RSV

Following news of RSV lower respiratory tract infections in infants immunized with Moderna’s investigational RNA vaccines, FDA advisors said the trial investigators should continue the study, while keeping an eye out for further safety signals.

A judge in the U.K. last month sided with Pfizer over GSK in a respiratory syncytial virus vaccine patent lawsuit, positioning both companies to compete for that market and laying down a marker for ongoing legal clashes in other parts of the world.

While Moderna’s Spikevax beat Wall Street estimates in the third quarter, William Blair analyst Myles Minter in a Thursday note to investors said sales of the company’s respiratory syncytial virus vaccine mRESVIA was significantly lower than expected.

The French drugmaker’s newly launched respiratory syncytial virus antibody Beyfortus far exceeded analyst expectations, bringing in almost $700 million in the third quarter. Leerink Partners analyst David Risinger in a Friday note to investors said Sanofi expects Q4 Beyfortus sales similar to Q3.

The CDC’s vaccine advisors on Thursday maintained that respiratory syncytial virus immunization is only recommended for adults aged 75 and older, and in seniors 60 to 74 years who are at risk of severe disease.

Pfizer’s Abrysvo is the first respiratory syncytial virus vaccine that can be used for adults less than 50 years of age. Tuesday’s label expansion covers younger adults who are deemed at higher risk of RSV-related lower respiratory tract disease.

This week marked the start of the third-quarter earnings season, with Johnson & Johnson exceeding Wall Street’s expectations. Pfizer is projected to have a strong quarter, while Eli Lilly could pull ahead of Novo Nordisk in the obesity space. Moderna, by contrast, has a decidedly negative outlook.

Merck’s investigational antibody clesrovimab demonstrated more than 60% effectiveness in reducing some types of respiratory syncytial virus-associated infections in infants, while Pfizer’s RSV vaccine Abrysvo showed 90% effectiveness at preventing the most severe RSV cases in adults 60 years and older.

The lawsuits claim that Moderna used and profited from crucial mRNA technology in its COVID-19 vaccine Spikevax and respiratory syncytial virus shot mResvia.

If approved, the co-administration of Arexvy and Shingrix could provide a more convenient vaccination regimen for patients and potentially bolster GSK’s faltering sales for both vaccines.