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 Food and Drug Administration announced that five months is the recommended interval between a primary dosing regimen and booster for Moderna’s COVID-19 vaccine. Previously, the recommended gap was six months.
The Department of Health and Human Services (HHS) today updated its guidance to hospitals on the reporting of COVID-19-related data.
Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., recommended 12-15 year olds receive a single booster dose of the Pfizer COVID-19 vaccine at least five months after the initial two-dose series, expanding the agency’s recommendation for 16 and 17 year olds to younger…
COVID-19 vaccination during pregnancy was not associated with greater risk of preterm or small-for-gestational-age birth in a study comparing over 10,000 women who received at least one dose of COVID-19 vaccine during pregnancy with more than 36,000 women who did not, the Centers for Disease…
Two new COVID-19 home tests are now available to consumers in the U.S. Tests from SD Biosensor and Siemens in December gained Food and Drug Administration emergency use authorization, in part driven by the Department of Health and Human Services’ accelerated pathway to support FDA’s review of tests…
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 (…