As per a press release by Pfizer Inc, the company and BioNTech SE announced on Monday that the companies have applied to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-g dose in the three-dose primary series for children aged 6 months to 4 years.
Due to the prevalence of respiratory diseases among children under 5 years of age, updated COVID-19 vaccinations may avoid hospitalization and serious illness.
If permitted, this age group would get a primary series consisting of two 3-g doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-g dose of the Omicron BA.4/BA.5-adapted bivalent vaccine.
The European Medicines Agency is currently deliberating a request to extend the marketing authorization for the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine developed by Pfizer and BioNTech to include children aged 6 months to 4 years (EMA).
In the United States and European Union, the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is now approved as a booster dose for ages 5 and older (EU).
The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) were co-developed by BioNTech and Pfizer and are based on BioNTech’s patented mRNA technology.
BioNTech is the Marketing Authorization Holder for BNT162b2 (Original) and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada, and other countries. BioNTech also holds emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other nations.