Bavarian Nordic is working to get their MVA-BN (Jynneos) mpox vaccine to those affected in African countries, as well as working towards a clinical trial for the younger pediatric population, and potential regulatory approval in Europe for adolescents.
Image Credit: Bavarian Nordic
On Saturday, Bavarian Nordic announced its plans to provide their Jynneos mpox vaccine to tackle the current mpox outbreak.
“We are manufacturing at a larger scale; building up an inventory for orders that we anticipate for this year, while ensuring that we have some surge capacity in the event of another outbreak or a large order,” Thomas Duschek, communications partner, Bavarian Nordic, said in an interview with Contagion. “This means that—in addition to our existing commitments—we will be able to supply a total of 10 million doses by the end of 2025, including up to 2 million doses this year.”
Last week, both the Africa CDC and World Health Organization made declarations about the outbreak in the continent as well as the potential threat globally.
In an interview with Contagion, Peter Costa, MPH, MCHES, North American medical director, Bavarian Nordic, talks about what the data has found about the mpox vaccine.
“Data from 3 case-control studies published on the CDC website suggest vaccine effectiveness of 66%-89% after complete vaccination with 2 doses of JYNNEOS, and 36%-75% after partial vaccination with 1 dose,” Costas said. “In an analysis of more than 9500 mpox cases, unvaccinated individuals were nearly 10x more likely to get mpox than persons who were fully vaccinated.”
He adds that a total of 56 deaths occurred among unvaccinated mpox patients, and none occurred among those who were fully vaccinated.
Bavarian Nordic is scaling up manufacturing to meet anticipated orders and ensure surge capacity.
Data from three case-control studies show that the Jynneos vaccine is 66%-89% effective after 2 doses and 36%-75% effective after 1 dose.
The majority of mpox cases in Africa have been reported in individuals under 18 years old. Bavarian Nordic is working to expand vaccine access to adolescents and younger children through clinical studies and regulatory approvals.
There has been data being reported that children in Africa are being greatly affected by mpox. In fact, the majority of the current mpox cases in Africa have been reported in people younger than 18 years old.
Bavarian Nordic recently submitted clinical data to the European Medicines Agency to potentially support the use of the mpox vaccine in adolescents (12–17-year-olds). These data were generated through a collaboration with the National Institute of Allergy and Infectious Diseases, on a clinical study in more than 300 individuals, 12-17 years of age. Additionally, in collaboration with the Coalition for Epidemic Preparedness Innovations, Bavarian Nordic will shortly initiate a clinical trial to assess the immunogenicity and safety of the vaccine in children from 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations.
“We are also working with the WHO on a regulatory path to ensure access to all countries, while in parallel seeking approval for use in adolescents and conducting clinical studies in Africa to further expand the use to children,” Bavarian Nordic CEO Paul Chaplin, said in a statement.
“Our role is to supply the vaccines once requested—but it is the government authorities in Africa who will decide how, when and where any vaccines will be used. At the request of government purchasers, we are prepared to increase production of mpox vaccine,” said Duschek.
