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.