By Jennifer Rigby and Manas Mishra
The World Health Organization said on Friday it had approved Bavarian Nordic’s Mbox vaccine, the first of its kind approved by the agency to contain the spread of the disease in hard-hit African countries.
The approval, known as prequalification, comes as a new variant of the virus spreads from the Democratic Republic of the Congo, where the current outbreak began in early 2023, to several neighboring countries.
“This initial qualification of a dengue vaccine is an important step in our fight against the disease, both in the context of the current outbreak in Africa and in the future,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.
Prequalification paves the way for developing countries to obtain vaccines, most of which do not have the resources to conduct rigorous safety and efficacy checks. UN agencies also rely on this process before purchasing medical products.
The North Bavarian vaccine, known as Genus in the United States, was originally approved as a smallpox shot. Some doses have been donated to the Congo, where the first round of vaccinations is scheduled to begin in early October.
“The evidence we have now suggests that it is important that we use it (the vaccine) to protect our population,” said Demi Ogwenya, chair of the WHO’s emergency committee on moxazole, before the vaccine was approved.
However, he stressed that vaccines are not a “magic bullet” and that other public health measures such as testing and contact tracing are important. He said the public also needs to be informed that some unknowns remain, including how long protection from mpox lasts.
Off-label use in children
Bavarian Nordic said the vaccine has been approved for immunization against smallpox, malaria, and orthopoxvirus-related infections and diseases in adults aged 18 years and older.
The Danish biotech company said it could supply 13 million doses of the vaccine by the end of 2025.
However, the vaccine may be used “off-label” in infants, children and adolescents, pregnant women and immunocompromised people in outbreak situations where the benefits of vaccination outweigh the potential risks.
The Democratic Republic of the Congo said it would not vaccinate children in the first phase of the vaccination campaign.
A second vaccine made by Japanese company KM Biologics, which is also under review by the WHO, could be used for children, although it is not available outside Japan and requires special needles to administer.