logo
  

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

pfizer covid19 010621 06dec22 lt

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.

For More Such Health News, visit rttnews.com

For comments and feedback contact: editorial@rttnews.com

Health News

Follow RTT