Moderna Files For FDA Review Of Updated COVID-19 Vaccine

Reuters (5/23, Santhosh) reported Moderna said Friday that it had “filed a marketing application for the review of its updated COVID-19 vaccine” with the FDA. Branded as Spikevax, Moderna said the submission for the new vaccine “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 “accounts for about 70% of total cases in the U.S.” Moderna expects to “launch the updated vaccine by mid-August,” but COVID-19 vaccine manufacturers are “seeing greater regulatory scrutiny and facing tighter requirements for their shots that could increase their expenses.”