Food and Drug Administration (FDA) Director General Enrique Domingo said on Tuesday, December 29, that neither the Department of Health nor the FDA were consulted over the early use of a COVID-19 vaccine on soldiers and other government officials. 

“I do not know who made that decision, but [when] I spoke to Secretary (Francisco Duque III), nagulat din po siya (he was also surprised). We were not consulted; it was not done in consultation with the Department of Health or the FDA,” Domingo said in a press briefing.  

Domingo made the remarks following confirmation that some top officials of the Duterte government and members of President Rodrigo Duterte’s close-in security were already vaccinated against COVID-19, despite the absence of an approved vaccine for the disease in the country. 

“Until now, we are firm in our stand that the public should not be vaccinated yet because there have been no registered vaccines that have undergone the review of the FDA at this time,” Domingo added. 

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Why does this matter?

The early use of an unregistered vaccine has prompted public backlash for appearing to prioritize select individuals outside of the government’s own list of target priority groups – first of whom are frontline health workers treating COVID-19 patients. 

Health experts have also cautioned against the use of an unapproved vaccine, as these could not be guaranteed to be both safe and effective. Aside from the efficacy of the vaccines themselves, medical experts have pointed out that regulations were also in place to ensure that proper handling, storage, and administering of the vaccines was observed to ensure these remained effective. 

Domingo earlier pointed out that with COVID-19 vaccines, which have only been granted emergency use authorizations by regulatory bodies, regulatory officials and medical experts take extra precaution to assess their risks and benefits. 

“We’re giving emergency use authorization, which means that we…allow them knowing they will be useful, that they will help us, that the benefit outweighs the risk. If our people are getting products outside that system, I would be very wary. I would be very afraid for them,” Domingo said.

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What’s happening now?

The FDA’s regulatory enforcement unit is currently investigating the use of the COVID-19 vaccines, Domingo said. The probe seeks to find out the status of the vaccination activities as well as what vaccine was used, among other questions. 

Malacañang, meanwhile, has sought to deflect questions and criticism on the matter, saying the issue was “over.” Presidential Spokesperson Harry Roque, a lawyer, defended the selective vaccination by saying that the doses were donated, and stressing that taxpayers’ money was not spent for their acquisition.

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Still, donations like food and medicine usually pass the DOH’s Bureau of International Health Cooperation which coordinates with the FDA for clearances, Domingo said.

“In this case, wala pong dumaan sa amin (nothing went through us),” he said. – Rappler.com