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WHO prequalifies the first mpox vaccine
The World Health Organization (WHO) has announced the MVA-BN vaccine as the first mpox vaccine to be added to its prequalification list.
The prequalification approval is expected to provide timely and increased access to this vital product in communities in urgent need, reduce transmission and help contain the outbreak. The WHO assessment for requalification is based on information provided by the manufacturer, Bavarian Nordic A/S, and a review by the European Medicines Agency, the vaccine's record-keeping regulatory agency.
“This first prequalification of a measles 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. “We now need an urgent increase in procurement, donations and deployment to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives.”
The MVA-BN vaccine can be administered to people over 18 years of age as an injection of 2 doses 4 weeks apart. After prior cold storage, the vaccine can be stored at 2–8°C for up to 8 weeks.
“The prequalification of the MVA-BN vaccine by WHO will help accelerate the ongoing procurement of measles vaccine by governments and international agencies such as Gavi and Unicef to help communities on the front lines of the current crisis in Africa and beyond,” she said. Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “The decision may also help national regulatory authorities expedite approvals, ultimately increasing access to quality-assured measles vaccine products.”
The World Health Organization's Strategic Advisory Group of Experts (SAGE) on Immunization reviewed all available evidence and recommended use of MVA-BN vaccine in the context of mppox outbreaks for persons at high risk of exposure. Although MVA-BN is not currently approved for use in persons under 18 years of age, this vaccine may be used “off-label” in infants, children, and adolescents, as well as in pregnant women and immunocompromised individuals. This means that the use of the vaccine is recommended in outbreak conditions where the benefits of vaccination outweigh the potential risks.
WHO also recommends the use of a single dose in outbreak situations with limited supply. WHO emphasizes the need to collect additional data on the safety and efficacy of vaccines in these circumstances.
Available data indicate that a single-dose MVA-BN vaccine given before exposure has an estimated efficacy of 76% in protecting humans against mpox, while a 2-dose schedule achieves an estimated efficacy of 82%. Post-exposure vaccination is less effective than pre-exposure vaccination.
The good safety profile and efficacy of the vaccine have been consistently demonstrated in clinical studies as well as in real-world use during the global epidemic that has been ongoing since 2022. In light of epidemiological changes and the emergence of new virus strains, it remains important to collect as much data as possible on the safety and efficacy of vaccines in different contexts.
Since the launch of the emergency use list for measles vaccines by the WHO Director-General on 7 August 2024, the WHO conducted an assessment of the suitability of the MVA-BN vaccine product and program.
“The findings of the assessments are particularly relevant in the context of the declaration of a Public Health Emergency of International Concern (PHEIC) related to the increase in measles in Africa,” said Dr. Rogerio Gaspar, WHO Director of Regulation and Retraining. “We are moving forward with prequalification and emergency listing procedures with the manufacturers of two other mpox vaccines: LC-16 and ACAM2000. We have also received 6 expressions of interest so far for mpox diagnostic products for emergency use.”
On August 14, 2024, the WHO Director-General declared the escalating measles outbreak in the Democratic Republic of Congo and other countries a PHEIC.
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 various epidemics in 14 countries in the African region (based on data as of September 8 2024).
Editor's note:
WHO Prequalification (PQ) and Emergency Use Listing (EUL) are mechanisms used to assess the quality, safety and efficacy of medical products, such as vaccines, diagnostics and drugs (optional: including biotherapeutics), and the suitability of products for use in low and middle income country context. PQ or EUL listed products assist in international, regional and national procurement decisions by UN and partner procurement agencies and Member States. The PQ is based on a review of the entire data set on the quality, safety and efficacy of medical products, including a risk management plan and programmatic suitability. EUL is a risk-benefit assessment to address urgent requirements during public health emergencies based on the limited data available. Under the EUL, manufacturers are required to commit to continuing to generate missing information to meet prequalification requirements. Once this information is available, a PQ request must be submitted to complete the entire process to obtain a referral for international procurement in emergency and non-emergency situations.
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Sources 2/ https://www.who.int/news/item/13-09-2024-who-prequalifies-the-first-vaccine-against-mpox The mention sources can contact us to remove/changing this article |
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