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’s vaccine advisory committee June 15 voted unanimously to recommend updating the current COVID-19 vaccine composition for fall to a monovalent vaccine based on an XBB variant of the virus.
The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years old, similar to findings for doses one and two.
The Food and Drug Administration authorized for marketing the first at-home over-the-counter test for COVID-19 using a traditional premarket review pathway rather than emergency use authorities.
The Centers for Medicare & Medicaid Services May 31 released regulatory changes to the COVID-19 health care staff vaccination requirements and long-term care facility testing requirements.
The Centers for Disease Control and Prevention this week recommended health care facilities use a risk-based assessment, stakeholder input and local metrics to determine how and when to require universal masking to prevent COVID-19 transmission.
The Centers for Disease Control and Prevention (CDC) May 8 updated its COVID-19 infection control and prevention guidelines.
A new Centers for Medicare & Medicaid Services bulletin reviews the anticipated end dates for certain COVID-19-related Medicaid and Children’s Health Insurance coverage flexibilities.
Consumers and health care providers should not use certain SD Biosensor Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics due to bacterial contamination, but throw them in the trash, the Food and Drug Administration announced.
The Centers for Disease Control and Prevention April 19 recommended a second Moderna or Pfizer COVID-19 bivalent vaccine dose for adults aged 65 and older at least four months after their initial bivalent dose, and for immunocompromised individuals at least two months after their initial bivalent…
If President Biden signs as expected Congress’ joint resolution ending the COVID-19 national emergency immediately, the Centers for Medicare & Medicaid Services’ COVID-19 waivers and flexibilities will remain in place through May 11 as planned.