2 COVID-19 vaccines pass pre-evaluation, sent to FDA for clinical trial application— DOH

Kristine Sabillo, ABS-CBN News

Posted at Dec 11 2020 12:53 PM | Updated as of Dec 11 2020 01:40 PM

MANILA — The Department of Health's vaccine experts panel (VEP) and ethics review board have approved clinical trial applications of two COVID-19 vaccines, clearing the way for final evaluation by the Food and Drug Administration, a health official said yesterday.

“For those naka-approve na sila pareho (For those approved by both VEP and ethics review board) like Janssen and Clover, they will go through the FDA process already and we will await for the information to be given to us by the FDA,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing.

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Janssen Pharmaceuticals is under multinational giant Johnson & Johnson while Clover Biopharmaceuticals is a Chinese company. Both are applying to run clinical trials in the Philippines for their COVID-19 vaccines.

Besides the two, another Chinese company, Sinovac, has already passed the vaccine expert panel while British-Swedish pharmaceutical company AstraZeneca was cleared by the ethics review board.

Sinovac recently made headlines after a Washington Post article revealed how the company admitted to bribing Chinese drug regulators from 2002 to 2011. Philippine officials have said the drug might be among the first the country would procure for inoculation here.

Meanwhile, AstraZeneca is the only company that has a supply deal with the Philippines through the private sector.

Russia’s Gamaleya Institute, which has yet to complete its requirements for application, is also being considered by the Philippines.

Other vaccine frontrunners are American companies Pfizer and Moderna, which both showed high efficacy rates according to initial trials. The United Kingdom has already begun inoculations using Pfizer's COVID-19 vaccine.

Vergeire said they are just waiting for Moderna to respond to their comments on the required confidential data agreement (CDA). On the other hand, they are trying to work out a single CDA for Pfizer and all the involved government agencies.

Vergeire said this would streamline the process so that the DOH would not need to send a new CDA after the Department of Science and Technology’s vaccine expert panel studies Pfizer’s document.

The DOH said it could not say yet if Moderna and Pfizer are applying for clinical trials or supply deals.


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