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[Federal Register Volume 89, Number 237 (Tuesday, December 10, 2024)]
[Notices]
[Pages 99267-99268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Government-Owned Materials; Availability for Access

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

ACTION: Notice.

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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 [email protected].

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

[[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 
([email protected]).
    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 [email protected].

    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
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