---

After prequalification of MVA-BN on 13 September 2024, the LC16m8 jab has become the second mpox vaccine to be approved by the World Health Organization (WHO) for emergency use listing (EUL).

While prequalification is predicated on the evaluation of the complete set of quality, safety, and efficacy data of health products, including programmatic suitability and risk management plans, EUL is a risk-benefit analysis that is used to handle urgent demands during public health emergencies.  

Emergency use listing is triggered when the benefits outweigh risks with the current available data.

Health products that receive prequalification or emergency use listing help the United Nations (UN), partner procurement agencies, and member states make decisions on national, regional, and international procurement.

Key numbers

Beginning in January and leading up to 31 October 2024, mpox cases have been reported across 80 countries, including 19 countries in Africa.

Despite being endemic in the Democratic Republic of Congo (DRC), the over 39,000 suspected cases and more than 1000 fatalities are numbers that have concerned the entire world.

As a result, this heavy disease burden experienced in the central African country and other parts of the world led to the WHO’s Director-General’s declaration of an mpox public health emergency of international concern (PHEIC) on 14 August 2024.

---

RELATED: Big step as WHO prequalifies the first vaccine against mpox

---

About the vaccine

The vaccine LC16m8 was developed and produced in Japan by KM Biologics.

After careful evaluation of data sourced from the manufacturer and review by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, WHO’s Technical Advisory Group for EUL of vaccines recommended use of the jabs in individuals over one year of age as a single-dose vaccine.

In addition, the WHO Strategic Advisory Group of Experts on Immunization reviewed available evidence and approved the use of the LC16m8 vaccine in outbreak settings in children and others with a documented high risk of exposure to mpox.

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

LC16m8 is not recommended in immunocompromised individuals, including active cancer, transplant recipients, immunodeficiency, active treatment with immunosuppressive agents, or those living with HIV having a CD4 count of less than 200 µl.

With this listing, the Government of Japan has pledged 3.05 million doses of the vaccine along with the requisite specialized bifurcated needles for inoculation to the DRC, being the hardest-hit country as a result of the outbreak.

Importance of vaccination

Vaccination, particularly in groups considered to be at high risk, has been recommended as a key strategy in fighting the spread of the mpox virus. Together with efficient testing and diagnosis, clinical care, and infection prevention initiatives, vaccination can be a powerful tool in reducing morbidity and mortality of the disease.

About the Monkeypox virus

Monkeypox is a disease caused by the Mpox virus, a genus of the Orthopoxvirus and having two distinct subtypes referred to as genetic clades I and II.

Clade I is endemic in Central Africa, while II is in West Africa.

Notably, the ongoing global outbreak is due to the clade II subtype.

Typical symptoms of the disease include mucosal lesions, rash, muscle aches, headache, and fever. Transmission occurs through physical contact with infected humans or animals, as well as contact with infected surfaces.

---

Did you find find this insightful? Subscribe for more.

---