FDA

US Pharmaceutical company Pfizer has expressed intention to apply for an emergency use authorization (EUA) for its coronavirus disease (COVID-19) pill Paxlovid, the Philippine Food and Drug Administration (FDA) said.

“Mayroon pong intensiyon ang Pfizer na magrehistro po ng produkto nila under an EUA application. Kahapon po ay nakatanggap kami ng email, mayroon po silang update data (Pfizer has an intention to register their product under an EUA application. Yesterday, we received an email, they have updated data),” said FDA officer-in-charge Oscar Gutierrez on Thursday, Jan. 13.

Gutierrez said that the FDA is closely coordinating with representatives from Pfizer.

“Hindi pa po nakapag-file ang Pfizer ng kanilang application pero nagkakaroon na po kami ng preliminary discussion on how they can comply with the requirements of the FDA for EUA
(Pfizer has not yet filed their application but we are having a preliminary discussion on how they can comply with the requirements of the FDA for EUA),” he said.

To note, an EUA is an authorization issued for unregistered drugs and vaccines in a public health emergency.

Self administered test kits

In a related development, Gutierrez said two companies manufacturing self-administered antigen COVID-19 test kits have applied for special certification.

“Dalawa na po ang nag-apply po ng ating self-administered test kit – ito po yung (There are two already that have applied. These are) Clearbridge Medical Philippines, Inc. at MOHS Analytics, Inc.,” he said.

The Research Institute for Tropical Medicine (RITM) is also conducting a technical validation on the two test kits, said Gutierrez.

“Yung RITM may sarili siyang requirements eh so hindi ko po kayang i-predict kung gaano kabilis sila gagawin. Pero once na natanggap ng FDA iyong tinatawag na validation performance report, within 48 hours po mabibigyan po ng special certification iyong applicant (RITM has its own requirements, so I can't predict how fast they will do it. But once the FDA receives the validation performance report---within 48 hours, the applicant will be given a special certification),” he said.

The test kits must show "97 percent specificity and 80 percent sensitivity" in order to pass the RITM validation, the FDA official said.

#Emergency Use Authorization

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