The Food and Drug Administration has asked COVID-19 drug manufacturers Pfizer and Moderna to expand the size of their clinical trials for children ages 5 to 11 amidst reports of heart inflammation and other rare side effects that occurred in teens and young adults who received the vaccines. Public health officials hope that this added step does not delay the vaccine developers’ bid for emergency use authorization (EUA) by the FDA for children in this age group.
Currently, only the Pfizer vaccine has been authorized for use in kids ages 12 to 15, according to Johns Hopkins Medicine. Moderna’s vaccine for children as young as 12 is expected to be authorized any day now, according to CNBC.
The two mRNA vaccines may have caused myocarditis and pericarditis in 1,200 Americans, including 500 who were under the age of 30, according to a report by the Centers for Disease Control and Prevention.
According to HealthDay, the pharmaceutical companies were asked to add 3,000 children to their trials in this age category, twice the number originally proposed . Moderna has agreed to expand their trials and expects to seek FDA authorization for the younger age group by late 2021 or early 2022.
Pfizer said it expected clinical trial outcomes for this population by September, followed by results for kids ages 2 to 5 years soon after and for toddlers 6 months to 2 years in October and November. The vaccine developers have enrolled thousands of children across the Unites States, Poland, Finland, and Spain, says Healthline.
Although there hasn’t been an exact date for the vaccines to be ready for kids in the 5 to 11 category, Dr. Alok Patel, a pediatrician at Stanford Children’s Health, predicts they will be available in the fall.
“Pfizer is planning on submitting data for emergency use authorization of its COVID-19 vaccine for 5 through 11-year-old children in September or October—assuming the safety and efficacy profile is like older groups,” he said. “We can expect an authorized vaccine shortly thereafter. For younger children, my educated guess is it may be later toward the end of 2021 or early 2022.”
Healthcare experts hope that the timing of the EUA will coincide with school openings this fall. While children often get less sick from COVID-19, children of all ages have landed in intensive care and even died from the disease.
“We’re still learning about the spectrum of COVID in kids,” Patel told Healthline. “The risk is also increased for any children with underlying comorbidities, such as asthma, diabetes, or any type of immunosuppression.”
Patel added that there is no reason to suspect that younger children will have adverse side effects from the vaccines, but he pointed out that younger immune systems are different, so each group deserves its own trial just to make sure. Pfizer has said it has lowered the dose of the vaccine for kids under the age of 12.
While the troublesome side effects of heart inflammation were noted in older children and teenagers, Patel noted that they were very rare, and that the risk of getting COVID-19 is far higher.
“The cases of heart inflammation tend to be mild and self-resolving,” Patel explained. “Taking your chances with COVID is worse than with the vaccine, as the virus itself can cause heart inflammation alongside MIS-C (multisystem inflammatory syndrome), organ damage, and worse.”
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