WHO Pre-Qualifies First Mpox Vaccine, Recommends Single Dose and ‘Off-Label’ Use for Children/
Bavarian Nordic’s MVA-BN vaccine, has become the first mpox vaccine to be added to the World Health Organization (WHO) prequalification (PQ) list, enabling its use globally. The WHO has also recommended that single doses be given in supply-constrained outbreak situations instead of the usual two doses, and “off label” use for children as the vaccine is not yet approved for under-18s. WHO Prequalification (PQ) and Emergency Use Listing (EUL) are mechanisms used to evaluate quality, safety and efficacy of medical products, such as vaccines, diagnostics and medicines, and product suitability for use in low- and middle-income countries. “PQ is based on the review of full set of quality, safety and efficacy data on medical products, including risk management plan and programmatic suitability,” according to a Friday media release from WHO. “WHO’s assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic, and review by the E...
