The Pfizer vaccine has been approved for kids, but is it safe? FOX21 has the facts.

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Ten-year-old David Battistelli, left, uses his right arm to indicate which side he wants to receive a COVID-19 vaccination as his mother, Paula, looks on at National Jewish Health, during the pediatric vaccine rollout Wednesday, Nov. 3, 2021, in east Denver. Several dozen children were the first in the Mile High City to receive a vaccination against the coronavirus. (AP Photo/David Zalubowski)

COLORADO SPRINGS — Now that the Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech COVID-19 Vaccine for children five through 11 years old, parents around the country need to decide whether to vaccinate their kids.

With the authorization comes questions regarding the vaccine’s safety, effectiveness, and side effects. FOX21 has gathered questions from parents, including those who work at FOX21 News, to find the information they need to help them make an informed decision.

This article will also debunk common myths about the COVID-19 vaccine.

FILE – This October 2021, photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. (Pfizer via AP, File)

What is the new authorization?

The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in order to prevent kids ages five to 11 from contracting COVID-19. The Pfizer vaccine is administered as a two-dose primary series, three weeks apart. It is a lower dose (10 micrograms) than what was used for people 12 years and older (30 micrograms). 

Why is the vaccine now available for kids ages 5-11?

Before the authorization, kids ages five to 11 could not get the vaccine. Why? Kids ages five to 11 do not have the highest chance of contracting the virus. For that reason, the FDA focused on getting senior citizens, adults, and teenagers vaccinated first.

Now that groups with a higher chance of contracting the virus have had the opportunity to be vaccinated (an opportunity that is still present), the FDA has started to focus on protecting children.

How do doctors know the vaccine works?

Doctors have based the vaccine’s effectiveness on an ongoing randomized, placebo-controlled study that has included around 4,700 children in the five to 11 age goup.

Children were split into two groups: one group received two doses of the Pfizer-BioNTech COVID-19 vaccine. The other group received a placebo.

A placebo is an inactive substance that looks and tastes like the drug being tested but has no effect on the disease the new drug is intended to treat. A placebo is sometimes called a sugar pill, or dummy.

Massachusetts General Hospital

The FDA compared the immune response of 264 children from this study (the five to 11 year olds) to 253 participants 16 through 25 years of age from a previous successful study. (It’s important to note the older individuals had two higher doses of the vaccine.)

Doctors found the immune responses of the five to 11-year-olds were comparable to the older participants. Meaning the effectiveness of the vaccine on younger kids was just as good as it was on older children.

The FDA also kept watch on the children after they received their second dose. (Remember, the Pfizer vaccine requires two doses, three weeks apart). During that time, only three out of the 1,305 kids who received the Pfizer vaccine contracted COVID-19. However, 16 out of the 663 placebo recipients contracted the virus. Based on those statistics, doctors found the vaccine to be 90.7% effective in preventing COVID-19 in young children. 

Even if the vaccine works, is it safe?

1,444 vaccine recipients were followed for safety for at least two months after the second dose.

Commonly reported vaccine side effects included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite.

More children reported side effects after the second dose than after the first dose. However, doctors say side effects were generally mild to moderate in severity, happened within two days after vaccination, and most went away within one to two days.

The FDA and the Centers for Disease Control and Prevention (CDC)have previously found increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Pfizer vaccine, and, particularly, after the second dose.

The highest observed risk was found among boys ages 12 through 17.

Because of those previous results, the FDA conducted its own benefit-risk assessment to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause.

FDA’s Benefit-risk Assessment Compared:

  • # of COVID-19 cases the vaccine can prevent
  • # of Hospitalizations the vaccine can prevent
  • # of Intensive Care Unit (ICU) admissions the vaccine can prevent
  • # of Deaths from COVID-19 the vaccine can prevent
  • # of Potential myocarditis cases the vaccine might cause
  • # of Hospitalizations the vaccine might cause
  • # of ICU admissions the vaccine might cause
  • # of Deaths the vaccine might cause

Result: The FDA’s model predicts that the benefits of the vaccine would outweigh its risks in children five through 11 years of age.

Ongoing Safety Monitoring

Pfizer Inc. has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children five through 11 years of age. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety problems.

It is mandatory for Pfizer Inc. and vaccination providers to report to any serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death in vaccinated individuals. It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS. And Pfizer Inc. must submit a summary and analysis of all identified vaccine administration errors, in monthly safety reports, to the FDA.

Registered Nurse Natasha McDannis inoculates Otto Linn-Walton, 8, with the first dose of the Pfizer-BioNTech COVID-19 vaccine for children five to 12 years at NYC Health + Hospitals Harlem Hospital, Thursday, Nov. 4, 2021, in New York. (AP Photo/Jeenah Moon)

Vaccine Facts

  • The Pfizer vaccine cannot give someone the virus that causes COVID-19 or other viruses.
    • mRNA vaccines (which is the type of vaccine the newly-authorized Pfizer vaccine is) do not use the live virus that causes COVID-19. It cannot cause infection with the virus that causes COVID-19 or other viruses.
  • COVID-19 vaccine, including the Pfizer vaccine, do not affect or interact with our DNA in any way.
    • mRNA never enters the nucleus of the cell where our DNA (genetic material) is located, so it cannot change or influence our genes.
  • The mRNA and the spike protein do not last long in the body.
    • Our cells break down mRNA and get rid of it within a few days after vaccination.
    • Scientists estimate that the spike protein, like other proteins our bodies create, may stay in the body up to a few weeks.
  • The mRNA technology used to make the COVID-19 vaccine is brand new.
    • mRNA technology has been in the works for decades. It helps scientists and doctors because it can be made in a lab and is created using easy-to-get materials.
  • If I’ve already had COVID-19, I don’t need a vaccine.
    • Evidence continues to show that getting a COVID-19 vaccine is the best protection against getting COVID-19, whether you have already had COVID-19 or not.
  • The vaccine will the vaccine affect my child’s ability to, one day, have children?
    • According to the FDA, none of the COVID-19 vaccines have any link to a child’s future fertility.

FOX21 understands parents still have important questions related to the vaccine and their child’s health. Do you have a question you want us to research? Contact us by filling out the contact form below.

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