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COVID-19: CDC Updates Safety Guidance, Bebtelovimab Goes Commercial

The Centers for Disease Control and Prevention (CDC) on Aug. 11 updated its guidance on COVID-19 safety measures, changing quarantine guidelines and ending its social distancing recommendation.

Individuals exposed to someone with COVID-19 no longer need to quarantine, regardless of vaccination status, unless they experience symptoms or test positive. Further, the agency no longer recommends staying at least six feet apart from others to reduce the risk of spreading infection.

CDC also no longer recommends testing of asymptomatic people without known exposure in most community settings.

Agency leaders noted the lessened risk of severe illness, hospitalization, and death compared with earlier in the pandemic when the guidance was issued, accrediting mask wearing, vaccination rates, testing, and improved ventilation.

“This guidance acknowledges that the pandemic is not over, but also helps us move to a point where COVID-19 no longer severely disrupts our daily lives,” said senior CDC epidemiologist Greta Massetti, PhD, MPH.

Nonetheless, the agency continues to emphasize the importance of staying up-to-date on vaccinations to prevent cases of serious illness.

The updated guidance reiterated that Americans should follow the CDC’s full isolation recommendations in the case of a positive COVID-19 test, including a minimum of five-day isolation, wearing a mask around others for at least 10 days, and avoiding people at high risk of severe illness from COVID-19.

FDA Warns Of False Negative Antigen Test Results

The Food and Drug Administration (FDA) advised Aug. 11 that Americans should perform repeat at-home COVID-19 antigen testing in the case of a negative result to avoid the risk of receiving a false negative result.

The administration especially suggests that individuals exposed to COVID-19 who are not presenting COVID-19 symptoms use multiple antigen tests across a four-day period, as at-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polymerase chain reaction tests.

FDA clarified that individuals who receive a positive result initially or after a repeat test most likely have COVID-19.

Bebtelovimab Transitions to Commercial Marketplace

The FDA updated on Aug. 5 its emergency use authorization for bebtelovimab, the monoclonal antibody product used to fight COVID-19 infections, to allow commercial distribution of the product.

The Department of Health and Human Services (HHS) has coordinated with Eli Lilly and Company to facilitate the transition from the government supply to the commercially available supply to avoid a disruption in the drug’s availability.

Lilly made the product commercially available for purchase Aug. 15, through a sole distributor, AmerisourceBergen. The distributor sells bebtelovimab to licensed and approved customers, including  hospitals, infusion centers, long-term care facilities, and clinics, but not retail pharmacies.

HHS stressed that sites with an excess of the government-supplied drug should prioritize its use for uninsured patients and use the commercially available supply for those with Medicare, Medicaid, and private insurance.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Andrea Lugo is a communications associate at America's Essential Hospitals.

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