Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the US Food and Drug Administration (FDA) for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease.
This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure.
Overall, it is estimated that RSV infections in older adults account for approximately 60,000 to 160,000 hospitalisations and between 6,000 and 10,000 deaths each year in the US.
Pfizer’s application was supported by results from the ongoing phase 3 RENOIR trial, designed to assess the efficacy, immunogenicity and safety of a single dose of the vaccine – to be sold under the brand name Abrysvo – in adults aged 60 years and older.
At an interim analysis, the study showed the vaccine was 85.7% effective among participants with two or more symptoms of RSV, and 66.7% for two or more symptoms.
Annaliesa Anderson, senior vice president and chief scientific officer, vaccine research and development at Pfizer, said: “A vaccine to help prevent RSV had been an elusive public health goal for more than half a century… Abrysvo will address a need to help protect older adults against the potentially serious consequences of RSV disease.”
The approval comes less than a month after the FDA approved GSK’s RSV vaccine, Arexvy, also for adults aged 60 years and older.
The US Centers for Disease Control and Prevention’s advisory committee is set to meet later this month to discuss the vaccines which, pending sign off, are expected to be available for older adults in the US before the next RSV season.
Pfizer is also pursuing regulatory applications for its maternal RSV vaccine candidate to help protect infants against the complications of the disease.
The candidate was recommended for approval last month by an FDA panel of experts, which voted that the available data supported the efficacy and safety of RSVpreF.
The FDA will now consider the panel’s advice as it makes a decision regarding the potential approval of the vaccine, with a decision expected in August.