Bavarian Nordic has entered into an agreement with Grand River Aseptic Manufacturing (GRAM) for fill and finish of the firm’s smallpox/monkeypox vaccine, Jynneos.
In September 2019, the US Food and Drug Administration (FDA) gave Bavarian Nordic the go ahead to manufacture and distribute the liquid-frozen suspension of its vaccine Jynneos (known as Imvanex in Europe) for smallpox and monkeypox in adults aged 18 years and over.
Now, with the firm receiving an additional order for 2.5 million doses of the vaccine from the US Biomedical Advanced Research and Development Authority (BARDA) in July 2022, taking its request to 5.5 million doses in total for 2022/23, US-based contract manufacturer GRAM is set to provide fill/finish services to help fulfil the contracts.
According to Bavarian Nordic, tech transfer of the manufacture process to GRAM has already begun. Additionally, the respective companies are aiming to complete this within three months to allow for production to begin later this year.
“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,” said Bob Fenton, coordinator of the White House National Monkeypox Response.
“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 US – and allow us to deliver our current and future supply more quickly to locations nationwide.”
Bavarian Nordic claims that by upping capacity through GRAM to fulfil a substantial number of orders from BARDA, the firm can advance delivery of vials to the US at the same as “freeing up” capacity for other countries around the world.
Bavarian Nordic claims that GRAM will up its capacity by fulfilling a substantial number of orders from BARDA. In turn, this allows the firm to advance deliver of vials to the US at the same time as “freeing up” capacity for other countries around the world.
The company says it has increased the filling capacity at its own production site located in Denmark, which is now double the capacity observed prior to the monkeypox outbreak in May this year. Furthermore, the Denmark plant received US and EU approval in June 2022.
“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,” said Paul Chaplin, president, and CEO of Bavarian Nordic.
“With this agreement we will significantly expand our manufacturing capabilities into the United States allowing Bavarian Nordic to meet the growing worldwide demand.”