WHO says partners can start talks to buy mpox vaccines before its approval

The World Health Organization said on Friday its partners such as Gavi and UNICEF can start buying mpox vaccines before they are approved by the U.N. health agency, to get inoculations to Africa faster as the continent battles an escalating outbreak of the virus.

Traditionally, organisations like Gavi, which helps lower-income countries buy vaccines, can only start purchasing shots once they have approval from the WHO. But the rules have been relaxed in this instance to get talks moving, as the WHO's approval is due in a few weeks.

Two vaccines, made by Denmark's Bavarian Nordic BAVA.CO and Japan's KM Biologics, are already approved by regulators around the world, including the U.S. and Japan, and have been in widespread use for mpox since 2022. Around 1.2 million people have had Bavarian Nordic's vaccine in the U.S. alone. The WHO is expected to grant an emergency licence to the shots in September.

Mpox, a viral infection that spreads through close contact and is usually mild but can kill, was declared a public emergency of international concern by the WHO last week after a new offshoot of the virus spread quickly in Democratic Republic of Congo and beyond.

Earlier this month, the WHO asked vaccine manufacturers to submit information so it could accelerate its approval process, and grant an emergency licence by mid-September.

However this week, one of the vaccine manufacturers, Bavarian Nordic, said it needed orders immediately from organisations such as Gavi and the WHO to make more shots this year, raising fears that lower-income countries could miss out or be forced to rely on precarious donations from high-income countries, as happened during the COVID-19 pandemic.

Some donated mpox vaccines are due to arrive in Africa next week, the Africa Centres for Disease Control and Prevention has said. The agency has said 10 million doses are needed.

"While we see the news from WHO as a positive, we are not able to comment on specific negotiations. We will update the market in due time if and when orders materialize," a spokesperson for Bavarian Nordic said.

A spokesperson for Gavi said that getting donated doses to countries, and into vaccination programmes, was the first priority.

"When it comes to procuring vaccines directly, since a public health emergency of international concern was announced last week, we have intensified our efforts, with near-daily contact with manufacturers: we are ready to go as soon as we get a clear picture on demand,” the spokesperson said.

KM Biologics did not immediately respond to requests for comment.