Justice Secretary Menardo Guevarra on Wednesday said he has ordered the National Bureau of Investigation (NBI) to investigate the reported illegal distribution and use of unregistered vaccines against COVID-19.
Guevarra said the NBI is mandated to determine possible violations of the Food and Drug Administration (FDA) Act, the Consumer Act, and the Medical Practice Act.
He clarified, however, that the investigation would not focus solely on the inoculation of members of the Presidential Security Group (PSG) using an unauthorized vaccine as early as September.
The FDA has yet to issue any emergency use authorization (EUA) to any vaccine for COVID-19.
President Rodrigo Duterte earlier said some Filipinos, including military men, have already received COVID-19 vaccine from Sinopharm despite the lack of approval from the FDA.
Presidential Security Group (PSG) commander Brigadier General Jesus Durante III later confirmed that some of the President’s security aides have been administered with an anti-COVID-19 vaccine.
He declined to say how they obtained the vaccines, however, and said they did not seek the President’s permission for the inoculation.
The Integrated Bar of the Philippines (IBP) said the people responsible for PSG vaccinations could be liable for violating the FDA Act.
IBP president Domingo Egon Cayosa added that officials cannot conceal the source of the vaccine.
The Food and Drug Administration Act of 2009 prohibits the manufacture, importation, exportation, sale, and distribution, among others, of “any health product that is adulterated, unregistered or misbranded.” Those convicted of the crime will be sentenced to one to 10 years of imprisonment or a fine of P50,000 to P500,000, the law says.
Defense Secretary Delfin Lorenzana said the vaccines used were smuggled into the country because they did not get clearance from the FDA. Still, he defended the early inoculation of the PSG members, saying it was “justified.”
Earlier, presidential spokesman Harry Roque said the vaccines had been donated—but did not say who donated them or where they came from.
PSG chief Durante said the vaccinations began in September and the last batch was in October.
“All of the personnel inoculated so far are doing good. No side effects whatsoever,” he said in an ANC interview. He also said the President was not informed about the inoculations until after the PSG men were vaccinated.
“We didn’t ask permission. We just informed him about it after all the close-in personnel were vaccinated. He was surprised,” he added.
Durante refused to disclose how many PSG personnel were inoculated but said the men were always with the President. He also did not confirm nor deny if he received the vaccine.
“We are soldiers so we have to take risks just to accomplish our mission. The bottom line here is we have to accomplish our mission at all costs,” the PSG commander told ANC’s Headstart.
Durante said no public funds were used to buy the vaccine, as the PSG “asked” and “requested” for it. However, he refused to disclose from whom it was sourced.
“It could be a person, it could be a state, or whatever,” he said.
He said he took full responsibility for the unauthorized vaccinations.
The Bureau of Customs (BOC) said it is investigating the possible smuggling of the vaccines.
A spokesman for the bureau said even if the vaccines were donated, they would still need approval from regulatory agencies.
FDA Director-General Eric Domingo said the investigation into the unauthorized vaccine was not a witch hunt.
“It’s really a regulatory process for the FDA. We are not out to cause trouble for anyone,” Domingo said.
Domingo said the FDA’s mandate is to ensure the safety and efficacy of medicines, food and other products that are available to the public.
“That means we should be able to trace it, to know the process it went through before it reaches consumers, and how it was used,” said Domingo in an interview on Teleradyo on Wednesday.
He said he believed the FDA would get the full cooperation of those involved in the investigation.
He said those who received the vaccine won’t be held accountable.
But a health expert on Wednesday said the vaccination of the PSG members without regulatory approval would set a bad precedent in the government’s massive vaccination program next year.
“First, it’s a violation of FDA (Food and Drug Administration) rules in terms of trying to bring in unregistered products even as donation,” said Dr. Tony Leachon, former adviser of the government’s pandemic task force.
“Number 2, it could actually sabotage the national vaccination program considering there’s a grand plan for this one,” Leachon said during an interview on ANC’s “Matters of Fact.”
Leachon also criticized Malacañang for saying the vaccine could be considered as “tokens.”
“How can it be a token in minimal value? It’s one of the most sought-after products in the world right now,” he said.
Government officials earlier cited national security for bringing in the vaccine, even though the Food and Drug Authority was yet to approve any candidate vaccine.
Senator Francis Pangilinan, meanwhile, chided government officials for offering conflicting statements about the unauthorized vaccinations, with Roque saying they were not illegal, contradicting the FDA and the Bureau of Customs. He advised them to create a “group chat” so they could get their stories straight.
Lorenzana on Wednesday said the rest of the Armed Forces of the Philippines would wait for the official rollout of COVID-19 vaccines that the government will buy before they can be inoculated.
On Tuesday, 160 health professional organizations on Tuesday called for the safe and transparent use of COVID-19 vaccines amid reports that vaccines yet to be approved had been used for inoculations.
The Healthcare Professionals Alliance Against COVID-19 (HPAAC) pointed out that even if a vaccine was approved in other countries, its storage, transport, and distribution were complex procedures.
“Improper handling can damage vaccines and can render them useless. This is why distribution channels and processes need to be transparent and regulated,” HPAAC said in its statement.