Last week, the FDA approved the Pfizer / BioNTech COVID vaccine for children aged 5 to 11 years. After conducting their review, the CDC now recommends this policy for children of this age group, who can begin receiving their first dose during the week.

While many families look forward to the opportunity for their children to be vaccinated, some are skeptical. And many parents have questions about how COVID-19 affects young children, the safety of the vaccine at this age, and whether the benefits outweigh the potential risks. As a pediatric infectious disease specialist, I hear some questions come up again and again. Here’s what we know so far.

How does COVID-19 affect children at this age?

While children continue to be less likely to have adults – especially adults 65 and older – get very sick from COVID-19, some children get very sick. Thousands of children from 5 to 11 are hospitalized or need intensive ICU support to diagnose the disease. About 150 children in this age group were killed by COVID-19. In addition, more than 5,000 cases of malignant condition known as MIS-C that could be followed by COVID-19 infection have been reported. Most MIS-C cases occur in children in this age group.

How has the Delta virus affected children?

The Delta virus version of the old COVID virus is easily spread, especially to people who have not yet received the vaccine. Children 5 to 11 years of age are always at risk of infection, given their suitability for vaccination. In fact, more than one in five new cases were recorded in the past two months while the Delta infection increased in the US occurred in this age group, according to weekly reports from the American Academy of Pediatrics and the Children’s Hospital Association.

Can children spread the virus to others?

Several detailed reports describing outbreaks associated with settings such as summer camps, kindergartens, and schools, as well as those that track the spread of COVID-19 in homes, clearly show that children can spread the virus and infect others close to them.

What are the terms and doses of COVID approved for children aged 5 to 11 years?
Pfizer / BioNTech is the first FDA-approved COVID vaccine in this age group, based on the results of a randomized controlled trial examining safety and immune responses. The different tests presented by Moderna are considered separately.

In young children, the Pfizer / BioNTech trial compared three doses:

  • 30 micrograms (adult capacity)
  • 20 micrograms
  • 10 micrograms.

This part of the study showed that 10 micrograms, a very small dose, caused a few side effects while producing strong immune responses similar to those achieved in high doses.

In the next phase of the study, more than 2,200 children aged 5 to 11 were randomly assigned to receive a 10-microgram dose of vaccine (two-thirds of participants) or a placebo dose (one-third of participants). They all received two shots, separated for three weeks.

Those who were given the vaccine had the same immune responses as 16- to 25-year-olds who received a full two-dose dose shot.

When Pfizer / BioNTech submitted data to the FDA, there were not many cases of COVID-19 infection in the study participants. Of the 19 cases recorded, most had received a placebo gun. Estimates suggest that the effectiveness rate of the vaccine is 90%. (Effectiveness measures how much vaccine reduces infection in a controlled study.) The tests confirmed that the Delta virus type caused infections.

What do we know about the negative effects on children over the years?

Most children had no side effects other than pain at the injection site. Those who experience side effects are more likely to experience fatigue, headaches, and / or muscle aches after the second dose than the first dose. For example, only 6% of children develop a fever after the second dose of vaccine. There are no instances of serious conflict.

What is still unknown?

In rare cases, Pfizer / BioNTech COVID-19 vaccine is associated with myocarditis, an inflammation of the heart. When this happens, it is most noticeable in young men following their second dose of mRNA vaccine (Pfizer / BioNTech or Moderna). Most cases are mild, and children may not show any signs of long-term damage to the heart.

Among children 5 to 11 years of age who received the Pfizer vaccine during the trial, there were no cases of myocarditis. However, this side effect is very rare and may not be apparent until the number of children receiving the vaccine is very high. The FDA and Pfizer / BioNTech will continue to monitor this age group for any possible adverse side effects.

Can children be vaccinated against COVID-19 and the flu at the same time?

Yes. Children and adults can safely get both vaccines at the same time. The CDC urges everyone to get a flu shot to help stay healthy during the flu season.

A randomized, controlled trial in the UK examined adults who received a flu shot or a placebo gun in one arm and their second dose of Pfizer / BioNTech vaccine in the other arm. Researchers have reported in Preprints and The Lancet that side effects and immune responses are the same, whether a flu shot or a placebo shot was given simultaneously with the COVID vaccine.

What are some steps parents can take to protect their children from COVID-19?

Parents should keep in mind that a person is not fully vaccinated and is not vaccinated until 14 days after the second dose of Pfizer vaccine. Masks are recommended for anyone who is not vaccinated, or not fully vaccinated, when indoors and out-of-home. If COVID-19 prices are high where you live, the mask may be recommended for indoor and outgoing people.

Parents can continue to promote other simple practices that help prevent colds, flu, and COVID-19, such as a watch

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