Moderna, Inc. (MRNA) Submits Updated COVID Vaccine for Regulatory Review
Moderna, Inc. (NASDAQ:MRNA) announced on Friday that it has submitted a marketing application to the U.S. Food and Drug Administration (FDA) for review of its updated COVID-19 vaccine.
The revised version of the vaccine, marketed as Spikevax, follows FDA guidance recommending that this year's shots target variants from the JN.1 lineage, specifically favoring the LP.8.1 strain. Current government data shows LP.8.1 is responsible for about 70% of COVID-19 cases in the US.
Moderna, Inc. (NASDAQ:MRNA), a pioneer in mRNA-based medicine, has been advancing treatments by combining science, health, and technology. The company gained prominence for developing one of the first and most effective COVID-19 vaccines during the pandemic.
Moderna, Inc. (NASDAQ:MRNA) expects to roll out the new version of Spikevax by mid-August.
The updated filing comes amid heightened regulatory oversight under new FDA leadership. Vaccine manufacturers now face stricter requirements, which could drive up development costs. Earlier this week, the FDA announced that companies will need to conduct new clinical trials for annual boosters aimed at healthy adults under 65, reserving approvals mainly for older or high-risk groups.
Top US vaccine official Vinay Prasad said developers will be required to run placebo-controlled trials in adults aged 50 to 64, and will be encouraged to do the same in very young children. Moderna, Inc. (NASDAQ:MRNA) has not revealed the age groups its new vaccine is intended for or whether it conducted additional trials.
Earlier this week, the company pulled its application for approval of its combined flu and COVID-19 vaccine candidate following discussions with the FDA.
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