WHO Approves First Monkeypox Vaccine, Surprising Even the Manufacturer

In a significant advancement in the fight against monkeypox, the World Health Organization (WHO) has granted approval to the first vaccine designed to combat the virus. This decision marks a crucial milestone in global health efforts against monkeypox. The rapid announcement of approval took even the vaccine’s manufacturer, Bavarian Nordic, by surprise.

The vaccine, known as Jynneos, is produced by the Danish company Bavarian Nordic. It had already received approvals from regulatory authorities in Europe, the United States, and other high-income countries, especially during the global monkeypox outbreak of 2022. However, lower- and middle-income countries rely on the WHO’s prequalification process to ensure that vaccines, medicines, and health technologies are safe and suitable for use in settings with limited health resources. The WHO had previously delayed this process, which has now finally resulted in approval.

Despite declaring monkeypox a global public health emergency last month, the WHO faced criticism for the delay in granting prequalification or emergency use authorization (EUA) for the vaccine. Bavarian Nordic had submitted safety and efficacy data for Jynneos to the WHO in 2023.

In defense of its slow evaluation process, the WHO stated that a thorough review of the vaccine was necessary. Furthermore, the three vaccines used against monkeypox were originally developed for smallpox vaccination. Distributing these vaccines to areas with limited resources, such as Central Africa, presents different challenges compared to high-income countries. As a result, the WHO decided to proceed cautiously to address these unique challenges effectively.

With the WHO’s approval, the fight against monkeypox gains new momentum. This decision is particularly significant for countries that depend on WHO prequalification. It not only acknowledges the safety and effectiveness of the vaccine but also indicates that the WHO is improving its processes to handle global health emergencies more efficiently.

Ultimately, the approval of the monkeypox vaccine highlights the need for international health organizations to make timely decisions to address global health challenges swiftly and effectively. Bavarian Nordic’s Jynneos vaccine has now become a vital tool in helping countries affected by monkeypox to curb the spread of the virus.