Bavarian Nordic’s Mpox Vaccine Receives Recommendation from U.S. CDC Advisory Committee for Routine Use in Adults at Risk
25 Oktober 2023 - 8:03PM
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 factors1 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
recommendations2. 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) treatment3, 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 for full prescribing
information.
About Bavarian NordicBavarian
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.
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.
ContactsEurope: Rolf Sass
Sørensen, Vice President Investor Relations, Tel: +45 61 77 47
43US: Graham Morrell, Paddock Circle Advisors,
graham@paddockcircle.com, Tel: +1 781 686 9600
Company Announcement no. 35 / 2023
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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