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Article History

Received: 7 March 2025

Accepted: 12 June 2025

First Online: 1 July 2025

Declarations

:

: Federico Mensa, Özlem Türeci, and Uǧur Şahin are BioNTech employees and may hold stock or stock options. Özlem Türeci, Uǧur Şahin, Kena A. Swanson, and Kayvon Modjarrad report holding an interest in a patent relevant to this manuscript. Jing Zou, Xuping Xie, and Yanping Hu have received funding from Pfizer. Oyeniyi Diya is no longer an employee at Pfizer Ltd. All other authors (Juleen Gayed, Francine S. Lowry, Hua Ma, Vishva Bangad, Mark Cutler, Todd Belanger, David Cooper, Xia Xu, Robin Mogg, Annaliesa S. Anderson, Alejandra Gurtman and Nicholas Kitchin) are Pfizer employees and may hold stock or stock options.

: The study protocol was approved by the WCG Central institutional review board (approval number: 20233321; Princeton, NJ, USA), which was utilized by each study site. This substudy was conducted according to the protocol and consensus ethical principles derived from international guidelines (i.e., Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines), applicable good clinical practice guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and other relevant laws and regulations. All participants were required to provide a signed statement of informed consent before study-specific procedures were performed.