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).
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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.
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By GlobalData“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.
