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

Author:

Sher Lawrence D1,Boakye-Appiah Justice K2,Hill Sungeen2,Wasserman Emily3,Xu Xia4,Maldonado Yvonne5ORCID,Walter Emmanuel B6,Muñoz Flor M7ORCID,Paulsen Grant C8,Englund Janet A9ORCID,Talaat Kawsar R10,Barnett Elizabeth D11,Kamidani Satoshi12ORCID,Senders Shelly13,Simões Eric A F1415,Belanger Kelly3,Parikh Vrunda3,Ma Hua4,Wang Xingbin4,Lu Claire3,Cooper David3,Koury Kenneth3,Anderson Annaliesa S3,Türeci Özlem16,Şahin Uğur16,Swanson Kena A3,Gruber William C3,Gurtman Alejandra3,Kitchin Nicholas2,Sabharwal Charu3

Affiliation:

1. Peninsula Research Associates , Rolling Hills Estates, California , USA

2. Vaccine Research and Development, Pfizer Ltd , Hurley , UK

3. Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA

4. Vaccine Research and Development, Pfizer Inc , Collegeville, Pennsylvania , USA

5. Pediatric Infectious Disease, Stanford University School of Medicine , Palo Alto, California , USA

6. Duke Human Vaccine Institute , Duke University School of Medicine, Durham, North Carolina , USA

7. Pediatrics Infectious Disease, Texas Children’s Hospital, Baylor College of Medicine , Houston, Texas , USA

8. Department of Pediatrics, University of Cincinnati College of Medicine and Division of Pediatric Infectious Diseases, Cincinnati Children’s Hospital Medical Center , Cincinnati, Ohio , USA

9. Department of Pediatrics, Seattle Children’s Hospital , Seattle, Washington , USA

10. International Health, Johns Hopkins University , Baltimore, Maryland , USA

11. Department of Pediatrics, Boston Medical Center, BU Chobanian & Avedisian School of Medicine , Boston, Massachusetts , USA

12. The Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine , Atlanta, Georgia , USA

13. Senders Pediatrics , South Euclid, Ohio , USA

14. Department of Pediatrics, Children’s Hospital Colorado, University of Colorado School of Medicine , Aurora, Colorado , USA

15. Samshoma Medical Research Inc. , Denver, Colorado , USA

16. BioNTech , Mainz , Germany

Abstract

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.

Publisher

Oxford University Press (OUP)

Reference34 articles.

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