Smallpox Vaccine Review Extended by FDA

Bavarian Nordic MVA-BN smallpox vaccine is based on a live, attenuated vaccinia virus, unable to replicate in humans

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Bavarian Nordic announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the review of the Company’s Biologics License Application (BLA) for the liquid-frozen formulation of the MVA-BN® smallpox vaccine will be extended by 3 months. 

The BLA was granted a priority review by the FDA in December 2018, originally targeting a 6-month review process. 

However, the FDA has assessed that due to the amount of data submitted during the review phase, the agency now requires more time, and has extended the target PDUFA action date to September 2019. 

The MVA-BN smallpox vaccine is based on a live, attenuated vaccinia virus, unable to replicate in humans. 

Smallpox, caused by the variola virus, was a highly contagious infectious disease that caused infected individuals to develop a fever and a progressive, disfiguring skin rash. And, those who survived were usually left with scars, which were sometimes severe, says the Centers for Disease Control and Prevention (CDC). 

Smallpox vaccines are important since on average, 3 out of every 10 people who got it died. 

Bavarian Nordic has already delivered 28 million doses of the liquid-frozen MVA-BN smallpox vaccine to the U.S. Strategic National Stockpile for emergency use in people with compromised immune systems. 

The liquid-frozen version of the MVA-BN vaccine is currently approved in the EU under the trade name IMVANEX® for active immunization against smallpox of the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis). 

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And, in Canada MVA-BN is approved under the trade name IMVAMUNE® for active immunization against smallpox in a public health emergency of persons 18 years of age and older who are contraindicated to replicating smallpox vaccines. 

On January 19th, 2019, the U.S. Biomedical Advanced Research and Development Authority (BARDA) exercised another option under an ongoing contract for freeze-dried MVA-BN® smallpox vaccine.   

Additionally, on September 19th, 2018, Public Health England (PHE) said that the IMVANEX smallpox vaccine will be used to vaccinate healthcare workers treating English patients and those involved in monkeypox cases. 

Monkeypox is a febrile rash illness caused by the monkeypox virus. 

At this time, there are no PHE approved vaccines for the prevention of monkeypox. 

In 2019, Bavarian Nordic will initiate a Phase 3 lot consistency study of the freeze-dried formulation to support the approval of this formulation. 

Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safer therapies against cancer and infectious diseases.