Pfizer’s COVID-19 vaccine for young children could be approved Tuesday

Coronavirus

RALEIGH, N.C. (WNCN) – The CDC Advisory Committee on Immunization Practices was scheduled to make a decision on Pfizer’s COVD-19 vaccines for children ages 5 to 11.

It would then be up to CDC director Dr. Rochelle Walensky to give the agency’s official stamp of approval. Before that can happen, the advisory committee has a lot of information to sort through.

Dr. Christina Johns, senior medical advisor for PM Pediatrics, told CBS 17 the FDA and CDC have been looking at very specific information.

“I think they’ll also be looking at the effectiveness data and how effective the vaccine was in the study participants in terms of preventing hospitalization, death and infection itself,” Johns said. “And then there will be looking for any adverse events or and the side effect profile as well. So, all of those things are going to be the key features that will we’ll want to look at closely before making any decisions.”

Pfizer has said its vaccine was 91 percent effective against symptomatic COVID-19 infection. The two-shot regimen of 10 microgram doses would be a third of what adults receive.

Of the 1,518 children in the trials, injection site reactions were the most common side effects. Seventy-five percent of trial participants reported some kind of injection site reaction.

Systemic reactions detected were fatigue and headache but they were reported by less than half of the participants.

Pfizer said side effects were most often seen after the second dose. An FDA briefing document reported most of those were mild to moderate in severity.

The company reported no children dropped out of the trial because of side effects and there were no deaths among trial participants.

A rare side effect impacting the heart muscle is likely to be one of the things the CDC will 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.

The 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.

Below are the side effects for children ages five to 11 after each dose.

SYMPTOMDOSE 1DOSE 2
Pain at the injection site74.1%71%
Redness at the injection site14.7%18.5%
Swelling at the injection site10.5%15.3%
Fever5%13%
Fatigue33.6%39.4%
Headache22.428%
Chills4.6%9.8%
Vomiting2.2%1.9%
Diarrhea5.9%5.3%
New or worsened muscle pain9.1%11.7%
New or worsened joint pain3.3%5.2%

The CDC’s advisory committee was scheduled to start discussions on the vaccine just after 11 a.m. Tuesday. Voting was scheduled for just after 4 p.m. Click here to watch.

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