Moderna Inc. has submitted a marketing application to the U.S. Food and Drug Administration (FDA) for the review of its updated COVID-19 vaccine, the company announced Friday. The updated shot, branded as Spikevax, is designed to target newer variants of the virus, specifically those within the JN.1 lineage, with a particular focus on the LP.8.1 subvariant.

According to U.S. government data, the LP.8.1 strain currently accounts for around 70% of COVID-19 cases nationwide, prompting health authorities to push for vaccines tailored to the dominant variants.

Moderna said its submission followed the FDA’s recent guidance, which advised manufacturers to update their formulations in response to the evolving virus. The company anticipates launching the updated vaccine by mid-August, pending regulatory approval.

Currently, three COVID-19 vaccines are authorized for use in the U.S.—Moderna’s and Pfizer-BioNTech’s mRNA vaccines, as well as Novavax’s protein-based shot.

Under the FDA’s new leadership, regulatory standards for COVID-19 vaccines have become more stringent. The agency announced this week that new clinical trials will be required for annual COVID-19 booster approval in healthy individuals under age 65. As a result, future booster doses may be limited primarily to older adults and those at higher risk of severe disease.

Vinay Prasad, the FDA’s top vaccine regulator, stated that all vaccine manufacturers will be asked to conduct placebo-controlled trials in healthy individuals aged 50 to 64 and are encouraged to include very young children in future studies. Moderna did not specify the age groups targeted by the updated vaccine or whether any new clinical trials were conducted as part of the current application.