FDA yet to start evaluation of Sinopharm’s vaccine due to lack of documents

MANILA, Philippines — The Food and Drug Administration (FDA) has yet to start its evaluation on Sinopharm’s application for emergency use authorization (EUA) due to lack of documents, FDA Director General Eric Domingo said Wednesday.

In a televised briefing, Domingo confirmed that a certain Southmed Pharma Corp. applied for Sinopharm’s EUA in the country.

But Domingo said it had only submitted Sinopharm’s Phase 1 clinical trial results and its letter of intent to apply for an EUA.

“Nung Monday afternoon po, may isang local pharmaceutical company, distributor na nag-online, nagsubmit ng letter na mag-aapply daw po sila ng emergency use authorization for Sinopharm. Unfortunately, wala pa pong mga dokumentong kasama ito,” Domingo said.

(On Monday afternoon, a local pharmaceutical company, a distributor, applied online and submitted a letter to apply for Sinopharm’s emergency use authorization. Unfortunately, the necessary documents were not included.)

“So hiningi pa po namin sa kanila yung mga dokumento na kailangan para maevaluate natin yung kanilang application katulad ng katunayan na sila nga ang distributor ng Sinopharm sa Pilipinas, yung kanila pong mga clinical trial results, mga certificate ng good manufacturing practice ng bakuna,” he added.

(So we’re asking them for documents that we need to evaluate their application, such as proof that they’re Sinopharm’s distributor in the Philippines, their clinical trial results, and certificate of the vaccine’s good manufacturing practice.)

Domingo said that Sinopharm also has yet to publish its clinical trial phase 3 results.

“’Pag ganito po, hindi naman po natin maumpisahan. Maumpisahan lang po ang evaluation kapag yung datos na hinihingi natin ay nandyan na. Very objective po kasi ang pag-approve ng bakuna, may checklist po tayo na hinahanap dyan— safety, efficacy and quality,” Domingo said.

(In this circumstance, we cannot start. We will only begin the evaluation if the data we’re asking for is already with us. We’re very objective in approving vaccines, we have a checklist that we’re looking for—safety, efficacy, and quality.)

Malacañang said President Rodrigo Duterte will wait for Sinopharm, his preferred vaccine brand, to secure an EUA before receiving it.

Covid-19 vaccines that have so far secured an EUA from the FDA are those developed by Pfizer-BioNTech, AstraZeneca, and Sinovac.

JE