FDA Recommends the Emergency Authorization of Moderna ’s COVID-19 Vaccine for Children Ages 6 to 17

The Food and Drug Administration’s (FDA) advisory committee voted unanimously on June 14 to recommend the emergency-use authorization (EUA) of Moderna’s COVID-19 vaccine for children ages six to 17 years. If it’s also recommended by the U.S. Centers for Disease Control and Prevention (CDC), Moderna’s will be the second COVID-19 vaccine available to this age group. (The FDA and CDC previously issued an EUA for the Pfizer-BioNTech COVID-19 vaccine in October 2021 for children five years and older.) Because the company submitted data that broke down the children into two age groups—from six to 11 years old, and 12 to 17 years old—the 22-member panel voted separately for the two populations. Each vote was unanimous that the benefits of vaccination outweighed the risks. [time-brightcove not-tgx=”true”] The committee’s recommendation is based on data submitted by Moderna’s scientists on the safety and efficacy of its two-dose vaccine for kids ages 6-17. Those studies found that the vaccine—which is the same one authorized for adults but in a smaller dose—is as effective at protecting children from getting seriously ill or dying from COVID-19 as it is at protecting adults, even against different variants of the virus. The FDA’s panel of pediatric and immunology experts reviewed two studies conducted by Moderna in children, which showed that kids ages six to 17 generated levels of virus-neutralizing antibod...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news