Drug Approval | August 29, 2025
Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone
The agreement has an initial term until March 31, 2029 and no further details on the financial terms of the deal are being disclosed
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance
Announces changes to commercial organization to prepare for multiple product launches in 2024 and 2025
Supply readiness follows months of manufacturing to ensure timely and ample supply
The forecast across the seven years between 2022 and 2028 saw an average decline of 7%, resulting in a $10 billion drop in the total forecast sales between 2021 and 2028
mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
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