WHO approves Bavarian Nordic’s mpox vaccine

The World Health Organization has approved Bavarian Nordic’s mpox vaccine, the first jab it has greenlit to combat the outbreak that has killed at least 643 people in Africa so far this year.

The vaccine is approved for people over the age of 18 as a two-dose jab — but the WHO has also said it “may be used ‘off-label'” for infants and children, and in pregnant and immunocompromized people, where the benefits outweigh the potential risks.

WHO also recommends single-dose use where supplies are limited, but stressed the need to monitor safety and efficacy.

Bavarian Nordic said Thursday it could deliver “another 50 million doses” over the next 12-18 months, “pending regulatory approvals and demand” — on top of the 13 million doses it announced previously, through 2025.

“Current circumstances provide 13 million doses by the end of next year,” Rolf Sass Sørensen, head of investor relations, told POLITICO.

However, the company is in talks with global medicines regulators to authorize a new way of manufacturing the same vaccine, that would speed up production.

This, coupled with possible onboarding of manufacturing partners local to the outbreak, could enable the company to deliver up to an extra 50 million doses by the end of next year, he said.

WHO faced criticism over how long it took to approve mpox vaccines, given outbreaks have been ongoing in Africa for years. Before friday’s news, the WHO had already given the go-ahead for vaccine buyers GAVI and UNICEF to procure mpox vaccines pending approval.