COVID-19: CDC, FDA and CMS Guidance

This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.

The Centers for Disease Control and Prevention announced a pair of changes to its recommendations regarding Pfizer’s COVID-19 vaccine.
Pfizer said it has submitted a supplemental biologics license application for its COVID-19 vaccine, asking that the Food and Drug Administration expand approval to include individuals age 12 to 15.
The Centers for Disease Control and Prevention endorsed updated recommendations expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine over Johnson & Johnson’s COVID-19 vaccine, as proposed by the agency’s Advisory Committee on Immunization Practices. 
The Food and Drug Administration updated its fact sheets for providers and recipients and caregivers for the Johnson & Johnson COVID-19 vaccine, with each revised document outlining a contraindication for the vaccine’s administration to individuals with histories of thrombosis with…
About four in 10 eligible U.S. adults aged 65 or older received a booster or additional primary dose of COVID-19 vaccine between Aug. 13 and Nov. 19, with lowest coverage among American Indian or Alaska Native (30%), Hispanic or Latino (34%), and Native Hawaiian or other Pacific Islander persons (…
The Food and Drug Administration authorized using the combination monoclonal antibody therapy Evusheld to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components.
The Food and Drug Administration announced the widely anticipated expansion of Pfizer’s COVID-19 vaccine emergency use authorization to allow booster doses for 16- and 17-year-olds.
Mutations in the omicron variant of the SARS-CoV-2 virus may impact certain molecular tests for COVID-19, the Food and Drug Administration announced.
The Food and Drug Administration authorized administering bamlanivimab and etesivimab together to treat or prevent COVID-19 in all pediatric patients exposed to or testing positive for the virus who are at high risk for progressing to severe disease.
The Centers for Medicare & Medicaid Services will not enforce its COVID-19 vaccine mandate for health care workers while enjoined by district courts in Missouri and Louisiana, the agency confirmed in a memorandum.