The World Health Organisation (WHO) listed KM Biologics' mpox vaccine for emergency use on Tuesday, making it the second shot to receive approval by the global health agency.
It declared mpox a global public health emergency for the second time in two years in August after a new variant of the virus, called clade Ib, spread from the Democratic Republic of Congo (DRC) to neighbouring countries.
In September, after facing criticism for moving too slowly on vaccines, the agency cleared Bavarian Nordic's vaccine for mpox and said it was considering LC16, made by Japan's KM Biologics, as a potential vaccine option.
The government of Japan will donate 3.05-million doses of the vaccine, along with specialised needles, to DRC, the WHO said.
The vaccine has been used in Japan during previous mpox outbreaks and was shown to be safe and effective, including in people with well-controlled HIV, it said.
KM Biologics, a unit of candy maker Meiji Holdings, mainly produces vaccines for humans and veterinary use.
According to the latest WHO figures, there have been more than 50,500 confirmed and suspected cases of mpox in Africa this year, and more than 1,100 deaths on the continent due to the illness.
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