MHRA broadens Pfizer Abrysvo licence to include RSV disease prevention

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer’s (NYSE: PFE) extension to the licence of the Abrysvo (respiratory syncytial virus vaccine (bivalent, recombinant) to include the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18-59 years of age who are at increased risk for lower respiratory tract disease caused by RSV.

Hetal Naik, primary care lead, Pfizer UK said: “Anyone of any age can catch RSV, and whilst most people will get better on their own, there are some who remain more at risk. Our RSV vaccine is already available through the national immunization program to help protect newborns through maternal immunization and older adults, with growing real-world evidence demonstrating its positive impact on reducing NHS pressures. As the evidence base continues to grow, these real-world findings will be key to help guide future decisions on eligibility, ensuring that those at greatest risk of severe RSV disease can benefit from vaccination.”

The licence extension was based on positive data from Pfizer's clinical trials, which demonstrated the efficacy of Pfizer's RSV vaccine in preventing RSV-associated LRTD in adults aged 18-59 years considered to be at high risk of developing severe lower respiratory tract disease caused by RSV. The RSV vaccine was generally well-tolerated, with a safety profile consistent with that observed in older adults.