Imvanex regulatory update

EMA's CHMP issued a positive opinion recommending approval of an MAA from Bavarian for its Imvanex smallpox vaccine. The third-generation modified vaccinia Ankara (MVA) virus vaccine is recommended for use under exceptional circumstances for primary vaccination or booster vaccination against smallpox in adults, including those with immunodeficiencies. The committee recommended use of Imvanex under exceptional circumstances because of a lack of comprehensive efficacy and safety data, citing the rarity of the condition and the fact that clinical trials cannot be carried out.

In April, HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded Bavarian a contract valued at up to $228 million to supply 8 million doses of the smallpox vaccine to the U.S. Strategic National Stockpile. Bavarian has been delivering the vaccine, which is known as Imvamune in the U.S., to the U.S. stockpile since 2010 under a separate 2007 contract to supply 20 million doses of the vaccine (see BioCentury, April 22). ...