25.10.2023 20:03:29 - dpa-AFX: GNW-Adhoc: Bavarian Nordic's Mpox Vaccine Receives Recommendation from U.S. CDC Advisory Committee for Routine Use in Adults at Risk
COPENHAGEN, Denmark, October 25, 2023 - Bavarian Nordic A/S (OMX: BAVA)
announced today that the U.S. Centers for Disease Control and Prevention's (CDC)
Advisory Committee on Immunization Practices (ACIP) has voted in favor of
recommending the routine use of JYNNEOS(®), the Company's FDA-approved mpox
vaccine, in adults at risk of mpox infection. Specifically, the ACIP voted to
recommend that individuals 18 years and older with certain risk factors(1)
should receive the two-dose regimen of JYNNEOS. Previously, ACIP had recommended
JYNNEOS for individuals at risk of mpox only during an outbreak.
The recommendations will be forwarded to the Director of the CDC and the U.S.
Department of Health and Human Services for review and following approval, the
recommendations will be published in the Morbidity and Mortality Weekly Report.
The CDC estimates that 2 million U.S. individuals are eligible for vaccination
against mpox under these recommendations(2). To date, approximately 23% of this
group has received the recommended two doses of JYNNEOS during the 2022/2023
outbreak, leaving a significant number of people vulnerable to infection with
mpox. Pending approval of the updated recommendations, Bavarian Nordic is
targeting a commercial launch of JYNNEOS in the U.S. in the first half of 2024.
This represents the second national recommendation for Bavarian Nordic's mpox
vaccine in adult risk groups following a similar endorsement by the Standing
Committee for Vaccination (STIKO) in Germany during 2022. More recently, the
European AIDS Clinical Society (EACS) also recommend the use of the vaccine for
adults infected with HIV, or on pre-exposure prophylaxis (PrEP) treatment(3),
which may support additional national recommendations for the use of the vaccine
in the future.
"Since the outbreak of mpox last year, Bavarian Nordic has supplied millions of
doses of our vaccine to more than 70 countries worldwide, which has had a
positive impact on controlling this unprecedented outbreak of mpox. Despite the
best efforts of numerous governments and health agencies around the world a
large proportion of individuals at risk remain unvaccinated and vulnerable to
mpox infections. The broadened ACIP recommendation recognizes the significance
of maintaining a high awareness of the disease among risk groups and the
importance of ensuring broader access to the vaccine beyond an outbreak
situation. Entering the private mpox vaccine market in the U.S offers an
opportunity to provide improved access to JYNNEOS and to build a steady
commercial business segment, complimenting the existing smallpox stockpiling
business with the U.S. government. With our unwavering commitment to improving
public health, we look forward to working with healthcare professionals to make
our vaccine available for all individuals at risk," said Paul Chaplin, President
and CEO of Bavarian Nordic.
About JYNNEOS(®)
JYNNEOS(®) (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) is approved
for the prevention of smallpox and mpox disease in adults 18 years of age and
older determined to be at high risk for smallpox and mpox infection. The vaccine
was developed in collaboration with the U.S. government originally to ensure
supply of a smallpox vaccine for the entire population, including
immunocompromised individuals who are not recommended vaccination with
traditional replicating smallpox vaccines.
JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in 2019 and
in 2021, ACIP voted to recommended JYNNEOS for pre-exposure vaccination of
people at occupational risk for orthopoxvirus exposures. In 2022, the CDC issued
interim guidance, enabling pre- and post-exposure use of JYNNEOS during the mpox
outbreak and an Emergency Use Authorization (EUA) was issued allowing the use of
JYNNEOS in people under 18 years.
Visit www.jynneos.com (http://www.jynneos.com) for full prescribing information.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company focused on the research
and development, manufacturing and commercialization of life-saving vaccines. We
are a global leader in smallpox and mpox vaccines, which have been developed
through our long-standing partnership with the U.S. Government to enhance the
public health preparedness and have a strong portfolio of vaccines for travelers
and endemic diseases. For more information visit www.bavarian-nordic.com
(http://www.bavarian-nordic.com).
Forward-looking statements
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control, that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. All such forward-looking
statements are expressly qualified by these cautionary statements and any other
cautionary statements which may accompany the forward-looking statements. We
undertake no obligation to publicly update or revise forward-looking statements
to reflect subsequent events or circumstances after the date made, except as
required by law.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel:
+45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com
(mailto:graham@paddockcircle.com), Tel: +1 781 686 9600
Company Announcement no. 35 / 2023
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(1) Persons at risk include gay, bisexual, and other men who have sex with men,
transgender or nonbinary people who in the past 6 months have had one of the
following: A new diagnosis of >= 1 sexually transmitted disease; More than one
sex partner; Sex at a commercial sex venue; Sex in association with a large
public event in a geographic area where mpox transmission is occurring, sexual
partners of persons with the aforementioned risks, and persons who anticipate
experiencing any of the aforementioned.
(2) CDC. JYNNEOS Vaccine Coverage by Jurisdiction as of September 26, 2023.
https://www.cdc.gov/poxvirus/mpox/cases-data/mpx-jynneos-vaccine-coverage.html
(3) https://www.eacsociety.org/media/guidelines-12.0.pdf
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