GSK marketing authorisation application for RSV older adult vaccine accepted by EMA under accelerated assessment

MAAs may be eligible for accelerated assessment if the EMA's Committee for Medicinal Products for Human Use decides the product is of major interest for public health and therapeutic innovation. A European regulatory decision is anticipated in Q3 2023. If approved, GSK's RSV older adult vaccine candidate has the potential to be the vaccine available to help protect older adults from RSV lower respiratory tract disease (LRTD).

The MAA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, which showed high overall vaccine efficacy against RSV LRTD in adults aged 60 years and above. The vaccine was well tolerated with a favourable safety profile. Consistent high vaccine efficacy was observed against LRTD in severe disease, adults aged 70-79 years, adults with underlying comorbidities, and across RSV A and B strains.

This is the second major regulatory development for GSK's RSV older adult vaccine candidate following Japanese regulatory submission acceptance in October 2022. GSK's RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant. There are currently no RSV vaccines for older adults approved anywhere in the world.

RSV is a common contagious virus affecting the lungs and breathing passages. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment available for adults. In adults, RSV infection is typically mild, but may lead to severe outcomes. Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including chronic obstructive pulmonary disease, asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.