Filtered By: News

FDA approves compassionate use of Sinopharm vaccine for PSG

The Food and Drug Administration (FDA) has approved the compassionate use of the COVID-19 vaccine from China's Sinopharm for the benefit of the Presidential Security Group (PSG) members, Malacañang said Thursday.

At a press briefing, presidential spokesperson Harry Roque said the compassionate use will cover 10,000 doses.

“It (getting Sinopharm) was a decision of PSG,” Roque said.

Roque, however, did not provide further details on how the PSG will procure the vaccines, saying he does not have that information.

Pressed why Sinopharm was the PSG’s choice, Roque pointed to the delayed delivery of COVID-19 vaccines Pfizer-BioNTech and AstraZeneca which were scheduled to arrive in the country mid February via the COVAX facility—a global effort which raised resources to fund COVID-19 response initiatives, including COVID-19 vaccines. 

“I think the answer is obvious ‘no, wala tayong nakukuhang supply pa sa ngayon ng Pfizer at saka ng AstraZeneca, naantala nga po iyong pagdating na inaasahan natin na mid-February at ngayon inaasahan natin either third or fourth week,” Roque said.

A vaccine needs to secure an emergency use authorization from the FDA for it to be legally administered in the Philippines. Sinopharm has yet to apply for an EUA before the FDA.

The FDA, however, can allow the use of the vaccine without EUA approval provided that the vaccine secured a compassionate use permit.

Some members of PSG, however, have already received COVID-19 shots that were donated to them as early as September or October last year, according to PSG commander Brigadier General Jesus Durante III in December.

Durante made the admission after President Rodrigo Duterte claimed during a televised address that some members of the military received shots of COVID-19 vaccine supposedly manufactured by  Sinopharm.

Last January 27, FDA Director General Eric Domingo said the probe on PSG members getting inoculated with unregistered COVID-19 vaccine has hit a blank wall after their queries went unanswered by the PSG.

Illegal vaccination probe

In a separate statement sent to GMA News Online on Thursday, Domingo clarified that the issuance of compassionate use for Sinopharm does not absolve the PSG of possible liability over their admission that they vaccinated themselves with an unregistered Sinopharm vaccine in September and October last year.

“[The compassionate use permit is] for future use. The investigation is still being pursued,” Domingo said.

Likewise, Domingo underscored that the FDA’s issuance of permit for compassionate use is not tantamount to FDA’s stamp of approval.

“The PSG applied and complied with all requirements for the CSP. It was granted yesterday and the PSG Hospital takes full responsibility for the vaccines and will report utilization and outcomes to FDA,” Domingo pointed out.

“The CSP (compassionate special permit) is for future use and the permit is for one time importation,” Domingo added.

The PSG, Domingo said, applied for the CSP permit for Sinopharm last January 18.

Ultimately, Roque said that the PSG deserves to get the COVID-19 vaccine immediately because such is necessary to protect the President.

“Kaya nga po compassionate use dahil kinakailangan mabakunahan na iyong ibang miyembro pa ng PSG dahil nga po sa kanilang trabaho na nagbibigay seguridad sa ating Presidente,” Roque said. — KBK/RSJ, GMA News