The Food and Drug Administration (FDA) has asked for more children aged 5 to 11 to participate in Covid-19 vaccine trials to determine whether a rare side effect in the form of heart inflammation is more common among younger groups.
The FDA reached out to Pfizer and Moderna, whose vaccines were linked to the side effect, to expand their 5-to-11-year-old trial groups to include at least 3,000 children. Regulators have stated that the expanded trials would better help them understand the potential side effects of the two pharmaceutical companies’ mRNA vaccines in younger populations.
A spokesperson for Moderna confirmed that the company is “actively discussing a proposal” with the FDA to expand its trials “to enroll a larger safety database which increases the likelihood of detecting rarer events.” However, a final number of the size of the trial has yet to be determined.
According to the New York Times, Pfizer is also in talks to include younger children in its vaccine trials, although a spokesperson for the company said that it has no updates to its previous trial timeline or details. In March 2021, Pfizer announced that they have begun their vaccine trials which include children between the ages of six months to 11 years old, which involves around 4,500 children at more than 90 clinical trial sites. However, it is unclear the size of the group aged five to 11 years old.
In June 2021, the FDA added a warning to the Pfizer and Moderna Covid-19 vaccines about the risk of cardiac inflammations – myocarditis and pericarditis in particular. Myocarditis is where the heart muscle becomes inflamed, whilst pericarditis involved the inflammation of the heart’s lining. The warnings were added after an increase in reports of heart inflammation in younger children and teenagers following administration of the Covid jab, which tragically has led to a number of deaths.
Despite this, the Centers for Disease Control (CDC) has stated that cases of myocarditis and pericarditis after Covid-19 vaccination are rare, promising that the jabs are safe and effective, recommending “everyone 12 years and older get vaccinated as soon as possible.”