Manila Bulletin - 2021-05-05


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



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. “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 to 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 itself of an unregistered drug, medical device, or food product. The FDA chief 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 broadcast 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. The FDA had earlier granted a CSP to the PSG to use the 10,000 donated vaccines developed by Chinese pharmaceutical firm Sinopharm. Duterte feared death Shortly after getting inoculated, President Duterte revealed he is afraid he won’t last if he got infected with the coronavirus disease (COVID-19), warning “hardheaded” Filipinos to stay at home amid the surge of cases. “Alam mo hindi ito biro. 'Pag tinamaan ka ng COVID, it's kamatayan. Usually madalas diyan two days patay… karamihan iyong mga severe cases. Iyong iba nililibre pero 'yong namatay, two days tapos (You know, this is not a joke. When COVID hits you, it’s death. Usually, you’re dead in two days... most of the severe cases. Others survive but those who died, they’re finished in two days),” he said in a televised public address on Monday night. The Chief Executive admitted even he is afraid for himself because of his old age. “'Pag ako ang tinamaan, there's no way sa katanda ko (When that hits me, there’s no way in my age), there's no way of telling whether I would live to see the light of day the following day,” he said. “Hindi ko kayo tinatakot. Sinasabihan ko kayo gamitin ninyo utak ninyo. Delikado ang pandemya. It's not a – hindi laro ito o sakit-sakitan. Pagka tinamaan ka nito, wala na (I’m not trying to scare you. I’m telling you to use your heads. The pandemic is dangerous. It’s not a – it’s not a game. If you get this, it’s over).” (With a report from Raymund F. Antonio)



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