ArticleInfectious diseases and therapy2026
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.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04955626 (A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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A phase 3 master protocol to evaluate additional dose(s) of bnt162b2 in healthy individuals previously vaccinated with bnt162b2
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19 authors.
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Abstract
introductionVariant-adapted COVID-19 vaccines can induce more robust immune responses against closely matched circulating variants than original vaccines.
methodsWithin 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.
resultsA 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.
conclusionsOmicron BA.1-adapted COVID-19 vaccines can broaden immune responses against Omicron BA.1 SARS-CoV-2 variants.
trial registrationClinicalTrials.gov identifier, NCT04955626.
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