The Food and Drug Administration (FDA) is currently reviewing the Certificate of Product Registration (CPR) application of vaccine maker Janssen for its Covid-19 vaccine.
This was reported by Department of Health (DOH) Officer-in-Charge Maria Rosario Vergeire on Tuesday, Aug. 9.
“According to the Food and Drug Administration, as of Aug. 9, isa pa lang po na manufacturer ang nakapag-apply ng CPR sa kanila and this would be Janssen from J&J,” said Vergeire in a press briefing.
“Right now, the FDA is currently reviewing and exercising the necessary work para sa application ng Janssen,” she added.
A CPR is being issued by the FDA to manufacturers to allow the market and selling of their products commercially.
To note, Janssen Biotech Inc. is owned by Johnson & Johnson.
On April 20, 2021, the FDA announced that it approved the Emergency Use Authorization application of Janssen for its single-shot Covid-19 vaccine.