COVID-19 vaccines

No Sinopharm EUA application currently under review – FDA

Sofia Tomacruz
No Sinopharm EUA application currently under review – FDA

COVID-19 VACCINE. A staff member checks a pack of COVID-19 vaccines on a production line at a packaging workshop inside the Beijing Institute of Biological Products of Sinopharm's China National Biotec Group (CNBG), during a government-organised visit to the company in Beijing, China February 26, 2021.

Photo by Tingshu Wang/File Photo/Reuters

Food and Drug Administration Director General Eric Domingo says two groups that reached out to the agency have not submitted requirements and remain unresponsive

The Food and Drug Administration (FDA) said on Thursday, April 8, that it is not currently reviewing any emergency use application (EUA) for Sinopharm’s coronavirus vaccine as it has not received all the required documents to carry out a full review.

Over a month after Malacañang announced that a group had submitted an EUA for the Sinopharm vaccine, FDA Director General Eric Domingo said that the two parties that had reached out to the agency have yet to submit documentary requirements. 

“For the applicants of Sinopharm, as of now, two have written and we asked them for requirements but they haven’t answered and they haven’t submitted these requirements,” Domingo said. 

“So technically there is no Sinopharm application that is under evaluation here in the FDA,” he added. 

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Duterte’s preference

On March 1 – as the Philippine’s launched its COVID-19 vaccine campaign with the arrival of China’s Sinovac vaccine – Presidential Spokesman Harry Roque announced ahead of the FDA that an EUA application for Sinopharm was submitted to the agency. 

The Sinopharm vaccine is President Rodrigo Duterte’s preferred anti-COVID-19 jab, as announced previously by Malacañang.

But in the Philippines, Sinopharm is at the center of controversies over smuggled vaccines and unregulated use. Members of Duterte’s close-in security, a senator, Cabinet member, former special envoy Ramon Tulfo, and other ranking government officials got hold of and used the Sinopharm vaccine despite the absence of the required EUA. 

The FDA earlier launched a probe into the Presidential Security Group’s use of smuggled Sinopharm vaccines but months since health authorities reached out to the groups, the President’s security has not responded. 

The FDA had also earlier granted a compassionate special permit to the PSG for 10,000 Sinopharm vaccines but Domingo said this was only for future use and would not clear the PSG’s past use of the smuggled vaccine

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As reports of the use of smuggled vaccines continued to surface, health officials repeated that the illegal use of such vaccines would be sanctioned. The FDA likewise cautioned the public  against getting unapproved vaccines, saying these were not assured to be safe or effective. – Rappler.com

Sofia Tomacruz

Sofia Tomacruz covers foreign affairs and is the lead reporter on the coronavirus pandemic. She also writes stories on the treatment of women and children. Follow her on Twitter via @sofiatomacruz. Email her at sofia.tomacruz@rappler.com.