The Food and Drug Administration (FDA) on Monday announced that it granted Pfizer Inc.'s Bivalent Vaccine an authorized Certificate of Product Registration (CPR).
With FDA's approval, Pfizer Bivalent Vax will soon be commercially available in the market nationwide.
"The Food and Drug Administration (FDA) is pleased to announce the approval of the application and grant of Certificate of Product Registration (CPR) for Tozinameran + Famtozinameran (15 mcg/15 mcg)/0.3 mL Dispersion for Booster Injection (IM) with a brand name. Comirnaty Original/Omicron B.A.4-5," it said in a statement.
DFA said it approved the CPR following a comprehensive evaluation process, extensive clinical trials, and thorough assessment conducted by members of Task Force Edward.
The newly-granted CPR is valid for five years.
"We urge the public to maintain confidence in the regulatory processes and to rely on accurate information from trusted sources regarding the COVID-19 vaccine," it said.
The bivalent vaccine targets both the original strain of the virus — COVID-19 and its Omicron subvariants, such as Omicron B.A 4 and Omicron BA.B.
Last June 21, the national government launched the bivalent COVID-19 vaccination at the Philippine Heart Center in Quezon City.
Newly appointed Department of Health (DOH) received the first bivalent COVID-19 jab, making him the first recipient in the National Capital Region (NCR).
