WHO Adds First Mpox Vaccine to Its List, Expected to Accelerate Distribution

Geneva, Switzerland: The World Health Organization (WHO) announced on Friday that it has prequalified a vaccine for mpox (formerly known as monkeypox) for the first time, a significant move aimed at accelerating access to the vaccine to combat an ongoing epidemic in Africa. This announcement coincided with the arrival of the first MVA-BN vaccines in the Democratic Republic of Congo (DRC), currently the epicenter of the mpox outbreak.

WHO Director-General Tedros Adhanom Ghebreyesus emphasized the importance of this milestone, stating, "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." He urged the need for an urgent scale-up in procurement, donations, and distribution to ensure equitable access to the vaccine in areas most affected by the virus. "We need to prevent infections, stop transmission, and save lives," he added.

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The WHO's prequalification listing serves to evaluate the quality, safety, and efficacy of medical products, including vaccines. This process facilitates the procurement of these vaccines by the United Nations and other international agencies, particularly benefitting lower-income countries that may lack the resources for independent evaluations.

Yukiko Nakatani, WHO's assistant chief in charge of access to medicines and health products, stated, "The WHO prequalification of the MVA-BN vaccine will help accelerate ongoing procurement of mpox vaccines by governments and international agencies on the frontlines of the ongoing emergency in Africa and beyond."

Mpox is transmitted to humans through infected animals but can also spread from person to person through close contact. The disease presents symptoms such as fever, muscular aches, and large boil-like skin lesions, which can be fatal in some cases. Recently, the WHO declared mpox an international emergency, highlighting a concerning surge in cases of the new Clade 1b strain in the DRC, which has spread to neighboring countries.

Since the beginning of the year, the DRC has reported nearly 22,000 mpox cases and 716 related deaths. To support the country’s vaccination efforts, approximately 200,000 doses have been delivered by the European Union, along with an additional 50,000 doses from the United States.

The WHO based its prequalification assessment on data provided by Bavarian Nordic A/S, the manufacturer of the MVA-BN vaccine, and a review conducted by the European Medicines Agency. The organization noted that the vaccine has demonstrated a good safety profile and consistent performance in clinical studies and real-world use.

According to the WHO's guidelines, the vaccine is suitable for individuals aged 18 and older and is administered in two doses, spaced four weeks apart. However, given that many mpox cases and fatalities in the DRC have occurred in children, the WHO has indicated that the vaccine may be used "off-label" for infants, children, and adolescents, as well as pregnant and immunocompromised individuals. This recommendation applies particularly in outbreak settings where the potential benefits of vaccination outweigh any associated risks.

In cases where vaccine supply is limited, the WHO suggests that a single dose of the MVA-BN vaccine may still be effective. Current data indicates that a single pre-exposure dose has an estimated 76% effectiveness in protecting against mpox, while the two-dose regimen is estimated to be 82% effective.

As the world confronts the ongoing challenges posed by mpox, the WHO's prequalification of the MVA-BN vaccine represents a vital step towards enhancing global health security and ensuring that those most at risk receive timely access to necessary vaccinations