Bivalent Omicron BA.4/BA.5 BNT162b2 Vaccine in 6-Month- to <12-Year-Olds.

IF 2.5 4区医学 Q3 INFECTIOUS DISEASES Journal of the Pediatric Infectious Diseases Society Pub Date : 2024-08-24 DOI:10.1093/jpids/piae062

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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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.

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二价 Omicron BA.4/BA.5 BNT162b2 疫苗用于 6 个月至 12 岁以下儿童。

背景：由于SARS-CoV-2未来的流行病学和演变情况尚不确定，因此在儿科人群中使用安全有效的COVID-19疫苗仍然非常重要：我们报告了一项正在进行的1/2/3期主研究（NCT05543616）的两个开放标签子研究的数据，该研究调查了编码祖先和Omicron BA.4/BA.5尖峰蛋白的变异型二价COVID-19疫苗（二价BNT162b2）的安全性和免疫原性。本文介绍的开放标签组评估了剂量 4 与二价 BNT162b2 的 6 个月结果：6个月后得出结论：这些安全性和免疫原性数据支持变异型 BNT162b2 在儿童中具有良好的效益-风险特征。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the Pediatric Infectious Diseases Society Medicine-Pediatrics, Perinatology and Child Health

CiteScore

6.70

自引率

0.00%

发文量

179

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.