The Moderna presentation yesterday showed some alarming healthcare data. COVID vaccine rates this year in the U.S. are running at one quarter that of flu while COVID hospitalization rates are twice as high. Providing protein-based vaccines doesn't seem to be fully filling the gap in compliance. This could mean the FDA is seeking other ways to boost vaccine numbers this season. P3 data for mRNA-1083, the flu/covid combo will be released this quarter. If the combo can demonstrate non-inferior efficacy and equivalent safety to both mRNA-1010* (flu) and mRNA-1283 (next-gen COVID) it could potentially be considered for EUA in this calendar year.
*mRNA-1010 showed superiority to an active comparator in P3 and a filing is expected this year. mRNA-1283 expected to receive EUA.