Clinical trials for the Moderna COVID-19 vaccine will now be expanded to children ages 5 to 11. This will increase the likelihood of detecting potential rare side effects from the vaccine, the company confirmed to CNBC News.
The U.S based company's trial began in late March to research the effects of the virus. Now with the addition of the younger age range, it will have a more broad subject field. The company has not said how many children it hopes to enroll.
The Food and Drug Administration added a warning label to the Pfizer and Moderna Covid-19 vaccines last month to list a rare risk of heart inflammation. The potentially rare side effect was reported in groups of young people who took the vaccine.
"It is our intent to expand the trial, and we are actively discussing a proposal with the FDA," Moderna said in a written statement to CNBC. "At this point, we expect to have a package that supports authorization in winter 2021/early 2022, should the FDA choose to use the authorization avenue."
The FDA asked both Moderna and Pfizer on Monday to include 3,000 children from the ages of 5 to 11 in their trials, The New York Times reported.
Pfizer said it had not provided any updates to its trial timelines or details, the company said to CNBC.
In May, the FDA permitted the use of the Pfizer-BioNTech Covid vaccine for the 12-15 age range, and Moderna’s vaccine is expected to be authorized at any time.
In June, it was reported that more than 1,200 people ages 30 and under were diagnosed with myocarditis or pericarditis after receiving their shots. Myocarditis is the inflammation of the heart muscle, and pericarditis is the inflammation of the tissue surrounding the heart.
Per a million doses of both vaccines, there have been 12.6 heart inflammation cases reported.
Now with the expansion of trials, Moderna will monitor the risks of the vaccine on children, the last group to be vaccinated as health officials fight to end the pandemic.
