHOTO)

Metro Manila (CNN Philippines, October 10) — The country may begin conducting COVID-19 vaccine trials by next month, the Department of Health said Saturday.

The DOH said government agencies are now gearing up for the trials "which are set to begin in November," led by the Inter-Agency Task Force's Sub-technical Working Group on COVID-19 Vaccine Development, with the Department of Science and Technology as its chair.

"The vaccine trials may begin upon the FDA's (Food and Drug Administration) regulatory review and approval of the conduct of the clinical trials," the DOH said in a statement.

The group is composed of different agencies, with the Foreign Affairs department working on bilateral partnerships for the vaccine while coordinating with the Trade department and the National Development Company for possible local production. The DOH meanwhile will oversee the participating hospitals and the FDA will approve any vaccines to be sold to the public.

"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 assured.

Clinical trial applications will be sent to the group while documents will be reviewed by a vaccine expert panel and ethics review committee, the DOH added.

This comes after three developers submitted applications to conduct phase 3 trials for a potential COVID-19 vaccine. These are the Gamaleya Research Institute from Russia, Jannsen Pharmaceuticals Companies of Johnson & Johnson from the United States, and Sinovac from China. The DOH did not mention if the companies already passed the standards to push through with the tests. 

Phase 3 of a clinical trial is the critical stage where thousands of patients have to be inoculated with the potential vaccine to test its safety and efficacy. It is usually the final step before approval for mass rollout.

The trials come as the government studies more COVID-19 testing methods, such as antigen and non-invasive saliva testing.

Presidential Adviser for Entrepreneurship Joey Concepcion said the equipment from Israel for trials on a COVID-19 test using saliva are now in the country, although they have not yet been approved by the FDA.

"Wala pa silang FDA approval dito sa Israel pero walang problema pwede sila magstart ng trials," Concepcion told CNN Philippines' Newsroom Weekend. "Pero they should meet with the board composed of DOH and RITM (Research Institute of Tropical Medicine) to make sure that the trials will be done properly," he said.

[Translation: The one from Israel does not have approval yet from the FDA but there's no problem, because they can start the trials. But they should meet with the board composed of the DOH and Research Institute of Tropical Medicine to make sure that the trials will be done properly.]

Concepcion mentioned that the antigen test pilot study in Baguio City has been showing "very good" results. Antigen tests use a throat swab where results can become available within four to six hours compared to days with the RT-PCR. On the other hand, saliva tests do not require swab insertion for sample collection, he explained.