Published May 4, 2021, 2:51 PM
The Food and Drug Administration (FDA) on Tuesday, May 4, said it cannot assure for the safety and quality of the products used under the condition of a Compassionate Special Permit (CSP) as it did not undergo evaluation by the agency.
Food and Drug Administration (FDA) Director General Eric Domingo
FDA Director General Eric Domingo said an unregistered drug, medical device, or food product used under the condition of a CSP does not undergo evaluation by the FDA.
“So when we give a compassionate special permit it is very clear that we have no assurance of safety, efficacy, and quality because it did not undergo evaluation with the FDA,” Domingo said in virtual press briefing.
FDA: Duterte s Sinopharm vaccine under limited use permit
May 4, 2021 11:23 AM PHT
In an interview with GMA s
Dobol B TV, FDA Director General Eric Domingo said that the limited use permit was granted to the Presidential Security Group (PSG) before the vaccines arrived in the country. He did not specify though when the Sinopharm shots arrived in the country. Ito ‘yung hiningi ng PSG dati bago pa dumating ang mga bakuna dito sa Pilipinas. Mayroon silang donation from China at hiningan ito ng special permit para nga maprotektahan ang Presidente at mukhang yun din po ang ginamit sa ating pangulo kagabi, Domingo said.
Duterte vaccination: A look at Sinopharm compassionate use permit for PSG
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President
Rodrigo Duterte received his first dose of Sinopharm’s vaccine against COVID-19 despite it being given a “compassionate special permit” for his close-in security personnel only.
Sinopharm has also yet to be granted an
emergency use approval by the country’s
Food and Drug Administration.
In a Facebook Live aired on Monday night, May 3, Duterte was shown being administered with a dose of the vaccine from China by Health Secretary
Francisco Duque III. The 76-year-old president was also with his former aide-turned-senator.
Harry Roque.
This was the same vaccine brand the
Food and Drug Administration (FDA)
FDA Director General Eric Domingo said the agency cannot determine yet the efficacy and other information regarding the vaccine since it has yet to be evaluated by the agency.
“Hindi pa naman siya dumaan din talaga sa evaluation sa amin (The vaccine has not yet went through our evaluation),” Domingo told reporters in a virtual briefing Tuesday, May 4.
Citing the evaluation of the World Health Organization (WHO), Domingo said the efficacy of Sinopharm is similar to the China’s Sinovac vaccine.
“From what I have read in other evaluations like from the WHO, its efficacy is also similar to Sinovac especially for those 18 to 59 years old and also for those without comorbidity. It has a high efficacy rate of about 70 to 80 percent,” he said.
President Duterte has been finally vaccinated against the coronavirus disease (COVID-19) with the Chinese-made Sinopharm vaccine.
President Duterte receives the coronavirus vaccine from Health Secretary Francisco Duque III on May 3, 2021 (Photo: Sen. Go/Facebook)
Duterte received his first shot of the coronavirus vaccine in Malacañang on Monday evening, May3. The vaccine was administered by Health Secretary Francisco Duque III.
The process was broadcast via Facebook Live by his long-time aide Senator Bong Go. The video lasted for 1 minute and 39 seconds. The video, however, was cut before the public could see the needle of the syringe actually go through the President’s arm.