1. Bivalent Omicron BA.4/BA.5 BNT162b2 Vaccine in 6-Month- to <12-Year-Olds.
- Author
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Sher LD, Boakye-Appiah JK, Hill S, Wasserman E, Xu X, Maldonado Y, Walter EB, Muñoz FM, Paulsen GC, Englund JA, Talaat KR, Barnett ED, Kamidani S, Senders S, Simões EAF, Belanger K, Parikh V, Ma H, Wang X, Lu C, Cooper D, Koury K, Anderson AS, Türeci Ö, Şahin U, Swanson KA, Gruber WC, Gurtman A, Kitchin N, and Sabharwal C
- Subjects
- Humans, Child, Preschool, Male, Female, Infant, Antibodies, Viral blood, Child, Antibodies, Neutralizing blood, Vaccine Efficacy, Spike Glycoprotein, Coronavirus immunology, BNT162 Vaccine immunology, COVID-19 prevention & control, COVID-19 immunology, SARS-CoV-2 immunology, COVID-19 Vaccines immunology, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage, Immunogenicity, Vaccine
- Abstract
Background: With the future epidemiology and evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uncertain, the use of safe and effective coronavirus disease 2019 (COVID-19) vaccines in pediatric populations remains important., Methods: We report data from two open-label substudies of an ongoing phase 1/2/3 master study (NCT05543616) investigating the safety and immunogenicity of a variant-adapted bivalent COVID-19 vaccine encoding ancestral and Omicron BA.4/BA.5 spike proteins (bivalent BNT162b2). The open-label groups presented here evaluate dose 4 with bivalent BNT162b2 in 6-month- to <12-year-olds who previously received three original (monovalent) BNT162b2 doses. In 6-month- to <5-year-olds, primary immunogenicity objectives were to demonstrate superiority (neutralizing titer) and noninferiority (seroresponse rate) to Omicron BA.4/BA.5 and noninferiority (neutralizing titer and seroresponse rate) to SARS-CoV-2 ancestral strains in participants who received bivalent BNT162b2 dose 4 compared with a matched group who received three doses of original BNT162b2 in the pivotal pediatric study (NCT04816643). In 5- to <12-year-olds, primary immunogenicity comparisons were descriptive. Reactogenicity and safety following vaccination were evaluated., Results: In 6-month- to <5-year-olds, dose 4 with bivalent BNT162b2 met predefined immunogenicity superiority and noninferiority criteria against Omicron BA.4/BA.5 and ancestral strains when compared with dose 3 of original BNT162b2. In 5- to <12-year-olds, bivalent BNT162b2 induced robust Omicron BA.4/BA.5 and ancestral strain neutralizing titers comparable with dose 3 of original BNT162b2. The safety profile for dose 4 of bivalent BNT162b2 given as dose 4 was consistent with that of original BNT162b2 in 6-month- to <12-year-olds. Reactogenicity events were generally mild to moderate. No adverse events led to discontinuation., Conclusions: These safety and immunogenicity data support a favorable benefit-risk profile for a variant-adapted BNT162b2 in children <12 years old., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society.)
- Published
- 2024
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