FDA approves Pfizer bivalent vaccine's product registration certificate

Coronavirus vaccines may soon be commercially available in the country after the Food and Drug Administration (FDA) on Monday announced it had granted a certificate of product registration (CPR) for the Pfizer bivalent COVID-19 vaccine.

“The FDA is pleased to announce the approval of the application and grant of CPR for Toziameran + Famtozinameran (15 mcg/15 mcg)/ 0.3 mL Dispersion for Injection with a brand name, Comirnaty Original/ Omicron B.A. 4-5,” it said in a press statement.

“The FDA has granted the CPR with five years validity after a comprehensive evaluation process, extensive clinical trials, and thorough assessment of all available scientific data and information provided by the vaccine manufacturer and comprehensive evaluation process,” it added.

Pfizer submitted a CPR application under monitored release for their vaccine doses to the FDA in February. Their application was evaluated by Taskforce Edward, which was tasked to streamline the approval and evaluation of COVID-19 vaccines.

FDA Director General Dr. Samuel Zacate encouraged pharmaceutical firms to apply for the issuance of CPR or market authorization for their vaccine shots.

The Department of Health (DOH) previously said bivalent vaccines provide protection against the original COVID-19 strain SARS-CoV-2 and Omicron subvariants BA.4 and BA.5.

Earlier this month, the DOH allowed the use of Pfizer bivalent jabs as a third booster dose pending the arrival of COVID-19 bivalent vaccines in the country.

Last week, the national government officially started giving the doses to healthcare personnel, saying they are among those who will be prioritized for the inoculation as they would need additional protection against the virus.

Meanwhile, the FDA urged the public to “maintain confidence in the regulatory processes and to rely on accurate information from trusted sources regarding the COVID-19 vaccine”.

“The FDA will continue to prioritize transparency and provide regular updates to keep the public informed,” it said. — DVM, GMA Integrated News