FDA highlights risk of myocarditis in review of Pfizer’s COVID vax for kids

The Food and Drug Administration on Friday said that it has concluded that the “overall benefits” of Pfizer’s COVID-19 vaccine for children 5 to 11 years old “may still outweigh the risks.”

However, there have been reports of Myocarditis and pericarditis, which are two different types of heart inflammation, after the mRNA-based Pfizer and Moderna vaccines, typically after the second dose. According to the reports by CDC, the symptoms include chest pain, faster heartbeat and shortness of breath. The official website says, “[m]ost patients with myocarditis or pericarditis who received care responded well to medicine and rest and felt better quickly.”

Most of the cases after the vaccine have occurred in younger males and required hospitalisations, says federal health officials. Although the data suggests cases are “rare.”

In its review, the FDA has come up with a variety of “benefit-risk outcome” situations, which are based on different estimates of vaccine effectiveness and rates of COVID-19 in the community. It has been estimated that Pfizer’s COVID-19 vaccine would more frequently prevent COVID related cases in children than cause “excess myocarditis cases.”

In case, the number of COVID-19 were to decrease in June, the FDA predicted the US might not see enough severe COVID-19 cases in children to outnumber the incidents of myocarditis or pericarditis. “The model results indicate that the benefits of the vaccine are highly dependent on the incidence of COVID-19,” the FDA said.

Meanwhile, a recent study suggested that Pfizer’s kid-size COVID-19 vaccine doses are 91 per cent effective against coronavirus and have been observed to be safe.

The study says that the kid-size doses of Pfizer’s vaccine are safe for children aged between 5 and 11. This study has come at a time when the US health experts have been mulling starting vaccine campaigns for younger children of the age group 5 to 11 years.

As of now, the US is already administering full-strength Pfizer shots to children aged 12 and above. However, experts and parents are anxiously awaiting kid-size doses.

This will help provide safety to children, especially as schools have started reopening and children are back in classrooms with their peers. WION