By Muhammad Amaan
The World Health Organisation (WHO) has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, making it the second mpox vaccine to be supported by WHO.
The world health body said on Tuesday in a statement that the decision was taken after its Director-General, Tedros Adhanom Ghebreyesus’ declaration of an mpox public health emergency of international concern (PHEIC) on August 14.
“This decision is expected to facilitate increased and timely access to vaccines in communities where mpox outbreaks are surging.
“In 2024, cases have been reported across 80 countries, including 19 countries in Africa, based on data as of October 31.
“The Democratic Republic of the Congo, the hardest-hit country, recorded a large majority of suspected cases more than 39,000, and more than 1,000 deaths.
“The Government of Japan has announced that it will donate 3.05 million doses of the LC16m8 vaccine, along with specialised inoculation needles, to the Democratic Republic of the Congo,” it said.
According to the statement, it is the largest donation package announced to date in response to the current mpox emergency.
“LC16m8 is a vaccine developed and manufactured by KM Biologics in Japan. The Technical Advisory Group (TAG) for EUL of vaccines convened to discuss the outcome of the LC16m8 vaccine review, including the product and programmatic suitability assessments.
“The TAG recommended the vaccine for use in individuals over one year of age as a single dose vaccine, via a multiple puncture technique using a bifurcated needle,” it said.
Meanwhile, Dr Yukiko Nakatani, WHO’s Assistant Director-General for Access to Medicines and Health Products said that listing marked a significant step in the response to the current emergency.
Dr Nakatani said that it would also provide a new option to protect all populations, including children.
“Vaccines are one of the important tools to help contain the outbreak as part of a comprehensive response strategy.
“The strategy also includes improved testing and diagnosis, treatment and care, infection prevention control, and engagement and education within affected communities.
“WHO’s assessment for EUL is based on information submitted by the manufacturer and review by the Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese regulatory agency of record for this vaccine.
“The LC16m8 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,” she said.
According to her, the WHO Strategic Advisory Group of Experts (SAGE) on Immunisation reviewed available evidence.
“It recommended the use of LC16m8 vaccine in outbreak settings in children and others with a documented high-risk of exposure to mpox.
“However, minimally replicating vaccines, such as LC16m8, will not be used during pregnancy and in people who are immunocompromised.
“Immunocompromised persons include those with active cancer, transplant recipients, immunodeficiency, and active treatment with immunosuppressive agents.
“They also include people living with HIV with a current CD4 cell count of <200 cells µl,” Nakatani said.
According to her, the Global Advisory Committee on Vaccine Safety reviewed the updated safety data on LC16m8 on Sept.20.
She said that the committee recommended that healthcare workers should be trained on the use of bifurcated needles to prevent injuries and adverse effects.
In light of the changing epidemiology and emergence of new virus strains, it remains important to collect as much data as possible on vaccine safety and effectiveness in different contexts.
“The WHO continues to work closely with manufacturers, global partners, and countries to ensure the availability and administration of safe and effective life-saving products,” she said.
Nakatani added that on September 13, WHO prequalified the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine and expanded its indication to include use in individuals aged 12 years and older on 8 October 2024.
