The only vaccine against monkeypox comes from Bavaria

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German-Danish vaccine manufacturer Bavarian Nordic A/S secured a vaccine order from an undisclosed European country following confirmed monkeypox cases in Europe. The order comes shortly after the U.S. government exercised a USD 119 million contract option for the first manufacturing of freeze- dried smallpox vaccine Jynneos®. The vaccine was developed by Bavarian Nordic’s research site in Martinsried. The company, headquartered in Denmark, is the only one in the world to hold regulatory approval.

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 mortality rate of 1-10%.

Vaccine manufacturer Bavarian Nordic, headquartered in Denmark, has now signed a contract with an undisclosed European country to supply its smallpox vaccine Imvanex® in response to new cases of monkeypox emerging in Europe in May 2022. To date, more than 20 cases have been confirmed in England, Portugal and Spain, with additional suspected cases under investigation.

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.

Bavarian Nordic originally received the order to develop a vaccine from the USA after the September 11 terrorist attacks. The Bush administration feared attacks with biochemical weapons - including smallpox viruses. The idea at the time was to vaccinate the entire U.S. population. This plan was never implemented, but in Martinsried, Bavarian Nordic's research site, research continued on various smallpox vaccines, including monkeypox. Then, in 2019, Bavarian Nordic received approval for the Jynneos® vaccine, making it the only company in the world to have approval.

While the exact circumstances of the current monkeypox cases in Europe are not yet clear, the speed with which they have developed requires rapid and coordinated action by public health authorities. In the U.S., a single case has been confirmed in a traveler from Canada, where no cases have been confirmed yet, but several cases remain under investigation. With increasing cases of monkeypox, the USA is preparing to issue vaccines.

As a first step, the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, recently exercised the first options under the contract with Bavarian Nordic to supply a freeze-dried version of the smallpox vaccine Jynneos® so that the first doses of this version can be manufactured in 2023 and 2024.

This represents the first set of options with a total value of USD 299 million to convert the existing bulk vaccine, previously purchased by BARDA, to approximately 13 million freeze-dried Jynneos® doses.