Small groups, like PSG, can get special vaccine permits – FDA
MANILA, Philippines — The Food and Drug Administration said Monday that special vaccine permits can be issued to smaller groups, like the Presidential Security Group (PSG) which is still facing questions on their vaccination for the coronavirus.
FDA Director General Eric Domingo told President Rodrigo Duterte in a briefing that the agency can issue compassionate special permits (CSPs) to small groups, even without an emergency use authorization.
“Of course it is their (PSG) priority to protect you (the president),” Domingo said partly in Filipino. “We understand the importance of what they do and there’s a safe way to do it if they want to do it.”
However, Domingo admitted in a message to Philstar.com that CSPs cannot be applied retroactively — which means that it does not cure the illegal use of the unregistered vaccines by the PSG.
CSPs were first conceived in 1992, with the FDA recognizing that “there is a need for patients who are terminally or seriously ill to have access to drugs and devices which are not yet registered or are in the process of registration in the Philippines.”
A specialized institution or specialty society would be the only ones to file a request for CSPs.
FDA rules previously allowed CSPs only for patients suffering from acquired immune deficiency syndrome, cancer and life-threatening conditions, but these were amended in July 2020 to include emerging or re-emerging infectious diseases considered as public health emergencies or public health threats, such as the coronavirus.
But the FDA, in Administrative Order No. 2020-0028, cautioned that the grant of a CSP to a drug does “is not an assurance of [its] safety, efficacy and quality,” adding that these may even cause unexpected serious adverse reactions.
“Therefore, it is imperative for the physician to carefully assess based on sound clinical judgement prior to availing the CSP whether the benefit of the use of the unregistered or investigational product outweighs the potential risks it may pose to the patient,” the FDA said in the order.
Smuggled vaccines
In the same briefing, Duterte defended the PSG’s use of smuggled coronavirus vaccines, saying that his security detail must be protected against COVID-19 to carry out their duties.
He also ordered them to stay mum about their use of the vaccines, going as far as warning of a “crisis” with Congress should his guards be compelled to explain their actions.
The Senate is scheduled to look into the government’s COVID-19 immunization plan next week, but it is not yet certain whether the controversial vaccination will be discussed in the same legislative probe.
Senate Minority Leader Franklin Drilon said the upper house must summon PSG commander Brig. Gen. Jesus Durante III when it probes the government’s inoculation plan.
Various government agencies such as the Food and Drug Administration, the National Bureau of Investigation and the Bureau of Customs are investigating the entry of smuggled COVID-19 vaccines into the country.
The law prohibits the manufacture, import, sale and distribution of unregistered vaccines and drugs. It, however, stops short of penalizing people who receive unauthorized inoculation.
Health workers and advocates slammed the early COVID-19 vaccination given to the president’s security detail as they were “bypassed and especially leapfrogged by those not even listed yet.”
Healthcare workers should be the first in line to get coronavirus vaccines under the government’s prioritization scheme, while uniformed personnel are fifth on the list.
Aside from the president's security group, at least one Cabinet member was also said to have been inoculated with an unauthorized vaccine. — with a report from Gaea Katreena Cabico
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