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FDA: J&J's Janssen files EUA application for single-dose COVID-19 vaccine


Janssen, the pharmaceutical arm of American drugmaker Johnson & Johnson, has filed an application for emergency use authorization (EUA) of its single-dose COVID-19 vaccine, the Food and Drug Administration (FDA) said Monday.

“[They filed] last Wednesday. Now under evaluation,” FDA chief Eric Domingo told GMA News Online.

In January, the vaccine showed 66% efficacy in preventing COVID-19 in a large global trial against several coronavirus variants.

It is also 85% effective against severe COVID-19 and prevents hospitalization 28 days after immunization.

The Department of Science and Technology said Janssen’s Phase 3 clinical trial in the Philippines was already underway in Metro Manila, Calabarzon, and Western Visayas.

Last month, Alejandro Cravioto, the chair of the World Health Organization's Strategic Advisory Group of Experts (SAGE) on Immunization, said the vaccine has proven effective "in the countries where there is a high spread of the variants."

Vaccine czar Secretary Carlito Galvez Jr. earlier said the Philippine government was close to signing a supply agreement with Johnson & Johnson. 

The FDA has so far approved the emergency use of the vaccines developed by Pfizer-BioNTech, AstraZeneca, Sinovac, and Sputnik V.

The Philippines has inoculated over 737,000 individuals with the Sinovac and AstraZeneca jabs as of March 30.

The country has 795,051 infections with 646,100 recoveries and 13,425 deaths as of Sunday afternoon.

DOST welcomes application

The Department of Science and Technology (DOST), one of the bodies involved in the evaluation of vaccines, welcomed Janssen’s EUA application.

“One good thing is that Janssen Pharmaceuticals did clinical trials in the Philippines, the results of which only the vaccine developing company can announce,” DOST Secretary Fortunato de la Peña said in a statement.

“More vaccines with EUA approved by the FDA means more vaccines can enter the country adding to the adequacy of supply,” he added.

Companies must secure the approval of the DOST’s Vaccine Expert Panel and the Ethics Review Board before it can file an EUA application with the FDA. —AOL/KBK, GMA News

 

 

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