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.
Expedited approvals
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.