Nine Things Parents Should Know About the Pfizer Pediatric COVID-19 Vaccine Authorization

On Nov. 2, 2021, the Pfizer COVID-19 vaccine was authorized for emergency use by the FDA for children ages 5 to 11.

The Pfizer COVID-19 vaccine is a 2-dose series of vaccinations that are taken three weeks apart. Each dose will be 1/3 the dosage of the adolescent/adult Pfizer COVID-19 vaccine.

Below are nine things parents should know about COVID-19 vaccination for children ages 5 to 11 from Loyola Medicine’s experts.

1. Are COVID-19 vaccines safe?

Yes, COVID-19 vaccines approved for emergency use authorization (EUA) in the United States are safe. The vaccines go through the same testing and clinical trials as all vaccines and no serious safety concerns have been identified.

2. What are the benefits of vaccinating children?

While most children are at lower risk for severe illness from COVID-19, there are still many unknown long-term effects. While uncommon, it is also possible for children infected with COVID-19 to become seriously ill or worse.

Vaccination also allows for a safer return to activities and normal life. Vaccination will:

• Help prevent the risk of serious illness including Multisystem Inflammatory Syndrome in Children (MIS-C)
• Help prevent long-term effects of COVID-19
• Reduce the risk of passing COVID-19 infection to family members and others at high-risk for severe illness from COVID-19

3. How effective are COVID-19 vaccines in children ages 5-11?

Clinical trials show COVID-19 vaccines are very effective in children ages 5 to 11, preventing 90.7% of symptomatic infections and no severe cases of COVID-19 during the clinical trials.

In fact, data shows the immune response for children was very similar to that of trial participants ages 16-25, even with the lower dosage administered to children.

Additionally, clinical trials found the vaccine works against the Delta variant as well as other known COVID-19 variants of concern.

4. What side effects are common in children?

Side effects in children ages 5 to 11 were similar to those in older children and adults ages 16-25. The most common side effects include:

• Pain at the injection site
• Fatigue (feeling tired)
• Headache

5. Are there any long-term side effects?

Side effects are generally mild and resolve quickly. Long-term side effects are unlikely, as clinical studies demonstrated safety for multiple months past the typical timeframe for vaccine reactions.

6. Will kids get the same dose of the vaccines as adults?

For the Pfizer vaccine, 5- to 11-year-olds will receive one-third the dosage of adults. Clinical trials showed that this dose, delivered in a two-dose regimen, was safe and generated similar antibody levels as the full dose did for adults.

7. Could COVID-19 vaccines impact puberty or menstruation?

There is no clinical evidence to suggest COVID vaccines have effects on puberty or fertility.

8. Will COVID-19 vaccines be required by schools?

It will be up to each state's government to decide whether a COVID-19 vaccine is required for school entry.

9. What about concerns of myocarditis?

In extremely rare cases, recipients of the mRNA COVID-19 vaccines have developed myocarditis, or inflammation of the heart.

This reaction was not observed in Pfizer's clinical trial for children aged 5 to 11. While the remote possibility of myocarditis cannot be ruled out, the benefits of the vaccine still outweigh the risks.

COVID-19 infection is far more likely to cause myocarditis than the vaccine, and infection can lead to other serious complications.

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