World Health Organization gives mpox vaccine ‘pre-qualification’ approval

The World Health Organization Friday approved MVA-BN as the first mpox vaccine added to its pre-qualification list. Director General Tedros Adhanom Ghebreyesus declared mpox a global health emergency in August. File Photo by World Health Organization / TWITTER

“This first pre-qualification 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 future,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus in a statement. “We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives.”

Data shows a single dose of MVA-BN has an estimated effectiveness of 76% in protecting people against mpox. With two shots it’s 82% effective.

“The WHO pre-qualification 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,” WHO Assistant Director-General for Access to Medicines and Health Products Dr. Yukiko Nakatani said.

Nakatani added that the WHO action will help national regulatory authorities around the world fast-track the vaccine approvals which in turn will increase access worldwide.

In August, the WHO declared mpox a global health emergency following a recommendation from an emergency committee on mpox.

The vaccine is not licensed for people under 18 but the WHO said it may be used “off-label” in infants, children and adolescents as well as pregnant and immunocompromised people.

That guidance means in outbreak settings, the benefits of vaccination outweigh the potential risks as other mpox vaccines are being developed.

“We are progressing with pre-qualification and emergency use listing procedures with manufacturers of two other mpox vaccines: LC-16 and ACAM2000. We have also received 6 expressions of interest for mpox diagnostic products for emergency use listing so far,” Dr Rogerio Gaspar, WHO Director for Regulation and Pre-qualification, said in statement.

According to the WHO over 120 nations have confirmed more than 103,000 mpox cases since the global outbreak started in 2022.