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 warned health care providers and the public not to use an antigen test for COVID-19 made by Innova Medical Group and distributed under several names.
The Centers for Disease Control and Prevention is asking jurisdictions to distribute portions of their COVID-19 vaccine allocations to enable administration at hospitals, emergency departments and urgent care facilities following patients’ discharge.
Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program must administer the vaccines at no cost to recipients, the Department of Health and Human Services reminded providers and health plans in a letter.
The Food and Drug Administration is warning health care providers and the public not to use two COVID-19 antigen and antibody tests, due to high risk of false results.
The Centers for Medicare & Medicaid Services May 28 issued a new informational bulletin on COVID-19 vaccines for adolescents ages 12 and older, which addresses access and eligibility, along with information on patient outreach and education.
Moderna asked the Food and Drug Administration to grant full approval of its COVID-19 vaccine for people age 18 years and older.
The Centers for Disease Control and Prevention recommended clinicians report all cases of inflammation of the heart muscle (myocarditis) or lining (pericarditis) after COVID-19 vaccination to the Vaccine Adverse Event Reporting System, citing an increase since April in cases reported after…
The Food and Drug Administration reminded health care providers to give patients who self-collect anterior nasal samples for SARS-CoV-2 testing in health care settings step-by-step instructions.
The Food and Drug Administration authorized storing thawed, undiluted vials of the Pfizer COVID-19 vaccine at refrigerator temperatures (35°F to 46°F) for up to 30 days after the company submitted data showing the vials can remain stable that long, up from the previously authorized five days.