FDA reviewing full authorization of Janssen COVID vaccine: health dept

Gillan Ropero, ABS-CBN News

Posted at Aug 09 2022 03:52 PM

COVID-19 vaccine ABS-CBN News
Navotas senior citizens along with their companions receive the single-dose Johnson & Johnson COVID-19 vaccine on July 27, 2021, under the local government's "Vax 1, Take 1" inoculation drive. Mark Demayo, ABS-CBN News

MANILA — The Food and Drug Administration is reviewing Janssen's application for a certificate of product registration (CPR) for its COVID-19 vaccine, the Department of Health said on Tuesday.

The Philippines in April last year gave Janssen emergency use authorization for its single-dose vaccine. A CPR will allow manufacturers to sell their products to the public. 

Janssen is the only coronavirus vaccine manufacturer that has applied for a CPR as of Tuesday, according to DOH officer-in-charge Maria Rosario Vergeire.

"The FDA is currently reviewing and exercising the necessary work para sa application ng Janssen sa kanilang tanggapan," Vergeire told reporters.

(The FDA is currently reviewing and exercising the necessary work for Janssen's application before its office.)

The DOH has also presented to the Inter-Agency Task Force Against COVID-19 some considerations as the country's state of calamity declaration is set to lapse next month, Vergeire said.

The country's vaccination program is anchored on the state of calamity declaration and vaccines' emergency use authorization will "cease to be valid" if it is not extended, she said.

Government's emergency procurement, tax exemptions for donors, price controls for COVID-19 drugs and testing kits, and health workers' benefits will also cease, Vergeire said.

"Lahat pinag-aaralan at nakikipag-usap at coordinate tayo with other agencies so we can be able to manage lahat ng prosesong mawawala and everybody will still be protected," she said.

(We're studying everything and coordinating with other agencies so we can manage all processes that will cease and everybody will still be protected.) 

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