Bavarian Nordic A/S

Clinical study in children 2-11 years of age follows the recent EMA and WHO approvals of the MVA-BN mpox vaccine for adolescents 12-17 of age. COPENHAGEN, Denmark, October 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a clinical study of the MVA-BN® mpox/smallpox vaccine in children 2 to 11 years of age. The first children have now been vaccinated in the study, which is currently enrolling in the Democratic Republic of Congo (DRC) with plans also to include sites in Uganda. A total of 460 individuals are expected to participate in the study, which will compare the safety and immunogenicity of the vaccine between children aged 2 to 11 years of age to adults. The study (NCT06549530) is partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Results from this study could support an extension of the current approval of MVA-BN to include children from 2 years of age and older. Last month, the WHO prequalified the vaccine for adolescents 12 to 17 years of age, adopting the recent approval from the European Medicines Agency (EMA) for this age group. Paul Chaplin, President & CEO of Bavarian Nordic, said: “Children remain highly vulnerable to mpox infections in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to effective vaccines that can be safely administered to this young population. Following the recent approval of MVA-BN for adolescents, we are pleased to initiate this study, which could provide additional data to further extend the indication to also include children, and we thank CEPI and our partners in Africa for their support of this important work.” Dr Nicole Lurie, Executive Director of Preparedness and Response at CEPI, said: “The findings of this study will be crucial in shaping mpox vaccine strategies that could protect children and bring an end to this devastating and widespread outbreak, while also providing pivotal vaccine guidance in local endemic populations to tackle mpox outbreaks that could strike in the future.” While this study represents the first investigation of MVA-BN as an mpox/smallpox vaccine for younger children, a recombinant version of MVA-BN (Mvabea®) was approved by EMA in 2020 as part of a prime-boost vaccine regimen1 for the prevention of disease caused by Ebola virus in individuals 1 year of age and older. Clinical studies supporting this approval encompassed more than 3,300 individuals across Europe, USA, and Africa including over 800 children and adolescents 1 to 17 years of age in Africa2. The safety profile of Mvabea in children 1 to 17 years of age was generally similar to that observed in adults. About the mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore and Mexico (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 population (from 12 years old) in individuals considered at risk for smallpox or mpox infection. 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 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 1 Mvabea® was licensed in 2014 to Johnson & Johnson as part of a prime-boost vaccine regimen. 2 https://www.ema.europa.eu/en/documents/assessment-report/mvabea-epar-public-assessment-report_en.pdf Attachment 2024-10-29-en

iStock, Anne Czichos The mpox vaccine induced an antibody response in adolescents aged 12 to 17 years that matched that in adults, suggesting the shot can be used to protect the highly susceptible group. Bavarian Nordic ’s mpox vaccine Jynneos is safe to use in adolescents and can induce an antibody response that matches its effect in adults , according to the interim findings of a study funded by the National Institutes of Health. The results, which were unveiled Wednesday at the 2024 IDWeek conference in Los Angeles, come from a Phase II trial that administered Jynneos to more than 300 adolescents aged 12 to 17 years and compared the vaccine’s safety and efficacy to that in over 200 adults 18 to 50 years. Data were sparse with the NIH only revealing that Jynneos “generated antibody levels in adolescents equivalent to those observed in adults” two weeks after the second dose. “The vaccine was well tolerated through study day 210,” according to the NIH, which pointed out that side effects arose at similar frequencies between study groups. Mary Healy, associated professor of pediatrics infectious diseases at Baylor College of Medicine and who presented the study at IDWeek, called the results “an important milestone for people living in areas with mpox” while noting that the vaccine continues to be “an important solution” to protect vulnerable populations from the virus, particularly adolescents. Wednesday’s findings come just days after the World Health Organization prequalified the use of Jynneos for adolescents aged 12 to 17. According to the global health authority, this move will make the vaccine available for an age group of patients that are considered particularly vulnerable to the virus. The European Medicines Agency in September 2024 allowed the use of Jynneos in adolescents . The FDA has yet to grant a similar approval. Adding to the NIH’s most recent data on Jynneos, several studies in recent months have helped improve the industry’s understanding of the vaccine, not just regarding its efficacy and safety but also the durability of its effects and acceptable dosing. In April 2024, another NIH study found that even a dose-sparing regimen of Jynneos—where patients are given just one-fifths of its standard dose—can elicit an antibody response similar to that of the standard dose , though this effect waned much sooner. Earlier this month, another study showed that even at its approved dose, antibody titers appear to decline after six to 12 months , raising concerns about weakening protective immunity in patients that were vaccinated in during the 2022 outbreak. In August 2024, the WHO declared the mpox outbreak a public health emergency of international concern. Though cases were largely concentrated in the Democratic Republic of Congo and in Africa at the time, WHO Director-General Tedros Adhanom Ghebreyesus flagged “the emergency of a new clade of mpox” which appears to be a more aggressive and deadlier version of the virus. For Bavarian Nordic, the WHO’s declaration represents a promising windfall opportunity . In an August 2024 investor note, Jefferies analyst Peter Welford estimated that the company is looking at $600 million to $1 billion in revenue into 2025, if it can deliver its promised 10 million doses.

The NIH study team says the data supports the safety and quality of the vaccine’s immune response in adolescents. Image credit: Shutterstock/Halfpoint. A clinical trial by the US National Institutes of Health (NIH) has shown that Bavarian Nordic ’s mpox vaccine induced an antibody response in adolescents equivalent to that of adults. The interim results, presented at the Infectious Diseases Society of America’s IDWeek2024 conference in Los Angeles, could provide backing to aid the vaccine’s extended use in those under 18 years of age in the US and other areas where mpox cases have occurred. “[The interim data] would support an application to expand licensure of the vaccine to people in that age group,” an NIH’s National Institute of Allergy and Infectious Diseases (NIAID) spokesperson confirmed to Pharmaceutical Technology . Bavarian Nordic won an European Medicines Agency (EMA) approval for MVA-BN’s use in adolescents in September this year, whilst in the US it is still only approved in adults under the brand name Jynneos. During the 2022–2023 mpox outbreak, though, the FDA did grant the vaccine an emergency use authorisation for both pre- and post-exposure use in adolescents. The NIH stated that whilst several countries have approved the vaccine for the prevention of mpox and smallpox in adults, there is “insufficient data available to support licensure for people younger than 18 years,” as per a 16 October press release. See Also: Intercept’s liver disease drug Ocaliva faces FDA approval delay Avadel wins FDA approval for narcolepsy drug Lumryz in children The NIAID-sponsored Phase II study (NCT05512949) was conducted in the US in individuals aged between 12 and 17 years. After two doses, antibody levels were found to be equivalent at day 43 to those in adults aged 18 to 50 years. The overall frequency of adverse events was comparable between the study groups, with the vaccine well tolerated through day 210 of the study. Dizziness was reported more often in the adolescent group, but the NIH stated this is also seen in many other vaccines given to a younger age group. The randomised mid-stage study enrolled 229 healthy adolescents, some of whom have a human immunodeficiency virus (HIV) infection. People with compromised immune systems and those who are pregnant are being adversely affected by the Clade II mpox outbreak in Africa, with a large portion of those testing positive in the continent under the age of 18 years old. Whilst mpox cases have steadily increased in areas of Africa over the past decade, the number of cases reported so far this year has already exceeded last year’s total, with more than 24,000 confirmed or suspected mpox cases because Clade I and Clade II, including over 600 deaths. Even though the NIH study team says the data supports the safety and quality of the immune response in adolescents, the authors reiterated the need for further evaluation in younger children. Bavarian Nordic is gearing up for its own Phase II clinical trial (NCT06549530) to assess the immunogenicity and safety of MVA-BN in children between two and 12 years of age. The company has previously said it aims “to further extend the indication of the vaccine into younger populations”. The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is expected to start this month. In September, Bavarian Nordic said it would prioritise the production of two million mpox vaccines by the end of this year to help fight the disease in Africa. The Swiss biotech has already shipped 250,000 doses of the vaccine to the Democratic Republic of Congo, considered the epicentre of the outbreak. Note: The third paragraph of this article was amended on 18 October to include response from the NIAID spokesperson.