May 17, 2022 – The U.S. FDA has expanded emergency use authorization (EUA) for Comirnaty® (COVID- 19 vaccine, mRNA), made by Pfizer and BioNTech. The product is now authorized for use as a single booster dose for individuals 5-11 years old.

• The booster dose is authorized in children who have completed a primary vaccination series with Comirnaty at least five months prior.
• Comirnaty has been authorized since January 3, 2022, for use as a booster dose in individuals who are at least 12 years old.