FDA grants EUA to COVID-19 vaccine Sinopharm manufactured by Wuhan affiliate

Published August 25, 2021, 1:29 AM

by Analou de Vera

A staff member checks the packaging quality of COVID-19 inactivated vaccine products at a packaging plant of the Beijing Biological Products Institute Co., Ltd., a subsidiary of Chinese pharmaceutical firm Sinopharm, in Beijing Dec. 25, 2020. (Xinhua/Zhang Yuwei / MANILA BULLETIN)

The Food and Drug Administration (FDA) said that it has granted an emergency use authorization (EUA) for the coronavirus disease (COVID-19) vaccine manufactured by China’s Sinopharm-Wuhan.

FDA Director-General Rolando Enrique Domingo said that Sinopharm/China National Pharmaceutical Group has two manufacturing facilities— in Beijing and in Wuhan.

“Ang Sinopharm po kasi na gawa sa China—it’s the same vaccine pero may dalawa po siyang factory sa China (Sinopharm, which is made in China— it’s the same vaccine but it has two factories in China),” he said during President Duterte’s “Talk to the People” on Tuesday night, Aug. 24.

Domingo said that they issued an EUA to Sinopharm donated vaccines which were applied by the Department of Health (DOH) last June. These vaccines were from Sinopharm-Beijing, he said.

“Ang Sinopharm-Wuhan ay nabigyan na rin po ng emergency use authorization ng FDA nitong Aug. 19. So, may isang kumpanya na authorized mag distribute ng Sinopharm-Wuhan, so maari po itong bilhan ng ating pamahalaan (Sinopharm-Wuhan was also granted emergency use authorization by the FDA last Aug. 19. There is a company that is authorized to distribute Sinopharm-Wuhan, so our government can buy from them),” said Domingo.


Meanwhile, the EUA application of US-based pharmaceutical firm Novavax is not yet approved, said Domingo.

Domingo said that Novavax has not been granted an EUA “from any other country at this time,” adding that this vaccine “has not been used outside clinical trials.”

“At this time, hindi pa natin mabibigyan ng EUA hanggang hindi pa nabibigyan ng EUA doon sa bansa kung saan siya dinevelop. So naghihintay pa tayo ng progress dito (At this time, we cannot be able to give an EUA until it has secured an EUA from the county where it was developed. So we are still waiting for further progress about this),” said Domingo.