FDA approves Pfizer's bivalent COVID-19 vaccine for PH market

The Food and Drug Administration (FDA) has approved the product registration certificate for Pfizer's bivalent COVID-19 vaccine, potentially paving the way for its commercial availability in the Philippines.

The approved vaccine, branded as Comirnaty Original/Omicron B.A. 4-5, is a dispersion for injection containing Toziameran and Famtozinameran.

The FDA granted the certificate of product registration a five-year validity following a thorough evaluation of extensive clinical trials and scientific data submitted by Pfizer.

Pfizer initially applied for the CPR under monitored release in February, with the application being processed by Taskforce Edward, an entity established to expedite COVID-19 vaccine approvals.

FDA Director General Dr. Samuel Zacate urged other pharmaceutical companies to pursue market authorization for their vaccine products.

According to the Department of Health (DOH), bivalent vaccines offer protection against both the original SARS-CoV-2 strain and the Omicron subvariants BA.4 and BA.5.