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Introduction <p>Variant-adapted COVID-19 vaccines can induce more robust immune responses against closely matched circulating variants than original vaccines.</p> Methods <p>Within a phase 3 master study, monovalent Omicron BA.1-adapted BNT162b2 (BNT162b2-BA.1) was evaluated in healthy BNT162b2-experienced (cohorts 1−2) or COVID-19 vaccine-naive (cohort 3) 18&#xa0;to&#xa0;55&#xa0;year-olds. Primary immunogenicity endpoints in cohort 1 were geometric mean ratios (GMRs) of Omicron BA.1 neutralizing titers 1&#xa0;month after BNT162b2-BA.1 to those after one BNT162b2 dose and differences in percentages of participants with Omicron BA.1 seroresponse between BNT162b2-BA.1 and BNT162b2. In cohort 2, primary immunogenicity objectives (participants without evidence of previous SARS-CoV-2 infection) were to demonstrate superiority (GMR two-sided 95% CI lower limit &gt; 1) with respect to neutralizing titer levels and noninferiority with respect to seroresponse difference (difference two-sided 95% CI lower limit &gt; − 5%) for BNT162b2-BA.1 versus BNT162b2. In cohort 3, primary immunogenicity objectives were to demonstrate superiority with respect to neutralizing titer levels and noninferiority with respect to seroresponse after two BNT162b2-BA.1 doses compared with participants receiving BNT162b2 in an efficacy trial. Reactogenicity and adverse event frequencies were determined.</p> Results <p>A total of 1471 participants were included. In cohort 1 (BNT162b2-experienced), GMRs compared with one BNT162b2 dose were 2.87 and 2.64 after one or two BNT162b2-BA.1 doses, respectively, and differences in percentages of participants with seroresponse between BNT162b2-BA.1 and BNT162b2 were 29.0% and 21.0% for one or two BNT162b2-BA.1 doses. In cohort 2 (BNT162b2-experienced), one BNT162b2-BA.1 dose met prespecified superiority and noninferiority criteria with respect to GMR and difference in percentage of participants achieving seroresponse, respectively, compared with BNT162b2. In cohort 3 (COVID-19 vaccine-naive), superiority with respect to GMR and noninferiority with respect to difference in percentage of participants achieving seroresponse of BNT162b2-BA.1 to BNT162b2 were met. BNT162b2-BA.1 and BNT162b2 safety and tolerability profiles were similar.</p> Conclusions <p>Omicron BA.1-adapted COVID-19 vaccines can broaden immune responses against Omicron BA.1 SARS-CoV-2 variants.</p> Trial registration <p>ClinicalTrials.gov identifier, NCT04955626.</p>

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Immunogenicity, Tolerability, and Safety of BA.1-Adapted BNT162b2 Vaccine in 18- to 55-Year-Olds Previously Vaccinated with BNT162b2 or Who Were COVID-19 Vaccine-Naive

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月25日

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  • David Fitz-Patrick,
  • Omair Sahgal,
  • Leon F. Fouché,
  • Essack Mitha,
  • Mookho Malahleha,
  • Juleen Gayed,
  • Georgina Keep,
  • Ying Zhang,
  • Kayvon Modjarrad,
  • Todd Belanger,
  • Xia Xu,
  • David Cooper,
  • Federico J. Mensa,
  • Uǧur Sahin,
  • Ӧzlem Türeci,
  • Kena A. Swanson,
  • Annaliesa S. Anderson,
  • Alejandra Gurtman,
  • Nicholas Kitchin

摘要

Introduction

Variant-adapted COVID-19 vaccines can induce more robust immune responses against closely matched circulating variants than original vaccines.

Methods

Within a phase 3 master study, monovalent Omicron BA.1-adapted BNT162b2 (BNT162b2-BA.1) was evaluated in healthy BNT162b2-experienced (cohorts 1−2) or COVID-19 vaccine-naive (cohort 3) 18 to 55 year-olds. Primary immunogenicity endpoints in cohort 1 were geometric mean ratios (GMRs) of Omicron BA.1 neutralizing titers 1 month after BNT162b2-BA.1 to those after one BNT162b2 dose and differences in percentages of participants with Omicron BA.1 seroresponse between BNT162b2-BA.1 and BNT162b2. In cohort 2, primary immunogenicity objectives (participants without evidence of previous SARS-CoV-2 infection) were to demonstrate superiority (GMR two-sided 95% CI lower limit > 1) with respect to neutralizing titer levels and noninferiority with respect to seroresponse difference (difference two-sided 95% CI lower limit > − 5%) for BNT162b2-BA.1 versus BNT162b2. In cohort 3, primary immunogenicity objectives were to demonstrate superiority with respect to neutralizing titer levels and noninferiority with respect to seroresponse after two BNT162b2-BA.1 doses compared with participants receiving BNT162b2 in an efficacy trial. Reactogenicity and adverse event frequencies were determined.

Results

A total of 1471 participants were included. In cohort 1 (BNT162b2-experienced), GMRs compared with one BNT162b2 dose were 2.87 and 2.64 after one or two BNT162b2-BA.1 doses, respectively, and differences in percentages of participants with seroresponse between BNT162b2-BA.1 and BNT162b2 were 29.0% and 21.0% for one or two BNT162b2-BA.1 doses. In cohort 2 (BNT162b2-experienced), one BNT162b2-BA.1 dose met prespecified superiority and noninferiority criteria with respect to GMR and difference in percentage of participants achieving seroresponse, respectively, compared with BNT162b2. In cohort 3 (COVID-19 vaccine-naive), superiority with respect to GMR and noninferiority with respect to difference in percentage of participants achieving seroresponse of BNT162b2-BA.1 to BNT162b2 were met. BNT162b2-BA.1 and BNT162b2 safety and tolerability profiles were similar.

Conclusions

Omicron BA.1-adapted COVID-19 vaccines can broaden immune responses against Omicron BA.1 SARS-CoV-2 variants.

Trial registration

ClinicalTrials.gov identifier, NCT04955626.