Moderna reaffirms 2024 product sales outlook

Moderna said: “The company is reaffirming its 2024 product sales outlook as it enters the second year of the U.S. commercial endemic COVID market with increased clarity of market size and dynamics. Moderna continues to focus on public health efforts to increase vaccination coverage rates globally for the 2024/2025 season to reduce the substantial burden of COVID-19. The company is also prioritizing key international markets for greater commercial focus and is participating in the EU Health Emergency and Response Authority’s tendering procedure for up to 36 million doses of mRNA COVID-19 vaccines per year for up to four years. The company continues to expect initial regulatory approvals of its RSV vaccine, mRNA-1345, starting in the first half of 2024… The PDUFA – Prescription Drug User Fee Act – action date for mRNA-1345 is May 12, 2024, by which time the Company expects the U.S. FDA’s response to its Biologics License Application. If the outcome is positive, the company anticipates that the U.S. CDC Advisory Committee on Immunization Practices will include mRNA-1345 on the agenda of its June 26-28 meeting. Assuming that corresponding marketing authorizations would be granted as expected, the company also plans to launch its RSV vaccine in Australia and Germany in 2024 and other markets in 2025 due to regulatory and tender timing.”