The Danish vaccine manufacturer, which has had a long-standing agreement with the US government for smallpox vaccines, has seen orders shoot up in response to the monkeypox outbreak.
Michigan-headquartered GRAM will fill an additional order for 2.5 million doses of the vaccine received by Bavarian Nordic from the US Biomedical Advanced Research and Development Authority (BARDA) last month, using bulk vaccine already manufactured and invoiced under previous contracts with BARDA.
Combined with previous orders, BARDA has requested a total of 5.5 million doses for delivery in 2022 and 2023. Bavarian Nordic says the additional capacity added by GRAM will allow it to expedite orders to the US.
Tech transfer to GRAM has already been initiated: and the companies believe they can take the normal nine month transfer time down to three months, allowing manufacturing to start later this year.
Jynneos (known as Imvanex and Imvamune in the EU and Canada respectively) remains the only vaccine specifically approved for monkeypox.
Bob Fenton, Coordinator of the White House National Monkeypox Response said: “Rapidly increasing the supply and safe delivery of monkeypox vaccine to Americans at the highest risk of contracting the virus is a top priority for President Biden. 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.”
US vaccine contracts
Since 2003, Bavarian Nordic has worked with the US government on the development, manufacturing and supply of the non-replicating smallpox vaccine.
It has supplied nearly 30 million doses of the vaccine to the US, with the vast majority being delivered for emergency use - and now expired - before approval of the vaccine by the FDA in 2019 (which included an approval for the monkeypox indication).
BARDA has supported the development of a freeze-dried version of the vaccine with longer shelf-life to replace the stockpile and in 2017 awarded the compny a ten-year contract for supply of freeze-dried vaccines. Under this contract Bavarian Nordic has produced around 13 million doses in bulk vaccine.
In May 2022, BARDA exercised the first contract options for conversion of the bulk vaccine to freeze-dried doses, anticipated for delivery in 2023-2025.
In light of the current global monkeypox outbreak, BARDA has requested 5.5 million doses to be manufactured and delivered in 2022 and 2023 using the existing bulk vaccine, which will be filled in the current liquid-frozen formulation.
By engaging GRAM, Bavarian Nordic can also free up its own capacity to fulfil orders for other countries. It is also exploring other partnerships to further increase the manufacturing capacity in order to improve global access to the vaccine.
The company has already increased filling capacity at its own manufacturing site in Denmark, which is now operating at double the capacity as before the monkeypox outbreak in May 2022. Further increases in capacity are expected over the coming months.
Meanwhile, the company’s bulk manufacturing is now operational after a planned shutdown, allowing for production of new bulk vaccine.
Paul Chaplin, President and CEO of Bavarian Nordic said: “We have been working diligently since the beginning of the monkeypox outbreak to expand our manufacturing capacity and the agreement with GRAM is an important step. With this agreement we will significantly expand our manufacturing capabilities into the United States allowing Bavarian Nordic to meet the growing worldwide demand.”