PSG remains uncooperative in probe over Sinopharm inoculation last year, says FDA

Raphael Bosano, ABS-CBN News

Posted at May 04 2021 08:53 PM | Updated as of May 04 2021 09:04 PM

President Rodrigo Duterte salutes to a troop commander during the Presidential Security Group (PSG) Change of Command Ceremony at the PSG Compound in Malacañang Park, Manila on May 30, 2018. Alfred Frias, Malacañang Photo/File 


MANILA – Some members of the Presidential Security Group (PSG) remain uncooperative with the Food and Drug Administration's investigation on their illegal vaccination last year using the product of Sinopharm, the drug regulator's chief said on Tuesday.

Speaking to reporters, FDA Director-General Dr. Eric Domingo said the PSG has not responded to letters sent by the health department and his office asking for information on their inoculation against COVID-19.

The emergency use authorization (EUA) application of Sinopharm, officially known as China National Pharmaceutical Group Co., is still under review and being processed, making the distribution and use of the jabs illegal. 

The FDA said Sinopharm’s product is very similar to that of Sinovac’s, with both using inactivated virus to generate immune response. 

“Ilang beses nang nakiusap ang FDA, pati si Sec. Duque has asked for information. But there’s really nothing forthcoming. Wala talaga kaming mapiga," Domingo said.

"It is a very difficult situation, and until now hindi namin masarhan itong kasong ito," he added, noting that the probe seemed to be facing a "blank wall."

(We already tried communicating with them. Even Sec. Duque asked for information. But we cannot get anything from them. We cannot close this case.) 

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Domingo added that the agency has already gotten in touch with the Bureau of Customs to trace how the vaccine was smuggled in the country. But even this showed no sign of progress. 

No less than Defense Secretary Delfin Lorenzana had said that the 
experimental COVID-19 vaccines used by the PSG were smuggled.

It was only in February this year that the FDA issued a "compassionate use license" for the use of 10,000 Sinopharm vaccine doses by the PSG.

President Rodrigo Duterte was inoculated with the said vaccine on Monday night, with Health Secretary Francisco Duque III administering the shot.

Domingo explained that the compassionate special permit (CSP) was issued in order for the PSG to protect their members, their close-contacts, spouses an also Duterte from possible virus infection.

At the time the CSP was granted, no additional Sinopharm vaccines have supposedly entered the country, he said. It remained unclear when these shots reached the Philippines, he added.

Domingo pointed out the PSG is mandated by the FDA to submit a monthly report from the time they began administering the jabs. 

 FDA SURPRISED BY DUTERTE'S VACCINATION WITH SINOPHARM

The President's vaccination with the Sinopharm product came as a surprise to the FDA, according to Domingo, as the PSG has not submitted any report since being granted the permit in February. 

“As of early March, wala pang dumarating na donation from China na Sinopharm. I don’t have the full information yet kung kailan dumating at sa ilang tao nagamit,” he said.

(As of early March, we have not received any Sinopharm vaccine donations from China. I don't have any information yet when it arrived in the country and how many were vaccinated with it.) 

It is also unknown whether Duterte's vaccination by the said vaccine was recommended by a physician or if it was a personal choice. 

Duterte's longtime aide, Sen. Christopher Go, had said that the president's doctor approved the inoculation. Harry Roque, Duterte's spokesman, added that the president's first dose was covered by the compassionate use permit issued to the PSG.

Domingo said the CSP is not an assurance of safety, efficacy and quality of a product as it has not been evaluated by the FDA and other experts. 

The responsibility on a patient’s possible side effects lies solely on the party who applied for and was granted a CSP. In the President’s case, it is the PSG.

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Sinopharm has two COVID-19 vaccine products, the first developed by the Beijing Institute of Biological Products, an offshoot of the state-owned giant, and the second, by its subsidiary the Wuhan Institute of Biological Products.

Sinopharm said in December that the Beijing institute vaccine was 79 percent effective in preventing symptomatic COVID-19 diseases but it did not elaborate on the results or publish trial data. The product has been approved for general use in the United Arab Emirates and for emergency use in Argentina, Nepal, Egypt, Pakistan and Peru.

The second product, as of February this year, has been in phase 3 clinical trials in various countries since June. Participants in the first two phases of the product's trial were given two doses, 28 days apart.

In the Philippines, COVID-19 vaccine products from the following have been cleared for emergency use by the country's drug regulator: Pfizer-BioNTech, Oxford-AstraZeneca, Gamaleya Institute, Sinovac Biotech, Johnson & Johnson, and Bharat Biotech.

- With reports from Jamaine Punzalan and Job Manahan, ABS-CBN News; and South China Morning Post