How Do We Know the COVID-19 Vaccine Is Safe for Kids?

Parent and young child talking to a doctor

Now that Pfizer's COVID-19 vaccine has been authorized for use in children ages 5-11, parents and guardians will decide whether their elementary school kids should get the shot. We want parents to have the facts they need to feel safe and confident in their decision to get their children vaccinated.

Here's what we know about the vaccine's safety for kids:

The vaccine was studied extensively

All COVID-19 vaccines must meet the same rigorous safety standards as any other vaccine. This includes scientific study as well as review and recommendations by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

New findings specific to children ages 5-11 show the vaccine is safe and effective in children, just as we know it is safe and effective in adults and adolescents.

For children aged 5-11, a study of about 2,250 volunteers shows 90.7% efficacy for the vaccine in preventing symptomatic COVID-19 infection. All the children received two 10-microgram doses, which is one-third of the dose used for adults and adolescents, with the two shots spaced 21 days apart.

Children in the 5 to 11 age group have a more robust immune system than older children and adults, so they can get a lower vaccine dose and still produce antibodies to protect against COVID-19 infection.

The children in the original group of about 2,250 participants were monitored for at least two months after the second dose. An additional group of 2,250 who entered the study later were monitored for at least two weeks. No serious vaccine-related health problems were reported in either group. The study is ongoing, just as was done with the adult studies.

The vaccine shows no major side effects

Just like their older counterparts, some children in the study experienced mild side effects, such as pain at the injection site, fatigue and headache. Those side effects usually lasted a day or two.

A tiny percentage of people in older age groups, mostly male adolescents and young men, have  developed myocarditis or pericarditis — inflammation of the heart muscle or heart lining that usually resolves on its own— after vaccination. Myocarditis patients typically recover quickly and don't have lasting effects on their heart.

The benefits of COVID-19 vaccination outweigh the risks of myocarditis after vaccination. The risk of myocarditis is significantly higher after coronavirus infection itself, compared to vaccination.

None of the children involved in Pfizer's clinical trial for the 5-11 age group developed myocarditis or pericarditis.

The vaccine reduces the risk of infection

Any potential concerns about the safety of the vaccine should be weighed against the proven dangers of COVID-19 infection. Although children generally have milder symptoms than adults, some kids with COVID-19 can get severe lung infections, become very sick and require hospitalization. Children who recover from even mild COVID-19 are at risk for later developing a dangerous multi-system inflammatory disorder called MIS-C.

The Pfizer study showed that the vaccine is 90.7% effective in preventing kids ages 5-11 from developing symptoms from COVID-19 infection.

Find COVID-19 Vaccines

Read more stories like this