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Astra-Zeneca applies for FDA's emergency use approval; FDA to pursue inquiry into 'unauthorized' vaccination

Published Jan 6, 2021 05:40 pm

United Kingdom-based pharmaceutical company AstraZeneca has submitted its application for emergency use authorization (EUA) for its COVID-19 vaccine, the Food and Drug Administration (FDA) said. 

"Yes, they filed the application just now," said FDA Director-General Rolando Enrique Domingo on Wednesday. 

"The processing and evaluation will take three to four weeks depending on the completeness of their submission," he added. 

AstraZeneca is the second pharmaceutical company that applied for an EUA in the Philippines. The first to apply was American drug-maker Pfizer--which submitted its application last December. 

During his presentation at the Laging Handa press briefing, Domingo said that the FDA is expected to decide on Pfizer's EUA application by January 14. 

“Kahapon po, nagbigay ng konting mga katanungan yung ating mga eksperto na pinadala natin sa Pfizer at binigyan ko sila ng 48 hours to reply and to give us the information requested by our panel ,” Domingo said.

“Pagkatapos po noon, ibabalik nila sa akin yan ng January 10 at days after that, makakagawa na po tayo ng desisyon sa kanilang EUA application ,” he added. 

PSG probe

In a related development, Domingo said that the FDA will push through with its own inquiry into the reported unauthorized COVID-19 vaccination of some members of the Presidential Security Group (PSG)

“Ang FDA po meron namang set na proseso kung paano po namin hinahandle at iniinvestigate ang mga complaints at saka mga reports na ganito ,” Domingo said. 

“At itutuloy naman po namin yun according to the process laid out by FDA,” he added. 

During a televised briefing ,President Duterte told members of the PSG to stay mum on the issue if ever they will be invited to a congressional hearing to investigate the matter. 

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