Donated COVID-19 vaccines need FDA registration – Domingo

Donated vaccines still needed to be registered at the Food and Drug Administration (), FDA Director-General Eric Domingo clarified Wednesday amid reports that an unregistered COVID-19 vaccine was given to members of the Presidential Security Group ().

Domingo said registration is needed whether the medicine or vaccine is bought 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).

On Tuesday, PSG commander Brigadier General Jesus Durante III said his team got the COVID-19 vaccines for free but refused to name the source.

Durante said the PSG researched what vaccine they would acquire.

Donated COVID-19 vaccines need FDA registration – Domingo

“We’ve done our research about it so we made by all means, we were able to acquire itong vaccine na ito for our unit alone. Wala kaming intent na ipakalat ‘yun sa iba,” he said.

“Hindi ko rin masabi actually eh kung saan namin nakuha ‘yun, source namin, but maybe someday you’ll find out, you’ll know someday. For now, huwag muna, it could jeopardize itong vaccination program, procurement ng government natin,” he added.

The FDA chief said those who received the could not be held accountable. However, those who administered them should face sanctions.

“Depende po kasi sa circumstances, hindi ko talaga alam kung ano ang circumstances nito, kung sino nag inject,” Domingo said, but added that “technically,” administering the unregistered drug is illegal.

“Kasi kung imported ‘yan, tatanungin natin kung saan nanggaling,” he added.

The Bureau of  (BOC) revealed Tuesday that the imported COVID-19 vaccines given to the Presidential Security Group (PSG) did not have any formal communication to their agency. It added those involved could be facing civil and administrative cases if the vaccines were proved to be smuggled.