Lawrence D Sher, Justice K Boakye-Appiah, Sungeen Hill, Emily Wasserman, Xia Xu, Yvonne Maldonado, Emmanuel B Walter, Flor M Muñoz, Grant C Paulsen, Janet A Englund, Kawsar R Talaat, Elizabeth D Barnett, Satoshi Kamidani, Shelly Senders, Eric A F Simões, Kelly Belanger, Vrunda Parikh, Hua Ma, Xingbin Wang, Claire Lu, David Cooper, Kenneth Koury, Annaliesa S Anderson, Özlem Türeci, Uğur Şahin, Kena A Swanson, William C Gruber, Alejandra Gurtman, Nicholas Kitchin, Charu Sabharwal
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引用次数: 0
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.
期刊介绍：
The Journal of the Pediatric Infectious Diseases Society (JPIDS), the official journal of the Pediatric Infectious Diseases Society, is dedicated to perinatal, childhood, and adolescent infectious diseases.
The journal is a high-quality source of original research articles, clinical trial reports, guidelines, and topical reviews, with particular attention to the interests and needs of the global pediatric infectious diseases communities.
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