FDA Approves First COVID Treatment for Young Kids

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Lara Antal / Verywell

Key Takeaways

  • The FDA has approved the antiviral remdesivir for the treatment of children younger than 12 who have COVID-19 and are at a high risk of severe illness.
  • This announcement grants remdesivir full FDA approval.
  • Remdesivir is not a substitute for vaccination and does not prevent infection.

On April 25, the U.S. Food and Drug Administration (FDA) extended its approval of the COVID-19 antiviral treatment remdesivir (Veklury) to include infants and children, making it the first COVID treatment to become available for this vulnerable unvaccinated population.

Remdesivir has been a successful treatment option for adults and children over the age of 12 since its initial emergency use authorization (EUA) in October 2020. Now, the treatment’s use for children has been granted full FDA approval. It’s available for children and infants over 28 days old and weighing at least 7 pounds who test positive for COVID-19, and are hospitalized or at high risk for severe illness.

“This is exciting news, especially for children under the age of 5 who are not currently eligible for vaccination,” Alok Patel, MD, pediatric hospitalist and clinical assistant professor at Lucile Packard Children’s Hospital, told Verywell. “We are hopeful this will expand access to more patients and provide valuable data in treating children under the age of 12.”

Road to Approval

Remdesivir is an antiviral drug previously developed by Gilead Sciences in partnership with the Centers for Disease Control and Prevention (CDC) and the U.S. Army Medical Research Institute of Infectious Diseases to treat RNA-based viruses including:

  • Severe acute respiratory syndrome (SARS)
  • Middle East respiratory syndrome (MERS)
  • Ebola outbreak in 2015

With the rapid spread of COVID-19, researchers quickly discovered in clinical trials that remdesivir was effective at interrupting the replication cycle of all variants of COVID-19 including Delta, Omicron and its subsequent subvariants.

It allowed patients to recover from illness five days sooner than those that were given a placebo. To help combat severe COVID-19 illness, the FDA issued an EUA for remdesivir in the fall of 2020.

What to Know About Remdesivir

With the FDA expansion of approval for use in children under 12, remdesivir is now fully FDA-approved. This eliminates its current emergency use standing and paves the way for more patients to access the critical COVID-19 treatment.

While remdesivir, which can only be administered intravenously, is a step in the right direction, not everyone who tests positive for COVID-19 is a candidate for the antiviral drug. Currently, the FDA and Gilead Sciences recommend remdesivir if you meet the following criteria:

  • Over 28 days old and weighing at least 7 pounds
  • Hospitalized with COVID-19
  • Non-hospitalized patients who are at high risk for severe COVID-19 illness
  • Administered within seven days of symptom onset 

Infants and children considered at high risk for severe illness include those with:

  • Weakened immune system
  • Asthma or chronic lung disease
  • Diabetes
  • Obesity
  • Sickle cell disease
  • Congenital heart disease

Health experts have reported that nausea is the most common side effect of remdesivir. Other possible side effects include:

  • Elevated liver enzymes, which can be a sign of liver injury
  • Allergic reaction resulting in shortness of breath, swelling around lips and eyes, and changes in heart rate and blood pressure

While remdesivir is a significant addition to the healthcare professional’s toolbox in treating COVID-19, Patel warned that it is not a substitute for the COVID-19 vaccination. Antiviral medication is not designed to prevent infection or the spread of COVID-19, they are used to treat people who are already showing symptoms of the disease.

What This Means For You

Talk to your child’s pediatrician to see if remdesivir is an option for your child if they test positive for COVID-19 and are showing symptoms.

What Parents Can Do

The approval of remdesivir for the pediatric population helps provide vulnerable kids with effective treatment options to help keep them from developing severe COVID-19 complications.

For parents of small children who test positive for COVID-19 and are at high risk for hospitalization, reaching out to your child’s pediatrician to discuss remdesivir as a treatment option is a key to helping stop symptoms from progressing into severe illness and hospitalization.

While COVID-19 safety precautions continue to be lifted, prevention is still the best way to limit exposure and protect vulnerable populations from contracting the virus. Parents of small children and high-risk individuals should continue to:

  • Wear a mask in crowded environments
  • Vaccinate those that are eligible
  • Wash hands frequently
  • Disinfect high traffic areas
  • Avoid people who are sick

“This should be a relief to parents of kids younger than 5 who are at high risk,” Patel said. “This doesn’t mean they will be asymptomatic, but it will help the specific patients we are worried about.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

6 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Coronavirus (COVID-19) update: FDA approves first COVID-19 treatment for young children.

  2. Gilead Sciences. Veklury (Remdesivir) is first and only approved treatment for pediatric patients under 12 years of age with COVID-19.

  3. Eastman RT, Roth JS, Brimacombe KR, et al. Remdesivir: a review of its discovery and development leading to emergency use authorization for treatment of COVID-19. ACS Cent Sci. 2020;6(5):672-683. doi:10.1021/acscentsci.0c00489

  4. Gilead Sciences. Study results with VEKLURY (remdesivir).

  5. Gilead Sciences. Veklury (remdesivir) retains antiviral activity against omicron, delta and other emergent SARS-CoV variants in multiple in vitro studies.

  6. Centers for Disease Control and Prevention. People with certain medical conditions.

By Amy Isler, RN, MSN, CSN
Amy Isler, RN, MSN, CSN, is a registered nurse with over six years of patient experience. She is a credentialed school nurse in California.