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A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults

Author

Listed:
  • Miwa Haranaka

    (SOUSEIKAI PS Clinic)

  • James Baber

    (Vaccine Clinical Research, Pfizer Inc)

  • Yoichiro Ogama

    (SOUSEIKAI Sumida Hospital)

  • Masako Yamaji

    (Pfizer R&D Japan G.K.)

  • Masakazu Aizawa

    (Pfizer R&D Japan G.K.)

  • Osamu Kogawara

    (Pfizer R&D Japan G.K.)

  • Ingrid Scully

    (Vaccine Research and Development, Pfizer Inc)

  • Eleni Lagkadinou

    (BioNTech)

  • Ӧzlem Türeci

    (BioNTech)

  • Uğur Şahin

    (BioNTech)

  • Philip R. Dormitzer

    (Vaccine Research and Development, Pfizer Inc)

  • William C. Gruber

    (Vaccine Research and Development, Pfizer Inc)

  • Stephen Lockhart

    (Vaccine Research and Development, Pfizer Inc)

Abstract

We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 μg BNT162b2 or placebo 21 days apart. Overall, 160 individuals were randomized: 119 received BNT162b2, and 41 received placebo. Participants were stratified by age: 20–64 years (n = 130) and 65–85 years (n = 30). More than 97% of BNT162b2 recipients received 2 doses. Local reactions and systemic events were generally transient and mild to moderate. Severe adverse events were uncommon; there were no serious adverse events. One month after dose 2, SARS-CoV-2 50% serum neutralizing geometric mean titers were 571 and 366, and geometric mean fold rises were 55.8 and 36.6, in the younger and older age groups, respectively. In summary, BNT162b2 has an acceptable safety profile and produces a robust immune response, regardless of age, in Japanese adults. (ClinicalTrials.gov, NCT04588480).

Suggested Citation

  • Miwa Haranaka & James Baber & Yoichiro Ogama & Masako Yamaji & Masakazu Aizawa & Osamu Kogawara & Ingrid Scully & Eleni Lagkadinou & Ӧzlem Türeci & Uğur Şahin & Philip R. Dormitzer & William C. Gruber, 2021. "A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults," Nature Communications, Nature, vol. 12(1), pages 1-7, December.
    • Handle: RePEc:nat:natcom:v:12:y:2021:i:1:d:10.1038_s41467-021-27316-2
    DOI: 10.1038/s41467-021-27316-2
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    2. Ugur Sahin & Alexander Muik & Isabel Vogler & Evelyna Derhovanessian & Lena M. Kranz & Mathias Vormehr & Jasmin Quandt & Nicole Bidmon & Alexander Ulges & Alina Baum & Kristen E. Pascal & Daniel Mauru, 2021. "BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans," Nature, Nature, vol. 595(7868), pages 572-577, July.
    3. Annette B. Vogel & Isis Kanevsky & Ye Che & Kena A. Swanson & Alexander Muik & Mathias Vormehr & Lena M. Kranz & Kerstin C. Walzer & Stephanie Hein & Alptekin Güler & Jakob Loschko & Mohan S. Maddur &, 2021. "BNT162b vaccines protect rhesus macaques from SARS-CoV-2," Nature, Nature, vol. 592(7853), pages 283-289, April.
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