Notice2024-28924
Government-Owned Materials; Availability for Access
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 10, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 237 (Tuesday, December 10, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#c7a5a2a9ada6aaaea9e9afb2b5aba2be87a9aeafe9a0a8b1"><span class="__cf_email__" data-cfemail="3052555e5a515d595e1e5845425c5549705e59581e575f46">[email protected]</span></a>.
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:
<bullet> Prophylaxis against mpox in normal or high-risk populations
<bullet> Vaccine research
Competitive Advantages:
<bullet> MVA clone-1 material is believed to be functionally and
genetically similar to FDA-approved vaccine material
<bullet> Identification of vaccine candidates that can elicit
protective antibodies against mpox in normal or high-risk populations
<bullet> Royalty-free access for vaccine development and/or research
Development Stage:
<bullet> Pre-clinical
NIH Contributor: Bernard Moss, MD, Ph.D.
Publications:
<bullet> Earl PL, et al. (2004) Immunogenicity of a highly
attenuated MVA smallpox vaccine and protection against monkeypox.
Nature. 428:182.
<bullet> 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.
<bullet> 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
(<a href="/cdn-cgi/l/email-protection#6002050e0a010d090e4e0815120c0519200e09084e070f16"><span class="__cf_email__" data-cfemail="fc9e9992969d919592d294898e909985bc929594d29b938a">[email protected]</span></a>).
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 <a href="/cdn-cgi/l/email-protection#a3c1c6cdc9c2cecacd8dcbd6d1cfc6dae3cdcacb8dc4ccd5"><span class="__cf_email__" data-cfemail="0466616a6e65696d6a2a6c717668617d446a6d6c2a636b72">[email protected]</span></a>.
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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