liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.
Helping children recover more quickly
In a news release from drug maker Gilead Sciences, one pediatric infectious diseases doctor welcomed the news.
“This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” says Dr. Amina Ahmed, from Atrium Health-Levine Children’s Hospital in Charlotte, N.C. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”
The FDA noted that Veklury is not a substitute for getting a vaccination, although there is not yet a vaccine approved for children aged 4 and younger.
Two COVID vaccines, Pfizer and Moderna, have been fully approved and three are available for emergency use, depending on age.
The vaccines are meant to prevent serious clinical outcomes, including hospitalization and death, the FDA said.
People should also receive a booster, if eligible, the agency added.