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Wednesday, Dec 31, 2025

WHO Approves Second Vaccine for Mpox Emergency Use

KM Biologics' LC16m8 Vaccine Receives Emergency Use Authorization
The World Health Organization (WHO) has approved the LC16m8 vaccine from Japanese pharmaceutical company KM Biologics for emergency use, marking the second vaccine to receive such approval for mpox.

This decision aims to enhance access to vaccines in areas experiencing surges of mpox outbreaks, enabling countries to import and distribute the vaccine more rapidly.

WHO's Assistant Director-General, Yukiko Nakatani, highlighted the significance of this approval in providing protection for all populations, including children.

Earlier, WHO had prequalified the MVA-BN vaccine from Bavarian Nordic in September to combat the increasing mpox outbreaks.

On August 14, WHO declared an international emergency due to the spread of the Clade 1b strain in the Democratic Republic of Congo (DRC), which has since affected multiple neighboring countries.

The DRC is the most severely impacted, with over 39,000 suspected cases and more than 1,000 deaths.

The Japanese government has announced a donation of 3.05 million doses of the LC16m8 vaccine, along with specialized needles, to the DRC.

This is the largest donation package for the current mpox emergency.

WHO advises against using this vaccine during pregnancy or by immunocompromised individuals.

Mpox, previously known as monkeypox, is a viral disease transmitted from animals to humans, and can also spread through close physical contact.

It is characterized by fever, muscular aches, and large boil-like skin lesions, and can be fatal.
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