Latest news with #Jynneos
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
Reuters
31-03-2025
- Health
- Reuters
US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
March 31 (Reuters) - Denmark's Bavarian Nordic ( opens new tab said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its mpox and smallpox vaccine. The company said the newly approved formulation of its vaccine, Jynneos, provides advantages in terms of transportation, storage conditions and shelf life, which are important factors for long-term stockpiling. Make sense of the latest ESG trends affecting companies and governments with the Reuters Sustainable Switch newsletter. Sign up here. The vaccine's liquid-frozen formulation, which was approved by the FDA in September 2019, had specific cold-chain requirements, Bavarian Nordic said. The approval was primarily based on clinical data that showed comparability in terms of the immune responses and safety between the freeze-dried and liquid-frozen formulations, the company said. Freeze-drying is a method used to remove water from a product, to extend its shelf life and stability. Bavarian Nordic said it was contracted by the U.S Biomedical Advanced Research and Development Authority to develop and supply the freeze-dried version of Jynneos for stockpiling. Manufacturing under this contract was initiated in 2024, and the first vaccines will be delivered later in 2025, it added. In February, the World Health Organization said the mpox outbreak is still a public health emergency. Globally, there have been more than 25,000 cases confirmed by laboratory testing since the beginning of 2024, and over 70 deaths, mainly in Congo, according to the WHO. As per the WHO, the United States is one of 18 countries with the new form of mpox, clade Ib, with 4 cases since the start of 2024, as of March 21.
Reuters
18-03-2025
- Health
- Reuters
Widely used drugs on US imports list from Europe
Item 1 of 2 A combination image shows an injection pen of Zepbound, Eli Lilly's weight loss drug, in New York City, U.S., December 11, 2023 (left) and a box of Mounjaro, a tirzepatide injection drug used for treating type 2 diabetes and made by Lilly, at Rock Canyon Pharmacy in Provo, Utah, U.S., March 29, 2023. REUTERS/Brendan McDermid/George Frey/File Photo [1/2] A combination image shows an injection pen of Zepbound, Eli Lilly's weight loss drug, in New York City, U.S., December 11, 2023 (left) and a box of Mounjaro, a tirzepatide injection drug used for treating type 2 diabetes and made by Lilly, at Rock Canyon Pharmacy in Provo, Utah, U.S., March 29,... Purchase Licensing Rights, opens new tab Read more March 18 (Reuters) - Widely used prescription medicines could get caught up in the Trump administration's tariff trade wars and EU retaliation. The following is a list of major prescription drugs whose ingredients or components are imported into the United States from the European Union, based on U.S. Food and Drug Administration import data from 2023 and 2024. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Company Brand Name (chemical name) Used to Treat Country of Import Company Comments AbbVie (ABBV.N) Rinvoq (upadacitinib) rheumatoid arthritis Germany, Ireland Abbvie declined to comment on specific production or import sites for its drugs. The company said it "maintains a robust, diversified and redundant manufacturing network with geographic balance and multiple supply sites" Norvir (ritonavir) HIV Germany Humira (adalimumab) rheumatoid arthritis, psoriatic arthiritis, others Germany Amgen (AMGN.O) Blincyto (blinatumomab) A type of acute lymphoblastic leukemia Netherlands Prolia/Xgeva (denosumab) osteoporosis, preventing fractures from cancer in bones Netherlands Bavarian Nordic A/S ( Jynneos smallpox vaccine, also used for mpox Denmark Bavarian Nordic said it manufactures all its bulk vaccine/bulk drug substance for Jynneos in Denmark, and the fill and finish is done either at its own site in Denmark or in the U.S., depending on the markets served. Bristol Myers Squibb (BMY.N) Eliquis (apixaban) Blood thinner/clot preventer Ireland Opdivo (nivolumab) cancer immunotherapy Ireland Eli Lilly (LLY.N) Mounjaro, Zepbound (tirzepatide) type 2 diabetes, obesity Germany, Netherlands A Lilly spokesperson said the company prefers to source materials internally, as evidenced by its most recent manufacturing announcements. It does not disclose details of in-house vs external manufacturing Johnson & Johnson (JNJ.N) Stelara (ustekinumab) inflammatory bowel disease, psoriatic arthritis, other autoimmune conditions Ireland, Netherlands Invega/Invega Sustenna (paliperidone) schizophrenia Ireland Merck & Co (MRK.N) ritonavir antiviral Netherlands Keytruda (pembrolizumab) cancer immunotherapy Netherlands, Ireland Gardasil HPV vaccine for cancer prevention Ireland Novavax (NVAX.O) Nuvaxovid COVID-19 vaccine Germany Novavax said its vaccine is manufactured by The Serum Institute in India. Novo Nordisk ( Ozempic (semaglutide ) type 2 diabetes, Ireland, Germany, Denmark Novo said in a statement that it manufactures the active ingredients for its obesity and diabetes drugs in Denmark and United States only Wegovy (semaglutide) obesity Ireland, Germany Pfizer (PFE.N) Prevnar family pneumococcal vaccines for pneumonia prevention Ireland Penbraya meningococcal meningitis vaccine Ireland Comirnaty COVID-19 vaccine Ireland, Germany Eliquis (apixaban) blood thinner/clot preventer Netherlands Regeneron (REGN.O) Eylea (aflibercept ) Wet age-related macular degeneration, other eye conditions Ireland Regeneron has manufacturing facilities in both the U.S. and Ireland and is currently expanding its campus in New York. Roche (ROG.S) Avastin (bevacizumab) metastatic colorectal cancer, diabetic eye disease and other eye disorders Germany Roche declined to comment on which drug is produced where, and for which market. It said that a majority of its products cross different countries/continents across the development and supply chain.
