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WHO Approves LC16m8 Vaccine to Combat Mpox Outbreaks The World Health Organization (WHO) has granted emergency use listing (EUL) approval for the LC16m8 vaccine, developed by Japanese pharmaceutical company KM Biologics. This marks a significant step in the global fight against mpox, previously known as monkeypox. The approval aims to increase timely access to vaccines, especially in communities experiencing surging outbreaks.
The EUL authorization for the LC16m8 vaccine facilitates its rapid approval and distribution worldwide. This move allows countries to expedite the approval process and import the vaccine, making it available for high-risk populations and areas with active mpox outbreaks. According to Yukiko Nakatani, WHO’s Assistant Director-General for Access to Medicines and Health Products, the EUL approval is a critical development in the ongoing global response to the mpox emergency.
“It provides a new vaccine option to protect all populations, including children,” Nakatani said in a statement. This is the second mpox vaccine to receive the WHO’s EUL approval, after Bavarian Nordic’s MVA-BN vaccine was prequalified by the WHO in September 2024. The approval of both vaccines signals an intensified global effort to tackle the mpox crisis—a disease that has now spread to over 80 countries, including 19 in Africa.
The Democratic Republic of Congo (DRC) remains the hardest-hit country, accounting for the majority of the more than 39,000 suspected cases and over 1,000 deaths. In response, the Japanese government has committed to donating 3.05 million doses of the LC16m8 vaccine to the DRC, along with specialized inoculation needles.
This donation package is the largest announced to date to support the ongoing global mpox emergency. Mpox is a viral disease that primarily spreads from animals to humans, though human-to-human transmission is also possible through close contact. Symptoms include fever, muscle aches, and the development of boil-like skin lesions.
In severe cases, the disease can be fatal. Since the WHO declared mpox a public health emergency in August 2024, the spread of the virus, particularly the Clade 1b strain in the DRC, has raised alarm across the globe. The new approval of the LC16m8 vaccine provides a crucial tool in curbing the spread of mpox and protecting vulnerable populations.
While the LC16m8 vaccine offers a promising solution, the WHO has issued important safety guidelines. The vaccine should not be used during pregnancy or by individuals who are immunocompromised. As the vaccine becomes available in outbreak regions, its use will be carefully managed to ensure the safety of recipients.
The approval of the LC16m8 vaccine is a vital development in the global response to the mpox outbreak. As the disease continues to affect countries worldwide, particularly in Africa, increasing access to vaccines like the LC16m8 will be crucial in reducing transmission and preventing further outbreaks. The donation of millions of doses to the DRC marks a significant milestone in the fight against this dangerous virus.
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