Bavarian Nordic Expands Capacity with U.S. Contract Manufacturer for Filling of Smallpox/Monkeypox Vaccines
COPENHAGEN, Denmark, August 18, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Company has entered into an agreement with Grand River Aseptic Manufacturing (GRAM), a U.S. based contract manufacturer, for fill and finish of JYNNEOS smallpox/monkeypox vaccine. As announced on July 15, 2022, Bavarian Nordic received an additional order for 2.5 million doses the vaccine from the U.S. Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR), which will be filled at GRAM 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.
The tech transfer of the production process to GRAM has already been initiated. The aim is to complete the tech transfer within three months – a process which could normally take up to nine months, thus enabling GRAM to start manufacturing later this year.
By adding the capacity of GRAM to fulfil a significant part of the orders from BARDA, Bavarian Nordic will be able to expedite delivery of vials to the U.S. while also freeing up capacity for other countries. The Company has already taken several steps to increase the filling capacity at its own manufacturing site in Denmark, now operating at double the capacity as before the monkeypox outbreak in May 2022 with an expectation to further increase over the coming months. Additionally, the Company’s bulk manufacturing is now operational after a planned shutdown, allowing for production of new bulk vaccine. In parallel, the Company is exploring additional partnerships to further increase the manufacturing capacity in order to improve global access to the vaccine.
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.”
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.”
About our vaccine contracts with the U.S. government
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 Company a ten-year contract for supply of freeze-dried vaccines. Under this contract Bavarian Nordic has produced bulk vaccine, corresponding to approximately 13 million doses. 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.
About Grand River Aseptic Manufacturing, Inc.
About the Administration for Strategic Preparedness and Response
About Bavarian Nordic
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