What’s different about the dose of Pfizer’s COVID vaccine for kids?

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This October 2021 photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. Kid-size doses of Pfizer’s COVID-19 vaccine may be getting closer as government advisers on Tuesday, Oct. 25, 2021 began deliberating whether there’s enough evidence that the shots are safe and effective for 5- to 11-year-olds. (Pfizer via AP)

ALBANY, N.Y. (NEWS10)- Use of Pfizer’s COVID-19 vaccine for kids ages 5-11 was recommended by a Food and Drug Administration (FDA) panel with final emergency use approval hinging on the FDA commissioner. The panel of 18 voted almost unanimously in favor of the recommendation, according to the American Academy of Pediatrics (AAP).

If it’s approved, the dosage for kids would be a third of the doses administered to both kids 12-15 and teens/adults ages 16+. Kids 5-11 years old would receive a 10 microgram dose 21 days apart, as opposed to the 30 microgram dose given to individuals over 12. Pfizer’s report to the FDA said their vaccine proved to be 90.7% effective at preventing symptomatic COVID in young kids.

Similar to the 12-15 and 16+ age groups, clinical trial information had to be submitted to the FDA on the 5-11 group. The top reported side effects in all three age groups were injection site reaction or pain, fatigue, and headache. However, kids 5-11 reported these side effects in lower percentages than the other two age groups.

When reporting adverse reactions in adults 16+ Pfizer used general labeling of “injection site reaction” whereas for the 12-15 and 5-11 groups they use an “injection site pain” label along with injection site “swelling” and/or “redness” separately.

For comparison, NEWS10 looked at fatigue and headache, categories used between all three age groups. The instances experienced among kids 5-11 (fatigue 39.4%, headache 28%) were much lower than the instances experienced among kids 12-15 (fatigue 77.5%, headache 75.5%) and teens/adults 16+ (fatigue 62.9%, headache 55.1%).

Pfizer’s use of “injection site reaction” versus “injection site pain” can be seen in the table below as well as the other top reported side effects for all age groups.

Top reported side effects

5-1112-1516+
Injection site reaction84.1%
Injection site pain71%90.5%
Fatigue39.4%77.5%62.9%
Headache28%75.5%55.1%
Source: FDA

“Safety data from the trials, which included more than 3,000 children who received the vaccine, found the most common reactions were pain at the injection site, fatigue, and headache. Reactions were mostly mild or moderate. There were no serious adverse events related to the vaccine, including myocarditis or anaphylaxis,” AAP said.

Below is a more complete list of side effects experienced by each age group:

5-1112-1516+
Dosage10 micrograms30 micrograms30 micrograms
Injection site reaction84.1%
Injection site pain71%90.5%
Redness18.5%8.6%
Swelling15.3%9.2%
Fatigue39.4%77.5%62.9%
Headache28%75.5%55.1%
Muscle pain11.7%42.2%38.3%
Chills49.2%31.9%
Fever24.3%14.2%
Joint pain20.2%23.6%
Source: FDA

The Centers for Disease Control and Prevention (CDC) maintain that there have been fewer cases of COVID in kids than adults but that kids with underlying health conditions are at a greater risk for serious illness. A small percentage of kids have also developed multisystem inflammatory syndrome in children (MIS-C).

Kids with MIS-C usually have a fever, abdominal pain, vomiting, diarrhea, skin rash, and lesions in mucous membranes like the mouth. In more serious cases, kids with MIS-C can also develop hypotension, cardiac dysfunction, myocarditis (inflammation of the heart), and kidney injury, according to the CDC.

Approximately 5,200 children have experienced MIS-C after becoming infected with COVID, according to the CDC. The rare condition has killed 46 kids as of October 4. The average age of kids diagnosed with MIS-C was 9 and 60% of them were male, the CDC said.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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