WHO prequalifies Bavarian Nordic's vaccine as first shot against mpox [Seeking Alpha]
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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Source: Seeking Alpha
WHO's assessment for prequalification is based on data submitted by Bavarian Nordic and review by the European Medicines Agency, the regulatory agency of record for this vaccine. “This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. The approval will help accelerate access to the vaccine for all African countries. WHO Prequalification and Emergency Use Listing are mechanisms used to evaluate quality, safety and efficacy of medical products for use in developing countries. MVA-BN (or Modified Vaccinia Ankara-Bavarian Nordic) is indicated for active immunization against smallpox, mpox, and related orthopoxvirus infections and disease in all adults 18 years of age and older. According to recommendations from the WHO, the vaccine may however be used “off-label” in infants, children and adolescents,
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