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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS.

# ACTION:

Notice.

# SUMMARY:

The material listed below is owned by an agency of the U.S. Government and is available for transfer to achieve expeditious use and/or commercialization of results of federally funded research and development.

# FOR FURTHER INFORMATION CONTACT:

                        Access information may be obtained by communicating with the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852 by contacting Benjamin Hurley at 240-669-5092 or                         *benjamin.hurley@nih.gov.*

# SUPPLEMENTARY INFORMATION:

## Royalty-Free Starting Material (MVA-clone 1) for the Clinical Development, Evaluation, and Commercialization of a Viable Mpox Vaccine

Worldwide, leading health authorities have cited the growing need for a commitment to equitable vaccine access and its role in curtailing future epidemics—a vision that cannot be realized without significant improvements in the speed, scale, and access of vaccine manufacturing and deployment in historically underserved regions. For at-risk populations and those with contraindications to commonly deployed vaccines, such initiatives are even more vital.

Modified vaccinia virus Ankara (MVA), developed more than 30 years ago as a highly attenuated candidate smallpox vaccine, was recloned at the U.S. National Institute of Allergy and Infectious Diseases (NIAID) (referred to here as “MVA clone-1”) from a 1974-originating passage and evaluated for safety and immunogenicity in both normal and partially immune-deficient animals. Subsequent studies verified the protective ability of this attenuated vaccine against mpox in non-human primates, and clinical efforts since have resulted in FDA approval and availability of a two-dose MVA vaccine in the U.S.

                    In support of the global humanitarian effort to achieve equitable vaccine access and in light of the current public health emergency of international concern (PHEIC) declared by the World Health Organization in 2024—which has resulted in more than 500 deaths in the Democratic Republic of the Congo since the beginning of this year—the National Institute of Allergy and Infectious Diseases (NIAID) is seeking inquiries from parties interested in independent R&D and/or collaborative research to further develop, evaluate, and commercialize a viable mpox vaccine for distribution (particularly in developing nations/regions currently having minimal access to mpox vaccines) using NIH-provided starting material (MVA clone-1). While traditional licensing opportunities related to mpox detection are also available (                    *e.g.,*                     antibodies, neutralization assays), NIAID will transfer the MVA clone-1 material in question on a royalty-free basis to qualified partners in an effort to combat the current PHEIC. In the event that NIAID has limited ability to distribute material, or if supply approaches exhaustion, priority will be given to collaborators with a proposed plan demonstrating, in                           ( print page 99268)                        NIAID's sole judgment, the ability to develop a viable vaccine. Potential collaborators considered equally competitive in terms of capacity will also be evaluated based on their plans and intent to distribute in areas with immediate need, followed by the likelihood of the proposed plan contributing to the achievement of a self-sustaining vaccine ecosystem in developing nations.                

This material is available for access for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration agreement.

*Potential Commercial Applications:*
    - Prophylaxis against mpox in normal or high-risk populations
    - Vaccine research

*Competitive Advantages:*
    - MVA clone-1 material is believed to be functionally and genetically similar to FDA-approved vaccine material
    - Identification of vaccine candidates that can elicit protective antibodies against mpox in normal or high-risk populations
    - Royalty-free access for vaccine development and/or research

*Development Stage:*
    - Pre-clinical

*NIH Contributor:*                     Bernard Moss, MD, Ph.D.                

*Publications:*
    - Earl PL, et al. (2004) Immunogenicity of a highly attenuated MVA smallpox vaccine and protection against monkeypox. Nature.                      428:182.                
    - Wyatt LS, et al. (2004) Highly attenuated smallpox vaccine protects mice with and without immune deficiencies against pathogenic vaccinia virus challenge. Proc Nat Acad Sci USA.                     101:4590.                
    - Earl PL, et al. (2003) Development and use of a vaccinia virus neutralization assay based on flow cytometric detection of green fluorescent protein. J Virol.                      77:10684.                

*Intellectual Property:*                     N/A.                

*Technology Transfer Specialist:*                     To discuss access to this technology, please contact Benjamin Hurley at (                    *benjamin.hurley@nih.gov*).                

*Collaborative Research Opportunity:*                     The National Institute of Allergy and Infectious Diseases is seeking inquiries from parties interested in independent R&D and/or collaborative research to further develop, evaluate, and commercialize a viable mpox vaccine for distribution using this material. Please contact Benjamin Hurley at 240-669-5092 or                     *benjamin.hurley@nih.gov.*

Dated: December 4, 2024.

Jeremiah D. Mitzelfelt,

Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.

[FR Doc. 2024-28924 Filed 12-9-24; 8:45 am]

BILLING CODE 4140-01-P