The WHO has authorized its partners, including Gavi and UNICEF, to purchase mpox vaccines before WHO approval. This decision is intended to accelerate vaccine distribution in Africa, where an outbreak is currently occurring. Typically, organizations like Gavi, which supports vaccine acquisition for lower-income countries, are restricted to purchasing vaccines only after WHO approval. The WHO anticipates granting approval within weeks.
Two vaccines, manufactured by Denmark's Bavarian Nordic and Japan's KM Biologics, have received regulatory approval in several countries, including the U.S. and Japan. These vaccines have been used for mpox since 2022, with approximately 1.2 million individuals in the U.S. vaccinated using Bavarian Nordic's product. The WHO is expected to issue an emergency license for these vaccines by September.
Mpox was declared a Public Health Emergency of International Concern by the WHO following the rapid spread of a new virus variant in the Democratic Republic of Congo and other areas. The WHO recently requested vaccine manufacturers to submit data to expedite the approval process, aiming to issue an emergency license by mid-September.
Bavarian Nordic has indicated that immediate orders from organizations such as Gavi and the WHO are necessary to produce additional doses within the year. The Africa Centres for Disease Control and Prevention has reported that some donated mpox vaccines are expected to arrive in Africa next week.
