FDA: Sinopharm vaccine given to Duterte covered by special permit

Trending Now FDA: Sinopharm vaccine given to Duterte covered by special permit

May 04, 2021 12:36 pm
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MANILA, Philippines The countrys Food and Drug Administration said the COVID-19 vaccineadministered to President Rodrigo Duterte was covered by the compassionate use permit granted to the chief executives security group.

FDA Director General Eric Domingo said this in an interview with ABS-CBNs Teleradyo Tuesday afterDuterte received his first shot of the jab developed by Sinopharm Group Co. Ltd.

The countrys FDA has yet to approve the vaccine for emergency use. The Chinese-made jabhas been restricted to compassionate use only in the Philippines.

In February, the FDA granted the Presidential Security Groups application for compassionate special permit to access 10,000 doses of the Sinopharm vaccine. A CSP allows the use of unregistered medical products, such as the Sinopharm jab, for limited off-label use.

When you say compassionate special permit, its not an authorization given by the FDA. In this case, the head of the PSG hospital guarantees they studied the vaccine and they take full responsibility for it, Domingo said.

It is unclear why Duterte, a president, was covered by the permit given to his security team. But Domingo said the wives and partners of PSG personnel are also covered by the CSP.

The vaccine given to Duterte was the same one illegally administered to his security group before any jab had been approved for emergency use.

FDA yet to study Sinopharm jab

The FDA chief also said his agency has yet to evaluate the vaccine injected to Duterte by Health Secretary Francisco Duque III.

The FDA has yet to study it (Sinopharm vaccine), Domingo said.

He said there were EUA applications for the Sinopharm vaccines but parties have yet to submit requirements.

The chief executive has previously expressed confidence in vaccines made in China and Russia.

Currently, the vaccines developed by Sinovac, AstraZeneca and Gamaleya Research Institute are being rolled out in the Philippines.

Since the start of the vaccination program in March, over 1.6 million people have received first dose, while fewer than 300,000 have been fully vaccinated.