The U.S. Centers for Disease Control and Prevention (CDC) recommended Moderna's (NASDAQ: MRNA) COVID vaccine for use in children through adolescents for emergency use, providing another option to parents in the United States.
CDC Director Dr. Rochelle Walensky signed off on recommending the shot on Friday, after the agency's independent vaccine panel unanimously backed Moderna's vaccine for young Americans ages 6 to 17 after weighing its safety and efficiency data last Thursday. Now, pediatricians, pharmacies and other health care clinics can administer the shots across the country.
"It is critical that we protect our children and teens from the complications of severe COVID-19 disease. Today, we have expanded the options available to families by recommending a second safe and effective vaccine for children ages 6 through 17 years," said Walensky in a press statement on Friday. "Vaccinating this age group can provide greater confidence to families that their children and adolescents participating in childcare, school, and other activities will have less risk for serious COVID-19 illness."
The expansion of Moderna's EUA for children and adolescents has taken a longer time than the similar vaccine developed by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX), with the company asking the U.S. Food and Drug Administration (FDA) to authorize the shot for this age group over a year ago. The regulator held off on expanding the shot's use in the U.S. after other countries raised concern that Moderna's vaccine may carry a higher risk of heart inflammation, called myocarditis, than Pfizer's shot.
While there is no current data comparing both vaccine in children and teens--Moderna's shot was only expanded for use outside of adults this month--data between both vaccines in young adults appears to show Moderna's shot may have a higher risk of developing myocarditis, CNBC reports.
However, the CDC had found the risk of myocarditis is higher from COVID infection than vaccination, with the condition usually caused by viral infections in children through young adults. Most patients who developed myocarditis made a full recovery 90 days after diagnosis, according to a CDC survey.
For safety data, the most common side effects in this age group were the typical pain at the injection site, fatigue, headache, chills, muscle pain and nausea. There were no confirmed cases of myocarditis among trial participants. Moderna's dosage size is reduced to 50 micrograms for children ages 6 to 11, while adolescents receive the same dosage at adults at 100 micrograms.
For efficiency, the effectiveness of the shot against Omicron is unclear, as the clinical trials were conducted before the mutuate variant became the dominant global strain. However, like other vaccines developed to protect against the original SARS-CoV-2 virus, Moderna's vaccine is expected to prevent severe infection, hospitalization and death in this age group.
In effort to keep up with the evolving virus, Moderna is testing booster shots for this age group that target Omicron, with data expected later this year.