Bavarian Nordic announced that the company has secured a contract with an undisclosed European country to supply its IMVANEX smallpox vaccine in response to new cases of monkeypox.
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Bavarian Nordic’s smallpox vaccine is approved in the U.S. as JYNNEOS and in Canada as IMVAMUNE, both places with the approval extended to cover the monkeypox indication.
The vaccine is approved in Europe as IMVANEX for only the smallpox indication but has previously been provided for off-label use in response to monkeypox cases.
The first European case was confirmed on May 7, 2022, in an individual who returned from a travel to Nigeria, where monkeypox is endemic.
Subsequently, more than 20 cases have been confirmed across England, Portugal and Spain with additional suspected cases currently being investigated.
Evidence points to that most of the infections have been acquired locally in these countries. In the U.S., a single case has been confirmed in a traveler from Canada, where no cases are yet confirmed, but several remain under investigation.
Paul Chaplin, President and CEO of Bavarian Nordic said: “While the full circumstances around the current monkeypox cases in Europe remain to be elucidated, the speed of which these have evolved, combined with the potential for infections beyond the initial case going undetected, calls for a rapid and coordinated approach by the health authorities, and we are pleased to assist in this emergency situation.
"Infection control has been a high priority for societies during COVID-19, and this situation is an unfortunate reminder, that we cannot let our guard down, but must continue to build and strengthen our infectious disease preparedness to keep the world open.â€
Bavarian Nordic announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has exercised the first options under the contract to supply a freeze-dried version of JYNNEOS smallpox vaccine, thus allowing for the first doses of this version to be manufactured and invoiced in 2023 and 2024.
The options have a value of $119 million and represent the first options exercised to convert bulk vaccine, which has already been manufactured and invoiced under previous contracts with BARDA, into freeze dried doses of JYNNEOS smallpox vaccine.
Additional options on the contract valued at $180 million, if exercised support conversion of up to a total of approximately 13 million freeze dried doses of JYNNEOS smallpox vaccine that are expected to be manufactured in 2024 and 2025. The majority of the bulk vaccine for these doses has already been manufactured and invoiced.
The transfer of the freeze-drying process to the new fill and finish plant in Kvistgaard was initiated last year and following an FDA inspection in 2022 will lead to commercial manufacturing in 2023.
A supplement to the existing liquid frozen JYNNEOS BLA will be made comprising the Phase 3 data, which has already been completed and reported, together with the manufacturing data to support the approval of the freeze-dried version of JYNNEOS in 2024.
In parallel to these activities, we will, with the award of this first option, begin to manufacture and invoice freeze-dried JYNNEOS doses in 2023 and 2024.
Monkeypox is a rare, but serious disease, which is endemic in Central and West Africa. The disease is quite similar to human smallpox, although it is less severe with an estimated fatality rate of 1-10%. ■