THE World Health Organization (WHO) announced the MVA-BN vaccine as the first vaccine against it mpox which will be added to your default list.
The pre-selection approval is expected to facilitate early and increased access to this vital product in communities in urgent need, reduce transmission and help contain the outbreak. The WHO pre-selection assessment is based on information submitted by the manufacturer, Bavarian Nordic A/S, and the assessment by the European Medicines Agency, the regulatory body for the registration of this vaccine.
“This first pre-selection of the mpox vaccine is an important step in our fight against the disease, both in the context of current outbreaks in Africa and in the future,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, adding: “We now urgently need to scale up supplies, donations and development to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives.”
MVA-BN vaccine can be administered to persons over 18 years of age as a 2-dose injection 4 weeks apart. After prior refrigerated storage, the vaccine can be stored at 2–8°C for up to 8 weeks.
WHO Assistant Director-General for Access to Medicines and Health Products, Dr. Yukiko Nakatani, noted that WHO’s pre-selection of the MVA-BN vaccine will help accelerate the continued procurement of mpox vaccines by governments and international organizations such as Gavi and UNICEF to help communities on the frontlines of the ongoing emergency in Africa and beyond.
The decision may also help national regulatory authorities accelerate approvals, ultimately increasing access to quality-assured MPox vaccine products.
Available evidence on vaccine use
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization reviewed all available evidence and recommended the use of MVA-BN vaccine in the context of an mpox outbreak for individuals at high risk of exposure.
Although MVA-BN is not currently licensed for use in people under 18 years of age, this vaccine may be used “off-label” in infants, children and adolescents, and in pregnant women and immunocompromised individuals. This means that the vaccine is recommended for use in a focal setting where the benefits of vaccination outweigh the potential risks.
WHO also recommends using a single dose in outbreak situations with limited supply. WHO stresses the need to collect more data on the safety and efficacy of the vaccine in these cases.
Available data show that a single-dose MVA-BN vaccine administered pre-exposure has an estimated efficacy of 76% in protecting individuals against mpox, with the 2-dose regimen achieving an estimated efficacy of 82%. Post-exposure vaccination is less effective than pre-exposure vaccination.
The good safety profile and performance of the vaccine have been consistently demonstrated in clinical studies as well as in public use during the ongoing global epidemic from 2022 onwards. In light of the changing epidemiology and the emergence of new strains of the virus, it remains important to collect as much data as possible on the safety and efficacy of vaccines in different settings.
Since the initiation of emergency use listing for MPox vaccines by the WHO Director-General on 7 August 2024, WHO has been conducting product and scheduling evaluations of the MVA-BN vaccine.
According to Dr. Rogério Gaspar, Director of Vaccines Regulation and Prequalification at WHO, “the results of the assessment are particularly important in the context of the declaration of a Public Health Emergency of International Concern (PHEIC) related to the MPox outbreak in Africa.” Prequalification and emergency use registration procedures are therefore underway with the manufacturers of two other MPox vaccines: LC-16 and ACAM2000. “We have also received six expressions of interest for MPox diagnostic products for emergency use to date,” added Dr. Gaspar.
Successes in over 120 countries
The escalating mpox epidemic in the Democratic Republic of the Congo and other countries was declared a “public health emergency of international concern” by the WHO Director-General on 14 August 2024.
To date, more than 120 countries have confirmed more than 103,000 cases of MPOX since the start of the global epidemic in 2022. In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different cases in 14 countries in the African Region (based on data as of 8 September 2024).
In coordination with Member States, the World Health Organization (WHO) and partners have established a mechanism for access and distribution of mpox medical countermeasures, including vaccines, treatments and diagnostic tests. The Access and Allocation Mechanism (AAM) will increase access to these tools for those most at risk and ensure that limited resources are used efficiently and equitably.
This is part of the response to the Public Health Emergency of International Concern declared by WHO Director-General Dr Tedros Adhanom Ghebreyesus on 14 August 2024, following the outbreak of mpox in the Democratic Republic of the Congo and neighbouring countries. Fifteen countries in Africa have reported mpox this year. Recommendations issued following the opinion of the Emergency Committee on the International Health Regulations called on States Parties to ensure “equitable access to safe, effective and quality-assured antidotes for mpox”.