WHO Adds Mpox Vaccine to Prequalified LIst

With over 723 deaths from different mpox outbreaks in 14 countries of the African Region, the World Health Organization (WHO) has expanded access to one mpox vaccine.

On September 13, 2024, the WHO announced Bavarian Nordic A/S's MVA-BN (JYNNEOS®) vaccine is the first vaccine against mpox to be added to its prequalification list.

“The WHO prequalification of the MVA-BN vaccine will help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as Gavi and Unicef to help communities on the frontlines of the ongoing emergency in Africa and beyond,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, in a press release.

While MVA-BN is currently not licensed for persons under 18, this vaccine may be used “off-label” in infants, children, adolescents, pregnant women, and immunocompromised people. This means vaccine use is recommended in outbreak settings where the benefits of vaccination outweigh the potential risks.

Additionally, the WHO also recommends single-dose use in supply-constrained outbreak situations. 

Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “We are progressing with prequalification and emergency use listing procedures with manufacturers of two other mpox vaccines: LC-16 and ACAM2000."

The escalating mpox clade 1 outbreak in the Democratic Republic of the Congo and other countries was declared an emergency by the WHO Director-General on August 14, 2024. 

As of mid-Agust 2024, the United States has not reported mpox clade 1 cases, but the JYNNEOS vaccine is commercially available at select clinics and pharmacies.