Second mpox vaccine wins FDA approval - European Medical Journal

Second mpox vaccine wins FDA approval

stamp of approval
Words by Jade Williams

As the new strain of mpox continues to spread across Africa, with a handful of cases now recorded in Europe, the FDA has formally approved Emergent BioSolutions’ smallpox and mpox vaccine for use in preventing the virus in people at high risk of infection.  

This is the second smallpox vaccine to receive an additional indication for mpox, following the approval of Bavarian Nordic’s smallpox/mpox vaccine, and it is a welcome addition to the global defense against the virus. 

Joe Papa, President and CEO, Emergent BioSolutions, highlighted the importance of this approval in the company’s press release, noting that the indication “comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases”.  

The injection, originally approved in 2007 for smallpox prevention, has now been validated for mpox based on an animal study and existing human safety data. The vaccine is administered by pricking the skin several times with a bifurcated needle dipped in the vaccine solution. 

In a partnership with US government, Emergent BioSolutions will donate 50,000 doses of its vaccine through the humanitarian organisation Direct Relief to countries severely affected by the outbreak. These include the Democratic Republic of Congo, Burundi, Kenya, Rwanda and Uganda.   

With the new strain of mpox posing an escalating threat, the expanded use of Emergent’s vaccine is an important tool in the global effort to control the virus and prevent further spread. 

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