New Development Targets Prevention of Severe Respiratory Syncytial Virus Infections

The U.S. Food and Drug Administration (FDA) has granted approval for Pfizer’s RSV vaccine, Abrysvo, aimed at preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 18 to 59 who are at increased risk for severe disease.

### Background on CDC Recommendations

In June, the Centers for Disease Control and Prevention (CDC) updated its guidelines on RSV vaccinations. The agency currently recommends RSV vaccines for individuals aged 75 and older and for those aged 60 to 74 who face heightened risk of severe illness. While the FDA’s approval is a key step, the vaccine will not be available to the 18 to 59 age group until the CDC issues a formal recommendation.

### Clinical Trial Insights

The approval for Abrysvo in younger adults was based on findings from a late-stage clinical trial that assessed the safety and efficacy of two doses in immunocompromised adults aged 18 and older. Pfizer reported that the vaccine was well-tolerated, exhibiting a safety profile consistent with previous studies.

### CDC Advisory Meeting

CDC advisors are scheduled to review Pfizer’s data in an upcoming meeting later this week. However, a vote to extend the recommendation to younger adults is not expected at this time.

### Current Vaccine Approvals

As it stands, Pfizer’s RSV vaccine is approved for those aged 60 and older, as well as for pregnant women during the third trimester, providing protection to their infants against RSV.

### The Burden of RSV

RSV is known for causing cold-like symptoms but is also a significant contributor to pneumonia among toddlers and older adults. The virus is responsible for approximately 177,000 hospitalizations and 14,000 deaths annually in the United States.

This FDA approval represents a vital advancement in combating RSV, particularly for younger adults who may be at greater risk for severe complications from the virus.