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. 2024 Mar 14;187(6):1363-1373.e12.
doi: 10.1016/j.cell.2024.01.017. Epub 2024 Feb 15.

A multivalent mRNA monkeypox virus vaccine (BNT166) protects mice and macaques from orthopoxvirus disease

Adam Zuiani  1 , Charles L Dulberger  1 , Nilushi S De Silva  1 , Meghan Marquette  1 , Yu-Jung Lu  1 , Gavin M Palowitch  1 , Anja Dokic  2 , Ricardo Sanchez-Velazquez  2 , Katja Schlatterer  2 , Sanjay Sarkar  3 , Swagata Kar  4 , Bhavna Chawla  4 , Alibek Galeev  2 , Claudia Lindemann  2 , Daniel A Rothenberg  1 , Huitian Diao  1 , Alexandra C Walls  1 , Theresa A Addona  1 , Federico Mensa  1 , Annette B Vogel  2 , Lynda M Stuart  1 , Robbert van der Most  2 , John R Srouji  1 , Özlem Türeci  5 , Richard B Gaynor  1 , Uğur Şahin  6 , Asaf Poran  7
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Free article

A multivalent mRNA monkeypox virus vaccine (BNT166) protects mice and macaques from orthopoxvirus disease

Adam Zuiani et al. Cell. .
Free article

Abstract

In response to the 2022 outbreak of mpox driven by unprecedented human-to-human monkeypox virus (MPXV) transmission, we designed BNT166, aiming to create a highly immunogenic, safe, accessible, and scalable next-generation vaccine against MPXV and related orthopoxviruses. To address the multiple viral forms and increase the breadth of immune response, two candidate multivalent mRNA vaccines were evaluated pre-clinically: a quadrivalent vaccine (BNT166a; encoding the MPXV antigens A35, B6, M1, H3) and a trivalent vaccine (BNT166c; without H3). Both candidates induced robust T cell responses and IgG antibodies in mice, including neutralizing antibodies to both MPXV and vaccinia virus. In challenge studies, BNT166a and BNT166c provided complete protection from vaccinia, clade I, and clade IIb MPXV. Furthermore, immunization with BNT166a was 100% effective at preventing death and at suppressing lesions in a lethal clade I MPXV challenge in cynomolgus macaques. These findings support the clinical evaluation of BNT166, now underway (NCT05988203).

Keywords: Immunology; Nonhuman primate; Orthopoxviruses; Outbreak; Pandemic preparedness; Vaccinology; Virology; mRNA vaccine; monkeypox virus; mpox.

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Conflict of interest statement

Declaration of interests U.S. and O.T. are management board members and employees at BioNTech SE. R.B.G. serves on the Board of Directors for Alkermes PLC, Infinity Pharmaceuticals, and Zai Laboratory; serves on the Scientific Advisory Board for Leap Therapeutics; is a consultant for Third Rock Ventures; and is a stockholder and employee of BioNTech US. B.C. and S.K. are employees of Bioqual, Inc. S.S. is an employee of Southern Research. A.Z., C.L.D., N.D.S., M.M., Y.J.L., G.M.P., A.D., R.S.V., K.S., A.G., C.L., D.A.R., H.D., A.C.W., T.A.A., F.M., A.B.V., L.M.S., R.v.d.M., J.R.S., and A.P. are current/past employees of BioNTech SE/BioNTech US, are stockholders, and/or are inventors on patents and patent applications related to RNA vaccines.

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