Company Announcements

• The advance purchase agreement (APA) will be funded by Gavi’s First Response Fund, a mechanism created after the COVID-19 pandemic to ensure rapid access to scarce vaccine supplies in future health emergencies.
• Availability of all 500,000 doses has been secured for 2024.

COPENHAGEN, Denmark and GENEVA, Switzerland, September 18, 2024 – Bavarian Nordic A/S (OMX: BAVA) and Gavi, the Vaccine Alliance today announced an advance purchase agreement (APA) to secure 500,000 doses of the MVA-BN^® mpox vaccine (marketed as JYNNEOS^® or IMVANEX^®) to be supplied to countries in Africa impacted by the mpox outbreak. The doses will be for delivery in 2024.

The vaccines will be funded by Gavi’s First Response Fund, a new financial mechanism created in June 2024 to make cash rapidly available to purchase vaccines in health emergencies.

The MVA-BN vaccine received prequalification from the WHO on September 13, and Bavarian Nordic will be ready to supply the vaccines pending the signing of a supply agreement with UNICEF, Gavi’s alliance partner, which will be delivering these doses.

“The First Response Fund was designed in collaboration with Gavi donors and partners specifically to provide rapid early funding for emergencies such as mpox. Using it today to fund the first direct transaction for vaccines in support of equitable access and the global response, just over a month since mpox was declared a public health emergency, takes us a long way towards our goal of protecting those most at risk,” said Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. “We are committed to working with affected governments and our partners to turn these vaccines into vaccinations as quickly and effectively as possible and, over time, to build a global vaccine stockpile if sufficient funding is secured for Gavi’s work through 2030. We thank our donors for enabling us to act rapidly by committing funds to the First Response Fund before an emergency occurred.”

Paul Chaplin, President & CEO of Bavarian Nordic, said: “We are pleased to sign this agreement and strengthen our commitment to support Gavi and other global health partners, who have demonstrated strong leadership in making life-saving vaccines available for the vulnerable populations in developing countries for decades. The doses secured through this agreement will significantly increase the availability of mpox vaccines for African countries, and we are pleased that Gavi has selected our MVA-BN vaccine, which has proven highly effective during the global mpox outbreak in 2022.”

In addition to activating the First Response Fund, approved by the Gavi Board in June, Gavi moved rapidly to trigger the mechanism following the declaration of mpox as a public health emergency and unlocked emergency funding for affected countries to begin preparations for vaccine rollout, such as training of healthcare workers and community engagement and is working with donors and partners to help facilitate dose donations. Medium- and longer-term measures in place that are expected to be supportive of the mpox response include authorisation from Gavi’s Board, contingent on donor funding for Gavi’s next strategic period, to establish a stockpile of mpox vaccines for use in future outbreaks, and with an even longer horizon, to contribute to the establishment of a sustainable vaccine manufacturing industry in Africa through the African Vaccine Manufacturing Accelerator, which was also launched in June.

This APA follows the delivery into the DRC of over a quarter of a million doses of Bavarian Nordic vaccines donated by other nations and Bavarian Nordic. The doses will be allocated to those most in need as per WHO’s Access and Allocation Mechanism, published on September 13.

About the mpox vaccine
MVA-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 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 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.

About Gavi, the Vaccine Alliance
Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate more than half the world’s children against some of the world’s deadliest diseases. The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organisations that fund Gavi’s work here.

Since its inception in 2000, Gavi has helped to immunise a whole generation – over 1 billion children – and prevented more than 17.3 million future deaths, helping to halve child mortality in 78 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningococcal and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation, above all the zero-dose children who have not received even a single vaccine shot. The Vaccine Alliance employs innovative finance and the latest technology – from drones to biometrics – to save lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and X (Twitter)

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.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

Company Announcement no. 31 / 2024

Gavi Media contacts:
Meg Sharafudeen, msharafudeen@gavi.org ,+41 79 711 55 54
Eunice Kilonzo-Muraya, ekilonzo@gavi.org , +41 76 424 85 03

Attachment

• 2024-31-en