Vaccine manufacturer Bavarian Nordic, which announced the production of the monkeypox vaccine on May 18, 2022, is headquartered in Denmark and has offices in Germany, Switzerland and the United States. Their new plant was inaugurated last year and will be inspected by the FDA (U.S. Food and Drug Administration) in 2022.
Translation below
It is worth mentioning that on September 24, 2019, the FDA awarded approval of Jynneos to Bavarian Nordic A/S. Fda approved the application for priority review and, upon approval, issued a Material Threat Medical Response (MCM) priority review certificate to Bavarian Nordic A/S. (See another article for details)
There is also evidence that the company received NIH (National Institutes of Health) funding and was provided with samples.
The following text of the Bavarian Nordic website reads:
COPENHAGEN, Denmark, 19 May 2022 – Bavarian Nordic A/S (OMX: BAVA) today announced that it has signed a contract with an undisclosed European country to supply its IMVANEX ® smallpox vaccine in response to new monkeypox cases in May. 2022.
The first European case was confirmed on 7 May 2022 in a person returning from a trip to Nigeria where monkeypox is endemic. Subsequently, more than 20 cases have been confirmed in England, Portugal and Spain, and more suspected cases are currently under investigation. There is evidence that most infections are acquired locally in these countries. In the United States, a case has been confirmed by a traveler from Canada, the country that has not yet confirmed a case, but several cases are still under investigation.
Bavarian Nordic's smallpox vaccine is approved as JYNNEOS ® in the United States and IMVAMUNE ® in Canada, both of which have been expanded to cover monkeypox indications. The vaccine is approved in Europe as IMVANEX ® for smallpox indications only, but has previously been offered for off-label use in response to monkeypox cases.
Paul Chaplin, President and CEO of Bavarian Nordic, said: "While the full picture of the current cases of monkeypox in Europe remains to be elucidated, the rate at which these cases are progressing, and the likelihood of infection beyond the undetected of the initial cases, calls for thanks to health authorities for a quick and coordinated approach, and we are pleased to be able to help in this emergency situation." Infection control has been a top priority for society during COVID-19, and this situation is a regrettable reminder that we cannot let our guard down and must continue to build and strengthen our infectious disease preparedness to keep the world open. ”