FDA issues update on COVID-19 treatments, hemodialysis machine risk

May 09, 2022 - 03:45 PM
FDA Update 900x400

The Food and Drug Administration last week extended to 24 months the shelf life for certain lots of refrigerated bamlanivimab. The combination monoclonal antibody therapy bamlanivimab and etesevimab is currently not authorized to treat or prevent COVID-19 in any U.S. region because it is not effective against the omicron variant. However, the Department of Health and Human Services and FDA recommend retaining both products in case future COVID-19 variants are susceptible to them, and are evaluating whether to extend the shelf life for etesevimab in the future.

In other news, FDA last week released a screening checklist and drug interaction tool to help prescribers identify patients eligible for the Pfizer COVID-19 antiviral pill Paxlovid; and a dashboard summarizing data from its project to track SARS-CoV-2 variants from wastewater samples. 

The agency also alerted health care providers that certain hemodialysis machines made by Fresenius Medical Care may expose patients to toxic chemicals, and recommended certain actions to ensure patients continue to receive needed care.

Related News Articles

#HealthCareInnovation Blog
A Strategy to Tackle Public Health Misinformation
In the fall of 2021, two years into the COVID-19 pandemic in the U.S., nearly 80% of adults said they had heard “at least one of eight different false…
Headline
Newest AHA COVID-19 vaccination digital toolkit seeks to beat the summertime blues
Summertime is right around the corner and AHA’s new social media toolkit promotes COVID-19 vaccination and boosters as a means for keeping kids active and…
Headline
FDA authorizes 4th Pfizer COVID-19 bivalent dose for certain children under 5
The Food and Drug Administration April 28 authorized a fourth Pfizer COVID-19 bivalent vaccine dose at least one month after the third dose for certain…
Headline
CDC: Monovalent vaccination was 76% effective at preventing mechanical ventilation, death in hospitalized COVID-19 patients during omicron
In a study of adults hospitalized between February 2022 and February 2023, when the omicron variant predominated, monovalent mRNA vaccination was 76%…
Headline
CDC recommends second COVID-19 bivalent booster for older adults, immunocompromised 
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…
Headline
HHS announces plan to support continued access to COVID-19 vaccines, treatments for uninsured
The Department of Health and Human Services on April 19 announced a $1.1 billion public-private partnership to help maintain access to COVID-19…