Latest news with #ACAM2000
Yahoo
06-05-2025
- Health
- Yahoo
US government exercises $144m option for smallpox
Amid a US measles outbreak the US government has placed a $143.6m order for Bavarian Nordic's smallpox/mpox jab Jynneos to bolster its infectious disease preparedness. The order is part of a ten-year contract awarded to vaccine-developer Bavarian Nordic by the US government's Biomedical Advanced Research and Development Authority (BARDA). The agreement between the pair includes options valued at $299m for the fill and finish of freeze-dried vaccines. Deliveries under the new contract options are planned for 2026. The additional options exercised by BARDA support the manufacturing and supply of freeze-dried Jynneos by conversion of bulk vaccine, as well as supplemental payments for all doses procured under the freeze-dried contract. The latter was triggered after the freeze-dried formulation's extended shelf life was demonstrated. The freeze-dried formulation of Jynneos provides greater flexibility in stockpiling. The US Food and Drug Administration (FDA) approved this version in March 2025 after Bavarian Nordic demonstrated comparability to the older liquid formulation in terms of immune responses. Bavarian Nordic has supplied a liquid-frozen formulation of its vaccine to the US government for stockpiling since 2010 and ramped up production in response to the mpox outbreak in 2022-2023. Liquid-frozen formulations require a temperature-controlled supply chain that keeps them frozen between production up until being used on a patient. Freeze-dried formulations have fewer supply chain limitations, conferring advantages such as easier transportation, storage conditions, and extended shelf life. Freeze drying is a dehydration process to extend its shelf life and molecular stability. Bavarian Nordic's CEO Paul Chaplin said: 'The freeze-dried vaccine, with its improved shelf life, provides a significant contribution to securing the long-term availability of countermeasures to protect US citizens against life-threatening diseases.' The ten-year contract for the freeze-dried version came amid calls to stockpile vaccines with longer shelf-lives. With the $144m order, Bavarian Nordic stated that $284m of the $299m has been exercised to-date. For a time, Jynneos was the only FDA-approved vaccine for the prevention of mpox. Emergent BioSolutions' ACAM2000 then became the second vaccine for the infectious disease, winning FDA approval to prevent mpox in those at high risk of infection in August 2024. Bavarian Nordic's product, also known as MVA-BN and Imvanex in other regions, has been a key pillar of fighting the ongoing mpox outbreak in Africa. The biotech has sent more than a million doses of the vaccine to countries experiencing outbreaks and promised further ramp-ups in vaccine production.
Yahoo
01-04-2025
- Health
- Yahoo
FDA approves Bavarian Nordic's freeze-dried mpox and smallpox vaccine
The US Food and Drug Administration (FDA) has approved the freeze-dried formulation of Bavarian Nordic's smallpox and mpox vaccine in a move expected to provide flexibility in stockpiling the jab. Marketed as Jynneos in the US, the vaccine currently exists in a liquid-frozen formulation. These products require a temperature-controlled supply chain that keeps them frozen between production up until being used on a patient. Freeze-dried formulations have fewer supply chain limitations, conferring advantages such as easier transportation, storage conditions, and extended shelf life. Freeze drying is a dehydration process to extend its shelf life and molecular stability. The FDA approved Bavarian Nordic's new formulation after the vaccine maker demonstrated comparability to the old formulation in terms of immune responses. The freeze-dried formulation is approved for the prevention of smallpox and mpox disease in adults aged 18 years and older. This included a Phase II trial in 651 healthy volunteers who were given two doses of either the liquid-frozen vaccine or the freeze-dried counterpart. No statistical differences were observed between the groups in immune responses and no serious adverse events were recorded, although the freeze-dried group did have slightly higher local reactions. Bavarian Nordic also supplied non-clinical and manufacturing to the FDA as part of the supplemental biologics licence application (sBLA) submitted in May 2024. The US Government has been working closely with Bavarian Nordic to ensure a stockpile of the vaccines is available in the event of a mpox outbreak. The country has been stockpiling since 2010 and ramped up efforts after the 2022-2023 outbreak, where the disease had spread to all 50 states. Bavarian Nordic is working closely with the US Biomedical Advanced Research and Development Authority (BARDA) to replenish the country's vaccine stockpile. In 2017, BARDA awarded Bavarian Nordic a contract to develop a freeze-dried version of the vaccine with a longer shelf-life to replace the stockpile. In 2024, a follow-up $156.8m contract was awarded to support these efforts. Bavarian Nordic stated that manufacturing was initiated in 2024, and the first vaccines will be delivered later in 2025. Bavarian Nordic's CEO Paul Chaplin said: 'Today's FDA approval represents a significant milestone in our development of this next generation of Jynneos and in our collaborative efforts with the US Government to strengthen public health security.' For a time, Jynneos was the only FDA-approved vaccine for the prevention of mpox. Emergent BioSolutions' ACAM2000 then became the second vaccine for the infectious disease, winning FDA approval to prevent mpox in those at high risk of infection in August 2024. Bavarian Nordic's product, also known as MVA-BN and Imvanex in other regions, has been a key pillar of fighting the ongoing mpox outbreak in Africa. The biotech has sent more than a million doses of the vaccine to countries experiencing outbreaks and promised further ramp-ups in vaccine production. The World Health Organization (WHO) has said the mpox outbreak is still a public health emergency, as per a February update. There have been more than 100,000 cases globally in the ongoing outbreak of Clade II mpox. There have been four cases of Clade I mpox in the US, with the most recent two in New Hampshire and New York in February 2025. "FDA approves Bavarian Nordic's freeze-dried mpox and smallpox vaccine" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
13-03-2025
- Business
- Yahoo
Emergent signs financial investment agreement with Swiss Rockets
Emergent BioSolutions has entered a strategic financial investment agreement with Swiss Rockets to support infrastructure development, research and the expansion of the latter's biotech portfolio. Swiss Rockets is the parent company of Rocketvax. Alongside the investment, a strategic partnership is planned, positioning Emergent to spearhead the US manufacturing and commercialisation offerings for four of Rocketvax's pipeline candidates targeting cancer, autoimmune disorders and infectious diseases. One of these is a next-generation live-attenuated nasal spray SARS-CoV-2 vaccine. In animal studies, this vaccine has shown superior efficacy compared with messenger ribonucleic acid (mRNA) Covid-19 vaccines. Rocketvax had previously initiated a partnership by signing a letter of intent with the US National Institutes of Health (NIH) under the Project NextGen initiative, facilitating a clinical trial to investigate a new vaccine leveraging the technology of Rocketvax. Emergent provides health solutions for threats such as anthrax, botulism, Ebola, mpox, opioid overdose emergencies and smallpox. Rocketvax focuses on developing next-generation vaccines using molecular biology technologies based on live attenuated viruses. Rocketvax CEO Dr Vladimir Cmiljanovic stated: 'By partnering with Emergent BioSolutions, we are combining cutting-edge vaccine innovation with world-class production and regulatory expertise. 'This joint venture not only accelerates the development of next-generation vaccines but also paves the way for groundbreaking advancements in global healthcare. Our shared vision is to revolutionise disease prevention and immunotherapy, bringing life-saving solutions to millions worldwide. 'By joining forces with Emergent, we can leverage their world-class production capabilities to deliver next-generation vaccines that have the potential to transform disease prevention and immunotherapy.' In August 2024, Emergent received US Food and Drug Administration (FDA) approval for its supplemental biologics licence application for ACAM2000, expanding its use to include the prevention of mpox. "Emergent signs financial investment agreement with Swiss Rockets" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
