FDA unveils game-changing revisions to Moderna vaccine
Shot can remain at room temperature for 24 hours; 15 doses can be extracted with upcoming new vial
Moderna revealed that based on submitted stability data, the FDA has authorized its Covid-19 vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for up to 24 hours, an increase from the previous 12 hours. Further, a punctured vial is now useable for up to 12 hours, up from the previous six hours. These new guidelines are now reflected in an updated emergency use authorization (EUA) label.
FDA has also authorized a new vial with a maximum of 15 doses, which is expected to start shipping in the coming weeks. The agency also authorized a maximum of 11 doses of its vaccine in the current format, up from the previously authorized 10 doses per vial.
Moderna, with its two-dose jab, possesses one of three Covid vaccines authorized for emergency use in the US, alongside that of Pfizer-BioNTech (two doses) and Johnson & Johnson (one dose).
FDA Approves Actemra Biosimilar
January 31st 2025Celltrion’s Avtozma has been indicated for the treatment of giant cell arteritis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, systemic juvenile idiopathic arthritis, and COVID-19—in the same dosages and formulations as its tocilizumab reference product.
