After FDA OK, what you need to know about Pfizer vaccine for ages 5 to 11

The U.S. Food and Drug Administration on Friday gave emergency use authorization to Pfizer's COVID-19 vaccine for children ages 5 to 11, and it's expected the Centers for Disease Control will issue approvals early next week.

“Pediatricians are elated at this turn of events,” said Dr. Shelly Vaziri Flais, who practices with Pediatric Health Associates in Naperville. “We are thrilled to protect our children and their families. It's like Christmas.”

For many parents, the news is a welcome relief, but it comes with questions. Here are answers from the experts.

Q: How effective and safe is the Pfizer vaccine?

A: “Pfizer's study was really based on 2,200 children; 70% received the vaccine,” said pediatrician Michael Bauer, medical director at Northwestern Lake Forest Hospital. “And there were very few cases of breakthrough (infections), nobody hospitalized, and there were no adverse effects from the vaccine.”

Noted Flais, “whether you're talking about children or adults, this is probably the most heavily studied vaccine in the planet's history.”

Q: What are the side effects?

A: As with other vaccines like the flu shot, “headache, fatigue, fever, pain at the injection site, muscle aches,” Bauer said.

Q: How can I get a vaccine?

A: About 500,000 initial doses are headed to Illinois for distribution among pediatric practices, health organizations, hospitals, retail pharmacies, county health departments and clinics. Parents are advised to contact their children's doctors about shots or check pharmacy and county websites for updates.

As of Friday, numerous entities like Walgreens were still waiting for CDC approval before online scheduling goes live.

Q: What is the dosage?

A: Pfizer's vaccine must be given in two shots, three weeks apart, and it is one-third of the dose given to people 12 and older. “They found it was enough to transfer that critical immunity while avoiding unnecessary side effects,” Flais said.

Q: How strong is the protection against COVID-19 after one dose?

A: “The first dose is great — it exposes your immune system to the spike protein booster,” Flais said. But the second shot is “critical.” With shot two, the body recognizes the protein “and really revs up the machinery to generate antibodies for that spike protein. So you definitely don't want families to say, ‘Oh we got our first dose, we can party now.'”

Q: Isn't COVID-19 just a mild illness for kids?

A: “While COVID by and large is a mild respiratory illness for most children, there is no way to predict who is going to get a severe case,” Bauer said.

“We certainly see healthy children with no risk factors that can suffer the ravages of COVID-19,” he noted, adding there have been more than 700 pediatric deaths in the U.S.

Flais noted, “There's been greater than 2 million cases in 5- to 11-year-olds, and over 8,000 of these kids have been hospitalized” with one-third of them in ICUs.

Q: I read on social media the shot could have other alarming negative results. Is that true?

A: Adverse effects related to “infertility, puberty, menstrual cycles, changing your DNA — those are urban legends and are not risk factors,” Bauer said.

Q: Have there been adverse effects associated with the vaccine?

A: Some extremely rare cases of myocarditis, which is inflammation of the heart muscle, have occurred mostly among males between the ages of 12 and 30. Most responded well to care, according to the CDC.

Meanwhile, “the risk of developing myocarditis — if you get COVID-19 — is much, much, much higher,” Bauer said.

Have more questions? Check out the American Academy of Pediatrics website at

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