FDA 'surprised' by Cabinet officials, soldiers' use of unregistered COVID-19 vaccine

As soldiers and top officials of the Duterte government rolled up their sleeves to receive COVID-19 vaccines, not even the director general of the country’s Food and Drug Administration was aware of the early inoculation activities. 

FDA Director General Eric Domingo said on Monday, December 28, that President Rodrigo Duterte’s news that some members of the Armed Forces of the Philippines already received a vaccine caught him by surprise, considering the government itself had not yet approved any vaccine for emergency use. 

“You can imagine my surprise. I was there and of course we have been hearing rumors about people bringing them in, peddling them, and I’ve been asking my agents to run after them. Of course hearing it officially that some people have received it, it was very surprising,” Domingo said in an interview on ANC. 

Domingo said he was not aware of what vaccine was used by public officials – only that there have been no vaccines registered with the FDA for use in the country. 

“I have no idea. I don’t know what brand it is or from what country it came from because as of now, there is no registered vaccine that has been authorized to be used in the Philippines,” he said. 

Why does this matter?

News of government officials being vaccinated against COVID-19 took place despite the absence of an approved or registered vaccine against the disease in the country. 

It is only the FDA which can approve any and all COVID-19 vaccines that will be used in the Philippines. Health officials have repeatedly cited this was required by law to ensure that vaccines to be used in the country were assured to be both safe and effective. 

On Monday, the Department of Health reiterated that “all vaccines should undergo the evaluation and regulatory process of our regulatory and expert bodies.”

Domingo, for his part, warned of the risks associated with receiving an unregistered COVID-19 vaccine. 

“These are all products under development. We have to realize that. We’re not even giving whole marketing authorization. We’re giving emergency use authorization which means that we will only use this vaccines even while they are still under development…we allow them knowing they will be useful, that they will help us, that the benefit outweighs the risk,” he said. 

What's the status of vaccine approval?

While the government has considered at least 17 potential candidates for purchase or use in Phase 3 clinical trials, Domingo said no vaccine has been registered for use against the disease. 

As of December 28, the FDA was reviewing applications for trials in the country from 3 companies including China’s Sinovac, Clover Biopharmaceuticals, and Johnson & Johnson’s (Janssen Pharmaceuticals Inc). 

Aside from this, Domingo added only Pfizer has applied for a special emergency use authorization for its COVID-19 vaccine. 

What comes next?

Domingo said he would send an official letter seeking for more information on the early vaccination of officials from the Office of the President. 

“I’m going to send an official letter in the same way that when we had these rumors of a senator and a congressman having injections. I wrote them formally that there was a rumor you had an injection. Can you please tell me who is peddling them or where you are getting them because this is not allowed,” he said. 

Domingo, however, admitted that he could not compel authorities to divulge more information if they refuse to answer. 

He said: “We do work with the law enforcement agencies and continue with the investigations when we hear something like this. But that’s as far as I can go when it comes to this.”

Meanwhile, he gave assurances the FDA was taking every step to ensure that vaccines approved for the use of the public will follow “proper” processes. 

“We will concentrate on making sure that only vaccines that pass standards will be made available to the public,” Domingo said.  – Rappler.com

Sofia Tomacruz

Sofia Tomacruz covers foreign affairs and is the lead reporter on the coronavirus pandemic. She also writes stories on the treatment of women and children. Follow her on Twitter via @sofiatomacruz. Email her at sofia.tomacruz@rappler.com.