The Food and Drug Administration on Sept. 11 approved and authorized for emergency use updated Pfizer-BioNTech and Moderna COVID-19 vaccines that target XBB.1.5., the omicron subvariant of SARS-CoV-2, the virus that causes COVID-19.
The Centers for Disease Control and Prevention (CDC) on Sept. 12 recommended that everyone 6 months and older get an updated vaccine. The decision comes as the agency reported that COVID-19 hospital admissions increased for the eighth week in a row.
The updated, monovalent mRNA vaccines are each approved for those 12 years old and older and are authorized under emergency use for youth ages 6 months through 11 years old. Bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines no longer are authorized for use.
The agency also is tracking the BA.2.86 variant and working to better understand its potential impact on public health. The variant is not driving current COVID-19 cases and hospitalizations in the United States, but because of its sequence divergence, CDC initially was concerned about a significant reduction in antibody activity.
Recent studies found that the updated vaccine neutralizes against BA.2.86 as well as EG.5, which currently makes up 21.5 percent of national COVID-19 cases.
HHS Awards $1.4 Billion to Project NextGen
The Department of Health and Human Services on Aug. 22 awarded more than $1.4 billion for Project NextGen to support the development of future COVID-19 vaccines and therapeutics.
Project NextGen coordinates across the federal government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability.
Awards include $1 billion to four Biomedical Advanced Research and Development Authority clinical trial partners to support vaccine Phase IIb clinical trial studies and $326 million to support the development of a new monoclonal antibody for COVID-19 prevention.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.