On Friday, the World Health Organization (WHO) announced it has approved the first vaccine to protect against mpox. The decision was so swift that even the company’s CEO making the vaccine was caught off guard.
The vaccine, developed by Danish company Bavarian Nordic, has already been approved by regulatory authorities in Europe, the U.S., and other wealthy nations after a global mpox outbreak in 2022. However, low- and middle-income countries rely on the WHO to determine which vaccines and medicines are safe and effective for their limited healthcare budgets, a process known as ”prequalification.” Until now, the WHO had declined to act.
The WHO faced mounting criticism for declaring a global public health emergency for mpox last month without offering the same vaccine its seal of approval. Bavarian Nordic had submitted safety and effectiveness data for its vaccine, Jynneos, back in 2023, but the WHO had taken its time. They argued that careful review was necessary, particularly because Jynneos, along with two other vaccines used to combat mpox, was originally designed for smallpox. Additionally, delivering it in low-resource areas like Central Africa posed challenges different from those in wealthier countries.
Then, out of the blue, on Friday morning, the WHO gave the green light.
”This first prequalification of a vaccine for mpox is a crucial step in our fight against the disease, both for current outbreaks in Africa and for the future,” said Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, in a statement.
Paul Chaplin, CEO of Bavarian Nordic, admitted that the sudden approval took him by surprise.
“We got there eventually—I’m not exactly sure how,” Chaplin said. “But it’s great news. This will make the regulatory path much smoother.”
Mpox was first identified more than 50 years ago in the Democratic Republic of the Congo (DRC), where it has remained a constant health threat. While the global outbreak that started in 2022 slowed in 2023, people in the Congo continue to be infected. In 2023, a new version of the virus emerged, which is sexually transmissible. This year alone, the Congo has seen over 21,000 suspected mpox cases and 700 deaths.
Despite the urgency, no vaccines have yet been publicly administered in the country.
Last week, about 245,000 donated doses of Jynneos—contributed by the EU, the U.S., and Bavarian Nordic—began arriving in Kinshasa, the capital of Congo. The Congolese government hopes to start rolling them out by October 2.
Interestingly, the WHO’s prequalification decision came just ahead of a planned meeting next week, where a WHO committee was supposed to evaluate the vaccine for emergency use.
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