FDA: Pfizer needs CPR for full vaccine approval in PH

Pfizer must first apply for and secure a Certificate of Product Registration (CPR) before its COVID-19 vaccine can receive full approval in the Philippines, according to Food and Drug Administration (FDA) Director General Eric Domingo.

The US FDA recently granted full approval to the Pfizer-BioNTech COVID-19 vaccine for individuals aged 16 and above, marking the first time a COVID-19 vaccine has received such approval.

Domingo stated that Pfizer is expected to pursue full approval in other countries, including the Philippines, which would expand the vaccine's accessibility.

COVID-19 vaccines may possibly become commercially available in the Philippines by early 2022, following the full approval of the Pfizer jab in the United States.

Once fully approved, the vaccine could be sold and distributed not only to the government but also to private hospitals, clinics, and pharmacies.

The FDA estimates that processing an application for full approval would take approximately one month.

Issuing a CPR would supersede the need for an emergency use authorization (EUA) for the COVID-19 vaccine.