COPENHAGEN, DENMARK: Bavarian Nordic A/S announced today that the European Health Emergency Preparedness and Response Authority (HERA) has ordered 110,000 doses of MVA-BN smallpox/monkeypox vaccine, which will be made available to EU Member States, Norway and Iceland in response to the current monkeypox outbreak.
Established by the European Commission in September 2021, HERA’s purpose is to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies, by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures.
Deliveries of vaccines to HERA will commence immediately and will be completed during the next months.
Paul Chaplin, President and CEO of Bavarian Nordic said: “We are pleased to enter an agreement with HERA on supplying our vaccine, thus helping to improve the EU readiness and response during the current outbreak of monkeypox throughout Europe. By now, there are registered cases of monkeypox in more than 20 European countries, and while we have already delivered significant quantities of our vaccine to some individual EU member states, the supply to HERA now enables a more integrated and coordinated approach across the entire EU, in line with HERA’s mission.”
As a consequence of the order from HERA, and other smaller orders, Bavarian Nordic raises its expectations for the financial results for 2022 with revenue now expected to be between DKK 1,900 and 2,100 million (previously between DKK 1,800 and 2,000 million), EBITDA expectations raised to a loss between DKK 600 and 800 million (previously a loss between DKK 700 and 900 million) and cash and cash equivalents at year-end now between DKK 1,500 and 1,700 million (previously between DKK 1,400 and 1,600 million).
The guidance reflects the significant investments in research and development being made in 2022 to advance the Company’s two lead product candidates: a vaccine against respiratory syncytial virus (RSV) and a booster vaccine against COVID-19 into Phase 3 clinical trials.
About the smallpox/monkeypox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (marketed as IMVANEX® in Europe, JYNNEOS® in the U.S. and IMVAMUNE® in Canada) is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines.
The vaccine was approved by the European Commission in 2013 for immunization against smallpox in adults aged 18 years and older and has subsequently gained regulatory approvals in Canada and the U.S. where the approval has been extended to include the monkeypox indication as the only vaccine having obtained this to-date.
Bavarian Nordic has ongoing supply contracts with USA and Canada and has delivered the vaccine to a number of undisclosed countries globally as part of their national biological preparedness. In recent years, smaller quantities of the vaccine have been supplied in response to sporadic cases of monkeypox.
During the ongoing 2022 outbreak of monkeypox, Bavarian Nordic has worked with several governments to fulfil the immediate demand for the vaccine through a number of supply agreements and is working to secure manufacturing of vaccines to fulfil the demand in the medium- to long term.