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FDA Approves First COVID Treatment for Younger Kids — Still Dragging on Vaccine Approval

There's an estimated 19.5 million U.S. kids who can't yet get the COVID-19 vaccine.

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The Food and Drug Administration (FDA) has expanded the approval for an IV antiviral medication to treat COVID, making it the first treatment approved for COVID in kids under the age of 12. Here’s what parents need to know.

The agency approved the use of remdesivir, also called Veklury, for kids who test positive for COVID-19. The medication can be used in kids as young as 28-days-old and who weigh at least three kilograms (about seven pounds). The medication is approved for use in kids who are hospitalized, as well as those who are not hospitalized, but are at risk of the disease potentially progressing to a severe condition, the FDA states.

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a statement, according to MedPage Today.

Although it’s good that there’s finally an approved COVID treatment for young kids, there still isn’t an approved vaccine for kids under the age of 5.

The FDA previously set a date in May for the Vaccines and Related Biological Products Advisory Committee to review the trial results for vaccines for kids under 5-years-old. However, those tentatively scheduled meetings were eventually scrapped as Pfizer and BioNTech decided to pull their data and wait for more information about the efficacy of the vaccine in that age group.

NBC News reports that people familiar with the current plans say the FDA could authorize the COVID-19 vaccine for the youngest age group in June.

It’s estimated that there currently are 19.5 million kids under the age of 5 in the U.S. and Puerto Rico, all of whom are without an approved COVID-19 vaccine. This is the only age group in the U.S. that doesn’t yet have an available vaccine for COVID, the approval process of which has been met with delays, setbacks, and lengthened trials.