U.S. FDA Updates Pfizer's COVID-19 Vaccine Authorization

The U.S. Food and Drug Administration (FDA) issued a letter today updating Pfizer Inc.'s COVID-18 vaccine authorization.

Addressed to Pfizer's Leslie Sands on April 28, 203, the new authorization for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals six months through 4 years of age with certain types of immunocompromised, who have previously received three 0.2 mL doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent):

• a fourth dose administered at least one month following the most recent dose;
• additional doses may be administered at the healthcare provider's discretion, considering the individual's clinical circumstances.

This issue was discussed during the U.S. CDC's Advisory Committee on Immunization Practices meeting on April 19, 2023.