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2 COVID-19 vaccine developers endorsed to FDA for approval to conduct clinical trials

Published Dec 10, 2020 01:57 pm

Two COVID-19 vaccine developers have been endorsed to the Food and Drug Administration (FDA) for approval to conduct clinical trials in the country.

In a “Laging Handa” press briefing Thursday, Department of Science and Technology (DoST) Secretary Fortunato dela Pena revealed that Chinese pharmaceutical companies Sinovac Biotech and Clover Biopharmaceuticals already have vaccine evaluation and ethics approval.

(NOEL CELIS / AFP / MANILA BULLETIN)

"Ang sistema kasi diyan basta naiendorse na namin ‘yung mga vaccines na nagdaan na sa vaccine evaluation at saka sa ethics approval, ang FDA na ngayon ang magdedecide kung approved or hindi (The process here is that once we endorse the vaccines that went through the vaccine evaluation and ethics approval, it will be up to FDA to approve or not)," he said.

"How long it will take, FDA ang nakakaalam niyan (only FDA knows)," he added.

On the other hand, Jansen and AstraZeneca have ethics clearance and are just waiting for the vaccine evaluation to finish.

Dela Pena is letting the DoH probe Sinovac, following claims of bribery against them.

"As far as the evaluation, we rely on the data that were submitted to us and that will be one of the bases for the decision whether they would be given approval for conducting clinical trials by the FDA," Dela Pena said.

Department of Health (DoH) Secretary Francisco Duque III had earlier said that they will look into the bribery claims against Sinovac, citing a Dec. 4 report from US-based Washington Post, saying that the Chinese pharmaceutical company has a court record that shows “bribing China’s drug regulator for vaccine approvals.”

Dela Pea said the country is prepared and that they are just awaiting the announcement from the World Health Organization on what vaccines will be used during the Solidarity Trials and when it will be released.

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