The EMA launched its PRIME scheme to enhance support and enable accelerated assessment for the development of medicines that target an unmet medical need. Only one in four requests for PRIME eligibility are granted, according to the EMA.
There is currently no approved vaccine for RSV and access to the scheme has been granted upon an assessment that the available clinical data overall shows the potential of MVA-BN-RSV, Bavarian Nordic’s vaccine candidate, to address the unmet medical need in the proposed target population.
RSV is a common and pervasive seasonal respiratory illness that is highly contagious. Infections occur in people of all ages and feels like a common cold for most young adults, but it can be life-threatening for infants, the immunocompromised and older adults…