The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine.

On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer Inc.). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 μg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the ACIP issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥ 16 years for the prevention of COVID-19.

The body of evidence for the Pfizer-BioNTech COVID-19 vaccine was primarily informed by one large, randomized double-blind placebo-controlled phase II/III clinical trial that enrolled more than 43,000 participants. Interim findings from this clinical trial, using data from participants with a median of 2 months of follow-up, indicate that the Pfizer-BioNTech COVID-19 vaccine was 95.0% effective (95% confidence interval = 90.3%–97.6%) in preventing symptomatic laboratory-confirmed COVID-19 in persons without evidence of previous SARS-CoV-2 infection.

The ACIP interim recommendation and will be updated as additional information becomes available.

Centers for Disease Control and Prevention (CDC). The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020. December 13, 2020. Available at: click here. Accessed December 15, 2020.