Health
Bavarian Nordics sign agreement to perfect US smallpox monkeypox vaccine
A Danish vaccine manufacturer that has long-term contracts with the U.S. government for smallpox vaccines has seen a surge in orders in response to the monkeypox outbreak.
Michigan-based GRAM will fulfill a follow-on order for 2.5 million doses of the vaccine received by Bavarian Nordic last month from the Biomedical Advanced Research and Development Agency (BARDA). This will use bulk vaccines already manufactured and billed under a previous agreement with BARDA.
Together with previous orders, BARDA has requested a total of 5.5 million deliveries in 2022 and 2023. Bavarian Nordic said the extra capacity added by GRAM will allow it to expedite orders to the US.
Technology transfer to GRAM has already begun, and the company believes it can reduce transfer time from the usual nine months to three months, allowing it to begin manufacturing later this year.
Jynneos (known as Imvanex and Imvamune in the EU and Canada, respectively) is the only vaccine specifically licensed against monkeypox.
White House National Monkeypox Response Coordinator Bob Fenton said: “Rapidly increasing the supply and safe delivery of monkeypox vaccine to Americans most at risk of contracting the virus is a top priority for President Biden. , will significantly increase our ability to fill and terminate government-owned doses, allowing us to deliver current and future supplies to locations across the country more quickly.”na
US vaccine contract
Since 2003, Bavarian Nordic has worked with the US government to develop, manufacture and supply non-replicating smallpox vaccines.
The company has supplied approximately 30 million doses of the vaccine to the United States, most of which have been shipped for emergency use and are now expired, but in 2019 the vaccine was approved by the FDA (for monkeypox). ) was performed.
BARDA is helping develop a freeze-dried version of the vaccine with a longer shelf life as an alternative to stockpiles, and in 2017 awarded the company a 10-year contract for the supply of freeze-dried vaccines. Under this contract, Bavarian Nordic will manufacture approximately 13 million doses of bulk HIS vaccine.
In May 2022, BARDA exercised its first contractual option to convert bulk vaccines to freeze-dried doses, with deliveries scheduled for 2023-2025.
In light of the current global monkeypox outbreak, BARDA calls for manufacturing and delivering 5.5 million doses in 2022 and 2023 using existing bulk vaccines to be filled into current liquid frozen formulations Did.
Working with GRAM will also free up Bavarian Nordic’s capacity to process orders for other countries. We are also exploring other partnerships to further increase our manufacturing capacity to improve global access to vaccines.
The company has already increased filling capacity at its own manufacturing site in Denmark and is now operating at twice the capacity it had before the monkeypox epidemic in May 2022.
Meanwhile, the company’s mass production is now up and running after a planned shutdown, allowing it to produce new bulk vaccines.
Bayern Nordic President and CEO Paul Chaplin said: “We have been working diligently to expand our manufacturing capacity since the monkeypox outbreak began, and the agreement with GRAM is an important step. We will expand and enable Bavarian Nordic to meet growing demand around the world.”na
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Sources 2/ https://www.biopharma-reporter.com/Article/2022/08/22/bavarian-nordic-signs-us-smallpox-monkeypox-vaccine-fill-finish-agreement The mention sources can contact us to remove/changing this article |
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