GlobeNewswire by notified

Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S.

Share

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 mpox
Visit the CDC website for comprehensive information about mpox:
https://www.cdc.gov/poxvirus/mpox/about/index.html

About Bavarian Nordic
Bavarian 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 information
Appropriate 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 to
avoid 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 – investors
Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
Graham Morrell, Paddock Circle Advisors (US), graham@paddockcircle.com, Tel: +1 781 686 9600

Contact – media
Michelle 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.

References
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, 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

5https://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


Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

CNH NAMES GERRIT MARX AS CEO: Mr. Marx returns to CNH from Iveco Group, succeeding Scott W. Wine who has decided to leave the Company having successfully overseen the delivery of the 2021 Business Plan21.4.2024 18:21:00 CEST | Press release

CNH NAMES GERRIT MARX AS CEO Mr. Marx returns to CNH from Iveco Group, succeeding Scott W. Wine who has decided to leave the Company having successfully overseen the delivery of the 2021 Business Plan Basildon, April 21, 2024 CNH Industrial N.V. (NYSE:CNHI) announces the appointment of Gerrit Marx to the role of CEO effective July 1, 2024. He succeeds Scott Wine, whose request to leave the Company at the end of the current three-year business plan cycle to pursue other interests, has been accepted by the Board. Mr. Marx rejoins CNH from Iveco Group where as CEO he has led that company’s drive into a new era of connectivity, integrating the latest digital and data technologies with Iveco’s product offering. He has also chaired Iveco’s powertrain business overseeing its transition to alternative propulsion systems. Prior to first joining CNH in January 2019, Mr. Marx worked for 20 years in senior roles at McKinsey, Daimler Trucks, and Bain Capital, living in Brazil, China, Europe and Jap

Olof Persson to replace Gerrit Marx as CEO of Iveco Group starting from July 202421.4.2024 18:15:00 CEST | Press release

Turin, 21st April 2024. The Board of Iveco Group N.V. (EXM: IVG) (or “the Group”) announces that Olof Persson will succeed Gerrit Marx as Group CEO when the latter leaves the Group to take up his appointment as the CEO of CNH Industrial N.V. (NYSE: CNHI) on 1st July 2024. Mr. Persson, who is currently an Iveco Group Board Independent Director, will step in to the role of CEO, having been closely involved in the development of the Group’s plans as presented at our recent Capital Markets Day. Suzanne Heywood, Chair of Iveco Group commented: “On behalf of everyone at Iveco Group I’d like to thank Gerrit for his energetic and successful leadership over the past two and half years and wish him every success in his new role. We are fortunate indeed that Olof, with his wealth of relevant industry experience, will step in as CEO and provide a guarantee of continuity in execution of the plans we presented in March.” Olof Persson said: “As a Board member I have been greatly impressed by the enti

Conferize A/S offentliggør aktieemission med fortegningsret for eksisterende aktionærer21.4.2024 17:48:46 CEST | pressemeddelelse

Selskabsmeddelelse nr. 11/2024 København, den 21. april 2024 IKKE TIL OFFENTLIGGØRELSE I USA, CANADA, AUSTRALIEN, JAPAN ELLER NOGEN ANDEN JURISDIKTION, HVOR FREMSÆTTELSE AF UDBUDDET VILLE UDGØRE EN OVERTRÆDELSE AF LOVGIVNINGEN I DEN PÅGÆLDENDE JURISDIKTION. Conferize A/S offentliggør aktieemission med fortegningsret for eksisterende aktionærer Bestyrelsen i Conferize A/S („Conferize“ eller „Selskabet“) har i dag besluttet at forhøje Selskabets aktiekapital med minimum nominelt DKK 2.000.000,00 og op til nominelt DKK 5.878.705,65 fordelt på minimum 200.000.000 stk. og op til 587.870.565 stk. nye aktier a nominelt DKK 0,01 („Udbudte Aktier“) med en tegningskurs på DKK 0,01 pr. Udbudt Aktie („Tegningskursen“) med fortegningsret for Selskabets eksisterende aktionærer i forholdet 1:3 („Udbuddet“). Brutto provenuet ved en fuldtegnet emission forventes at udgøre DKK 5,9 mio. Minimum udbuddet på DKK 2,0 mio. er garanteret gennem forhånds- og garantitilsagn. Selskabet har modtaget bindende forh

Correction to Company announcement – No. 23 / 202419.4.2024 22:20:51 CEST | Press release

Correction to Company announcement – No. 23 / 2024 Copenhagen, Denmark, April 19, 2024 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) (CVR-no. 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, has a correction to company announcement No. 23 /2024, April 19, 2024 - regarding transactions in Zealand’s shares or related securities conducted by persons discharging managerial responsibilities and/or their closely associated persons it was reported that member of the management, Henriette Wennicke, was allocated a total of 8,008 restricted stock units with a total value of DKK 9,577,568.00. The correct number was a total of 8,008 restricted stock units with a total value of DKK 4,788,784.00. Please see the attached file(s). # # # About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10

Nokia Corporation: Repurchase of own shares on 19.04.202419.4.2024 21:30:00 CEST | Press release

Nokia Corporation Stock Exchange Release 19 April 2024 at 22:30 EEST Nokia Corporation: Repurchase of own shares on 19.04.2024 Espoo, Finland – On 19 April 2024 Nokia Corporation (LEI: 549300A0JPRWG1KI7U06) has acquired its own shares (ISIN FI0009000681) as follows: Trading venue (MIC Code)Number of sharesWeighted average price / share, EUR*XHEL430,8933.30CEUX--BATE--AQEU--TQEX--Total430,8933.30 * Rounded to two decimals On 25 January 2024, Nokia announced that its Board of Directors is initiating a share buyback program to return up to EUR 600 million of cash to shareholders in tranches over a period of two years. The first phase of the share buyback program in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR), the Commission Delegated Regulation (EU) 2016/1052 and under the authorization granted by Nokia’s Annual General Meeting on 4 April 2023 started on 20 March 2024 and ends by 18 December 2024 with a maximum aggregate purchase price of EUR 300 million. Total cost of

HiddenA line styled icon from Orion Icon Library.Eye