The European Medicines Agency (EMA) has approved the use of Bavarian Nordic’s mpox vaccine in adolescents, increasing the chances for its use in this age group in Africa.
The label extension is via a type II variation – a route used when a major change is needed in the marketing authorisation for a medicine approved in Europe. Bavarian Nordic applied for the change last month.
The Committee for Medicinal Products for Human Use (CHMP) recommended extending the marketing authorisation to teenagers, which the European Commission (EC) then backed, as per a 19 September press release.
The decision means that, in addition to adults, adolescents in Europe aged 12 to 17 years can now receive the vaccine.
Bavarian Nordic’s MVA-BN vaccine is called Imvanex in Europe but is known as Jynneos in countries such as the US and Singapore. Currently, the vaccine is only approved for adults by the US Food and Drug Administration (FDA).
A Bavarian Nordic spokesperson confirmed to Pharmaceutical Technology that the company has “plans to expand this approval process to other high-risk countries”.
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The CHMP’s decision was based on data from a US National Institutes of Health (NIH)-sponsored trial involving 315 adolescents and 211 adults. Data from the trial demonstrated non-inferiority of immune responses between the two age groups after two doses, along with a similar safety profile.
Bavarian Nordic’s CEO Paul Chaplin said: “This represents an important milestone in our efforts to make our vaccine available for all populations and will help improve access for some of the most vulnerable individuals mostly impacted by the ongoing mpox outbreak in Africa.”
The EMA did however request Bavarian Nordic to submit final results from the study by May next year to fully assess safety in adolescents, as per a separate release by the agency.
EMA’s greenlight for the vaccine could open up pathways for its use in adolescents in Africa based on World Health Organization (WHO) prequalification. Last week, Imvanex was added to the WHO’s prequalification list, facilitating ‘off-label’ use in infants, pregnant women, and immunocompromised people, amongst others, in outbreak settings.
Bavarian Nordic is gearing up for a Phase II clinical trial (NCT06549530) to assess the immunogenicity and safety of MVA-BN in children 2-12 years of age. The company said it aims “to further extend the indication of the vaccine into younger populations”. The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is expected to start next month.
Since the mpox outbreak began in January, there have been just over 25,000 cases and more than 720 deaths in Africa. The most affected country at the moment is the Democratic Republic of the Congo, according to WHO.
On 18 September, the Global Alliance for Vaccines and Immunization (GAVI) entered a purchase agreement with Bavarian Nordic to secure 500,000 doses for countries in Africa.
Earlier this month, Bavarian Nordic said it would prioritise the production of two million mpox vaccines by the end of this year.
