COVID-19 vaccine used on Duterte yet to be evaluated by FDA

Published May 4, 2021, 4:44 PM

by Jhon Aldrin Casinas

The Chinese-made vaccine Sinopharm that was used to inoculate President Duterte against the coronavirus disease (COVID-19) has not yet underwent evaluation by the country’s Food and Drug Administration (FDA).

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.

“Its safety profile also doesn’t show any significant safety issues, but documents regarding the manufacturing and the clinical trials of the vaccine has yet to be submitted to us so we have not yet conducted an in-depth evaluation of the vaccine,” he added.

However, it appears that the FDA was left in the dark regarding the arrival of the donated Chinese-made vaccine in the country.

“Ako officially wala pa akong report kasi na natatanggap sa PSG kasi pinapa-report namin sila every month. Yung last nga na pinareport namin sila hindi pa daw dumadating yung vaccines (I officially do not have a report yet from the PSG because we require them to report every month. The last time they reported, the vaccines had not arrived yet),” Domingo said.

“So I suppose itong next month na report nila doon pa ako nila dapat i-inform. So yes until yesterday hindi ko naman alam pa na meron nang Sinopharm (So I suppose in their report next month they will inform me. So yes until yesterday I didn’t even know that Sinopharm vaccine has arrived),” he added.

But the FDA chief said the PSG hospital, which was the one granted with the CSP, did not a violate the condition of the permit since the FDA only requires CSP holders to report to them every month.

“Hindi naman kasi yung reporting naman talaga is at the end of the month, hindi naman siya per use (They did not [violate the conditions] because the reporting is at the end of the month, it is not per use),” Domingo said.

He said that the FDA is trying to be “a little more relax” in requiring hospitals and other CSP holders to submit their reports.

“So as a rule we ask for monthly report. So basta naman magsa-submit every month, wala namang problema (So as long as they submit every month, there is no problem),” he said.

“Monthly after use ang ating requirement ng reporting,” he added.

President Duterte was inoculated against COVID-19 using the Chinese-made Sinopharm vaccine in Malacañang on Monday evening, May 3.

Presidential spokesman Harry Roque said the dose used on the President was covered by the CSP issued to the PSG hospital by the FDA for the use of the 10,000 donated vaccines.

The FDA granted a CSP for a limited number of Sinopharm vaccine doses for the use of PSG members in February.