US will manufacture monkeypox vaccine in bid to expedite delivery

An agreement between the Danish manufacturer of the only U.S.-approved monkeypox vaccine and a Michigan-based company would move the final packaging steps to the U.S. in an effort to expedite the delivery of millions of doses.

Company and administration health officials on Thursday announced Denmark-based Bavarian Nordic entered into an agreement with U.S.-based contract manufacturer Grand River Aseptic Manufacturing (GRAM). 

The priority will be to fill and package 2.5 million vials of the Jynneos vaccine that were ordered by the Biden administration in July. Jynneos is the only monkeypox vaccine approved by the Food and Drug Administration. 

Officials said in a statement that the technology transfer of the production process from Bavarian Nordic to Grand River has already been initiated, with the aim of completing it within three months. 

The process could normally take up to nine months, health officials said.

“This partnership between Bavarian Nordic and GRAM will significantly increase the capacity to fill and finish government-owned doses – for the first time in the U.S. – and allow us to deliver our current and future supply more quickly to locations nationwide,” White House monkeypox response coordinator Bob Fenton said in a statement.

There are more than 13,500 monkeypox cases in the U.S., and demand for the vaccine has far outstripped supply. The Biden administration has faced criticism for underestimating the outbreak and not moving quickly enough to secure more doses from the factory overseas, including frozen material it had already paid for.

Bavarian Nordic has been producing freeze-dried bulk vaccines since 2017, corresponding to approximately 13 million doses. 

The U.S. did not exercise the first contract options for conversion of the bulk vaccine to freeze-dried doses until May, and delivery is not anticipated until 2023-2025. The U.S. has requested 5.5 million doses to be manufactured and delivered in 2022 and 2023 using the existing bulk vaccine.

By adding the capacity of the domestic company, Bavarian Nordic said it will be able to expedite delivery of vials to the U.S. while also freeing up capacity for other countries. 

During a press briefing on Thursday, Dawn O’Connell, who leads the Health and Human Services Department’s Administration for Strategic Preparedness and Response, said the administration has been working to try to help Bavarian Nordic increase its manufacturing capacity.

“As you know, they’re a small manufacturer. So one of the first things we did as this monkeypox outbreak took hold was began conversations with them about how they might expand that capacity,” O’Connell said. 

“We are also helping them in other ways … potentially working with a larger pharmaceutical company, for example,” O’Connell said.