COPENHAGEN, Denmark, September 12, 2024 - Bavarian Nordic A/S (OMX: BAVA), the vaccine manufacturer of MVA-BN®, the only approved non-replicating smallpox and mpox vaccine (marketed as JYNNEOS®, IMVAMUNE® and IMVANEX®) today provided an update of its supply and manufacturing activities in support of the ongoing mpox outbreak.
Since the declaration of mpox as a Public Health Emergency of Continental Security (PHECS) by the Africa Centers for Disease Control (CDC) and the subsequent declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO), Bavarian Nordic has intensified the collaboration with global stakeholders to support the joint efforts to combat the mpox outbreak.
Importantly, thanks to donations from the European Commission, the U.S. government and Bavarian Nordic, the first doses of MVA-BN arrived last week in the Democratic Republic of Congo (DRC), the epicenter of the mpox outbreak. More than 250,000 doses have already been shipped, and further donations of more than 500,000 doses of MVA-BN have so far been pledged by other countries.
UNICEF and Africa CDC have indicated that there is an urgent need for sufficient vaccine to protect up to 1 million people in the high-risk areas of the DRC, while potentially up to 10-12 million doses could be required through 2025. Bavarian Nordic is committed to ensuring equitable access to its mpox vaccine, and in response to the current outbreak and the strong demand from governments and organizations, including HERA, Gavi, UNICEF and Africa CDC, the Company has prioritized the production of MVA-BN for the rest of the year to provide up to 2 million doses by year-end.
This decision has meant that certain existing orders for 2024 will be pushed out to 2025 to provide greater flexibility to fulfill additional urgent and imminent needs in other markets. While this will defer part of the planned revenue for 2024 into next year, new orders entered in the recent weeks will offset the deferred revenue, and thus the Company's financial guidance for 2024 remains unchanged.
These new supply contracts include multi-year agreements with countries across different continents, including countries who have pledged vaccines for Africa. In addition, Bavarian Nordic has responded to the UNICEF emergency tender, calling for the immediate supply of up to 2 million doses in 2024, and has ongoing discussions with other organizations and individual governments around the globe.
Bavarian Nordic has informed Gavi and UNICEF that by focusing the full capacity to address the current public health emergency, the Company could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024. While this appears to be sufficient to meet the anticipated short- to medium-term demand as expressed by customers and partners, the Company continues to explore additional levers that could further expand the capacity. This includes looking to transfer manufacturing to other companies either in Africa or other parts of the world. Based on these early, but highly constructive discussions, together with further planned improvements in the manufacturing process, Bavarian Nordic has identified another 50 million doses that pending regulatory approvals and demand could be supplied during the next 12-18 months.
Paul Chaplin, President & CEO of Bavarian Nordic, said: "As the supplier of the only non-replicating mpox vaccine that has shown to be highly effective during an mpox outbreak, we have been working closely with all governments and organizations to support the international efforts to combat the latest public health emergency. Just as during the outbreak in 2022/23, we will support all requests for vaccine and have already secured agreements and submitted responses to the UNICEF tender that will hopefully secure more access to MVA-BN globally. We remain committed to the equitable access either through prioritizing our own capacity, accelerating planned improvements in the manufacturing process and by exploring ways to further expand capacity through partnerships around the globe. Once again Bavarian Nordic, through innovation and our commitment to improving and saving lives has stepped forward as an important part of the international community's response to the current public health emergency."
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.
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
Since the declaration of mpox as a Public Health Emergency of Continental Security (PHECS) by the Africa Centers for Disease Control (CDC) and the subsequent declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO), Bavarian Nordic has intensified the collaboration with global stakeholders to support the joint efforts to combat the mpox outbreak.
Importantly, thanks to donations from the European Commission, the U.S. government and Bavarian Nordic, the first doses of MVA-BN arrived last week in the Democratic Republic of Congo (DRC), the epicenter of the mpox outbreak. More than 250,000 doses have already been shipped, and further donations of more than 500,000 doses of MVA-BN have so far been pledged by other countries.
UNICEF and Africa CDC have indicated that there is an urgent need for sufficient vaccine to protect up to 1 million people in the high-risk areas of the DRC, while potentially up to 10-12 million doses could be required through 2025. Bavarian Nordic is committed to ensuring equitable access to its mpox vaccine, and in response to the current outbreak and the strong demand from governments and organizations, including HERA, Gavi, UNICEF and Africa CDC, the Company has prioritized the production of MVA-BN for the rest of the year to provide up to 2 million doses by year-end.
This decision has meant that certain existing orders for 2024 will be pushed out to 2025 to provide greater flexibility to fulfill additional urgent and imminent needs in other markets. While this will defer part of the planned revenue for 2024 into next year, new orders entered in the recent weeks will offset the deferred revenue, and thus the Company's financial guidance for 2024 remains unchanged.
These new supply contracts include multi-year agreements with countries across different continents, including countries who have pledged vaccines for Africa. In addition, Bavarian Nordic has responded to the UNICEF emergency tender, calling for the immediate supply of up to 2 million doses in 2024, and has ongoing discussions with other organizations and individual governments around the globe.
Bavarian Nordic has informed Gavi and UNICEF that by focusing the full capacity to address the current public health emergency, the Company could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024. While this appears to be sufficient to meet the anticipated short- to medium-term demand as expressed by customers and partners, the Company continues to explore additional levers that could further expand the capacity. This includes looking to transfer manufacturing to other companies either in Africa or other parts of the world. Based on these early, but highly constructive discussions, together with further planned improvements in the manufacturing process, Bavarian Nordic has identified another 50 million doses that pending regulatory approvals and demand could be supplied during the next 12-18 months.
Paul Chaplin, President & CEO of Bavarian Nordic, said: "As the supplier of the only non-replicating mpox vaccine that has shown to be highly effective during an mpox outbreak, we have been working closely with all governments and organizations to support the international efforts to combat the latest public health emergency. Just as during the outbreak in 2022/23, we will support all requests for vaccine and have already secured agreements and submitted responses to the UNICEF tender that will hopefully secure more access to MVA-BN globally. We remain committed to the equitable access either through prioritizing our own capacity, accelerating planned improvements in the manufacturing process and by exploring ways to further expand capacity through partnerships around the globe. Once again Bavarian Nordic, through innovation and our commitment to improving and saving lives has stepped forward as an important part of the international community's response to the current public health emergency."
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.
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
12/9 2024 10:58 ProInvestorNEWS 2
122211 Bavarian vil producere flere mpox-vacciner i år: Andre ordrer rykkes til 2025
12/9 11:39
Bavarian Nordic omstiller produktionen for at producere flere mpox-vacciner allerede i år.
Samtidig skubbes andre eksisterende ordrer ind i 2025 - dog uden at det påvirker de finansielle forventninger til året.
Det meddeler det danske vaccineselskab torsdag, efter at der allerede tidligere var flaget for muligheden.
Ændringen sker i et forsøg på at sikre flere vacciner, der kan sendes afsted til flere afrikanske lande, som lige nu er hårdt plaget af mpox-udbrud, der tidligere gik under navnet abekopper.
Nærmere bestemt betyder beslutningen, at selskabet kan levere 13 mio. doser inden udgangen af 2025, hvor af 2 mio. doser ventes at kunne blive leveret i år.
- Bavarian Nordic vil sikre lige adgang til sin mpox-vaccine, og som svar på det aktuelle udbrud og den stærke efterspørgsel fra regeringer og organisationer, herunder HERA, Gavi, UNICEF og Africa CDC, har virksomheden prioriteret produktionen af MVA-BN for resten af året, som vil give op til 2 mio. doser ved årets udgang, skriver selskabet.
- Denne beslutning betyder, at visse eksisterende ordrer for 2024 vil blive skubbet til 2025 for at give større fleksibilitet til at opfylde mere presserende og overhængende behov på andre markeder, lyder det videre.
Derfor udskydes også en del af den planlagte omsætning for i år, men nye ordrer, som er indgået over de seneste uger, ventes at opveje den udskudste omsætning.
- Dermed forbliver selskabets økonomiske forventninger for 2024 uændrede, skriver Bavarian Nordic.
Bavarian har indtil videre afsendt 250.000 doser, mens yderligere 500.000 donerede doser er bestilt.
.\˙ MarketWire
12/9 11:39
Bavarian Nordic omstiller produktionen for at producere flere mpox-vacciner allerede i år.
Samtidig skubbes andre eksisterende ordrer ind i 2025 - dog uden at det påvirker de finansielle forventninger til året.
Det meddeler det danske vaccineselskab torsdag, efter at der allerede tidligere var flaget for muligheden.
Ændringen sker i et forsøg på at sikre flere vacciner, der kan sendes afsted til flere afrikanske lande, som lige nu er hårdt plaget af mpox-udbrud, der tidligere gik under navnet abekopper.
Nærmere bestemt betyder beslutningen, at selskabet kan levere 13 mio. doser inden udgangen af 2025, hvor af 2 mio. doser ventes at kunne blive leveret i år.
- Bavarian Nordic vil sikre lige adgang til sin mpox-vaccine, og som svar på det aktuelle udbrud og den stærke efterspørgsel fra regeringer og organisationer, herunder HERA, Gavi, UNICEF og Africa CDC, har virksomheden prioriteret produktionen af MVA-BN for resten af året, som vil give op til 2 mio. doser ved årets udgang, skriver selskabet.
- Denne beslutning betyder, at visse eksisterende ordrer for 2024 vil blive skubbet til 2025 for at give større fleksibilitet til at opfylde mere presserende og overhængende behov på andre markeder, lyder det videre.
Derfor udskydes også en del af den planlagte omsætning for i år, men nye ordrer, som er indgået over de seneste uger, ventes at opveje den udskudste omsætning.
- Dermed forbliver selskabets økonomiske forventninger for 2024 uændrede, skriver Bavarian Nordic.
Bavarian har indtil videre afsendt 250.000 doser, mens yderligere 500.000 donerede doser er bestilt.
.\˙ MarketWire
13/9 2024 12:13 ProInvestorNEWS 0122226 Bavarian Nordic Receives WHO Prequalification for Mpox Vaccine
First mpox vaccine to obtain prequalification by the WHO
Approval 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 risks[1].
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 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.
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. 30 / 2024
First mpox vaccine to obtain prequalification by the WHO
Approval 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 risks[1].
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 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.
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. 30 / 2024
