FDA approves Bavarian Nordic manufacturing capabilities, frees up 786,000 more monkeypox vaccine doses

Monkeypox vaccine production is about to experience a significant surge following the U.S. Food and Drug Administration’s (FDA) approval this week of a supplement to the Bavarian Nordic JYNNEOS vaccine and its fill-and-finish capabilities.

Through an expedited inspection and approval process, FDA signed off on the company’s new manufacturing facility in Denmark, allowing it greater means to meet the demand for the smallpox/monkeypox vaccine. On Twitter, the FDA stated that it had previously facilitated a shipment of 786,000 vaccine doses for distribution once the manufacturing changes were approved. Those have now been released to supplement ongoing vaccination efforts.

“HHS is working to make these doses available to states and jurisdictions as soon as possible to fulfill their needs and will announce allocations tomorrow,” HHS Secretary Xavier Becerra said in a statement, referring to a Thursday release of details. “Aggressively responding to the monkeypox outbreak is a critical priority for HHS. Within days of the first U.S. case, we activated a multi-pronged response, significantly increasing vaccine supply and distribution, expanding access to tests, making treatments available for free, and educating the public on steps to reduce risk of infection. We will continue to accelerate and strengthen our response in the coming days and will work with partners on the ground, in the community, and internationally to combat this virus and protect those at risk.”

Nevertheless, the government has come under criticism for its response to the outbreak. In the most recent case, Democrats dispatched a letter to the White House last week criticizing the pace of the FDA inspection and calling for increased speed amid calls from local authorities that demand for shots was outstripping supply at clinics.

While the United States has secured millions more doses of JYNNEOS for production and distribution through 2023, the FDA had to inspect and sign off on the new Bavarian Nordic plant to guarantee production met its quality standards in the interim. While that inspection was underway, doses were shipped to the United States, where the Centers for Disease Control and Prevention (CDC) reported more than 4,600 cases had been detected as of July 27, 2022. It now hosts the largest number of monkeypox cases worldwide, with European nations following closely behind.

None of these have historically hosted the otherwise rare monkeypox. According to the CDC, of the more than 20,000 cases reported worldwide since the year’s outbreak, only 327 of these have occurred in nations where the disease was endemic.