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FDA approves compassionate use license on vaccines for PSG personnel
In this file photo taken on Feb. 2, 2021 A health worker holds a vial with the Pfizer-BioNTech COVID-19 vaccine against the novel coronavirus at the vaccination center in Freising, southern Germany, on February 2, 2021
AFP/Christof Stache

FDA approves compassionate use license on vaccines for PSG personnel

Franco Luna (Philstar.com) - February 11, 2021 - 3:33pm

MANILA, Philippines — The government's Food and Drug Administration has issued compassionate use license for 10,000 doses of the China-based Sinopharm coronavirus vaccine to be administered to the Presidential Security Group, months after the latter already took the smuggled vaccines which were illegal at the time. 

Speaking at a press briefing Thursday afternoon, presidential spokesperson Harry Roque made the announcement, adding that the issuance was made in accordance with the application of the PSG. 

"I do not know if it is retroactive. I do not know when it will actually start its next round of vaccination of involving Sinopharm," he said. "All that I know is that PSG has applied and was granted compassionate use for 10,000 dosage."

RELATED: Authorities warn public vs buying unauthorized COVID-19 vaccines

Under Republic Act No. 9711, the importation, selling, distribution and non-consumer use of health products not yet registered with the FDA is prohibited.

Earlier Thursday, Police Gen. Debold Sinas, the chief of the national police, said that police units have been mobilized to take action against black-market activity for counterfeit vaccines, vowing to "strictly implement this official policy, and take appropriate police action in accordance with existing laws."

"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 [us]," FDA Director-General Eric Domingo also told reporters in a text message later Thursday.

"For future use and the permit is for one-time importation. They first applied on Jan. 18 and they recently completed all requirements," he also said. 

Not retroactive

Asked if the application of CSP could be used retroactively, Domingo told Philstar.com in a text message earlier: "Not really. Because CSP is used to import the drug or the vaccine." 

To recall, members of the Presidential Security Group earlier in December admitted to administering on themselves the illegal, smuggled, and unregistered China-made vaccines that did not yet have the green light from the FDA's regulatory processes.

In an interview aired over ANC's "Headstart" at the time, Domingo was quoted as saying: "Definitely somebody definitely did something wrong. With the FDA law, it says it is illegal to import, distribute, manufacture, use unregistered drugs."

RELATED: Roque justifies soldiers getting jabs of unauthorized COVID-19 vaccine

Yet government officials still saw fit to staunchly defend the move, saying it was done to protect the president from possible coronavirus transmission. Like most violations of health protocols, the issue has since gone unaddressed, with no less than Roque himself tagging it as a closed issue and urging the public to "stop" discussions on it. 

"Let's stop the politics. We already know that this issue that is being used by the enemies of the government is not going to end," he said then.

Whether the vaccination was meant to protect the president or not completely misses the point, as healthcare collectives have said that "24 million health workers and patients were bypassed, and especially leapfrogged by those not even listed yet were able to receive it illegally."

The Department of Health in its latest case update Wednesday afternoon reported that the national caseload had breached 541,560. — with reports from Gaea Katreena Cabico and Xave Gregorio

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COVID-19 DEPARTMENT OF HEALTH DOH FDA FOOD AND DRUG ADMINISTRATION NOVEL CORONAVIRUS PRESIDENTIAL SECURITY GROUP PSG
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