3 vaccine makers hurdle PH’s ethics review; Moderna, Pfizer consider application — DOH

Kristine Sabillo, ABS-CBN News

Posted at Dec 07 2020 12:41 PM

Source: Department of Health

MANILA — Three COVID-19 vaccine makers seeking to run clinical trials in the Philippines passed the country's ethics review board, one of the requirements needed before undergoing evaluation by the Food and Drug Administration, an official said Monday.

“Approved na rin sa ethics review board ang Janssen, ang AstraZeneca at saka yung Clover,” Health Undersecretary Maria Rosario Vergeire said after reiterating that Chinese companies Sinovac and Clover Biopharmaceuticals have already been given clearance by the vaccine expert panel.

(The ethics review board approved Janssen, AstraZeneca and Clover.)

Janssen of Johnson & Johnson and AstraZeneca are both Europe-based companies.

Officials have previously said that the application of China-based Sichuan Clover Biopharmaceuticals, Inc had already been forwarded to the FDA after passing both the ethics review board and the vaccine expert panel.

Vergeire explained that the ethics review and the vaccine expert panel evaluation are done in parallel with each other. Vaccine developers must secure both their approval before moving on to the FDA application.

Except for Clover, all the other vaccine developers mentioned are frontrunners in the race for a COVID-19 vaccine, conducting Phase 3 clinical trials in their home countries.

PFIZER, MODERNA

Two other frontrunners — American firms Moderna and Pfizer — are being eyed by the Philippine government either for procurement or clinical trials.

Vergeire said the government has already sent a confidentiality agreement to both companies in preparation for their application. However, she could not say if it were for clinical trials or procurement.

“Yung Sa Moderna, nagkaroon tayo ng pagbabalik nung confidentiality data agreement (CDA) ng DOST.
Ibinalik muna because meron tayong mga comments doon sa binigay natin na CDA, and we are awaiting for their response on this,” she said.

(For Moderna, we returned the confidentiality agreement of the FDA because we had comments on the CDA given to us. We are awaiting their response on this.)

Vergeire said the Department of Science and Technology’s Philippine Council for Health Research and Development also signed a confidentiality agreement, which was sent to Pfizer for “their consideration.”

Moderna and Pfizer were the first two vaccine developers who released initial data showing high effectivity rates against COVID-19.

Health Secretary Francisco Duque III said the Philippines may start rolling out its COVID-19 vaccination program either at the end of the first quarter or the start of the second quarter next year.

The country has recorded nearly 440,000 coronavirus infections, as of Dec. 6, of which, 22,646 are active cases. Its COVID-19 death toll stood at 8,554, while 408,634 have recovered.

The Philippines' first COVID-19 case was recorded on Jan. 30 in a Chinese woman who arrived from Wuhan City, China where the disease is believed to have first emerged.

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