FDA says ‘compassionate special permit’ may be issued to vaccinate small groups like PSG

Even without a registered vaccine yet, Food and Drug Administration (FDA) Director General Eric Domingo said the agency can issue a "compassionate special permit" to pave the way for inoculating small groups of people involved in critical missions such as President Rodrigo Duterte's guards.

Domingo issued the statement when asked by President Rodrigo Duterte Monday night during his regular Cabinet briefing whether the FDA can issue can give authority for the use of the vaccines for emergency purposes.

"If it's going to be a smaller group, for example 'yung PSG (Presidential Security Group), and of course, priority naman po talaga nila na kayo ay proteksyunan, then we can give compassionate special permit for this kasi maliit lang naman po 'yun and a hospital can take care of it and a doctor can administer safely," Domingo said.

"For smaller quantities, kahit walang EUA (emergency use authorization), we can do a special permit for that. . . .There's a safe way to do it," he added. 

According to the FDA, the EUA  is an "authorization issued for unregistered drugs and vaccines in a public health emergency. . . .The evaluation process of the product may be facilitated by reliance and recognition principles, but stricter conditions on the use and monitoring following authorization shall be imposed."

Controversy swirled after Duterte himself revealed last week that some Filipino soldiers -- they would later turn out to be members of the PSG -- had been vaccinated.

Justice Secretary Menardo Guevarra has ordered the National Bureau of Investigation (NBI) to look into unauthorized inoculations against COVID-19 using unregistered vaccines.

Domingo earlier emphasized that registration is needed whether the drug or the vaccine is procured or donated.

"Sa amin po kasi, kahit donated ang mga gamot at bakuna, dapat po kasi dumadaan siya sa Department of Health at ang Department of Health humihingi sa amin ng parang import permit at saka nire-register po sa FDA," said Domingo, also a DOH undersecretary.

"Ang concern namin is hindi naman kung binili o dinonate siya, hindi po kasi siya na-register sa amin," he added in an earlier interview.

The Senate is set to hold a Committee of the Whole hearing on the government's vaccination program next week, which could also tackle the use of the unregistered vaccine.

Duterte, however, ordered the PSG to keep silent on the vaccination of some of its members.

"If that is the case then I would ask the PSG to just shut up. Do not answer. Invoke the right against self-incrimination at wala kayong makukuha and do not force my soldiers to testify against their will," Duterte said in his weekly address to the nation.—LDF, GMA News