Orthopoxvirus infection

First mpox vaccine to obtain prequalification by the WHOApproval will help accelerate access to the vaccine for all African countries COPENHAGEN, Denmark, September 13, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that the Company has obtained prequalification from the World Health Organization (WHO) for IMVANEX® (MVA-BN®) as the first mpox vaccine to be added to the WHO prequalification list. MVA-BN is indicated for active immunization against smallpox, mpox, and related orthopoxvirus infections and disease in all adults 18 years of age and older. According to recommendations from the WHO, MVA-BN may however be used “off-label” in infants, children and adolescents, and in pregnant and immunocompromised people in outbreak settings where the benefits of vaccination outweigh the potential risks1. A prequalification or secondary, an emergency use listing is a prerequisite for governments and organizations like Gavi, UNICEF and others to procure and distribute vaccines in African countries, and while the WHO’s intent was to evaluate mpox vaccines for an emergency use listing, the agency has assessed that MVA-BN meets the criteria for a full prequalification. This assessment is based on information submitted by Bavarian Nordic, including certifications, assessment reports and positive opinions issued by the European Medicines Agency (EMA), which is the regulatory agency of record for this vaccine. Earlier this week, MVA-BN also received a provisional consent from New Zealand Medicines and Medical Devices Safety Authority, Medsafe and a full approval from the Mexican Federal Committee for Protection from Sanitary Risks, COFEPRIS. Paul Chaplin, President & CEO of Bavarian Nordic, said: “We are highly encouraged that our mpox vaccine has received prequalification from the WHO, which is a testament to the strengths of our vaccine and the quality of data, we have generated through numerous studies, as well as in real life. While we continue to work with WHO and other regulatory bodies to expand the approval to include children, who are severely impacted by the mpox outbreak, we are pleased that this approval will help accelerate access to our vaccine for communities across the entire African continent and we applaud the WHO for their swift review and action to make this happen.” About the mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland and Singapore (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EAA and United Kingdom (marketed as IMVANEX®). Originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general adult population in individuals considered at risk for smallpox or mpox infection. Supported by data from a clinical study, conducted by the U.S. National Institutes of Health (NIH), Bavarian Nordic has recently filed a submission to the European Medicines Agency to extend the approval to adolescents 12-17 years of age and is also working with partners, including the Coalition for Epidemic Preparedness Innovations (CEPI) to evaluate the safety and efficacy of the vaccine in children 2-12 years of age. Bavarian Nordic has been a long-term supplier of the vaccine to national stockpiles, and during the 2022-2023 mpox outbreak, the Company supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide. 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 smallpox and mpox vaccines, supplied to governments to enhance 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, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Company Announcement no. 30 / 2024 1 Smallpox and mpox (orthopoxviruses): WHO position paper, August 2024 (https://www.who.int/publications/i/item/who-wer-9934-429-456) Attachment 2024-30-en

African trial could potentially support licensure of mpox vaccine in endemic countries and expansion of current regulatory approvals to include childrenCEPI has awarded USD 6.5 million in funding to support the Phase 2 clinical trial which is projected to start later in 2024 COPENHAGEN, Denmark / OSLO, Norway, May 30, 2024 – Bavarian Nordic A/S (OMX: BAVA) and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a partnership to advance the development of Bavarian Nordic’s mpox vaccine in children in Africa. CEPI has awarded USD 6.5 million1 to support a Phase 2 clinical study evaluating the immunogenicity and safety of the MVA-BN® non-replicating vaccine in children from 2 years to less than 12 years of age compared to adults aged 18-50 years of age for the prevention of smallpox, mpox and related orthopoxvirus infections. Subject to regulatory approvals, the study plans to enroll a total of approximately 460 healthy individuals in endemic regions without previous mpox infection or poxvirus vaccination, who will receive two doses of the MVA-BN vaccine. Bavarian Nordic will be the sponsor of the trial which will be conducted in one or more African countries with planned initiation later in 2024. The new trial follows the publication of a continental plan by Africa CDC and African Ministries of Health to strengthen mpox preparedness and response efforts, as well as the World Health Organization’s (WHO) framework for enhancing prevention and control of mpox. Results from this study could provide assurance of the use of this vaccine in children, and thus support an extension of the current regulatory approvals for use of the vaccine in adults to also include children 2-12 years of age. Importantly, the study will also generate evidence on the vaccine in endemic African populations and could potentially support regulatory approval of MVA-BN in endemic countries. “We now understand that children suffer disproportionately from mpox, a concerning and neglected disease that has spread rapidly in recent years” said Dr Richard Hatchett, CEO of CEPI. “To address the risk that children face in DR Congo and other areas where the disease is endemic, CEPI is supporting this important trial which will provide key mpox vaccine safety and immunogenicity data in children. The findings of this study will be crucial in shaping mpox vaccine strategies to help protect children and potentially to bringing an end to the widespread outbreak in the DR Congo as well as mpox outbreaks that may strike in the future.” “We are very pleased to join forces with CEPI in their continued efforts to provide equitable access to a much-needed vaccine against mpox for endemic populations, and we are firmly committed to working with the local authorities to develop solutions for vulnerable populations, including children who sadly represent the vast majority of those affected by the ongoing mpox outbreak in the DR Congo.” Said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. About mpox in the DRC and other African countriesMultiple countries in Central and East Africa are currently tackling the largest and deadliest known mpox outbreak to date. Over 6,500 mpox cases and 345 deaths have been reported in the DR Congo this year alone, with children accounting for the majority of infections and deaths. Cases have also been confirmed in the Congo, Cameroon, Central African Republic and Liberia. Mpox was first identified in the DR Congo in 1970. In most cases, mpox symptoms—typically fever and headache, followed by painful lesions—disappear within a few weeks. However, for some, mpox can lead to medical complications, such as bronchopneumonia, sepsis, encephalitis, loss of vision, and even death. The mpox strain behind the current outbreak, known as Clade I, is estimated to be fatal in around 8-12% of cases. About the smallpox/mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EEA and United Kingdom (marketed as IMVANEX®). Originally developed in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general adult population (18 years and older) in individuals considered at risk for smallpox or mpox infection. During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents. Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada as well as several other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide. About CEPICEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. 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 smallpox and mpox vaccines, supplied to governments to enhance 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, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 CEPI:press@cepi.net+44 7387 055214 1 Approximate funding figure. Final budget still pending. Attachment 2024-05-30-en

As the monkeypox outbreak continues in the United States and other parts of the world, researchers and public health officials scramble to test known drugs against the disease. For that and more research stories, continue reading. Tecovirimat Appears Safe and Effective Against Monkeypox A research study out of the University of California-Davis Health found tecovirimat (TPOXX) overall safe and effective to treat monkeypox symptoms and skin lesions, but researchers will still proceed with caution. The antiviral drug is approved to treat smallpox, which was eradicated globally in 1980. TPOXX inhibits the protein involved in the release of the enveloped virus. The CDC allowed doctors to prescribe TPOXX for compassionate use for adults and children with orthopoxvirus infections, including monkeypox. The new study evaluated 25 patients with monkeypox who received TPOXX. They published their research in the journal JAMA. “We have to be very careful in how we interpret the data,” George Thompson, M.D., co-author and professor at the UC Davis School of Medicine, Department of Internal Medicine, Division of Infectious Diseases, and the Department of Medical Microbiology and Immunology, said. “It is hard to differentiate the side effects due to therapy from those caused by the infection.” The recent monkeypox outbreak has led to more than 45,500 cases, as of Aug. 22. Typically, symptoms resolve on their own in two to four weeks, although up to 13% of patients require hospitalization. The patients in the study were referred to UC Davis Medical Center, primarily via the Sacramento County Department of Public Health. Patients were offered the drug if they had skin lesions on multiple body parts or sensitive areas such as the face or genital region. By Day 7, 40% of patients’ lesions had healed. By Day 21, 92% reported being healed and pain-free. On average, the patients had symptoms or lesions for 12 days before initiating antiviral therapy. “Polypill” Cuts Cardiovascular Death by 33% After a Heart Attack Investigators at The Mount Sinai Hospital and Mount Sinai School of Medicine found that a three-drug “polypill” prevented secondary adverse cardiovascular events in people who previously had a heart attack and cut CV deaths by 33%. The drug was developed by the Spanish National Center for Cardiovascular Research (CNIC) and Ferrer and was tested in the Phase III SECURE trial. The three drugs in the pill are aspirin, ramipril and atorvastatin. Standard therapy after a heart attack includes an antiplatelet drug such as aspirin, ramipril or another drug to control blood pressure and a lipid-reducing drug like a statin. However, patient compliance is around 50%. The study evaluated the polypill to determine if the improved adherence led to a decrease in CV events, which it did. The polypill is commercially sold under the name Trinomia. How Astrocytes Contribute to Brain Disorders Scientists at the Salk Institute have identified a molecule, insulin-like growth factor (IGF), that can reduce disease symptoms in mice with neurodevelopmental disorders such as Rett, Fragile X and Down syndromes. The molecule is produced by astrocytes, a special type of brain immune cells that interfere with normal brain cell development in several neurodevelopment disorders. Astrocytes are star-shaped glial cells that outnumber neurons by a factor of five and are responsible for holding nerve cells in place and helping them develop and function properly. The researchers isolated astrocytes and neurons from the developing brains of mice with genetic mutations that cause Rett, Fragile X and Down syndrome. They then evaluated the levels of 1,235 different proteins produced by each type of astrocyte. In each disease, they found hundreds of proteins at higher or lower levels, with 120 common to all three. Their studies found that all astrocytes impacted by the three syndromes had a high level of Igfbp2, a protein that blocks IGF. The neurons make enough IGF, but it can’t get where it needs to be because the molecules astrocytes produce interfere with it. Excess Igfbp2 produced by astrocytes slows the growth of neurons. By blocking Lgfbp2 in mice with Rett syndrome, symptoms of the disease decreased. The researchers note that they have a long way to go before turning this discovery into a therapeutic, but the finding may lead to several new approaches to neurological diseases. Blocking Key Enzymes Can Boost T-Cell Responses in Cancer Immunotherapy A team of researchers at Louisiana State University Health New Orleans identified a vital immunosuppressive pathway and a promising approach to protecting T-cells’ ability to attack cancer cells. Immune cells that attack and kill cancer cells are called CD8 T-cells. To be effective, CD8 T-cells need a protein called NOTCH1. NOTCH1 is weakened by a compound, adenosine, produced by cancer cells. The research team worked with a Massachusetts biotech company, Nimbus Therapeutics, to test a CBL-B inhibitor, which, when used with existing immunotherapeutics, significantly increased the potency of the immunotherapy. The CBL-B inhibitor prevented NOTCH1 degradation in response to adenosine, which improved CD8+ T-cell effector functions, anti-cancer response and immunosuppression resistance. Long Covid Rare in Kids, But More Common than Hospitalization Researchers from the National Institutes of Health found that the incidence of Long COVID was lower in kids than in adults, but that more kids had Long COVID than kids who were hospitalized with acute COVID-19. The researchers used RECOVER Pediatric Electronic Health Records Cohort, and the study was authored by Suchitra Rao, M.D. with Children’s Hospital Colorado. There was overlap with adults regarding Long COVID and hospitalization, but Long COVID included some unique features in children, such as the risk of the inflammatory syndrome PASC. The study examined electronic health record data from 659,286 children who were tested for SARS-CoV-2 and compared 59,893 children who tested positive with those who tested negative. “We concluded that many of the symptoms children experience post-COVID-19 are similar to what is seen in adults, but there are some features more unique to children, such as myocarditis, abnormal liver enzymes, hair loss, skin rashes and diarrhea,” Rao wrote.