The World Health Organization (WHO) has listed KM Biologics' mpox vaccine for emergency use, marking the second shot approved by the agency to fight the ongoing outbreak and the first for children with the disease.

WHO said the move to grant emergency use listing to Japan-based KM Biologics’ vaccine, called LC16m8, is expected to facilitate increased and timely access to shots in areas affected by a surge in cases. The Japanese Government has announced that it will donate 3.05 million doses of LC16m8, along with specialised inoculation needles, to the Democratic Republic of Congo (DRC), marking the largest single donation package in the current outbreak. LC16m8 is administered using a five-puncture bifurcated needle and is approved for use in individuals over one year of age.

This means that WHO has authorised the first mpox vaccine for children, with the only other vaccine approved for use – Bavarian Nordic’s MVA-BN – only backed by WHO in people aged 18 and over. The agency does however permit its off-label use in younger populations based on subjective doctor opinions.  

WHO Assistant Director-General for Access to Medicines and Health Products Dr Yukiko Nakatani said: “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.”

WHO declared mpox a public health emergency of international concern in August this year after a new and more dangerous variant of the virus, clade Ib, spread in Africa from an epicentre in the DRC.

The only other vaccine being used against the mpox outbreak is Bavarian Nordic’s MVA-BN It is the only mpox vaccine approved by the US Food and Drug Administration (FDA), which is known under the brand name Jynneos. In Europe, it is known as Imvanex, where it is also approved in adults and adolescents, the latter indication coming via an approval extension in September this year. The Danish drugmaker is looking to expand the approval label of its vaccine to include children two to 11 years of age and has started a Phase II trial to support the approval.

There have been over 20,000 cumulative confirmed and suspected infections in the DRC, including 610 deaths, as per an August Africa CDC Epidemic Intelligence Report. Bavarian previously said it could supply 13 million doses of the vaccine by the end of next year by prioritising production, along with potentially transferring manufacturing to Africa.

KM Biologics also has vaccines for the prevention of influenza, hepatitis A and B, and Japanese encephalitis in its portfolio. In September, the biopharma signed an exclusive license option with Osivax for the latter’s broad-spectrum “universal” influenza vaccine candidates for the Japanese market.