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

Tuesday, December 8th, 2020. Filed under: News Philippine News

MANILA, Dec 8 (Mabuhay)– 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.

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

AstraZeneca, Janssen nearing initial clearance by PH COVID-19 vaccine expert panel

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.

Clinical trials of 2 Chinese COVID-19 vaccines may start yearend or early 2021— DOST

Coronavirus: international funding boost for Chinese vaccine maker Clover

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.

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.

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. (MNS)

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