GSK Expands Regulatory Approval for RSV Vaccine

The U.K. pharmaceutical company, GSK, is seeking to broaden the regulatory approval for its new respiratory syncytial virus (RSV) vaccine to include younger adults. This move comes as other manufacturers face shortages of their RSV products across the U.S.

The First Approved RSV Vaccine

This fall marks a significant milestone as RSV vaccines gain approval for specific age groups. While this common respiratory virus typically leads to mild illness in healthy adults, it can cause severe infections in infants and seniors.

Strong Uptake for GSK’s RSV Vaccines

Despite a lukewarm recommendation from the influential vaccines advisory committee of the Centers for Disease Control and Prevention (CDC), analysts and executives report strong uptake of GSK’s and Pfizer’s RSV vaccines targeting older adults.

Limited Supply of Infant RSV Shot

On Monday, the CDC highlighted the limited supply of a new shot called Beyfortus, developed by Sanofi and AstraZeneca, which prevents RSV in infants. As a result, doctors are advised to ration available doses and prioritize the highest-risk infants for vaccination.

Promising Future for RSV Prophylactics

Considering the high demand for RSV prophylactics, GSK anticipates peak sales of over £3 billion ($3.6 billion) for its RSV shot, Arexvy. Similarly, Pfizer predicts its RSV shot, Abrysvo, will generate annual sales exceeding $2 billion.

It is evident that the expansion of regulatory approval for GSK’s respiratory syncytial virus vaccine offers hope in combatting the impact of this harmful respiratory virus on a wider population.

RSV Vaccine Rollout Progress: Pfizer and GSK Q3 Earnings Report

Investors eagerly await updates on the progress of the RSV vaccines as Pfizer and GSK prepare to release their third-quarter earnings reports. Pfizer is scheduled to report on Tuesday, while GSK will follow on Wednesday. According to prescription data, Pfizer’s vaccine has already secured approximately 35% of the market, with GSK’s vaccine accounting for the remainder.

GSK’s focus is on expanding vaccine approval to include younger adults. In a recent announcement, the company revealed positive results from a Phase 3 study, demonstrating similar immune responses among adults aged 50 to 59 compared to those aged 60 and above. With intentions of being the first company to provide regulators with data for this age group, GSK anticipates approval as early as next year.

Highlighting the significance of the findings, GSK’s chief scientific officer, Tony Wood, stated, “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD.”

In June, the CDC’s vaccine advisors issued a recommendation allowing adults aged 60 and above to “may receive” an RSV vaccine if deemed appropriate by both the individual and their physician. However, analysts and investors had anticipated a stronger recommendation from the advisory committee. To address this, the same committee will convene this week to review additional data and potentially strengthen the recommendations for this age group.

While anticipation builds, Pfizer shares saw a slight decline of 0.6%, and GSK’s American depositary receipt experienced a modest drop of 0.1% on Wednesday.