BAVARIAN NORDIC

Mpox continues to spread in DRC and Burundi, with focus on vaccines, drugs, improved care, diagnostics, and public health messaging to control the outbreak. Existing smallpox vaccines provide cross-protection, and new mpox-specific vaccines are in development. Antiviral drugs are being tested, and improved care in clinical trials reduced fatality rates. Rapid and point-of-care diagnostics are needed. Public health messaging must address misinformation and low awareness.

Bavarian Nordic A/S announced an agreement with UNICEF to supply 1 million doses of the MVA-BN mpox vaccine for Africa, with all doses available by end of 2024.

FDA approves FluMist for self- or caregiver-administration, Novavax updates COVID-19 vaccine, GSK reports positive data for co-administered RSV and shingles vaccines, WHO adds MVA-BN mpox vaccine to prequalification list, New England ranks as most vaccinated region, pharmacist education reduces vaccine hesitancy, and Vaxcyte announces positive data for 31-valent pneumococcal conjugate vaccine.

Bavarian Nordic receives $63M order from BARDA to replenish bulk vaccine inventory and produce 1M freeze-dried JYNNEOS® doses for U.S. smallpox/mpox preparedness, with bulk production in 2025 and freeze-dried deliveries in 2026.

Bavarian Nordic's MVA-BN vaccine approved by EMA for mpox and smallpox in adolescents 12-17 years old, following NIH-sponsored study. CEO Paul Chaplin praises EMA's expedited review. A new trial for children 2-12 years old is planned, partially funded by CEPI.

DRC, facing a severe mpox outbreak, received 99,100 vaccine doses from the EU, aiming for nearly 200,000 total. Over 19,000 cases and 650 deaths highlight the urgency. Vaccine logistics are challenging due to DRC's size and infrastructure. The WHO declared mpox an international emergency, prompting global health organizations to contribute. The EMA approved Bavarian Nordic's mpox vaccine for adolescents, emphasizing vulnerable populations. Comprehensive public health measures, including education and community engagement, are crucial alongside vaccination efforts.

Bavarian Nordic A/S announced the European Commission's approval of Imvanex (MVA-BN) smallpox and mpox vaccine for adolescents 12-17 years old, following a CHMP recommendation. This marks the second EMA approval for MVA-BN in a younger population. A clinical study demonstrated non-inferior immune responses and similar safety profiles in adolescents and adults. Bavarian Nordic plans to extend the vaccine's indication to children 2-12 years old through an upcoming clinical trial.

EMA approves MVA-BN for mpox and smallpox in adolescents 12-17 years, following clinical study data showing non-inferior immune responses and similar safety profiles. This marks the second EMA approval for a younger population using MVA-BN-based vaccines.

EMA approves Bavarian Nordic's mpox vaccine for adolescents aged 12-17 in Europe, based on NIH-sponsored trial data showing non-inferior immune responses and similar safety profile. Bavarian Nordic plans to expand approval to other high-risk countries, including Africa, where mpox has caused over 25,000 cases and 720 deaths.