Recipients of unregistered COVID-19 vaccine should consult doctor, says FDA chief

Recipients of the unregistered COVID-19 vaccine reportedly available in the Philippines should consult their doctors for the risk they have taken, Food and Drug Administration (FDA) director general Eric Domingo advised on Monday.

"It's a risk that you have taken. You know, you have had something injected on your arm, on your body and I do not know what it is. I don't know if your doctor knows what it is," Domingo said in an interview on CNN Philippines.

"I don't think anybody will be able to give a certification that you have been vaccinated, so you have to consult your doctor [on] what your next step is going to be because I personally have no answer for that," he added.

On Saturday, President Rodrigo Duterte claimed that many Filipinos, including some members of the military, already had themselves inoculated with a COVID-19 vaccine from Chinese pharmaceutical company Sinopharm even as it has yet to get approval from the FDA.

"Sabihin ko sa iyo, marami na ang nagpa-injection dito sa Sinopharm... Halos lahat ng sundalo natusukan na," Duterte had said.

"I have to be frank and I have to tell the truth. I will not foist a lie. Marami nang nagpatusok and lahat," he added.

Last month, it was reported that Senator Panfilo Lacson and House Majority Leader Martin Romualdez already had themselves injected against COVID-19. Lacson played coy when asked about it while Romualdez kept mum.

Cases to be filed

Domingo reiterated that the FDA has conducted several operations in Makati City and Binondo in Manila in response to reports on unauthorized COVID-19 vaccination, but has yet to arrest any individuals involved.

While those who received the vaccine may not be held liable, those who administered it may face cases, he said.

"For the consumer, there's nothing we can do about it. It's a personal choice but it is illegal to import an unregistered product, and to distribute it, and for a doctor, medical practitioner or any health personnel to administer unlicensed drugs in the country. So, if we do catch any of them, we will be filing cases against them," Domingo said.

There is no approved COVID-19 vaccine yet in the Philippines, Domingo said, as he urged the public not to patronize unauthorized immunization.

"The possibility of getting something either counterfeit or something that has been spoiled is very, very high. The side effects are also possible to happen. If something happens, there's no way to trace where these came from," he said.

Pfizer-BioNTech has applied for an emergency use authorization (EUA) for its vaccine last December 23, which may allow it to be the first to be made available in the country.

Domingo said it may take the FDA more or less 21 days to come up with a decision to grant the EUA or not.

"It can be shorter than that if we see that the evidence is very clear... but if after 21 days, we still need some more answers, it will take a little more than that. We will take all the time that we need," Domingo said.

"We're going to make sure that we have all the answers before we come up with the authorization," he added. —KBK, GMA News