Hier scheinen ja alle wieder weg zu sein. Der letzte Eintrag ist eine Woche alt. Dabei gab es gestern und heute zwei interessante Meldungen von BN:
1. von heute:
Bavarian Nordic Receives WHO Prequalification for Mpox Vaccine
https://www.bavarian-nordic.com/investor/news/news.aspx?news…
Zitat:
"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.
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."
-> Damit darf der Impfstoff jetzt auch off-label unter 18-jährigen, Schwangeren und Menschen mit geschwächten Immunsystem gegeben werden, wenn die Vorteile die Nachteile überwiegen. Das dürfte für den derzeitigen Ausbruch in Afrika auf jeden Fall gelten, wo bereits viele Kinder gestorben sind.
-> Außerdem haben Mexiko und Neuseeland (vorläufige) Zulassungen erteilt.
-> Und in Sachen Bereitstellung des für Afrika benötigten Impfstoffes geht es auch voran. Siehe die folgende Meldung.
2. von gestern:
Bavarian Nordic Provides Update on the Mpox Vaccine Supply Situation
https://www.bavarian-nordic.com/investor/news/news.aspx?news…
Zitate:
"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."
-> Wenn ich das richtig erinnere, waren bisher für 2025 10 Millionen Dosen avisiert, jetzt wäre es 1 Million mehr. Außerdem könnte BN bei Bedarf
weitere 50 Millionen Dosen innerhalb der nächsten anderthalb Jahre herstellen!
-> Außerdem wurden neue Mehrjahres(!)-Verträge mit diversen Ländern zur Impfstoff-Lieferung abgeschlossen.
