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 authorized using the monoclonal antibody therapy REGEN-COV for prevention in certain children and adults who are not fully vaccinated against COVID-19 or not expected to mount an adequate immune response to vaccination. 
Three-quarters of the 469 COVID-19 cases associated with summer events and large public gatherings this month in Barnstable County, Mass., were in people fully vaccinated against COVID-19, according to a report released by the Centers for Disease Control and Prevention.
About 8.9 million children aged 12-17 have received the Pfizer COVID-19 vaccine, the Centers for Disease Control and Prevention reported.
The Food and Drug Administration July 28 extended to six months the shelf life for Johnson & Johnson’s COVID-19 vaccine.
All clinicians should get vaccinated against COVID-19, encourage their staff and patients to get vaccinated, and recommend immunocompromised patients continue all prevention measures after vaccination, the Centers for Disease Control and Prevention yesterday, citing an urgent need to increase COVID…
The Centers for Disease Control and Prevention adjusted its guidance for fully vaccinated individuals, urging indoor masking in states that are labeled as “high” or “substantial” in their number of cases, including schools, where all in attendance should wear masks.
The Food and Drug Administration issued an emergency use authorization to Becton, Dickinson and Company for its sodium citrate blood specimen collection tubes for coagulation testing by authorized laboratories for COVID-19 and other patients.
Pfizer said its COVID-19 vaccine will receive a priority review from the Food and Drug Administration, indicating that Pfizer has completed its rolling submission of its application for the vaccine’s full authorization.
The Food and Drug Administration revoked its emergency use authorization for the Curative SARS-Cov-2 Assay test because the manufacturer has transitioned to using other authorized tests for testing offered at its laboratories. 
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will convene July 22 to discuss a pair of recent issues related to COVID-19 vaccines.