(Reuters) -Moderna said on Friday it has filed a marketing application for the review of its updated COVID-19 vaccine with the U.S. Food and Drug Administration.
The company said the submission for the vaccine, branded as Spikevax, is based on guidance from the FDA, which advised that the shots should be updated to target strains that are a part of JN.1 lineage, with a preference for the LP.8.1 variant.
Government data indicate the LP.8.1 strain — a subvariant of the previously targeted JN.1 strain — accounts for about 70% of total cases in the U.S.
Three COVID-19 shots have been authorized for use in the U.S. — Moderna (NASDAQ:MRNA) and Pfizer-BioNTech’s/ messenger RNA-based vaccines as well as Novavax (NASDAQ:NVAX)’s protein-based shot.
Moderna expects to launch the updated vaccine by mid-August.
Under the new FDA leadership, COVID vaccine makers are seeing greater regulatory scrutiny and facing tighter requirements for their shots that could increase their expenses.
Earlier this week, the FDA said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively limiting them to older adults and those at risk of developing severe illness.
Top U.S. vaccines regulator Vinay Prasad said all the COVID vaccine makers will be asked to conduct placebo-controlled trials in healthy 50- to 64-year olds and encouraged to conduct them in very young children.
Moderna did not disclose the age range the updated vaccine will target and did not mention if any additional clinical trials were conducted for it.