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FDA Approves Pfizer, Moderna's Omicron COVID Jabs in Younger Kids

The FDA, on Dec 8, granted emergency approval to Omicron BA.4/BA.5-adapted bivalent vaccines of Pfizer PFE/BioNTechBNTX and Moderna MRNA for children aged six months and older.

While a 10-µg dose of Moderna’s bivalent vaccine has been authorized for use as a booster dose in children aged six months through five years, Pfizer/BioNTech’s BA.4/BA.5 vaccine has been authorized as a third-dose (3-µg) in its three-dose primary series for children aged six months through four years.

Unlike Moderna, Pfizer/BioNTech did not receive emergency approval for the Omicron BA.4/BA.5 jab as a booster but as a part of the primary series. Children in this age group got three doses of Pfizer’s monovalent COVID-19 vaccine (3-µg) as their primary series.Following the label expansion, children under five years would receive a primary two-dose regimen consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine followed by a third 3-µg dose of the bivalent COVID-19 vaccine.

The Pfizer/BioNTech’s bivalent vaccine can be administered only to those children (aged between six months and four years) who have not completed their three-dose primary vaccination series or are yet to receive the third dose. The children in this age group who have already completed their primary regimen with Pfizer/BioNTech’s monovalent vaccine are not yet eligible to receive the bivalent vaccine dose. The data supporting the label expansion for Pfizer/BioNTech’s bivalent vaccine as a booster dose is expected in the next month.

Per the FDA, the bivalent vaccines are expected to provide increased protection against COVID-19 infections. As coronavirus continues to evolve, people need to vaccinate themselves as immunity from previously-administered COVID vaccines wanes over time. Though using monovalent vaccines as booster doses have restored these antibodies to their previous levels, this protection also weakens over time. As a result, there is a huge need for booster doses, which provide protection against the new emerging subvariants and thereby prevent serious outcomes caused by the disease.

These bivalent vaccines have also elicited a greater increase in neutralizing antibody titers against newer Omicron sub-lineages, like BQ.1.1, than the original vaccines.

The bivalent vaccines contain an mRNA encoding the spike protein in the original/monovalent vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.

The authorization granted to Moderna is based on clinical studies on their bivalent Omicron BA.1-adapted vaccines and pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines. The authorization to Pfizer/BioNTech is supported by data from clinical studies which evaluated their bivalent vaccine and post-authorization experience observed in individuals aged five years and older who have received the bivalent vaccine as a booster dose.

Pfizer/BioNTech and Moderna’s Omicron BA.4/BA.5 bivalent vaccines are already authorized for use in individuals aged five years and older.

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