FDA probing early, unauthorized use of COVID-19 vaccine
MANILA, Philippines — The country’s Food and Drug Administration said Tuesday it is investigating the early administration of coronavirus vaccine on President Rodrigo Duterte’s security detail despite the absence of an approved vaccine against the illness in the country.
FDA Director General Eric Domingo said the agency is looking into the details of the early COVID-19 vaccination activity involving members of the Presidential Security Group, which was only revealed Monday.
“Yesterday, I gave an order to our regulatory enforcement unit to conduct investigation to determine the status of vaccination activities. What happened, which vaccine was used?But, of course, that will probably take a few days,” Domingo said in Filipino in a briefing hosted by the Department of Health.
Accountability over the secret vaccinations is unlikely with the Palace the first to defend the use of the unauthorized vaccines.
The FDA has been conducting raids in clinics suspected of doing COVID-19 vaccination. But the early inoculation activity caught health officials by surprise as the DOH and the FDA were not informed about it.
“It was not [done] in consultation with the Department of Health or the FDA. Until now, we are firm in our stand that the public should not get vaccinated because there are no registered vaccines yet,” Domingo said.
The law prohibits the manufacture, import, sale and distribution of unauthorized vaccines and drugs. It, however, does not penalize people who receive shots of unregistered vaccines.
In a remark Saturday, Duterte said that almost all soldiers have received COVID-19 jabs from Chinese drugmaker Sinopharm. The firm has not applied to conduct large-scale clinical trials or applied for emergency use authorization in the Philippines.
Interior Secretary Eduardo Año also said that some Cabinet officials have been also vaccinated. He, however, has since revised this to say only one member of the Cabinet received the jab.
Under the government’s prioritization scheme of vaccine recipients, healthcare workers will be the first to get COVID-19 inoculated. Uniformed personnel are fifth in the said list.
‘Tokens’
Little is known about the controversial vaccination activity. But presidential spokesperson Harry Roque said the vaccines that the president’s security group took were donated.
The Anti-Graft and Corrupt Practices prohibits government officials and employees from “directly or indirectly requesting or receiving any gift, present, share, percentage or benefit, for himself or for any other person.”
Roque said the vaccines could be categorized as mere “tokens” so there was no violation of the anti-graft law.
But FDA’s Domingo stressed that even donated vaccines and drugs need to obtain clearance from the DOH and the FDA.
“For donated drugs or food, they should go through the DOH-Bureau of International Health Cooperation and then they coordinate with FDA for clearances. But in this case, this did not go through FDA,” he said.
The Coalition for People’s Right to Health said that even if the vaccines were donated, “ethics and FDA policies should have prevented this affront to our constitutional integrity.”
“By condoning the illegal vaccination, not only was the health of the vaccinated put at risk, but the entire vaccination effort itself has been undermined by vested interests,” the group said.
The local FDA has not issued any emergency use authorization to any COVID-19 vaccine. Only Pfizer has so far submitted application for EUA of its vaccine candidate in the country.
More than 471,000 cases of COVID-19, including 9,162 deaths, have been reported in the Philippines as officials fear a post-holiday surge in infections. — Gaea Katreena Cabico
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