FDA Approves First COVID Treatment for Use in Kids

By Cara Murez and Robin Foster HealthDay Reporters

HealthDay Reporter

TUESDAY, April 26, 2022 (HealthDay News) – The U.S. Food and Drug Administration on Tuesday accepted the antiviral remdesivir as the primary COVID-19 remedy for younger youngsters.

The drug had up to now solely been obtainable to this age group below a particular FDA emergency use authorization order.

Now, medical doctors treating youngsters below 12 who’re hospitalized or are at dwelling with mild-to-moderate COVID however a excessive danger for extreme COVID can readily prescribe Veklury (remdesivir) to their younger sufferers. Remdesivir had already been totally accepted to deal with individuals 12 and older.

“As COVID-19 may cause extreme sickness in youngsters, a few of whom don’t at the moment have a vaccination choice, there continues to be a necessity for protected and efficient COVID-19 remedy choices for this inhabitants,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated in an company information launch.

“Today’s approval of the primary COVID-19 therapeutic for this inhabitants demonstrates the company’s dedication to that want.”

In a information launch from drug maker Gilead Sciences, one pediatric infectious illnesses physician welcomed the information.

“This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” stated 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 famous that Veklury isn’t an alternative choice to getting a vaccination, though there’s not but a vaccine accepted for kids aged 4 and youthful. Two COVID vaccines, Pfizer and Moderna, have been totally accepted and three can be found for emergency use, relying on age. The vaccines are supposed to stop critical scientific outcomes, together with hospitalization and dying, the FDA stated. People also needs to obtain a booster, if eligible, the company added.

The approval was primarily based on outcomes from a section 3 scientific trial for adults, the FDA stated, noting that the course of the illness is comparable in each grownup and pediatric sufferers.

Continued

It can be supported by a section 2/3 scientific research of 53 pediatric sufferers, the FDA stated. Patients in that research had a confirmed COVID an infection starting from gentle to extreme and obtained the treatment for 10 days. Results, together with security outcomes, have been just like these already seen in adults, the company stated.

Possible unwanted side effects of the drug, which may solely be delivered by way of injection, embody elevated ranges of liver enzymes, which can be an indication of liver damage; and allergic reactions, which can embody adjustments in blood stress and coronary heart charge, low blood oxygen degree, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.

More info

The U.S. Centers for Disease Control and Prevention has extra on COVID-19.

SOURCE: U.S. Food and Drug Administration, information launch, April 25, 2022

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