MRNA Seeks FDA Nod for Updated COVID-19 Vaccine

Group 1 - Moderna has submitted a regulatory filing to the FDA for an updated version of its COVID-19 vaccine Spikevax, targeting the LP.8.1 variant [1] - The FDA's recent guidance recommends vaccine-makers to update their COVID-19 shots to target strains from the JN.1 lineage, with a preference for LP.8.1, which currently accounts for about 70% of total cases in the U.S. [2] - The FDA has also mandated that vaccine makers conduct randomized, placebo-controlled clinical studies to demonstrate the real-world benefits of yearly COVID-19 vaccine boosters for individuals under 65 years [3] Group 2 - Year to date, Moderna's stock has decreased by 37%, while the industry has seen a decline of 6% [4] - Other COVID-19 vaccines in the market include Pfizer/BioNTech's Comirnaty and Novavax's Nuvaxovid, with no recent updates from these companies regarding their vaccines [6] - Currently, only Moderna and Pfizer/BioNTech's vaccines are approved for individuals aged six months and above, while Novavax's vaccine is restricted to specific age groups and conditions [7]