By Sheryl Gay Stolberg
At the urging of federal regulators, two coronavirus vaccine makers are expanding the size of their clinical trials for children ages 5 to 11 — a precautionary measure designed to detect rare side effects including heart inflammation problems that turned up in vaccinated people younger than 30.
President Biden promised at a meeting in Ohio last week that emergency clearance for pediatric vaccines would come “soon,” but the White House has not been specific on the timeline. It was unclear whether expanding the studies will affect when vaccines could be authorized for children.
The Food and Drug Administration has indicated to Pfizer-BioNTech and Moderna that the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects. Those include myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, multiple people familiar with the trials said.
Questions about vaccinating children — including those under 12 — are of huge interest to parents and teachers. Regulators will be required to balance potential side effects of coronavirus vaccination against the risks of Covid-19.