The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Pfizer’s and BioNTech’s COVID-19 vaccine to include individuals 12 to 15 years of age. The companies also have initiated a biologics license application (BLA) with the FDA for approval of their COVID-19 vaccine in individuals 16 years of age and older.

Following the FDA’s expansion of the EUA to include adolescents from ages 12 to 15, the Advisory Committee on Immunization Practices of the US Centers for Disease and Control (CDC) issued a recommendation that endorsed the safety and effectiveness of the Pfizer–BioNTech COVID-19 vaccine and its use in 12- through 15-year-old adolescents. The CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away (as reported on May 12, 2021).

A pediatric study evaluating the safety and efficacy of the Pfizer/BioNTech COVID-19 vaccine in children six months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts, and subject to the data generated, submit a request for an EUA or a variation to conditional marketing authorizations for two cohorts: children two to five years of age and children five to 11 years of age, in September (September 2021). The readout and submission for the cohort of children six months to two years of age are expected in the fourth quarter of 2021.

Biologics license application

Pfizer/BioNTech have initiated a BLA for full marketing authorization for their COVID-19 vaccine in individuals 16 years of age or older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks (as reported on May 7, 2021) with a request for priority review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.

The Pfizer/BioNTech COVID-19 vaccine is currently available in the US under an EUA granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the US. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the FDA review process. The issuance of an EUA is not an FDA approval (licensure) of a vaccine.

Source: US Food and Drug Administration, Centers for Disease Control and Prevention, Pfizer (EUA), Pfizer (BLA), BioNTech (EUA), and BioNTech (BLA)