Bavarian Nordic has announced that the European Medicines Agency (EMA) has granted access to its priority medicines (PRIME) scheme for MVA-BN RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults ≥60 years of age.
There are no approved vaccines for RSV, and access to PRIME has been granted upon an assessment that the available clinical data overall show the potential of MVA-BN-RSV to address the unmet medical need in the proposed target population, describes the company.
“These grants highlight the potential of our vaccine to fulfil the significant unmet need for a preventative therapy, particularly for the elderly who may be at risk from serious complications from RSV.”
“Following the grant of a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) earlier this year, we are proud to receive eligibility for PRIME access for our RSV vaccine candidate, enabling us to pursue accelerated development and review processes with the regulatory authorities in both U.S. and Europe. These grants highlight the potential of our vaccine to fulfil the significant unmet need for a preventative therapy, particularly for the elderly who may be at risk from serious complications from RSV. As we continue the enrolment into the global Phase 3 trial of the vaccine, we look forward to working closely with both EMA and the FDA on accelerating the pathway towards approval,” says Paul Chaplin, President and CEO of Bavarian Nordic.
Photo of Paul Chaplin: Bavarian Nordic