Moderna has become the first company to file for Food and Drug Administration (FDA) authorization to develop an updated COVID-19 vaccine containing a monovalent XBB 1.5 composition.
XBB is an omicron subvariant of SARS-CoV-2, the virus that causes COVID-19. This announcement follows a June 16 recommendation by FDA’s Vaccines and Related Biological Products Advisory Committee.
Moderna stated that its updated COVID-19 vaccine would be available in time for fall vaccination upon authorization.
FDA and Invivyd Announce Monoclonal Antibody Treatment Pathway
Invivyd, a clinical-stage biopharmaceutical company, announced on June 26 that it reached general alignment with the FDA on a pathway to potential emergency use authorization (EUA) for adintrevimab, a monoclonal antibody candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.
While four monoclonal antibodies previously received EUA, none are currently authorized or approved for the prevention of symptomatic COVID-19 in the United States, because they are not expected to neutralize dominant omicron subvariants.
CDC Reports New Subvariant
Amid the global and national dominance of XBB descendent lineages, the Centers for Disease Control and Prevention now reports the circulation of a new subvariant, EU.1.1., which currently accounts for 1.7 percent of national COVID-19 cases.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.
