RALEIGH, N.C. (WNCN) – Pfizer is now asking the FDA to authorize its COVID-19 shot for children ages 5 to 11. The dosing would be about a third of what adults get.
A side effect impacting the heart muscle is likely to be one of the things the FDA and CDC take close look at as they review data submitted by Pfizer.
Myocarditis is a condition that causes inflammation of the heart muscle.
The condition has most commonly been seen in teen boys and young men after the second dose of the mRNA vaccines. Symptoms include chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart.
CDC is monitoring the condition closely and so far says the benefits of a vaccine still outweigh the risks. They have found the condition was usually mild and treatable.
Pfizer is now hoping its findings about safety and efficacy are good enough for the FDA and CDC.
“This is great news for protecting kids. Not just from getting infected but also from some of those long-term complications,” said Dr. Christina Johns, senior medical advisor for PM Pediatrics. Johns said all the evidence so far points to the vaccine being safe and effective.
Still, she says myocarditis is something regulators will investigate.
“This is absolutely a real safety signal and so I think we should be very clear about that. It is less of a risk with the vaccine than it is with a COVID-19 infection,” said Johns.
A CDC report found in boys and men aged 12 to 29, there were 41 cases of myocarditis per 100 million fully vaccinated people. The CDC says this age group is more likely to develop the condition through COVID-19 infection than through the vaccine.
“It’s absolutely OK to have questions, or not understand or be concerned,” Johns said.
Johns said it’s important to look to credible, scientific sources if you’re looking for answers to those concerns.
“Random Facebook posts are probably not the place to finding that. Talk to your health care provider. That is the person who will help you and guide you,” she said.
The FDA was scheduled to take up Pfizer’s application at a meeting towards the end of this month. CDC would then look at the data before providing a recommendation.
If everything goes smoothly, children ages 5 to 11 could start to get vaccinated sometime in November.