Rule2024-30568
Select Agent: Modified Junín Virus Vaccine Strain
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 26, 2024
Issuing agencies
Health and Human Services Department
Abstract
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), has determined that a previously excluded attenuated strain, Jun[iacute]n virus vaccine strain Candid No.1, has key attenuating mutations in the glycoprotein envelope at GP1 T168A and GP2 F427I. Revertants at either of these positions have increased pathogenicity and virulence. Therefore, Jun[iacute]n virus vaccine strain Candid No. 1 containing GP1 168T and/or GP2 427F is a select agent and is subject to the select agent and toxin regulations.
Full Text
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<title>Federal Register, Volume 89 Issue 247 (Thursday, December 26, 2024)</title>
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[Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)]
[Rules and Regulations]
[Pages 104888-104889]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
Select Agent: Modified Jun[iacute]n Virus Vaccine Strain
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notification of determination.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), has
determined that a previously excluded attenuated strain, Jun[iacute]n
virus vaccine strain Candid No.1, has key attenuating mutations in the
glycoprotein envelope at GP1 T168A and GP2 F427I. Revertants at either
of these positions have increased pathogenicity and virulence.
Therefore, Jun[iacute]n virus vaccine strain Candid No. 1 containing
GP1 168T and/or GP2 427F is a select agent and is subject to the select
agent and toxin regulations.
DATES: This determination is applicable as of May 3, 2024.
FOR FURTHER INFORMATION CONTACT: Daniel A. Singer, MD, MPH, FACP,
Acting Director, Division of Regulatory Science and Compliance, Centers
for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H21-
4, Atlanta, Georgia 30329, Telephone: (404) 718-2000.
SUPPLEMENTARY INFORMATION: Jun[iacute]n virus is a negative sense,
double stranded RNA virus and is the causative agent of Argentine
hemorrhagic fever. Jun[iacute]n virus causes chronic infection in
Calomys musculinus, the Drylands vesper mouse. Humans can become
infected upon exposure to infected animals or infected animals' waste.
Human-to-human spread is rare but can occur upon contact with an
infected person's bodily fluids.
In accordance with the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Bioterrorism Response Act), HHS
regulates biological agents and toxins that have the potential to pose
a severe threat to public health and safety (42 U.S.C. 262a(a)(1)). The
list of HHS select agents and toxins is provided in the HHS select
agent and toxin regulations (42 CFR part 73) and Jun[iacute]n virus, a
South American hemorrhagic fever virus, is included as a select agent
(42 CFR 73.3(b)).
The HHS select agent and toxin regulations established a process by
which an attenuated strain of a select biological agent that does not
have the potential to pose a severe threat to public health and safety
may be excluded from the requirements of the select agent and toxin
regulations (42 CFR 73.3(e)). On February 7, 2003, Jun[iacute]n virus
vaccine strain Candid No.1 was excluded from the regulations as it does
not pose a significant threat to public health and safety (McKee KT Jr,
Oro JG, Kuehne AI, Spisso JA, Mahlandt BG. ``Candid No. 1 Argentine
hemorrhagic fever vaccine protects against lethal Jun[iacute]n virus
challenge in rhesus macaques'' Intervirology. 1992: 34(3):154-63). This
exclusion was granted based on the historically safe use of this strain
as a vaccine against Argentine hemorrhagic fever for
[[Page 104889]]
agricultural workers at risk of occupational exposure in Argentina.
As set forth under 42 CFR 73.3(e)(2), if an excluded attenuated
strain is subjected to any manipulation that restores or enhances its
virulence, the resulting select agent will be subject to the
requirements of the regulations. CDC's Intragovernmental Select Agents
and Toxins Technical Advisory Committee (ISATTAC), which comprises
federal government subject-matter experts from HHS, the U.S. Department
Agriculture, the Department of Homeland Security, the Environmental
Protection Agency, and the Department of Defense, reviewed the data
published in the study, ``Restoration of virulence in the attenuated
Candid No.1 vaccine virus requires reversion at both positions 168 and
427 in the envelope glycoprotein GPC'' (published in the Journal of
Virology [<a href="https://doi.org/10.1128/jvi.00112-24">https://doi.org/10.1128/jvi.00112-24</a>] on March 20, 2024). The
ISATTAC concluded that the modified strains (Candid No.1 containing GP1
168T and/or GP2 427F) showed an increased virulence compared to the
parental excluded Candid No.1 strain when injected into guinea pigs and
huTfR1 mice. CDC concurred with the ISATTAC's assessment and, on May 3,
2024, CDC determined that given the restoration of virulence,
Jun[iacute]n virus vaccine strain Candid No.1 containing GP1 168T and/
or GP2 427F is a select agent and is subject to the select agent and
toxin regulations in accordance with 42 CFR 73.3(e)(2).
Dated: December 18, 2024.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-30568 Filed 12-23-24; 8:45 am]
BILLING CODE 4163-18-P
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</html>Indexed from Federal Register on December 26, 2024.
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