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NIH Director: Don’t Expect A Fully Approved Covid Vaccine For Young Kids This Fall

While the FDA has fully approved Pfizer’s Covid-19 vaccine for adults and teens, parents of young children will likely have to wait until closer to the end of the year for approval.

While the federal Food and Drug Administration (FDA) fully approved Pfizer’s Covid-19 vaccine for use in adults and teens 16 and older on Monday, health researchers have said it could be a while before we see full vaccine approval for young children. In an interview with NPR, the director of the National Institutes of Health (NIH) warned parents that a Covid-19 vaccine may not be fully cleared for use in children under the age of 12 until closer to the end of the year.

“I’ve got to be honest, I don’t see the approval for kids — 5 to 11 — coming much before the end of 2021,” NIH Director Dr. Francis Collins told NPR’s Morning Edition. “I know a lot of people are really anxious to see this move forward. It’s a difficult situation because kids under 12 are not just little miniature human beings. They have differences in their metabolism, their immune system.”

These differences are why vaccine manufacturers are currently conducting clinical trials in children. Along with testing the efficacy and safety of the vaccines in children, Collins said researchers are also looking to uncover the optimal dosage for children of various ages. “Do you give the same dose to a 6-year-old as you would to somebody who is 30? Probably need to look at that,” Collins said. “So, the companies — Pfizer, Moderna — are working hard on collecting data from rigorous trials to be sure they’ve got that part right, but actually the data hasn’t been submitted to the FDA yet.”

Both Pfizer and Moderna began clinical trials in children aged 6 months to 11 years in March. In April, Johnson & Johnson began studying its vaccine in children aged 12 to 17. More recently the company announced plans to launch trials with children aged 2 to 11 sometime this fall, The Hill reported.

According to Collins, Pfizer has said it may be ready to submit data from its pediatric clinical trials to the FDA by the end of September. And while that could lead the FDA to authorize Pfizer’s vaccine for emergency use in children younger than 12 years old as early as October, full approval of the vaccine in children would likely take several months, NPR has reported.

While research has shown children are less likely to experience severe illness as a result of Covid-19, they are far from being immune to the virus. As of Aug. 19, more than 4.59 million children have tested positive for Covid-19 since the pandemic began in March 2020, according to data collected by the American Academy of Pediatrics (AAP). What’s more, Covid-19 cases in children appear to be on the rise as children return to classrooms for a new school year.

“After declining in early summer, child cases have increased exponentially, with over a four-fold increase the past month, rising from about 38,000 cases the week ending July 22 to 180,000 the past week,” AAP said in a recent data report.

The U.S. Centers for Disease Control and Prevention (CDC) recommends everyone 12 years and older get vaccinated against Covid-19. Currently, only Pfizer’s Covid-19 vaccine has been given emergency authorization to be used in children age 12 and older. Both Moderna’s Covid-19 vaccine and Johnson & Johnson’s Janssen Covid-19 vaccine are authorized only for adults aged 18 and up.

If you think you’re showing symptoms of coronavirus, which include fever, shortness of breath, and cough, call your doctor before going to get tested. If you’re anxious about the virus’s spread in your community, visit the CDC for up-to-date information and resources, or seek out mental health support. You can find all of Romper’s parents + coronavirus coverage here.