FDA reviewing application of Janssen for full approval of COVID-19 jab — DOH

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FDA reviewing application of Janssen for full approval of COVID-19 jab â DOH
In this file photo taken on March 9, 2021 Johnson & Johnson's Janssen Covid-19 Vaccine is stored for use with United Airlines employees at United's onsite clinic at O'Hare International Airport in Chicago, Illinois.
AFP / Scott Olson / Getty Images North America

MANILA, Philippines — The Food and Drug Administration is currently reviewing the application of Janssen Pharmaceuticals for a certificate of product registration of its COVID-19 vaccine, the Department of Health said Tuesday.

Janssen, which is wholly-owned by Johnson & Johnson, is the only vaccine maker that has applied for a CPR, DOH officer-in-charge Maria Rosario Vergeire said in a briefing.

A CPR is issued by the Food and Drug Administration to manufacturers to distribute, market, or sell their products to the public.

“Right now, the FDA is reviewing and exercising the necessary work for the application of Janssen,” Vergeire said. 

In April 2021, the country’s drug regulator allowed the emergency use of the single-dose COVID-19 vaccine developed by Janssen.

According to the US Centers for Disease Control and Prevention, the Janssen jab was 66.3% effective in clinical trials at preventing laboratory-confirmed COVID-19 infection in individuals who received the vaccine and had no evidence of being previously infected.


In the same briefing, Vergeire said the COVAX Facility had agreed to replace all expired COVID-19 jabs, including those procured by local governments and the private sector.

“We are scheduling our replacements doon sa time na kakailanganin ang replaced doses. We currently have a sufficient vaccine supply,” Vergeire said.

More than 71 million Filipinos have completed vaccination against COVID-19. However, only 16.6 million people have received boosters.

The health official also said the country is coordinating with the US government and the Association of Southeast Asian Nations for the possible donations and purchase of vaccines needed to protect people from getting monkeypox.

Local health authorities have also identified three manufacturers of monkeypox vaccines.

“We’re looking at how to enter this procurement and also identifying sources of funds for this,” Vergeire said.



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