From CNBC: 2024-05-31 11:42:50

The FDA approved Moderna’s RSV vaccine for adults over 60, marking the company’s second product in the U.S. market. The vaccine, named mRESVIA, is the first mRNA shot approved for a disease other than Covid. The approval comes after a late-stage trial showed the shot’s efficacy against RSV, a virus causing thousands of deaths and hospitalizations among seniors annually.

Moderna’s RSV vaccine will compete against shots from GSK and Pfizer, with an advisory panel to the CDC set to vote on usage recommendations in June. The company expects a positive recommendation, aiming to boost revenue beyond its declining Covid jab. Moderna forecasts $4 billion in sales for 2024, demonstrating growth potential beyond Covid with its mRNA platform.

Investors see promise in Moderna’s diverse product pipeline, including a combination shot for Covid and flu and collaborations for cancer vaccines. The biotech company aims for sales growth in 2025 and profitability by 2026 with new product launches. Despite delays and efficacy decline concerns, Moderna’s mRNA technology remains key in addressing public health threats.

Initial plans for FDA approval in May were delayed due to administrative constraints, eventually granting approval following an 83.7% efficacy rate in preventing RSV symptoms. Concerns arose over the shot’s declining efficacy over months compared to competitors. Moderna defended the vaccine’s differences in trial design, highlighting its safety profile with mostly mild side effects reported.



Read more at CNBC: FDA approves Moderna RSV vaccine for seniors