Pfizer and BioNTech Receive FDA Authorization for Updated COVID-19 Booster in Children Aged 6 Months to 4 Years

U.S. FDA Expands Emergency Use Authorization for Pfizer (PFE.US) and BioNTech (BNTX.US) Updated COVID-19 Vaccine, Allowing Its Use as a Single Booster Dose in Children Aged 6 Months to 4 Years Who Have Received the Primary Vaccination Series.

Therefore, children in this age group will be eligible to receive the redesigned vaccine as a booster at least two months after completing the primary vaccination series of three doses of the monovalent vaccine.

Currently, the Omicron vaccine developed by Pfizer and BioNTech is awaiting full approval for use in individuals aged 12 and above, either as a primary vaccine or a booster shot.

In September this year, the U.S. rolled out the Omicron BA.4/BA.5-updated mRNA-based COVID-19 vaccine following FDA approval for emergency use.