FDA/CDC

CDC endorses Pfizer’s COVID-19 vaccine for young kids


 

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

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