Bavar­i­an Nordic's Dan­ish fa­cil­i­ty gets FDA thumbs up to ex­pand mon­key­pox vac­cine pro­duc­tion

With the WHO de­clar­ing the mon­key­pox out­break a glob­al health emer­gency, the FDA has now signed off on a Bavar­i­an Nordic man­u­fac­tur­ing fa­cil­i­ty that will in­crease the pro­duc­tion of the on­ly vac­cine.

On Wednes­day, Bavar­i­an Nordic an­nounced the ap­provals from the FDA and EMA to man­u­fac­ture the Jyn­neos small­pox vac­cine at its fill-fin­ish fa­cil­i­ty in Den­mark. With the ap­provals in hand, the com­pa­ny is now al­lowed to de­liv­er the vac­cine man­u­fac­tured at its site to the US and the EU. The in­spec­tions were com­plet­ed with no ob­ser­va­tions made by the reg­u­la­tors.

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