MVA-BN RSV is our product candidate for the prevention of RSV (Respiratory Syncytial Virus). The vaccine incorporates five different RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural response to an RSV infection.
We have rapidly advanced the clinical development of the vaccine and have generated highly promising Phase 2 results, confirming both broad and durable antibody and T cell responses against RSV, as well as mucosal immune responses that may be important for protection against RSV. The Phase 2 program in elderly included a revaccination of subjects after one year, following which the immune responses were rapidly and significantly increased, notably in subjects with the weakest immunity prior to the booster vaccination.
Discussions are ongoing with the FDA about the requirements for U.S. licensure of MVA-BN RSV in elderly, and during 2019, we expect clarity on the design of Phase 3, which is planned for initiation in 2020.
RSV (respiratory syncytial virus) has been recognized as a significant cause of respiratory illness in all age groups. It is highly infectious and the most common cause of lower respiratory tract infection in infants and children worldwide, resulting in a high number of hospitalizations. RSV infections are also a serious health concern in the elderly and in adults with cardiopulmonary disease.
According to estimates from WHO, RSV infects more than 64 million people globally each year and causes a similar number of deaths as influenza, yet unlike influenza, there is no vaccine to prevent RSV.
There are only two subtypes of RSV, A and B, which are typically present either simultaneously or alternately during yearly epidemics.