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.

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…
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.
The Centers for Medicare & Medicaid Services began requiring state Medicaid programs to cover counseling visits at which health care providers talk with families about COVID-19 vaccination for their children