Moderna said it has filed a marketing application with the U.S. Food and Drug Administration for its updated COVID-19 vaccine, Spikevax.
The submission follows FDA guidance that the shots target strains in the JN.1 lineage, with a preference for the LP.8.1 variant. Government data show the LP.8.1 strain accounts for about 70% of COVID-19 cases in the U.S.
Moderna expects to launch the updated vaccine by mid-August, pending approval.
Currently, three COVID-19 vaccines are authorized in the U.S., including Moderna’s and Pfizer-BioNTech’s mRNA vaccines as well as Novavax’s protein-based shot.
Under new FDA leadership, vaccine makers face greater regulatory scrutiny and tighter requirements that could increase costs.
This week, the FDA said it plans to require new clinical trials for annual COVID-19 boosters in healthy Americans under 65, focusing on older adults and those at higher risk.
FDA vaccines regulator Vinay Prasad said all COVID vaccine makers will be asked to conduct placebo-controlled trials in healthy 50- to 64-year-olds and encouraged to do the same in young children.
Moderna did not specify the age range for the updated vaccine or whether new clinical trials were conducted.
