FDA amends EUA of Pfizer-BioNTech COVID-19 vaccine for paediatric use

Yesterday, the FDA announced that it has amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech bivalent COVID-19 Vaccine. The vaccine is now approved to provide a single booster dose in children from six months to four years of age, at least two months after completing the primary course of vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine.

Since December 2022, children in this age group who have received two doses of the monovalent Pfizer-BioNTech COVID-19 vaccines were recommended to complete their three dose vaccination series with Pfizer-BioNTech’s bivalent vaccine. However, up until now these children were not eligible for a booster dose as their immunity is expected to be sufficient.

Now, children in this age group who have had three doses of the monovalent vaccine, before the bivalent vaccine was approved. These children can now receive the bivalent vaccine as a booster dose.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, commented: “Today’s authorisation provides parents and caregivers of children six months through four 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 [bivalent] Pfizer-BioNTech COVID-19 Vaccine […] Currently available data show that vaccination remains the best defence against severe disease, hospitalisation 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.”

Betsy Goodfellow