Bavarian Nordic A/S announced that the company has obtained prequalification from the World Health Organization (WHO) for IMVANEX® (MVA-BN®), the first smallpox vaccine to be added to the WHO prequalification list. MVA-BN is indicated for active immunization against smallpox, variola and orthopoxvirus infections and diseases in all adults aged 18 years and older. However, according to WHO recommendations, MVA-BN may be used “off-label” in infants, children and adolescents, as well as in pregnant women and immunocompromised individuals during disease outbreaks, when the benefits of vaccination outweigh the potential risks1.
Prequalification or, secondarily, Emergency Use Listing is a prerequisite for the purchase and distribution of vaccines in African countries by governments and organizations such as Gavi, UNICEF and others. While WHO’s intention was to assess smallpox vaccines for Emergency Use Listing, the agency determined that MVA-BN met the criteria for full prequalification. This assessment is based on information submitted by Bavarian Nordic, including certifications, assessment reports and positive opinions issued by the European Medicines Agency (EMA), which is the competent regulatory agency for the vaccine. Earlier this week, MVA-BN also received provisional authorization from New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) and full approval from Mexico’s Federal Committee for Protection against Health Risks (COFEPRIS).
