FDA expands use of remdesivir

BAR HARBOR — The Food and Drug Administration (FDA) on Jan. 21 expanded the authorized use of Veklury, known commonly as remdesivir, to be used in outpatients 12 years of age and older who test positive for COVID-19. 

The FDA recommends using the drug for those who have mild to moderate symptoms and are not currently hospitalized but are at high risk of progressing to severe symptoms that would require hospitalization and could lead to death. 

Remdesivir, which is administered intravenously, was previously only given to hospitalized patients. 

The FDA also revised its emergency use authorization of the drug to include pediatric patients younger than 12 who are not hospitalized with COVID-19 but are at a higher risk of developing severe symptoms, including hospitalization and death. 

The FDA noted that the expanded use does not replace getting vaccinated for those who are eligible. 

“This is a solid step forward. Remdesivir is an antiviral drug that has been used since early in the pandemic,” said Maine Center for Disease Control and Prevention (CDC) Director Dr. Nirav Shah via Twitter on Jan. 22. “The full FDA approval comes after a study published in [The New England Journal of Medicine] showed an 87 percent reduction in hospitalizations compared [with] placebo. That puts remdesivir on par with monoclonal antibodies.” 

Another important aspect of the treatment, Shah noted, is that it is not in short supply, unlike many other COVID-19 therapeutics. 

“Bottom line: This full approval is a big step forward,” Shah wrote. “Remdesivir is remarkably effective, safe and in good supply.” 

Keeping patients out of the hospital is the goal in Maine, Shah said, especially as the number of inpatients with COVID-19 has increased with the omicron variant. 

Some Hancock County residents have reported having to spend hours in their cars waiting to receive care from Northern Light Maine Coast Hospital because they were COVID-positive or awaiting test results. 

At a Northern Light Health briefing on Jan. 19, Dr. James Jarvis noted that patients shouldn’t have to wait a long time to receive care, but that time can be influenced by what space is available at the hospital. Other factors that affect waiting times are how risk can be mitigated by limiting people going in and out of the hospital, especially people who are COVID-positive or suspected to be positive, and what accommodations need to be made to bring people inside safely.  

Jarvis said the reports of long wait times highlight the lack of available bed space brought on by the pandemic. 

“We certainly feel for these kinds of situations when they arise,” he said. 

While scientific and medical discoveries continue to improve treatment options and limit hospitalizations for those with COVID-19, the emotional toll of the years-long pandemic wears on. 

A free online forum, sponsored by Maine Community Action Partnership, is scheduled for Jan. 27 from 6-7:15 p.m.  

Titled “Emotional Well-Being During a Pandemic,” the public forum will include a panel discussion about coping strategies, featuring Shah, Eric Eisle, Arabella Parnes and Abigail Young, a junior at Ellsworth High School. 

Those interested can register online at www.mecap.org/events. 

Rebecca Alley

Rebecca Alley

Reporter at The Ellsworth American
Rebecca is the Schoodic-area reporter and covers the towns of Eastbrook, Franklin, Hancock, Lamoine, Sorrento, Sullivan, Waltham, Winter Harbor and Trenton. She lives in Ellsworth with her husband and baby boy who was joyously welcomed in June 2020. Feel free to send tips and story ideas to [email protected]

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