4th Pfizer-BioNTech COVID-19 Vaccination Authorized for Toddlers

The U.S. Food and Drug Administration (FDA) today announced it amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children six months through 4 years of age at least two months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.

Since December 2022, children six months through 4 years of age who receive the first two doses with the monovalent Pfizer-BioNTech COVID-19 Vaccine should complete their three-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

“Today’s authorization provides parents and caregivers of children six months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on March 14, 2023.

“Currently available data show that vaccination remains the best defense against severe disease, hospitalization, and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.” 

The fact sheets for recipients, caregivers, and healthcare providers include information about the vaccine’s potential side effects and the risks of myocarditis and pericarditis.

The amendment to the EUA was issued to Pfizer Inc.