FDA looking into vaccination of soldiers, Cabinet execs using unregistered COVID vaccine

The Food and Drug Administration (FDA) is now investigating the inoculation of some military and Cabinet members with unauthorized COVID-19 vaccines, its director general, Eric Domingo, said on Tuesday.

Interviewed on Super Radyo dzBB, Domingo said the regulatory enforcement unit has yet to submit a report but pointed out they are looking into more details about the vaccination.

“Gusto ko po talaga malaman 'yung detalye kung paano po ang nangyari,” said Domingo, also undersecretary of the Department of Health.

“Saan ba nanggaling ang bakuna? Kung ano ba 'yung assurance natin na totoong bakuna 'yun at na-handle siya properly bago itinurok sa mga, allegedly, sundalo,” he added

Domingo said they will also ask the Philippine Army and Presidential Security Group (PSG) information on the personnel who received the unregistered vaccine.

“Dahil ang Army po ang mismong nagsabi, na ito pong head ng Philippine Army is mukhang nagsabi na merong nabakunahan so at least siya po maaari naming hingan ng impormasyon tsaka sa PSG,” he said.

Asked about Cabinet members who allegedly received the vaccine as claimed by Interior Secretary Eduardo Año, Domingo said he is not privy about it.

Domingo said Health Secretary Francisco Duque III also does not know who among the Cabinet officials have received the vaccine, and that he is not one of them.

On Saturday, President Rodrigo Duterte said some military personnel have already received a COVID-19 vaccine from Chinese manufacturer Sinopharm, which has no approval yet from the FDA.

The Armed Forces of the Philippines, after an internal inquiry, said those who received the vaccine were members of the Presidential Security Group.

Domingo said Sinopharm has yet to contact the FDA regarding possible application.

“Ang Sinopharm po kasi hindi pa lumalapit sa FDA. Wala pa po silang application na kahit ano dito sa Pilipinas tapos wala po silang representative dito sa Pilipinas,” he said.

Domingo added that the FDA will try to communicate with the Chinese manufacturer through the Chinese Embassy.

Domingo also said he finds it shocking than an unregulated vaccine has been reportedly used on military personnel and Cabinet members.

“Ito naman po ay ginagawa kasi natin to assure 'yung safety and quality po ng bakuna na gagamitin o ng gamot,” he said.

“Kaya nga po nakakagulat naman na may nangyaring ganoon na hindi man lang natin po nalaman sana man lang nasigurado po natin na na-handle properly and that it goes through a proper mean,” he added.

Domingo said the process of acquiring the vaccine could have been made legal only if the manufacturer applied for a “compassionate special permit,” which is issued to medicines for emergency and research purposes. The same permit was given to potential COVID-19 medicine Remdesivir for a clinical trial in the Philippines.

Philippine laws prohibit the manufacturing, importation, exportation, sale, distribution, and non-consumer use of unregistered products, according to FDA.

Violating manufacturers, importers, and distributors will be fined from P500,000 to P5 million. --KBK, GMA News