With the approvals of the final drug production, the company is now allowed to deliver drug product manufactured at its own site to the US and EU market, instead of using a third party, allowing it to achieve its ambitions of controlling the full manufacturing chain.
The vaccine is known as Jynneos in the US and Imvanex in the EU; and is approved for both smallpox and monkeypox. The company has seen increased demand for the vaccine in response to the current monkeypox outbreak, which was declared as a global health emergency by the WHO earlier this month.
An expedited pre-approval inspection (PAI) was conducted by the US Food and Drug Administration (FDA) at the facility at the beginning of July 2022. The inspection included the final drug production of Jynneos, which was previously performed at a contract manufacturer.
The approval by the European Medicines Agency (EMA) was granted upon assessment by the Committee for Medicinal Products for Human use (CHMP) of a type II-variation application submitted in June 2022, which, similar to the FDA approval, acknowledges Bavarian Nordic as the new drug product manufacturer of the Imvanex vaccine, in supplement to the inspection, and approval earlier granted, by the Danish Medicines Agency,
Bavarian Nordic says the expedited approvals were made possible thanks to close interactions between the company and regulatory authorities.
Meanwhile, US Department of Health and Human Services (HHS) Secretary Xavier Becerra says this cooperation will allow more doses to reach Americans.
“This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox," he said.
"The expedited inspection and approval by FDA of Bavarian Nordic’s fill-and-finish capabilities means that an additional 786,000 doses of vaccine are now available for use in the US. HHS is working to make these doses available to states and jurisdictions as soon as possible to fulfill their needs.
“Aggressively responding to the monkeypox outbreak is a critical priority for HHS."
Bavarian Nordic achieves vaccine manufacturing ambitions
The announcement also means Bavarian Nordic has fulfilled its ambition to control the entire value chain from manufacturing, filling, packaging and release to distribution of vaccines.
Paul Chaplin, President and CEO of Bavarian Nordic said: “We are proud to announce the successful completion of the FDA’s inspection and subsequent approval of our state-of-the-art fill and finish facility along with EMA’s approval.
"This achievement, which underscores the excellence of our manufacturing site and our ability to deliver high quality vaccines for improving and saving lives, was made possible through the dedication and commitment of our talented employees.
"We are thankful to both FDA and EMA for accelerating their review, during this monkeypox outbreak, which now has been named a public health emergency of international concern by the WHO, and we look forward to continuing our work with health authorities around the globe to ensure supply of vaccines against monkeypox.”