COVID-19 CRISIS

Only government, vaccine manufacturer can apply for EUA, says FDA

Only the drug manufacturer  o distributor and the government can request the Food and Drug Administration (FDA) for an emergency use authorization (EUA) to use a vaccine still in development, FDA director general Dr. Eric Domingo said Wednesday.

Interviewed on Dobol B sa News TV, Domingo said EUA does not mean the vaccine is ready for commercial use.

"Ang puwede lang [mag-request ng EUA ay] ang manufacturer, 'yung lisensiyadong mag-import, o ang gobyerno, kasi hindi naman marketing authorization ang ibibigay ng FDA, hindi lisensya para magbenta ng bakuna dahil under development pa po yung vaccine," he said.

"Wala pa pong makakapagbigay ng permiso para magbenta ng bakuna dahil under development pa po mga bakuna," he added, referring to potential COVID-19 vaccines still undergoing trials.

Domingo also said the Department of Health could apply for an EUA on behalf of a drugmaker.

"Maaaring ang Department of Health ang mag-apply ng emergency use authorization sa FDA. Bilang isang gagamit at mag-aangkat, maaari po siya mismo ang mag-apply, hindi kinakailangan yung mismong kumpanya," he said.

Through Executive Order 121 he signed last week, President Rodrigo Duterte allowed the FDA to issue an EUA for COVID-19 drugs and vaccines.

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

Domingo said COVID-19 vaccines that were granted EUA in richer nations have a good chance of getting an EUA from the Philippine FDA.

He said the process from the submission of documents by the applicant to the granting of EUA by the FDA may last three to four weeks. —KBK, GMA News