Moderna Anticipates Approval Decision for RSV Vaccine in May

Moderna’s experimental respiratory syncytial virus (RSV) vaccine is garnering high expectations from investors, according to a recent Biopharma Dive article.

The US Food and Drug Administration is expected to decide on the vaccine’s approval by the middle of May, the digital publication reported. The vaccine is delivered in a single-dose, prefilled syringe.

Both GSK and Pfizer currently offer RSV vaccines in the United States, but Moderna believes it has room to compete—particularly with a delivery method that, it maintains, is more convenient to administer, according to the report.

Last fall, the company downsized its COVID-19 vaccine manufacturing capacity to adjust to lower-than-expected vaccination rates in 2023. “2023 was a difficult year,” the article quoted Stéphane Bancel, CEO of Moderna, as saying in a prerecorded video for investors. “We managed a transition from a pandemic to endemic [market], which there was no playbook for.”

In addition to the RSV vaccine, Moderna is banking on vaccines for influenza and cytomegalovirus to contribute to its future growth, Biopharma Dive reported. A combination annual influenza and COVID-19 vaccine is also in the works.

The combination shot is “meant to be better suited to annual vaccinations in a world in which both viruses drive seasonal spikes in illness,” the article explained.

Reference

Pagliarulo N. Moderna pitches RSV shot, new vaccines after ‘difficult year of transition.’ Biopharma Dive. February 22, 2024. Accessed February 29, 2024. https://www.biopharmadive.com/news/moderna-covid-rsv-vaccine-q4-earnings-transition/708205/