Latest news with #Jynneos
Business Wire
30-06-2025
- Health
- Business Wire
AHF Urges Vaccine Equity as Mpox Cases Surge in Sierra Leone
KAMPALA, Uganda--(BUSINESS WIRE)--As Sierra Leone grapples with the rapid escalation of mpox cases, AIDS Healthcare Foundation (AHF) calls for urgent global action to improve vaccination efforts for the response, including Bavarian Nordic lowering the price of the vaccine and transferring technology and know-how to regional manufacturers. AHF also urges wealthy nations to donate vaccine doses from existing stockpiles. Sierra Leone accounted for 41% of the continent's cases as of June 24. Since January 10, the country has recorded 4,350 confirmed cases and 28 deaths. Since late March, only 40,000 people had been vaccinated, many of them frontline healthcare workers and high-risk groups, including people living with HIV. With limited isolation capacity and just two contacts traced per confirmed case, the response is stretched thin. According to the Africa CDC, more than 6.4 million vaccine doses are needed across the region to meet demand, yet access remains restricted by high prices and limited supply. 'We commend Sierra Leone's rapid response in collaboration with the Africa CDC, but they—and the entire region—should not have to fight this outbreak alone,' said Dr. Penninah Iutung, AHF Africa Bureau Chief. 'We urge high-income countries to immediately release vaccine doses from their reserves and support equitable access to prevention tools. We also call on Bavarian Nordic to reduce the cost of its Jynneos mpox vaccine and to share technology and production knowledge with qualified African manufacturers. Without affordable regional production and greater global collaboration, the world remains vulnerable to preventable infectious disease outbreaks like mpox.' The outbreak extends far beyond Sierra Leone, with the Democratic Republic of the Congo remaining as the epicenter of Africa's outbreak. Uganda, Burundi, Malawi, and over a dozen other countries have also reported significant case numbers. The World Health Organization continues to classify mpox as a Public Health Emergency of International Concern, citing surging cases, ongoing vaccine shortages, and rising instability. AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 2.4 million clients in 48 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: find us on Facebook: and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare
Yahoo
27-06-2025
- Health
- Yahoo
Bavarian Nordic begins mpox vaccine trial in pregnant women and infants
Bavarian Nordic has initiated two Phase III clinical trials of its mpox vaccine, Jynneos, in pregnant and breastfeeding women, as well as infants aged under two years. The first infants have been dosed in one Phase III study (NCT06844487), which aims to recruit 344 infants aged between four months and two years. In addition, the recruitment for 359 pregnant and breastfeeding women has started for an additional trial (NCT06844500). Both studies are part of the PregInPoxVac project. The PregInPoxVac project is led by the University of Antwerp and the University of Kinshasa and is supported by partners in Kenya (ACE Research) and Italy (Penta Foundation). It is funded by the European Union Global Health EDCTP3, the Coalition for Epidemic Preparedness Innovations (CEPI), and Bavarian Nordic. The studies will evaluate the safety and immunogenicity of MVA-BN in those living in the Democratic Republic of Congo (DRC), the epicentre of the ongoing mpox outbreak, where infants and pregnant women remain highly vulnerable to mpox. Bavarian Nordic CEO Paul Chaplin said: 'Through partnerships, we have made significant advances already by expanding access to our mpox vaccine for children and adolescents. "These new studies will fill the gap by providing important data about the use of MVA-BN in infants and pregnant women, and we applaud the study partners as well as the funding partners, EDCTP3 and CEPI for supporting this important work which could help support a label expansion for MVA-BN to include the most vulnerable populations.' Bavarian Nordic is also sponsoring a trial (NCT06549530) of MVA-BN in children aged 2-11 years, with topline data anticipated in Q3 2025. Jynneos is the only non-replicating mpox vaccine approved in the US, EU, Switzerland, Singapore and Mexico. It is also approved in the UK, where it is marketed as Imvanex. The vaccine was originally developed for smallpox, but studies have proven its efficacy in mpox. Last year, after the outbreak was confirmed, Bavarian Nordic set up studies in the epicentre and also promised 2.5 million doses of the jab to Africa via an agreement with UNICEF, which included a 500,000-dose commitment by the Global Alliance for Vaccines and Immunization (GAVI). Yesterday, US Health Secretary Robert F Kennedy, Jr (RFK) announced that the US would no longer financially support GAVI, according to Politico. This comes months after the country also stated it would be dropping certain funding to USAID, which also assists with vaccine distribution and research in third-world countries. Earlier this year, Bavarian Nordic shares rose 7% on its Q1 financial announcement, with strong revenue from vaccine sales. On top of this, the company also gained $160m earlier this month after it sold a priority review voucher; however, the buyer has not been disclosed. "Bavarian Nordic begins mpox vaccine trial in pregnant women and infants" was originally created and published by Clinical Trials Arena, 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. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
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.
