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ORIGINAL RESEARCH article

Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 15 - 2024 | doi: 10.3389/fimmu.2024.1445459
This article is part of the Research Topic SARS-CoV-2 Vaccines Beyond the Pandemic Era View all 3 articles

Booster Vaccination Using Bivalent DS-5670a/b is Safe and Immunogenic Against SARS-CoV-2 Variants in Children Aged 5-11 Years: A Phase 2/3, Randomized, Active-Controlled Study

Provisionally accepted
Rino Suzuki Rino Suzuki 1Miharu Suda Miharu Suda 1*Katsuyasu Ishida Katsuyasu Ishida 1*Kei Furihata Kei Furihata 1Aisaku Ota Aisaku Ota 1Kaori Takahashi Kaori Takahashi 1*Sachiko Sakakibara Sachiko Sakakibara 1*Tetsuo Nakayama Tetsuo Nakayama 2Fumihiko Takeshita Fumihiko Takeshita 1*
  • 1 Daiichi Sankyo (Japan), Tokyo, Japan
  • 2 Ōmura Satoshi Memorial Institute, Kitasato University, Tokyo, Japan

The final, formatted version of the article will be published soon.

    The ongoing nature of the coronavirus disease 2019 (COVID-19) outbreak and the emergence of new variants places a continuing burden on public health. Although children are often less severely affected, hospitalization rates and long-term sequelae are a concern, as is the consensus that children may be a reservoir for onward transmission. Increasing the number of available pediatric vaccine options is an important tactic, and we report here the positive results from a phase 2/3 non-inferiority study evaluating a heterologous third booster dose of DS-5670a/b (a bivalent messenger ribonucleic acid encapsulated in lipid nanoparticle [LNP-mRNA] vaccine) in children aged 5-11, compared with a homologous third booster using bivalent BNT162b2. Notably, this LNP-mRNA technology not only has the potential to rapidly produce new booster vaccines against COVID-19, but could also be harnessed in the future to generate targeted mRNA vaccines for use in other diseases. The data from the current study, when considered in the context of previous clinical trial results describing the efficacy and safety of monovalent and bivalent DS-5670 vaccines in adults, suggest that the manufacture of new DS-5670 vaccine compositions will permit a prompt and effective response against future variants of concern, thereby reducing societal and healthcare burdens.

    Keywords: Booster vaccination, Children, COVID-19, DS-5670a/b, non-inferiority, Omicron variant, SARS-CoV-2 (Min. 5-Max. 8) Word count: 3782 (limit 12, 000

    Received: 07 Jun 2024; Accepted: 29 Jul 2024.

    Copyright: © 2024 Suzuki, Suda, Ishida, Furihata, Ota, Takahashi, Sakakibara, Nakayama and Takeshita. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Miharu Suda, Daiichi Sankyo (Japan), Tokyo, Japan
    Katsuyasu Ishida, Daiichi Sankyo (Japan), Tokyo, Japan
    Kaori Takahashi, Daiichi Sankyo (Japan), Tokyo, Japan
    Sachiko Sakakibara, Daiichi Sankyo (Japan), Tokyo, Japan
    Fumihiko Takeshita, Daiichi Sankyo (Japan), Tokyo, Japan

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.