The U.S. Food and Drug Administration has authorized bivalent Pfizer-BioNTech covid-19 vaccine as booster dose for certain children 6 months through 4 years of age.
In a statement, the health regulator said it has amended the emergency use authorization or EUA of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
According to the agency, children 6 months through 4 years of age who completed their three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine more than two months ago are now eligible to receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent includes mRNA components corresponding to the original virus strain as well as to the omicron variant BA.4 and BA.5 lineages. It is broadly protective against COVID-19, and COVID-19 caused by the omicron variant.
The latest authorization is only for those children in this age group who completed their 3-dose primary vaccination series with the monovalent Vaccine, before the Pfizer-BioNTech COVID-19 Vaccine, Bivalent was authorized to provide the third dose in the 3-dose primary series.
In December 2022, the FDA authorized the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to be given as the third dose in the primary series for children in this age group, who already received the first two doses with monovalent Pfizer-BioNTech COVID-19 Vaccine.
These children who received Bivalent vaccine as their third dose are excluded from the latest FDA authorization for a booster dose of a bivalent vaccine at this time and are expected to have protection against the most serious COVID-19 outcomes.
The FDA in December last year had stated that it did not authorize omicron shots for those children who already received three doses of Pfizer’s vaccine because the agency was still waiting on supporting data for the booster dose.
For the latest authorization, the FDA evaluated immune response data from 60 children in this age group who had completed primary vaccination with three doses of monovalent Pfizer-BioNTech COVID-19 Vaccine and received a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in a clinical study.
The study participants, one month after receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, demonstrated an immune response to both the original SARS-CoV-2 virus strain and to omicron BA.4/BA.5.
The authorization is also supported by the agency’s previous analyses of the effectiveness of primary vaccination in individuals 16 years of age and older and individuals 6 months through 4 years of age.
In addition, previous analyses of immune response data in adults greater than 55 years of age who had received one booster dose with an investigational Pfizer-BioNTech bivalent COVID-19 vaccine (original and omicron BA.1) have also been considered.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.”
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