Europe regulator advises intradermal use of Bavarian Nordic monkeypox shot to boost supply

seekingalpha2022-08-19

An emergency task force of Europe's drug regulator has recommended the intradermal use of Bavarian Nordic's (OTCPK:BVNKF) (OTCPK:BVNRY) Jynneos monkeypox vaccine at a lower dose in a bid to increase ...

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Jynneos is only approved for use as a subcutaneous injection, or an injection under the skin. By giving it intradermally - just below the top layer of the skin - less amount of vaccine is needed.  \"People receiving the vaccine intradermally received one fifth (0.1 ml) of the subcutaneous dose (0.5 ml) but produced similar levels of antibodies to those who received the higher subcutaneous dose,\" the European Medicines Agency (EMA) said in a statement on Friday. The U.S. FDA on Aug. 9 issued an emergency use approval for Jynneos to be used intradermally, citing a 2015 study that found the shot provided a similar immune response to subcutaneous administration. The EMA's emergency task force made its decision based on a review of data from a trial with around 500 adults. It cautioned that there was a higher risk of local reactions such as longer-lasting redness or discoloration of the skin after intradermal injections.  Reuters on Aug. 10 had reported that European Union officials will also be weighing a \"dose-sparing\" approach to stretch out scarce monkeypox vaccine supplies. 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