Donated vaccine should still be registered —FDA chief

Vaccines should go through the normal registration process even if they are donated, the head of the Food and Drug Administration (FDA) said Wednesday, amid the controversy over an unregistered COVID-19 vaccine used on some soldiers.

Interviewed on Dobol B sa News TV, FDA Director General Eric Domingo emphasized that as far as they are concerned, registration is needed whether the drug or the vaccine is procured or donated.

"Sa amin po kasi, kahit donated ang mga gamot at bakuna, dapat po kasi dumadaan siya sa Department of Health at ang Department of Health humihingi sa amin ng parang import permit at saka nire-register po sa FDA," said Domingo, also a DOH undersecretary.

"Ang concern namin is hindi naman kung binili o dinonate siya, hindi po kasi siya na-register sa amin," he added, referring to the vaccine used on the soldiers belonging to the Presidential Security Group (PSG).

The PSG has admitted that some of its members have received vaccine against COVID-19 that they got for free. PSG commander Brigadier General Jesus Durante III, however, refused to identify the source of the vaccine.

Domingo said those who received the unregistered vaccine could not be held liable but stopped short on saying that those who administered it on the PSG members should face sanctions.

"Depende po kasi sa circumstances, hindi ko talaga alam kung ano ang circumstances nito, kung sino nag inject," he said, but added that "technically," dispensing unregistered drug is illegal.

Domingo said the FDA's Regulatory Enforcement Unit is already exerting efforts to unearth details surrounding the vaccine, including coordinating with the Bureau of Customs to determine how it entered the country.

"Kasi kung imported 'yan, tatanungin natin kung saan nanggaling," he said.

The BOC had earlier said that the vaccine used by the PSG had no papers.

The head of the investigating unit, Domingo said, has been ordered to coordinate with PSG and Armed Forces of the Philippines officials as as part of the investigation. He also said the probe is unlikely to reach the Office of the President.

"Ang sabi ng AFP at ng PSG sa kanila pong responsibilidad 'yon so I think hanggang doon lang po ang ating magiging imbestigasyon dahil doon naman po nangyari ang pagbabakuna," he said.

It was President Rodrigo Duterte who first bared that some soldiers have already been inoculated against COVID-19 even if the FDA is yet to approve a vaccine for local use. —KBK, GMA News