PSG may get “special permit” for COVID-19 vaccine sans EUA, says FDA

January 5, 2021

The Philippine Food and Drug Administration can issue a special permit for the use of vaccine against coronavirus disease even if there is no emergency use authorization amid the controversy involving the "smuggled" Chinese vaccines used by the Presidential Security Group.

During his "Talk to the People" on Monday night, President Rodrigo Duterte asked FDA Director General Enrique Domingo if he could issue an emergency clearance for the use of vaccines in the country.

Domingo told Duterte, "if it's going to be a smaller group, for example, PSG, and of course, it's really their priority to protect you, then we can give compassionate special permit for this."

He said the doctor could administer the vaccine safely.

Some quarters have been questioning the Duterte administration for the PSG members' use of Chinese COVID-19 vaccines even if there was no approval yet from FDA.

Apparently to justify the action of the PSG, Domingo said for small quantities of COVID-19 vaccine, his office could issue special permits even if there is no emergency use authorization.

"There's a way...we understand the importance of what they have to do and there's a safe way to do it if they want to do it," he said.

The PSG leadership and even Malacanang said that some of Duterte's security personnel had themselves vaccinated even without FDA approval of the drugs as their concern was the President's safety.

Meanwhile, in a televised press briefing on Tuesday, Presidential Spokesperson Harry Roque denied that Duterte ordered the FDA to come up with a special permit even without the EUA to accommodate the PSG.

He said the President merely asked Domingo if there is a way to get a permit since not all the PSG members have been vaccinated.

"So, the President did not mean anything but if I were to be asked for an opinion by the PSG, I would seriously advice PSG to follow what Usec. Domingo has said, apply for a special permit in order for all the PSG members can be vaccinated," he said.

As to the investigation on the use of "smuggled" vaccines by the PSG, Roque said other agencies could decide if they want to proceed with the probe.

On Monday night, Duterte criticized the plan of some senators to conduct investigation on the PSG's use of the unapproved COVID-19 vaccines.

He even defended the PSG personnel, saying their action was for self-preservation.

With such an argument of self-preservation, asked if anyone could access the COVID-19 vaccine regardless if it is FDA authorized or no so long as it is not for sale or advertised, Roque said, "No. The context by which the President said that pertains particularly to PSG alone. So, that can'd be used for all the situation."

"The President said that it was for self-preservation of PSG because their duty is to protect the President and they cannot do it if they cannot protect themselves," he explained. Celerina Monte/DMS