The World Health Organization on Tuesday approved an mpox vaccine from Japanese pharma company KM Biologics for emergency use, the second one to get the agency’s seal of approval.
The WHO said it granted emergency use listing (EUL) authorisation to the LC16m8 vaccine to “facilitate increased and timely access to vaccines in communities where mpox outbreaks are surging”.
A WHO EUL paves the way for countries worldwide to quickly approve and import the vaccine for distribution.
“WHO emergency use listing of the LC16m8 vaccine against mpox marks a significant step in our response to the current emergency, providing a new option to protect all populations, including children,” Yukiko Nakatani, WHO’s assistant director-general for access to medicines and health products, said in a statement.
The WHO had already in September prequalified another vaccine against mpox, Bavarian-Nordic’s MVA-BN, in a bid to help step up the fight against swelling mpox outbreaks.
The UN health agency on August 14 declared a fresh international emergency over mpox, amid mounting concern over a surge in cases of the new Clade 1b strain in the Democratic Republic of Congo that spread to nearby countries.
That and other mpox strains have been reported across 80 countries — 19 of them in Africa — so far this year, WHO said.
The DR Congo remains by far the hardest-hit country, having recorded a large majority of the more than 39,000 suspected cases and over 1,000 deaths.
WHO said that Tuesday’s announcement was particularly relevant since the Japanese government had announced it would donate 3.05 million LC16m8 doses along with specialised inoculation needles to the DRC.
“This is the largest donation package announced to date in response to the current mpox emergency,” it said.
The WHO warned the vaccine should not be used during pregnancy or by immunocompromised persons.
Mpox, previously known as monkeypox, is caused by a virus transmitted to humans by infected animals but can also be passed from human to human through close physical contact.
It causes fever, muscular aches and large boil-like skin lesions, and can be deadly.
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