The World Health Organization (WHO) has granted prequalification to the Bavarian Nordic vaccine for mpox, marking it as the first vaccine approved by the agency for the containment of mpox, particularly in countries severely affected by the disease.
This approval follows the spread of a new virus strain from the Democratic Republic of Congo where the outbreak began in early 2023, to neighboring countries.
"This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in the future," stated WHO Director-General Dr. Tedros Adhanom Ghebreyesus.
Prequalification by WHO enables developing countries to access the vaccine, as they often lack the resources to conduct comprehensive safety and efficacy evaluations. It is also a prerequisite for United Nations agencies to procure medical products.
The vaccine, initially approved for smallpox in the U.S., has been donated in some quantities to the Democratic Republic of Congo, with the first round of vaccinations scheduled to begin in early October.
"The evidence we have now is that it is important we take advantage of it (the vaccine) to protect our population," Dimie Ogoina, chair of the WHO's mpox emergency committee, stated before the approval.
However, he emphasized that vaccines were not a "magic bullet" and should be accompanied by other public health measures such as testing and contact tracing. He also noted uncertainties, including the duration of vaccine-induced protection.
"Off -Label" Use In Children
The manufacturer has announced that the vaccine is approved for use against smallpox, mpox, and related orthopoxvirus infections in individuals aged 18 years and older.
However, the vaccine may be used "off-label" in infants, children, adolescents, and pregnant or immunocompromised individuals in outbreak settings where the benefits of vaccination exceed potential risks.
A second vaccine produced by Japan's K M Biologics is also under WHO review, is available for use in children but is currently not available outside Japan and requires special needles for administration.
The Democratic Republic of Congo has stated that it will not include children in the initial phase of its vaccination campaign.