FDA SAYS

DOH can apply for emergency use authorization as public health user

The Philippine government, through the Department of Health, can apply for an emergency use authorization (EUA) for COVID-19 drugs and vaccines with the Food and Drug Administration.

In an interview on Double B sa News TV, FDA Director General Eric Domingo said that so far there are no COVID-19 vaccine manufacturers that have applied for an EUA.

Early this month, President Rodrigo Duterte allowed the FDA

An EUA will reduce the processing time for the approval of the vaccines for local use from six months to 21 days, officials said earlier.

Domingo said manufacturers can apply for an EUA or the DOH, on behalf of the government.

“As the user of the vaccine in the public health program the Department of Health can apply for EUA,” he said.

However, the FDA chief said this does not guarantee that DOH’s EUA can be approved automatically since the agency still needs pertinent documents and data.

Also he said the DOH should secure such documents and data for the FDA’s evaluation.

“Ibig sabihin meron silang kasunduan na ibibigay ang datos. Kasi ‘yung mga papeles, lahat ng dokumento to show certificate of good manufacturing practice, testing... manggagaling sa manufacturer,” Domingo said.

“Hindi makukuha ‘yun ng bibili kung hindi sila magkakasunduan ng manufacturer,” he added.

Health Secretary Francisco Duque III has been criticized for the delay in the shipment into the country of 10 million doses of Pfizer vaccine by January next year due to his supposed failure to work on the necessary documentary requirement –the Confidentiality Disclosure Agreement (CDA).

In his defense, Duque said the required CDA by Pfizer was originally intended to be signed by the Office of the President (OP) and not by the DOH.

He argued that the Health chief cannot sign the CDA on behalf of the whole government, which was why the Department of Science and Technology and vaccine czar Secretary Carlito Galvez Jr. had signed the CDA separately.

Domingo noted that outside of the US, UK, Canada “wala pa namang ibang ina-aplayan ang Pfizer” regarding EUA.

He also stressed that even if the FDA grants EUA for a vaccine, there is no guarantee that manufacturers are ready to supply vaccines to the Philippines.

“Kahit magbigay ng EUA ngayon hindi ko pa rin alam baka hindi pa sila ready mag-supply sa atin baka kaya naman hindi pa sila nag-a-apply dito dahil kahit makakuha sila ng EUA wala pa naman silang dadalhing bakuna sa Pilipinas,” Domingo pointed out.

“Alam naman natin na na-order na ng mga bansang maraming pera, mayayaman na bansa ang karamihan ng supplies available ng mga kumpanya na ito,” he said. —LBG, GMA News