US FDA Approves Moderna’s RSV Vaccine

US FDA Approves Moderna’s RSV Vaccine

The US Food and Drug Administration has given the green light to Moderna’s respiratory syncytial virus (RSV) vaccine, marking a significant milestone for the company. Moderna announced the approval on Friday, paving the way for a potential boost in revenue from this new product.

RSV is a virus that can lead to severe respiratory illness, particularly in young children and older adults. With about 14,000 deaths annually in adults aged 65 and older, the approval of Moderna’s vaccine for this age group is a crucial step in combating the impact of the virus.

Moderna’s RSV vaccine, known as mRESVIA, is the first mRNA-based vaccine not related to COVID-19 to receive FDA approval in the United States. Utilizing mRNA technology, this vaccine aims to teach the body to produce specific proteins that can help the immune system identify and combat the virus.

CEO Stephane Bancel expressed optimism about the approval, stating that it highlights the potential of Moderna’s mRNA platform to address various diseases. Analysts forecast strong sales for the RSV vaccine, with expectations reaching $830.5 million in the coming year.

The approval sets the stage for Moderna to enter the fall vaccination campaign, competing with market leaders GSK and Pfizer. Both companies have already launched their RSV vaccines, with GSK’s Arexvy approved for adults aged 60 and over, and Pfizer’s Abrysvo catering to older adults and pregnant women.

Despite initial setbacks in efficacy data compared to competitors, Moderna remains optimistic about the impact of its RSV vaccine. With the upcoming vote by the CDC on vaccine recommendations, the company is poised to make a significant impact in the fight against RSV.