The FDA confirmed that Janssen had submitted an application for emergency use of its COVID-19 vaccines in the Philippines.
The Food and Drug Administration (FDA) on Monday confirmed that Johnson & Johnson’s pharmaceutical arm Janssen had submitted an application for emergency use of its COVID-19 vaccine in the Philippines.
According to the Food and Drug Administration (FDA), Janssen had filed an application for emergency use authorization (EUA) of its COVID-19 vaccine as Janssen’s Phase 3 human clinical trial for its COVID-19 vaccine was currently underway in some areas across the Philippines.
The said vaccine was already authorized by the United States Food and Drug Administration for emergency use last month.
FDA Director-General Eric Domingo said that Janssen applied for emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines last March 31, 2021.
“[They filed] last Wednesday. Now under evaluation,” Domingo said.
Once authorized, Janssen will be the fifth COVID-19 vaccine manufacturer in the Philippines to get regulatory approval, following Pfizer-BioNTech, AstraZeneca-Oxford, Sinovac Biotech, and Gamaleya Research Institute.
Last January, the said vaccine showed 66 percent efficacy in preventing COVID-19 in a large global trial against several COVID-19 variants.
The said vaccine was also 85% effective against severe COVID-19 and prevented hospitalization 28 days after vaccination.
Alejandro Cravioto, the chair of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization, said last month that Janssen’s single-dose COVID-19 vaccine had proven effective in the countries where there’s a “high spread of the variants”.
Earlier, vaccine czar Secretary Carlito Galvez Jr. said that the Philippine government was finalizing the language of an agreement with Johnson & Johnson.