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.

Abbott Molecular Inc. issued a recall for its Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, distributed between May 13, 2020, and Aug. 31, 2021, for their potential to give false positive results.
The Centers for Disease Control and Prevention released an operational planning guide for pediatric COVID-19 vaccination and preliminary information on the pediatric Pfizer COVID-19 vaccine.
Available data support the safety and effectiveness of the Johnson & Johnson COVID-19 vaccine for emergency use authorization as a booster dose in individuals aged 18 and older at least two months after an initial single dose, the Food and Drug Administration’s Vaccines and Related Biological…
A Food and Drug Administration advisory panel voted unanimously to recommend an extra Moderna booster dose for certain individuals.
Food and Drug Administration staff provided their analysis of Johnson & Johnson’s COVID-19 booster application, indicating that a second dose provides substantially more protection against SAR-CoV-2 than the initial shot.
The Food and Drug Administration announced it will withdraw regulations for non-drug manufacturers who produced during the COVID-19 public health emergency alcohol-based hand sanitizer or alcohol for use in hand sanitizers.
The Food and Drug Administration released briefing documents for the convening of the agency’s Vaccines and Related Biological Products Advisory Committee, which will consider COVID-19 vaccine booster shot applications from Moderna and Johnson & Johnson.
The Centers for Disease Control and Prevention has released an initial document intended to assist jurisdictions across the country in planning for the distribution and administration of COVID-19 vaccines to the pediatric population.
The Centers for Medicare & Medicaid Services has modified its COVID-19 blanket waiver for Medicare-dependent hospitals (MDHs) to include hospitals that became newly classified as MDHs during the COVID-19 public health emergency.
The frequency of anxiety and depression symptoms among U.S. adults increased after August 2020 and peaked during December 2020 and January 2021, mirroring the national weekly number of new COVID-19 cases, according to a study released by the Centers for Disease Control and Prevention.