On September 13, 2024, the World Health Organization (WHO) announced that it added the first vaccine against monkeypox (mpox) to its prequalification list. The vaccine, MVA-BN, is manufactured by Bavarian Nordic A/S.
Prequalification is a mechanism “used to evaluate quality, safety and efficacy of medical products, such as vaccines . . . for use in [the] low- and middle-income country context.” This news comes just over a month after WHO triggered the process to list mpox vaccines for emergency use. According to the WHO, that decision was made in part due to the “severe outbreak of Mpox” in the Democratic Republic of the Congo where “the number of cases reported in the first six months of this year match the number reported in all of last year.” WHO Director-General Dr Tedros Adhanom Ghebreyesus commented, “[t]his 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.” WHO’s decision was based on information submitted by the vaccine’s manufacturer, Bavarian Nordic, as well as opinions issued by the European Medicines Agency, the regulatory agency of record.
MVA-BN is delivered to individuals over 18 years of age through a two-dose regimen administered four weeks apart. WHO’s announcement added that the “vaccine may be used ‘off-label’ in infants, children and adolescents, and in pregnant and immunocompromised people.” WHO also “recommends single-dose use in supply-constrained outbreak situations” based on estimated effectiveness of 76% for a single-dose (compared to 82% for the two-dose regimen).
A day before WHO’s prequalification announcement, Bavarian Nordic provided an update on its supply of the vaccine noting that “[m]ore than 250,000 doses have already been shipped” to the Democratic Republic of Congo. It further added that it “could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024.”
In related news, Bavarian Nordic announced earlier this week that the vaccine received a provisional consent in New Zealand and full approval in Mexico.