Top Infectious Disease News Stories Week of February 15 - February 21

Infectious Disease Regulatory Watch: January Highlights

This is our new monthly column looking at federal regulatory topics including recent decisions, personnel changes, and news related to the agencies and infectious disease.

In this month's column, we look at the recommendation changes made by the CDC to the pediatric vaccine schedule, as well as the American Academy of Pediatrics' response with its own vaccine schedule.

Strong Second-Season RSV Protection Data for Monoclonal Antibody in High-Risk Young Children

Merck has announced positive new findings from the second respiratory syncytial virus (RSV) season of itsphase 3 SMART trial evaluating clesrovimab (Enflonsia) in infants and young children at increased risk for severe RSV disease. The results were presented at RSVVW’26, the 9th conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy, and will be shared with the FDA and other global regulators.

The SMART trial assessed the safety, efficacy, and pharmacokinetics of Enflonsia across 2 RSV seasons in vulnerable pediatric populations, including children born prematurely and those with chronic lung disease or congenital heart disease. New data focused on children under 2 years of age who remained at increased risk entering their second RSV season and received Enflonsia at the start of that season.

The Human and Financial Costs of Delaying Vaccines

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) was scheduled to meet February 25-27 to further discuss childhood vaccine schedules. It remains to be seen if the committee will meet on those dates or reschedule. Considering the massive changes and confusion sown in recent meetings, there are con

One of the ideologies this committee has put forth is the idea of looking at a risk-based approach to vaccines—without any data—compared with the universal approach, which has been in use for several years. The latter approach has been considered a public health success, especially because vaccine-preventable diseases have decreased over the years.

GSK Highlights Real-World Efficacy Data for Its RSV Vaccine

GSK has unveiled new real-world effectiveness data for Arexvy, its adjuvanted respiratory syncytial virus (RSV) vaccine, at RSVVW’26, the ninth conference of the Respiratory Syncytial Virus Foundation (ReSViNET), held in Rome, Italy. The company is presenting 19 abstracts at the congress and supporting an additional 3, underscoring its expanding role in RSV research and prevention.

Arexvy is approved for the prevention of RSV-related lower respiratory tract disease in adults 60 years or older as well as adults aged 50 to 59 years who are at increased risk. RSV remains a significant cause of hospitalization among older adults, particularly during winter respiratory virus seasons, placing strain on both patients and health care systems.

Reversing Course, FDA Will Now Review Moderna's Influenza Vaccine

After refusing to review Moderna’s investigational influenza vaccine, mRNA-1010, the company announced today that the US Food and Drug Administration (FDA) will initiate a formal review of its biologics license application following a constructive Type A meeting with regulators. The FDA’s Center for Biologics Evaluation and Research has now accepted the amended submission and assigned a Prescription Drug User Fee Act goal date of August 5, 2026.

The review marks a significant turnaround after the FDA previously issued a refusal-to-file letter, citing the need for additional clarification on the regulatory approach. In response, Moderna proposed a revised pathway that differentiates approval by age group. Under the amended strategy, the company is seeking full approval for adults aged 50 to 64 years and accelerated approval for adults 65 years or older, coupled with a postmarketing commitment to conduct an additional study in older adults.