ELLSWORTH — 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.
Previously, remdesivir, which is administered intravenously, was only given to hospitalized patients.
Additionally, the FDA 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.
A few 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 wait time can be influenced by what space is available at the hospital. Other factors that influence waiting times include steps taken to mitigate risk 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 safely bring people inside.
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 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 slated for Jan. 27 from 6 to 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 mecap.org/events/.
In other COVID news, plans by the Biden Administration to make N95 masks available to the public are underway.
The goal of distributing 400 million N95s through pharmacies and community health centers comes as the CDC updated its mask guidelines to say that people “can choose” to wear the more robust face coverings that were initially reserved for health-care workers when supply constraints were a concern.
The guidance recommends that wearing any mask is better than not wearing a mask at all and that “you wear the most protective mask you can that fits well and that you will wear consistently.”