Janssen seeks EUA for its COVID-19 vaccine in PH

MANILA, Philippines — Belgium-based Janssen Pharmaceuticals has applied for an emergency use authorization (EUA) of its single-shot COVID-19 vaccine, the Department of Health (DOH) confirmed on Monday.

“Apat pa rin ang merong EUA sa atin: Pfizer, Sinovac, AstraZeneca, and Gamaleya or the Sputnik V. Meron po tayong recent application ngayon, ‘yung sa Janssen, ‘yung J&J (Johnson & Johnson),” Health Undersecretary Maria Rosario Vergeire said in an online press briefing.

(Four vaccine manufacturers have EUA in the country. These are Pfizer, Sinovac, AstraZeneca, and Gamaleya. We have a recent application from Janssen.)

Janssen, a subsidiary of J&J, applied for a EUA last Wednesday, Food and Drug Administration Director-General Eric Domingo told INQUIRER.net in a text message.

He said that it may take two to three weeks before the FDA can approve the EUA application of the Belgium-based firm.

The pharmaceutical company earlier started conducting clinical trials for its COVID-19 vaccine in the Philippines in February, according to the Department of Science and Technology. The company secured approval from the local FDA to conduct clinical trials in December last year.

Upon securing a EUA from the United States, J&J said on its website that “Phase 3 ensemble study… demonstrated [that] the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.”

JE