Latest news with #JYNNEOS
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
Yahoo
06-03-2025
- Business
- Yahoo
Bavarian Nordic AS (BVNKF) Q4 2024 Earnings Call Highlights: Strong Vaccine Growth and ...
Revenue: DKK5.7 billion for 2024. EBITDA Margin: 28%, equating to DKK1.6 billion. Travel Health Vaccine Growth: 22% increase compared to the previous year. Public Preparedness Revenue: DKK3.2 billion, driven by mpox outbreak and US JYNNEOS launch. Rabies Vaccine Growth: 16% increase. TBE Vaccine Growth: 19% increase. Gross Margin: 49%, impacted by manufacturing activities and write-downs. R&D Expenses: DKK863 million, including DKK70 million from San Diego site closure. Cash Flow from Operating Activities: Close to DKK2 billion. Cash and Cash Equivalents: Nearly DKK2.2 billion. Guidance for 2025 Revenue: DKK5.7 billion to DKK6.7 billion. Guidance for 2025 EBITDA Margin: 26% to 30%. Public Preparedness Guidance for 2025: DKK3 billion to DKK4 billion, with DKK2.5 billion secured by contracts. Travel Health Guidance for 2025: Approximately DKK2.5 billion. Chikungunya Vaccine Revenue Expectation for 2025: DKK50 million to DKK100 million. Warning! GuruFocus has detected 4 Warning Signs with BVNKF. Release Date: March 05, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Bavarian Nordic AS (BVNKF) reported strong financial performance for 2024 with revenue of DKK5.7 billion and an EBITDA margin of 28%. The travel health vaccine franchise grew by 22%, driven by strong sales of rabies and TBE vaccines. The company secured contracts for more than DKK3 million doses of mpox vaccine, contributing to strong growth in public preparedness. Successful tech transfer for rabies and TBE vaccines is on track, setting industry standards for timelines. Bavarian Nordic AS (BVNKF) launched JYNNEOS in the US private market, generating DKK178 million in revenue in its first year. The gross margin of 49% fell below target due to write-downs on MVA batches and a water damage incident at the manufacturing site. Vaxchora experienced negative revenue in Q4 due to product returns, highlighting challenges in the relaunch phase. The company faces uncertainties regarding US manufacturing requirements and potential tariffs, which could impact operations. There is a need to increase awareness of Chikungunya among healthcare professionals and the public, which could affect vaccine uptake. The first quarter of 2025 is expected to be light in terms of revenue and EBITDA, due to seasonality and timing of revenue recognition. Q: Can you provide an update on the rescheduling of the ACIP meeting and its impact on sales projections for 2025? A: The ACIP meeting scheduled for February was postponed and then canceled, and we haven't received any updates on when it will be rescheduled. Despite this, we plan to launch as scheduled, focusing on disease awareness among healthcare professionals. We have received significant interest in Europe, particularly in Germany, which should help us meet our sales projections of DKK50 million to DKK100 million for 2025. Paul Chaplin, CEO Q: What are you hearing from the US government regarding commitments to biodefense and manufacturing in the US? A: There are many rumors, but concrete discussions are rare. Previously, the US government indicated that some manufacturing elements should be in the US, but specialty products like ours might get waivers. We have some manufacturing set up in the US, which might mitigate potential impacts from new regulations. Paul Chaplin, CEO Q: How would potential tariffs affect your contracts with the US government? A: We have Grand River in the US for fill-finish operations, which might reduce sensitivity to tariffs. If tariffs are imposed, we would pass through any additional costs to the government. Paul Chaplin, CEO Q: Are you considering supplying vaccines for the Chikungunya outbreak in La Reunion Island? A: Yes, we are in discussions with various entities about the availability of our vaccine and how quickly we can supply it. Providing access to those in need is a high priority for us. Paul Chaplin, CEO Q: How do you plan to increase awareness of Chikungunya, and could a major outbreak help in this regard? A: We are focusing on raising awareness among the public and healthcare professionals about the severity of Chikungunya. While an outbreak could increase awareness, we are actively working on educational initiatives to inform people about the disease and its risks. Paul Chaplin, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
13-02-2025
- Health
- Yahoo
New mpox strain confirmed in US state for first time
The New York State Department of Health issued a health advisory Wednesday about the emergence of a new strain of mpox (formerly monkeypox). The first case of mpox clade Ib in New York State was confirmed in a symptomatic individual who had recently traveled from Africa. The present risk to the public remains low, the department noted, and there are no additional known community cases of this strain in New York State currently. Is Mpox The Next Covid? Infectious Disease Experts Address Pandemic Potential State Health Commissioner Dr. James McDonald shared that the infected individual is under the care of a physician and isolated "until the full resolution of symptoms." "There is no known local transmission of mpox clade Ib in the community where the individual lives or anywhere within New York State," he said in a statement. Read On The Fox News App McDonald added that the JYNNEOS vaccine, which is a two-dose preventative vaccine series for mpox, is "expected to be effective" against this new strain. "[It is] available for individuals at risk with the standing order I signed last year," he noted. "There is no immediate risk to the general public." For more Health articles, visit The health department added in its advisory that individuals should inquire with their local pharmacy or healthcare provider about vaccine availability as they continue to "monitor and maintain the situation." Mpox is "rarely fatal," according to the department, but can be dangerous for people with immunocompromising conditions, as well as older adults, young children and pregnant women. Symptoms can include rashes that progress to "painful skin lesions," in addition to swollen lymph nodes, fever, sore throat, headaches, back pain, low energy and muscle aches, the department listed. There is a "high likelihood of transmission" until these lesions scab over, which means infected individuals are encouraged to isolate until new skin forms at the lesion site. Mpox can spread through close, intimate contact with sores, scabs or rashes, the department stated, as well as through the respiratory droplets, saliva or mucus of an infected person. Those who plan to travel to areas with reported cases of mpox should consider being vaccinated with the two doses of JYNNEOS, experts recommend. Click Here To Sign Up For Our Health Newsletter Dr. Myles Druckman, global medical director at International SOS in California, told Fox News Digital that there have been reports of this strain in several countries in Central and Eastern Africa. "We're finding that other countries have also reported travel-associated cases of clade I, including Belgium, Canada, China, France, Germany, India, Ireland, Oman, Pakistan, South Sudan, Sweden, Thailand, the United Kingdom and Zimbabwe," he noted. "It's important to recognize that cases of this strain are expected due to the ongoing outbreak in multiple countries and the risks associated with global travel." Mpox can be infectious for up to four days before symptoms occur, but it is most contagious from the time symptoms appear until about two to four weeks later, according to Druckman. The expert emphasized that vaccination is recommended for high-risk individuals, such as healthcare workers with high exposure or people with weakened immune systems. "Prevention of mpox is mainly through vaccination and avoiding skin-to-skin contact with others – especially those with symptoms or visible outbreaks – and observing good personal hygiene and washing hands well and frequently," he article source: New mpox strain confirmed in US state for first time
Fox News
13-02-2025
- Health
- Fox News
New mpox strain confirmed in US state for first time
The New York State Department of Health issued a health advisory Wednesday about the emergence of a new strain of mpox (formerly monkeypox). The first case of mpox clade Ib in New York State was confirmed in a symptomatic individual who had recently traveled from Africa. The present risk to the public remains low, the department noted, and there are no additional known community cases of this strain in New York State currently. State Health Commissioner Dr. James McDonald shared that the infected individual is under the care of a physician and isolated "until the full resolution of symptoms." "There is no known local transmission of mpox clade Ib in the community where the individual lives or anywhere within New York State," he said in a statement. McDonald added that the JYNNEOS vaccine, which is a two-dose preventative vaccine series for mpox, is "expected to be effective" against this new strain. "[It is] available for individuals at risk with the standing order I signed last year," he noted. "There is no immediate risk to the general public." For more Health articles, visit The health department added in its advisory that individuals should inquire with their local pharmacy or healthcare provider about vaccine availability as they continue to "monitor and maintain the situation." Mpox is "rarely fatal," according to the department, but can be dangerous for people with immunocompromising conditions, as well as older adults, young children and pregnant women. Symptoms can include rashes that progress to "painful skin lesions," in addition to swollen lymph nodes, fever, sore throat, headaches, back pain, low energy and muscle aches, the department listed. There is a "high likelihood of transmission" until these lesions scab over, which means infected individuals are encouraged to isolate until new skin forms at the lesion site. "There is no immediate risk to the general public." Mpox can spread through close, intimate contact with sores, scabs or rashes, the department stated, as well as through the respiratory droplets, saliva or mucus of an infected person. Those who plan to travel to areas with reported cases of mpox should consider being vaccinated with the two doses of JYNNEOS, experts recommend. Dr. Myles Druckman, global medical director at International SOS in California, told Fox News Digital that there have been reports of this strain in several countries in Central and Eastern Africa. "We're finding that other countries have also reported travel-associated cases of clade I, including Belgium, Canada, China, France, Germany, India, Ireland, Oman, Pakistan, South Sudan, Sweden, Thailand, the United Kingdom and Zimbabwe," he noted. "Cases of this strain are expected due to the ongoing outbreak in multiple countries and the risks associated with global travel." "It's important to recognize that cases of this strain are expected due to the ongoing outbreak in multiple countries and the risks associated with global travel." Mpox can be infectious for up to four days before symptoms occur, but it is most contagious from the time symptoms appear until about two to four weeks later, according to Druckman. The expert emphasized that vaccination is recommended for high-risk individuals, such as healthcare workers with high exposure or people with weakened immune systems. "Prevention of mpox is mainly through vaccination and avoiding skin-to-skin contact with others – especially those with symptoms or visible outbreaks – and observing good personal hygiene and washing hands well and frequently," he added.
