FDA approves first COVID-19 drug to treat children under 12 

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On Monday, April 25, the U.S. Food and Drug Administration (FDA) made a highly anticipated announcement. According to the FDA’s official news release, it has approved the use of Veklury (remdesivir) to treat COVID-19 for children under the age of 12.

To receive this drug, a child must weigh at least 6.6 pounds (3 kilograms) and test positive for COVID. This includes both those hospitalized and not who have mild to moderate symptoms and are at an increased risk for a severe case of the virus, which could be fatal.

Veklury is now the first FDA-approved COVID-19 treatment for pediatric patients under the age of 12. The omicron variant has caused cases to spike in children. So, this announcement has revoked the former ‘emergency use only’ authorization to use Veklury to treat the youngest COVID patients. Monoclonal antibody therapy still has emergency use authorization from the FDA, but it is administered on a risk-benefit analysis.

Patrizia Cavazzoni, M.D., the director of the FDA’s Center for Drug Evaluation and Research, lauded the decision. She pointed out a continued need for “safe and effective COVID-19 treatment options for this population” due to the virus causing severe illness in children. Though omicron has proven to be less severe than other COVID-19 variants, it has resulted in a fourfold increase in pediatric hospitalizations.

Veklury is not a substitute for vaccination, but juveniles have limited vaccine options at this time. It has been shown to reduce the chances of hospitalization and death for patients of multiple ages, and the same efficacy is seen in children. Approved for hospitalized COVID patients in October of 2020, remdesivir is one of the first drugs to be cleared for treating the virus.

Side effects include increased liver enzymes, changes in heart rate and/or blood pressure, fever, wheezing, facial swelling, nausea, sweating, shivering, and low blood oxygen levels. However, these side effects tend to be relatively mild. Veklury is administered as an injection, and its efficacy has been demonstrated in clinical trials among adults.

The FDA continues to encourage those eligible to receive the COVID-19 vaccine and booster shots.

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