FDA: Duterte’s COVID-19 dose covered by compassionate permit

Published May 4, 2021, 9:53 AM

by Jhon Aldrin Casinas

The dose of Sinopharm vaccine administered to President Duterte was covered by the Compassionate Special Permit (CSP) granted for the doses of Chinese-made vaccine donated to the Presidential Security Group (PSG), the Food and Drug Administration (FDA) said Tuesday, May 4.

President Duterte receives the coronavirus vaccine from Health Secretary Francisco Duque III on May 3, 2021 (Photo: Sen. Go/Facebook)

“Yes, it was part of the PSG vaccines with CSP,” FDA Director General Eric Domingo told the Manila Bulletin in a text message when asked if the jab administered on the President was covered by the CSP issued to the PSG.

“This is what PSG requested before the vaccines arrived in the Philippines. They have a donation from China and they asked for a special permit for the vaccines to protect the President,” Domingo said in an interview over DZBB.

A CSP is a special permit issued by the FDA that grants an entity the privilege to avail of an unregistered drug, medical device, or food product.

The chief of the country’s food and drug regulatory agency said some parties are already in the process of applying for an emergency use authorization (EUA) for the Chinese-made vaccine in the country.

“Some are already applying to us for an EUA so that they can supply to our government as well. We are waiting for them to submit their requirements,” he said.

President Duterte was vaccinated against the coronavirus disease (COVID-19) using the Chinese-made Sinopharm vaccine in Malacañang on Monday evening, May 3.

Health Secretary Francisco Duque III administered the vaccine to the President.

The inoculation of the President was broadcasted via Facebook Live. But the video was cut before the public could see the needle of the syringe actually go through the President’s arm.

Presidential spokesman Harry Roque said the dose used on the President was covered by the CSP issued to the PSG hospital by the FDA.

The FDA has earlier granted a CSP to the PSG to use the 10,000 donated vaccines developed by Chinese pharmaceutical firm Sinopharm.