FDA: Sinopharm's COVID-19 vaccine being assessed for emergency use in PH


Posted at May 14 2021 12:22 AM

FDA: Sinopharm's COVID-19 vaccine being assessed for emergency use in PH 1
A sign of Sinopharm is seen at the 2020 China International Fair for Trade in Services (CIFTIS) in Beijing, China September 5, 2020. Tingshu Wang, Reuters/file

MANILA - The emergency use authorization (EUA) application of COVID-19 vaccine developer Sinopharm is still being assessed by Philippine experts, but it can be finished by next week, the Food and Drug Administration said Thursday. 

FDA Director-General Eric Domingo said the Department of Health (DOH) had a meeting with the firm's representatives Thursday morning. 

"Ang FDA naman kahapon pinadala na rin po sa vaccine expert panel yung mga scientific data at saka yung clinical trial data ng bakuna na ito para po kanila nang masuri at kung may katanungan ay maipadala po natin sa Sinopharm," Domingo explained during President Rodrigo Duterte's taped message. 

(The FDA already sent to the vaccine expert panel yesterday the scientific data and the clinical trial data of the vaccine, so they could evaluate it and consult with Sinopharm should questions arise)

"We hope po by next week matapos po natin ang mga evaluation nito," he added. 

(We hope to finish all the vaccine evaluation by next week)

An EUA would allow a vaccine under development to be used for the government vaccination program.


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Health Secretary Francisco Duque III earlier announced that he ordered his agency to file an emergency use clearance for the Chinese state firm's COVID-19 vaccine. 

This, he said, is so that the country won't have to return a batch of donations from Beijing, as the President had ordered. 

The World Health Organization (WHO) approved China's Sinopharm coronavirus vaccine for emergency use. It is the first vaccine developed by a non-Western country to win WHO backing.

Duterte was inoculated with the brand in early May even without emergency clearance. 

His aides had said he is covered by the compassionate special permit for the vaccine, which was last year granted on the Sinopharm shots used by the Presidential Security Group. 

Meanwhile, Domingo said they are also waiting for Novavax's COVID-19 vaccine to be granted emergency clearance in the United States or India in June so they could also file an application in the country. 

But Novavax earlier this week announced delaying its timeline for ramping up COVID-19 vaccine production and said it does not expect to seek regulatory authorization for the shot in the United States, Britain and Europe until the third quarter of 2021. 

To date, the FDA had cleared the vaccine candidates of the following for emergency use in the country: Moderna, Pfizer-BioNTech, Oxford-AstraZeneca, Gamaleya Institute, Sinovac Biotech, Johnson & Johnson, and Bharat Biotech.