By Jennifer Rigby and Manas Mishra
(Reuters) – The World Health Organization said on Friday it had authorized Bavarian Nordic's mpox vaccine, the first such shot approved by the agency to contain the spread of the disease in the hardest-hit African countries.
The approval, known as prequalification, comes as a new strain of the virus spreads from the Democratic Republic of Congo, where the current outbreak began in early 2023, to several neighboring countries.
“This first prequalification of an mpox vaccine is an important step in our fight against the disease, both in the context of the current outbreaks in Africa and in the future,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.
Prequalification paves the way for developing countries to access the vaccine, as most of these countries do not have the resources to conduct rigorous controls on the safety and efficacy of vaccines. UN agencies also rely on this process before purchasing medical products.
The Bavarian Nordic vaccine, known as Jynneos in the United States, was originally approved as a smallpox vaccine. Some doses have been donated to Congo, where the first round of inoculations is scheduled to begin in early October.
“The evidence we have now is that it is important that we take advantage of (the vaccine) to protect our population,” Dimie Ogoina, chair of the WHO's mpox emergency committee, had said before the approval.
However, she stressed that vaccines are not a “magic bullet” and that other public health measures, such as testing and contact tracing, are important. The public also needs to be informed that some unknowns remain, such as how long protection from mpox lasts, she said.
OFF-LABEL USE IN CHILDREN
Bavarian Nordic said the vaccine has been approved for immunization against smallpox, mpox and orthopoxvirus-related infections and diseases in adults aged 18 years and older.
The Danish biotech company has said it can 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, as well as in pregnant and immunocompromised individuals in outbreak settings where the benefits of vaccination outweigh the potential risks.
The Democratic Republic of Congo has said it will not vaccinate children in the first phase of its inoculation campaign.
A second vaccine made by Japan's KM Biologics, which is also under review by the WHO, can be used in children, although it is not available outside Japan and requires special needles for administration.
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