FDA clarifies: No official EUA application from Sinopharm yet, documents still incomplete

FDA clarifies: No official EUA application from Sinopharm yet, documents still incomplete

MANILA, Philippines — The country's Food and Drug Administration on Friday said Chinese state-owned Sinopharm has not yet "officially" submitted an application for its coronavirus vaccine, amending a statement made by Malacañang earlier this month.

Two local distributors for Sinopharm's COVID-19 vaccine have contacted the FDA, director general Eric Domingo told reporters during a briefing, but neither of them have sent the documents needed for the application to proceed.

"There are now two emails sent to the FDA. We have replied to both and given them the list of requirements and the process for EUA application but the two have yet to respond," Domingo said partially in Filipino.

"As of now, no application has been officially filed with documents and requirements."

Interim analysis of Phase 3 clinical trials showed that Sinopharm’s COVID-19 vaccine was 79.3% effective in preventing the disease. However, this data has not been peer-reviewed.

As of this writing, only vaccines from Sinovac, AstraZeneca, Pfizer and the Gamaleya Research Institute have been approved for emergency use by local regulators.

Presidential spokesperson Harry Roque announced on March 1 that Sinopharm filed an application for EUA in the country, catching by surprise even Domingo, who at the time said he had no knowledge of the matter.

The following day, Domingo said the FDA received an online application but was still checking the content of the submission.

In February, the FDA granted the Presidential Security Group "a compassionate use license for 10,000 dosages of Sinopharm." But the permit was issued retroactively, months after the PSG inoculated themselves with smuggled jabs.

Roque has repeatedly told reporters that he does not know where the jabs came from but has also previously said that they were not bought, implying a donation.

— Bella Perez-Rubio with a report from Gaea Katreena Cabico

Credit belongs to : www.philstar.com

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