GSK’s Marketing Authorization Application (MAA) for its respiratory syncytial virus (RSV) older adult vaccine candidate has been accepted by the European Medicines Agency (EMA) under accelerated assessment, the company announced, with a decision expected in the third quarter of 2023.
There is currently no US approved vaccine for RSV, a contagious virus characterised by several cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for children and older adults, according to the Centers for Disease Control and Prevention.
The submission is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 phase 3 trial, which demonstrated overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (LRTD) in adults aged 60 years and older.
Consistent high vaccine efficacy was also observed across a range of pre-specified secondary endpoints, underlining the impact the vaccine candidate could have on the populations most at risk of the severe outcomes of RSV.
Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee, was 94.1%. In participants with pre-existing comorbidities, such as underlying cardiorespiratory and endocrine metabolic conditions, vaccine efficacy was 94.6%, with 93.8% efficacy observed in adults aged 70 to 79 years.
The vaccine was well tolerated with a favourable safety profile, the company reported, and the observed solicited adverse events were typically mild-to-moderate, with the most frequent being injection site pain, fatigue, myalgia and headache.
The EMA’s acceptance is the second major regulatory development for GSK’s RSV older adult vaccine candidate following Japanese regulatory submission acceptance in October 2022.
Pfizer is also working on regulatory submissions for its bivalent RSV candidate, RSVpreF. The company announced positive phase 3 results in August, showing the vaccine was 85.7% effective among participants aged 60 years and older with three or more symptoms, and 66.7% for two or more symptoms, according to an interim analysis carried out by an external data monitoring panel. The vaccine was well-tolerated and no safety concerns were observed.
For the prevention of RSV disease in newborns and children, AstraZeneca and Sanofi’s Beyfortus (nirsevimab) was recommended for conditional marketing authorisation (CMA) in the EU. If approved, the long-acting antibody would be the first broadly protective option for newborns and infants, including those born healthy, at term or preterm, or with specific health conditions.