Latest news with #JYNNEOS®
The South African
18-07-2025
- Health
- The South African
Sierra Leone declares monkeypox public health emergency
Sierra Leone is currently experiencing a Clade II mpox outbreak, with active transmission reported across multiple districts as of 17 July 2025. Clade II, a less virulent variant of the monkeypox virus primarily linked to West Africa, has affected males and females aged 20 to 39 years almost equally. Health officials have confirmed person-to-person transmission, including through intimate contact. On 11 July 2025, the World Health Organisation (WHO) reported that the ongoing mpox outbreak in Sierra Leone is linked to Clade II of the monkeypox virus. On 16 January 2025, the Minister of Health, Dr Austin Demby, officially declared mpox a public health emergency after confirming two cases across multiple districts. Médecins Sans Frontières (MSF) has supported the response in Freetown, Kenema, Bombali, and Tonkolili districts. UNICEF also delivered 58 000 mpox vaccine doses with Gavi's support by March 2025. Gavi has confirmed an additional 50 000 doses for allocation, raising its total contribution to nearly 110 000 vaccines. CHALLENGES AND CONCERNS REMAIN Despite declining case numbers recently, data should be interpreted cautiously due to reporting delays. As of 17 July 2025, mpox vaccination is recommended for travellers to Sierra Leone engaging in at-risk activities. The standard protocol for maximum immunity involves two doses of the JYNNEOS® vaccine, administered 28 days apart. As a result, critical gaps persist in vaccine supply, surveillance, case management, and community engagement. GLOBAL CONTEXT AND FUTURE STEPS On 9 June 2025, the World Health Organisation reaffirmed that the mpox upsurge continues to constitute a Public Health Emergency of International Concern (PHEIC) following the fourth meeting of the International Health Regulations Emergency Committee (IHREC). Furthermore, resource constraints threaten the sustainability of operations, impacting personnel and laboratory surveillance. The global funding requirement of $145 million (approximately R 2.56 billion) for the mpox response remains largely unmet. This points out the importance of sustained international investment and coordinated efforts. Let us know by leaving a comment below, or send a WhatsApp to 060 011 021 11. Subscribe to The South African website's newsletters and follow us on WhatsApp, Facebook, X and Bluesky for the latest news.
Yahoo
06-05-2025
- Business
- Yahoo
Bavarian Nordic Awarded Contract Options from the U.S. Government for Production and Supply of Freeze-dried Smallpox/Mpox Vaccines
Bavarian Nordic A/S Exercised options total USD 143.6 million Secures manufacturing and supply of freeze-dried JYNNEOS® to the U.S. in 2026 COPENHAGEN, Denmark, May 6, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), has exercised additional options valued at USD 143.6 million under the existing contract to supply a freeze-dried formulation of JYNNEOS® smallpox vaccine. The options support the manufacturing and supply of freeze-dried JYNNEOS by conversion of bulk vaccine, previously manufactured under other contract options, as well as supplemental payments for all doses procured under the freeze-dried contract, triggered by the demonstration of an extended shelf-life. The supplemental payments will be invoiced pro rata with deliveries of the freeze-dried vaccines. Deliveries under the new contract options are planned for 2026. Bavarian Nordic's financial guidance for 2025 remains unchanged at total revenues of DKK 5,700-6,700 million and an EBITDA margin of 26-30%. From the Public Preparedness business, revenue of DKK 3,000-4,000 million is still expected, of which DKK 2,650 million has been secured, which is an increase of DKK 150 million following exercise of the options. Paul Chaplin, President & CEO of Bavarian Nordic, said: 'Following the recent FDA approval of the freeze-dried formulation of our smallpox/mpox vaccine, we applaud the U.S. government's steadfast commitment to improving national health security through the exercise of these options. The freeze-dried vaccine, with its improved shelf life, provides a significant contribution to securing the long-term availability of countermeasures to protect U.S citizens against life-threatening diseases.' About our contracts with the U.S. government Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing and supply of a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox and mpox, including people with weakened immune systems who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. Approved by the FDA in 2019, JYNNEOS was the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) threats through public-private partnerships.
Yahoo
31-03-2025
- Business
- Yahoo
Bavarian Nordic Receives U.S. FDA Approval of Freeze-Dried Smallpox and Mpox Vaccine
COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. The approval follows a standard review with the FDA of a supplemental Biologics License Application (sBLA) submitted in May 2024. The sBLA was primarily based on clinical data that showed comparability in terms of the immune responses and safety between the freeze-dried and liquid-frozen formulations, as well as other non-clinical and manufacturing data. The current liquid-frozen formulation of JYNNEOS, approved by the FDA in September 2019, has specific cold-chain requirements, while the freeze-dried formulation provides advantages in terms of transportation, storage conditions and shelf life, all of which are important factors for long-term stockpiling. 'Today's FDA approval represents a significant milestone in our development of this next generation of JYNNEOS and in our collaborative efforts with the U.S. government to strengthen public health security.' said Paul Chaplin, President and CEO of Bavarian Nordic. 'As a long-term supplier of JYNNEOS to the U.S. biological preparedness, we are committed to continue supporting the government's efforts to protect its citizens against current and future public health threats.' About our contracts with the U.S. governmentSince 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing and supply of a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox and mpox, including people with weakened immune systems who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. Approved by the FDA in 2019, JYNNEOS was the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents through public-private partnerships. Bavarian Nordic has supplied a liquid-frozen version of JYNNEOS to the U.S. government for stockpiling since 2010 and in response to the mpox outbreak in 2022-2023. The Company has been contracted by the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop and supply a freeze-dried version of JYNNEOS for stockpiling. Manufacturing under this contract was initiated in 2024, and the first vaccines will be delivered later in 2025. Federal funding acknowledgementsThis project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201700019C. About JYNNEOS®JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) 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 monkeypox 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, the Advisory Committee on Immunization Practices (ACIP) under the Centers for Disease Control and Prevention (CDC) voted to recommend 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 by the FDA 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 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 5 serious adverse events (SAEs), all non-fatal, which included Crohn's disease, sarcoidosis, extraocular muscle paresis, throat tightness, and hemolytic anemia. Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in <0.1% 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 1-833-365-9596 or the US Department of Health and Human Services by either visiting or calling 1-800-822-7967. Please see full Prescribing Information. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit 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. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: + 45 53 88 06 03 Company Announcement no. 12 / 2025 Attachment 2025-12-enSign in to access your portfolio
