The Food and Drug Administration (FDA) on Thursday asserted its authority to regulate vaccines after high government officials admitted that members of the President’s security detail got vaccinated against COVID-19 using an unauthorized vaccine.
“I think it’s really a lack of appreciation. They thought the FDA is like a rubber stamp. FDA… is an important unit of government because it deals with everything that we eat…processed food, household substances that we have and the medicines that we put into our bodies,” FDA Director General Eric Domingo said in an interview on ANC’s Headstart.
Domingo said people working at the FDA are doing their jobs to protect the public and ensure a level of assurance that what people are using is safe and effective.
“Maybe people don’t understand that we’re here not to make things difficult but to make things safe and effective for everybody,” he said.
He said there is no authorized COVID-19 vaccine in the Philippines at this time. As such, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any unauthorized vaccine remains prohibited.
The PSG on Wednesday admitted that some members of President Rodrigo Duterte’s close-in security detail had been vaccinated against COVID-19 as early as September this year using a Chinese vaccine that has not been approved for use in the Philippines.
A Palace spokesman urged the public to “just accept” that some soldiers were vaccinated against the COVID-19 while Interior Secretary Eduardo Año also said there was nothing illegal in the PSG’s early inoculation.
But while Defense Secretary Delfin Lorenzana said the early and unauthorized inoculation of PSG members was justified, he acknowledged that the vaccines were considered to be smuggled into the country.
Domingo said outside of Pfizer, no other company has applied for emergency use authorization from the FDA.
“We don’t have anything to approve. We are not delaying, if there is no company that is applying [for clearance],” he said.
He said they cannot force companies to give their papers or samples of their vaccines to be tested.
Domingo said their vaccine expert panel and regulators are now evaluating the Pfizer application for its emergency use authorization.
“The evaluation is going to take about two weeks. It was given to us right before Christmas. So I am giving evaluators up to the first week of January to do that. Of course, we have to consolidate the report,” he said.
The availability of the drug will not depend on the FDA, he said. “It will depend on the ability of the company to manufacture and supply to us,” said Domingo.
“Everybody is waiting for the COVID-19 vaccine but we’re not going to allow it unless we are sure that there is a certain amount of reasonable scientific evidence to believe that it is safe and effective against COVID-19,” he said.
Domingo stopped short of saying that sanctions will be forthcoming even if PSG commander Brigadier General Jesus Durante III said they administered the unregistered COVID-19 vaccines to themselves way back in September and October.
“Somebody definitely did something wrong. With the FDA Law, it says it is illegal to import, distribute, manufacture, or use unregistered drugs,” Domingo said in an ANC interview.
Domingo did not reply when asked if the agency would take action against the PSG.
He assured the public, however, that the FDA has competent investigators.
“Our regulatory enforcers are very good at doing investigations and I am happy that even Secretary (Menardo) Guevarra of DOJ has said they are going to send the NBI (National Bureau of Investigation) to investigate,” Domingo said.
“Our enforcement unit is going to work with the NBI and the Bureau of Customs so that we can find and trace where the lapses were and where the breach is in our regulatory process,” he added.
Domingo warned of the dangers of self injection after the head of the PSG said the President’s security team inoculated themselves.
“Everything could go wrong. Even the DOH [Department of Health] now, before they start inoculating, all their nurses are trained,” he said. Durante said members of the President’s security team vaccinated themselves within the PSG compound.
A health expert who heads the UST Hospital’s pediatric infectious diseases section, said the early vaccination of the PSG members with an unauthorized vaccine was a blow to public health authorities.
“To put it bluntly, it’s wrong… Ironically, it was done all the way back in September. It’s something unusual. It’s a blow to health authorities, as well,” Dr. Benjamin Co told ANC’s “Matters of Fact”.
While the PSG said its members had to be inoculated to protect the President against infection, Co said this doesn’t justify the illegal action.
Co said such vaccination was illegal because it didn’t have regulatory approval from the FDA, “the gatekeeper of safe and effective food, drug and medical devices.”
The PSG, he said, could have applied for a compassionate special permit for the use of COVID-19 vaccines, which were reportedly developed by Chinese drug maker Sinopharm.
“Otherwise, why is there a law? What for is the agency?” Co said.
Co also criticized high-ranking officials for justifying PSG’s action.
“You can’t correct a wrong by another wrong,” Co said.
Co does not share the view of Philippine Medical Association (PMA) that the issue should be swept under the rug.
“It needs to be investigated. Somebody has to be accountable for what happened so this doesn’t happen again,” Co said.
Senate Minority Leader Franklin Drilon on Thursday said he supports the order of Guevarra for the NBI to look into unauthorized inoculations against COVID-19 using unregistered vaccines.
He said laws appear to have been violated. He said the DOJ and the NBI are mandated by law to investigate.
“No one is above the law. The Rule of Law must be the rule, rather than an exception,” he added. Drilon said PSG chief Durante must be called to a hearing before the Senate.
“The most important ‘who’ and ‘how’ of the story remain a mystery. The PSG commander is deliberately withholding the basic questions of who and how from the public,” Drilon said.
Durante admitted that some members of the PSG “independently” inoculated themselves with unregistered Covid-19 vaccines, but refused to say where the vaccines came from.
Drilon said those behind the secret unauthorized use of the vaccine were “lying through their teeth” to protect those who were principally involved in the illegal importation of the unauthorized vaccine into the country.
He said there is no way the unauthorized vaccines could have entered the country without the Bureau of Customs (BOC) clearance.
“They cannot hide the truth. The truth will come out and we will find their fingerprints all over it. Those who caused the illegal importation and administration of the unauthorized vaccine must be held responsible. Otherwise, the environment of impunity is enhanced,” Drilon said.
Told that Durante took “full responsibility” for the administration of the unregistered vaccine, Drilon quipped: “Tell that to the Marines.”
He said that those involved cannot invoke “good faith” nor ignorance of the law: “It is a rule in law that ignorance of the law excuses no one from compliance therewith.”