MUNTINLUPA -- 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 Injection (IM) with brand name, Comirnaty Original/Omicron B.A.4-5. This significant milestone marks a crucial step in our nation's current challenge against the global health crisis.

On 16 August 2022, as part of the FDA’s commitment to supporting the President's initiative to shift its focus from COVID-19 crisis management to a more robust recovery of the national economy, Director General Dr. Samuel Zacate launched Taskforce Edward which has the primary objective to further enhance the availability and accessibility of COVID-19 vaccines to the public.

On 21 February 2023, Pfizer, Inc. submitted a CPR application under Monitored Release (MR) for their COVID-19 vaccine. The application was processed in line with FDA Circular No. 2022-004, Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 “Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals”

The FDA has granted the CPR with five (5) years validity after 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.

We acknowledge the collective efforts of the members of the Task Force Edward, scientific community, and researchers who have worked tirelessly to evaluate this vaccine. Their commitment to public health and the well-being of our nation has been
instrumental in achieving this significant milestone.

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. The FDA will continue to prioritize transparency and provide regular updates to keep the public
informed.

To this end, the FDA encourages the pharmaceutical industry to apply and complete the requirements for other COVID-19 vaccines, as we remain committed to expediting the evaluation and authorization of other promising vaccines to ensure a diverse portfolio of safe and effective options for the Filipino people. (DOH)