The World Health Organization (WHO) has approved the monkeypox vaccine from Bavarian Nordic, which is the first vaccine to get the green light to fight the epidemic that has killed at least 643 people in Africa this year.
The vaccine is approved for people over 18 as a two-dose injection — but the WHO also said it “may be used ‘off-label'” in infants and children, and in pregnant women and immunocompromised people, where the benefits outweigh the potential risks.
WHO also recommends the use of a single dose where supplies are limited, but emphasizes the need to monitor safety and efficacy.
Bavarian Nordic said on Thursday that it could deliver “an additional 50 million doses” over the next 12-18 months, “pending regulatory approvals and demand” – on top of the 13 million doses it previously announced by 2025.
“Current circumstances ensure 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 drug regulators to approve a new way of producing the same vaccine, which would speed up production.
That, along with the possible involvement of manufacturing partners local to the epicenter of the outbreak, could allow the company to deliver an additional 50 million doses by the end of next year, he said.
The WHO has faced criticism over how long it took to approve the measles vaccine, given that outbreaks in Africa have been going on for years. Before Friday’s news, the WHO had already given the green light to vaccine buyers GAVI and UNICEF to procure monkeypox vaccines pending approval.
