Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the
U.S.
COPENHAGEN, Denmark, April 2, 2024 –
Bavarian Nordic A/S (OMX: BAVA) announced today that JYNNEOS®, the
only FDA-approved mpox vaccine, is now commercially available in
the U.S., marking a significant expansion for access to JYNNEOS® by
establishing additional pathways for vaccine procurement,
distribution, and reimbursement by both public and private
payers.
Since 2022, in response to the global mpox
outbreak, JYNNEOS has been made available through public health
channels for individuals at risk of mpox infection. This was made
possible through Bavarian Nordic’s long-standing partnership with
the U.S. government to supply the vaccine for the national
stockpile and enabled by interim guidance from the Centers for
Disease Control and Prevention (CDC), recommending pre- and
post-exposure use of the vaccine for individuals at risk during the
outbreak. These recommendations were updated in October 2023 by
unanimous vote by the CDC's Advisory Committee on Immunization
Practices (ACIP), and JYNNEOS is now recommended for routine use in
individuals 18 years and older with certain risk factors1.
While mpox no longer constitutes a public health
emergency, infections are still occurring throughout the U.S., with
around 200 cases every month on average and transmission of the
virus having been reported across most of the states in 2024
to-date2. Since the beginning of the outbreak in 2022, more than
32,000 cases have been reported in the U.S., representing a third
of all cases reported globally3.
According to estimates from the CDC, two (2)
million U.S. individuals are eligible for vaccination against
mpox4. Recent data shows 60% of this population remains completely
unvaccinated, and 15% have received only one dose of the vaccine5.
Real-world data show that protection against mpox disease is
superior in vaccinees who received the full schedule of two
vaccinations as recommended by the CDC, compared to those who are
unvaccinated or have only received one dose of the vaccine6.
Through its existing nationwide vaccine
distribution structure, Bavarian Nordic is now making the mpox
vaccine commercially available across the nation. As of April 1,
health care providers can order JYNNEOS through their preferred
wholesaler and distribution partners to make it available for
at-risk individuals at local pharmacies and physician offices in
addition to public health clinics.
Paul Chaplin, President and Chief Executive
Officer of Bavarian Nordic, commented: “From the beginning of the
mpox outbreak, almost two years ago, the prompt availability of an
approved vaccine combined with a strong public health response have
helped to significantly reduce the impact of this debilitating
disease, but unfortunately, mpox has not gone away completely.
Building on the trust and reliability as a supplier of vaccines to
the U.S. government for more than a decade, we are proud to extend
our commitment to improving the nation’s public health by making
our mpox vaccine widely available to at-risk individuals through
the regular channels. We look forward to working with healthcare
providers across the nation to increase awareness and availability
of the mpox vaccine.”
Brian Hujdich, Executive Director, National
Coalition for LGBTQ Health, commented: “The expanded availability
of JYNNEOS is a vital step toward ensuring equitable access to
healthcare for the LGBTQ+ community and marks a significant stride
in preventing the spread of mpox. We must continue to advocate for
equitable policies that protect and support the health and
well-being of all individuals and encourage those at risk to
consult with their healthcare providers regarding vaccination.”
About mpoxVisit the CDC website for
comprehensive information about
mpox:https://www.cdc.gov/poxvirus/mpox/about/index.html
About Bavarian NordicBavarian Nordic is a
fully integrated vaccine company with a mission to protect and save
lives through innovative vaccines. We are a global leader in travel
vaccines and a preferred partner with governments on vaccines for
public preparedness. For more information visit
www.bavarian-nordic.com.
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. In October
2023, the CDC updated its guidance for use of JYNNEOS, and now
recommends routine use of the vaccine for at risk individuals 18
years and older.
Important safety informationAppropriate medical
treatment must be available to manage possible anaphylactic
reactions following administration of JYNNEOS. Anyone who has
experienced a severe allergic reaction following a previous dose of
JYNNEOS or following exposure to any component of JYNNEOS may be at
increased risk for severe allergic reactions.
Syncope (fainting) has been reported following
vaccination with JYNNEOS. Procedures should be in place toavoid
injury from fainting.
Immunocompromised persons, including those
receiving immunosuppressive therapy, may have a diminished immune
response to JYNNEOS.
Vaccination with JYNNEOS may not protect all
recipients.
In smallpox vaccine-naïve healthy adults, the
most common (>10%) solicited injection site reactions were pain
(84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and
itching (43.1%); the most common solicited systemic adverse
reactions were muscle pain (42.8%), headache (34.8%), fatigue
(30.4%), nausea (17.3%) and chills (10.4%).
In healthy adults previously vaccinated with a
smallpox vaccine, the most common (>10%) solicited injection
site reactions were redness (80.9%), pain (79.5%), induration
(70.4%), swelling (67.2%), and itching (32.0%); the most common
solicited systemic adverse reactions were fatigue (33.5%), headache
(27.6%), and muscle pain (21.5%).
The frequencies of solicited local and systemic
adverse reactions among adults with HIV infection and adults with
atopic dermatitis were generally similar to those observed in
healthy adults.
Across all studies, a causal relationship to
JYNNEOS could not be excluded for 4 serious adverse events (SAEs),
all non-fatal, which included Crohn’s disease, sarcoidosis,
extraocular muscle paresis and throat tightness.
Cardiac adverse events of special interest
(AESIs) considered causally related to study vaccination were
reported in 0.08% of subjects who received JYNNEOS and included
tachycardia, electrocardiogram T wave inversion, electrocardiogram
abnormal, electrocardiogram ST segment elevation, electrocardiogram
T wave abnormal, and palpitations. None of the cardiac AESIs
considered causally related to study vaccination were considered
serious.
To report SUSPECTED ADVERSE REACTIONS, contact
Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health
and Human Services by either visiting
www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.
Please see full Prescribing Information
Contacts – investorsRolf Sass Sørensen,
Vice President Investor Relations, Tel: +45 61 77 47 43Graham
Morrell, Paddock Circle Advisors (US), graham@paddockcircle.com,
Tel: +1 781 686 9600
Contact – mediaMichelle Trasatti,
michelle.trasatti@syneoshealth.com, Tel: +1 443-528-7427
Media are also encouraged to visit
https://www.bavarian-nordic.com/media/mpox for additional
background information and media kit, including photos and
b-roll.
References1 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, weekly data. Accessed April 1, 2024.
https://wonder.cdc.gov/nndss/static/2024/12/2024-12-table968-H.pdf
.
3 CDC. Ongoing 2022 Global Outbreak Cases and Data.
Accessed April 1, 2024.
https://www.cdc.gov/poxvirus/mpox/response/2022/index.html.
4 CDC. JYNNEOS Vaccine Coverage by Jurisdiction as
of September 26, 2023.
https://www.cdc.gov/poxvirus/mpox/cases-data/mpx-jynneos-vaccine-coverage.html
5
https://www.cdc.gov/poxvirus/mpox/response/2022/vaccines_data.html
6 CDC. 2022/2023 Mpox outbreak: situational
awareness and updates (October 25, 2023, ACIP meeting
presentation). Accessed April 1, 2024.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-10-25-26/02-MPOX-Minhaj-508.pdf
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