FDA assures ‘objective’ evaluation of Sinopharm’s COVID-19 vaccine

Published March 3, 2021, 3:17 PM

by Analou de Vera

The Food and Drug Administration (FDA) said it will be “objective” in scrutinizing the clinical trial data of the coronavirus disease (COVID-19) vaccine developed by China-based company Sinopharm.

FDA Director General Eric Domingo (MANILA BULLETIN FILE PHOTO)

The Sinopharm already submitted an application for the emergency use of its COVID-19 vaccine in the Philippines.

“Very objective ang pag approve natin ng bakuna. May checklist tayong hinahanap dyan. Safety, efficacy, and quality. Basta umabot sa pamantayan ay magbibigyan ng authorization. Pag hindi pumasa, hindi mabibigyan (We are very objective in approving vaccines. We have a checklist that we are using. The safety, efficacy, and quality. As long as they meet our standards, then we will grant them the authorization. If they fail, then we will not grant it to them),” said FDA-Director General Rolando Enrique Domingo during the “Laging Handa” press briefing on Wednesday, March 3.

Currently, the submitted documents by Sinopharm are still lacking. It only submitted the Phase 1 clinical trial results and their letter of intent, said Domingo.

“We are still asking for additional documents before we can start evaluating their application,” he said.

“Mabilis naman ang proseso ng FDA basta kumpleto ang dokumento lalo na kung may EUA galing sa mga stringent regulatory authorities, like US FDA or WHO (World Health Organization), kaya namin iyan 21 days. Pero depende iyan kung gaano ka kumpleto ang (documents) na isa-submit nila (The FDA’s process is quite fast as long as the documents are complete, especially if there is an EUA from stringent regulatory authorities, like the US FDA or WHO, we can do (the evaluation) in 21 days. But that depends on the completeness of their data that they are going to submit),” he added.

The FDA is also currently reviewing the EUA applications of Russia’s Gamaleya Research Institute and India’s Bharat Biotech. So far, three vaccine developers were granted an EUA in the country: the American company Pfizer, British-based AstraZeneca, and China’s Sinovac Biotech. Meanwhile, Domingo said that the Presidential Security Group (PSG) is still not responding to their queries regarding the unauthorized use of Sinopharm COVID-19 vaccines last year.

“We have not received any response from them, But the investigation is still ongoing,” he said.