“Compassionate special permit” may be issued in order to inoculate small groups like the PSG, according to FDA.
The Food and Drug Administration (FDA) said that the agency can issue a “compassionate special permit” in order to pave the way for vaccinating small groups of people involved in critical missions even without a registered vaccine yet such as the Presidential Security Group (PSG).
Food and Drug Administration Director-General Eric Domingo on Monday night issued the statement when asked by President Rodrigo Duterte during his regular Cabinet briefing whether the Food and Drug Administration could give authority for the use of COVID-19 vaccines for emergency purposes.
According to Domingo, the FDA could give a “compassionate special permit” if it’s going to be a smaller group and if the group’s priority was to protect the President, adding that a hospital could take care of it and a doctor could administer it safely.
“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. 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,” Domingo said.
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According to the Food and Drug Administration, the emergency use authorization (EUA) was an authorization issued for unregistered vaccines and drugs in a public health emergency and the evaluation process of the said product may be facilitated by reliance and recognition principles.
However, the Food and Drug Administration also said that more stringent conditions on the use and monitoring following authorization should be implemented.
Controversy swirled after President Duterte himself revealed that some Filipino soldiers had been vaccinated.
Justice Secretary Menardo Guevarra had ordered the National Bureau of Investigation (NBI) to investigate the unauthorized vaccinations using unregistered COVID-19 vaccines.
Domingo earlier emphasized that registration was needed whether a vaccine or a drug was donated or procured.
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