Three agencies to probe use of 'smuggled' vaccines on President's security staff; results out soon

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Metro Manila (CNN Philippines, December 30) — The Food and Drug Administration and the Bureau of Customs will investigate how unregistered COVID-19 vaccines entered the country and were administered to members of the Presidential Security Group.

Health Secretary Francisco Duque III on Wednesday said he only learned about the early vaccination of select PSG staff when President Rodrigo Duterte made the announcement over the weekend, stressing anew that he was not consulted about it.

Duque added he is leaving the probe to the FDA, which is tasked to study and approve medicines and vaccines for use in the Philippines.

"It (FDA) will have to investigate who imported this, who distributed it, who administered it, how was it brought to country. The Bureau of Customs, I think, will also help form a composite team that will investigate the issues surrounding these alleged vaccines given to the PSG," Duque told CNN Philippines' The Source.

"What I know is that after the holidays, I think the results will be out or will be concluded," he added.

Authorities gave limited details on the vaccination of PSG members, which apparently happened as early as September. PSG head Jesus Durante III said it was a matter of "national security" as they had to protect the President's health.

READ: PSG members got vaccinated first to 'protect' Duterte from COVID-19

The investigation will also cover who donated the vaccines to the PSG as well as the possible liability of the source of the doses.

Defense Secretary Delfin Lorenzana has called the vaccines "smuggled" as the shipments did not receive authorization from the FDA. He then asked the regulator to already fast-track the approval of vaccines so legitimate importers can already bring the doses in the country.

READ: Lawmakers, critics decry early vaccination of military

Meanwhile, Duque said he is not aware about other government officials who reportedly got vaccinated. Duterte earlier said China-made Sinopharm was used on members of the military, which has been clarified as referring to the PSG.

Asked whether Duterte has been vaccinated, Duque said what he knows is that the President's doctor "does not recommend" it, until a vaccine is evaluated and cleared for safety and efficacy.

"FDA law is very clear; this has to be followed. We should not violate this. If that happens, the risks might be too much to take because you have no idea as to the safety of such vaccines," Duque said, reminding the public to be "doubly careful" in receiving these new vaccines.

"It's best that they go through the process of scientific evaluation," Duque added.

Aside from the FDA and the BOC, the National Bureau of Investigation will also look into the "reported unauthorized distribution and administration of unregistered anti-COVID 19 vaccines" and see what laws were violated.

Justice Secretary Menardo Guevarra ordered the probe, but clarified that this was a "general instruction" not meant to single out what happened with the PSG.

"If the NBI finds sufficient factual basis to file a complaint, the DOJ will conduct the appropriate preliminary investigation and file a case in court, if probable cause has been established," he said.

Health authorities have assured that medical workers manning the frontlines of the COVID-19 response remain the priority for vaccines – at least, those secured through legal channels by the national government. These are expected by March 2021 at the earliest.

Under the FDA Act, those who import, sell, or distribute any unregistered health product may face imprisonment or monetary fines. The law does not penalize the person who was injected with the unregistered vaccines, but charges await those who import, sell, distribute, and dispense the drugs.