Pfizer Seeks FDA Approval For Bivalent COVID-19 Vaccine In Kids Under 5

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Vaccine partners Pfizer Inc. and BioNTech SE are seeking emergency use authorization or EUA from the U.S. Food and Drug Administration to offer their bivalent COVID-19 vaccine to children 6 months through 4 years of age. If authorized, the vaccine would be part of a primary series for children in this age group.

According to the companies, high level of respiratory illnesses are currently circulating among children under 5 years of age, and the updated COVID-19 vaccines may help prevent severe illness and hospitalization.

The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for ages 5 years and older in the U.S. and European Union or EU.

In a statement, the companies said they have submitted an application to the FDA for EUA of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series.

The proposed series would consist of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine.

The European Medicines Agency or EMA is already considering an application to extend Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent -Original and Omicron BA.4/BA.5- is FDA-authorized under EUA for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, is based on BioNTech's proprietary mRNA technology and were developed by both BioNTech and Pfizer.

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