US government asks monkeypox vaccine manufacturer Bavarian Nordic to find partners

US government asks monkeypox vaccine manufacturer Bavarian Nordic to find partners

A global shortage of supplies of a vaccine used to protect against serious monkeypox diseases has prompted the US to negotiate new terms with its sole manufacturer, Bavarian Nordic.

The White House Monkeypox Response Team told reporters that for the next order – 2.5 million doses – the US has asked Bavarian Nordic to partner with a contract manufacturer or to partner with a major pharmaceutical company.

A potential deal with Michigan-based Grand River Asceptic Manufacturing is in the works.

“As you know, they are a small manufacturer. They have one active line in the Copenhagen area that we rely on to fill and finish 2.5 million doses. But when we ordered that second 2.5 million to fill and finish, we’ve made it a requirement that they partner with a domestic U.S. contract manufacturing organization,” said Dawn O’Connell, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services (HHS). ).

The US is also helping the company in other ways, including partnering with major pharmaceutical companies to potentially partner with Bavarian Nordic.

The Danish company’s vaccine was originally developed to protect against smallpox, and animal model data is used to support its use as a monkeypox vaccine, as the disease comes from the same family as smallpox.

That’s why CDC director Dr. Rochelle Walensky’s limited data and the need to monitor and study vaccine efficacy in real time.

“We don’t yet know how well this vaccine will work in this outbreak,” Walensky said.

Currently, the vaccine is only expected to provide protection against serious illness and death, similar to COVID vaccines.

An employee of the vaccine company Bavarian Nordic shows a photo of a vaccine virus on a display in a laboratory of the company in Martinsried near Munich, Germany, May 24, 2022. The company, headquartered in Denmark, is the only one in the world to receive approval for a smallpox vaccine called Jynneos in the US and Imvanex in Europe, which is also effective against monkeypox.  REUTERS/Lukas Barth

An employee of the vaccine company Bavarian Nordic shows a photo of a vaccine virus on a display in a laboratory of the company in Martinsried near Munich, Germany, May 24, 2022. The company, headquartered in Denmark, is the only one in the world to receive approval for a smallpox vaccine called Jynneos in the US and Imvanex in Europe, which is also effective against monkeypox. REUTERS/Lukas Barth

Still, the federal government hopes to get as many high-risk individuals as possible — primarily men who have sex with men (MSM) — vaccinated in a short time. The CDC announced a pilot program to make the vaccine, as well as the treatment TPOXX, available at major events where LGBTQ+ individuals are likely to attend.

To date, many of the cases have been reported after recent male sexual contact, but there have also been reports of pregnant women and skin-to-skin contact.

As of August 17, more than 13,500 cases of monkeypox have been reported in the US, including territories, and more than 39,000 cases worldwide in 94 countries. The US is responsible for the majority of cases and is the country with the most available vaccine doses, according to the White House team.

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