COVID-19 Vaccine Receives Emergency Use Authorization for Children Ages 5 to 11

Some 28 million children ages 5 to 11 can now get the Pfizer-BioNTech COVID-19 vaccine under emergency use authorization granted by The Food and Drug Administration and Centers for Disease Control and Prevention.

Simon Li, an associate professor of pediatrics at Rutgers Robert Wood Johnson Medical School, which was part of the trial that include 4,647 children worldwide, and a principal investigator for the study at the Rutgers site, discusses what parents need to know as vaccinations roll out.

How effective is the vaccine in protecting children ages 5 to 11?
Pfizer recently reported that its coronavirus vaccine had a 90.7 percent efficacy rate in preventing symptomatic COVID-19 in its clinical trial. All of the cases occurred in July or later, which is when the highly transmissible Delta variant was spreading in the United States and globally.

The clinical trial showed that the COVID-19 vaccine generated a strong immune response that compares well to what we saw in people between 16 to 25 years old in that clinical trial. The response was similar against the original strain as well as the Delta variant.

What side effects might be expected?
The vaccine was well tolerated in this age group of children, and there appeared to be fewer side effects among younger children who got the vaccine compared with 16- to-25-year-olds. Children may notice pain at the injection site and could feel more tired than usual. Headache, achy muscles or joints, and even fever and chills are also possible. These side effects are usually temporary and generally clear up within 48 hours.

We have not seen any cases of inflammation of the heart muscle or in the lining around the heart post-vaccination in this age group. We are aware of the rare reports of myocarditis, especially in young males in the older age group, following vaccination. However, this is an extremely rare side effect.

As with any vaccine, there is a remote chance that it could cause a severe allergic reaction within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask your child to stay at the place where they received the vaccine for monitoring after vaccination.

Why is the dose smaller for children under 12?
As is the case with the older children, this age group will receive two doses, three weeks apart. The clinical trial found that this age group achieved an effective immune response with 10 micrograms of the vaccine per dose — one-third of the dose given to older children and adults. 

The children who received the lower dose of vaccine produced a response comparable to the levels of antibodies seen in the earlier trials of participants ages 16 to 25, who receive two doses of 30 micrograms given three weeks apart.  The initial part of that study showed that the under-12 volunteers who had the 30 microgram dose had many minor side effects whereas those who received the 10 microgram dose had much less. In fact, as compared to the 16- to 25-years-olds, these minor side effects such as fevers, chills, muscle and joint pain were much less. 

Children who are close to turning 12 should still receive the dose for those ages 5 to 11.

What would you tell parents who prefer to “wait and see” what happens with the vaccine?
Although children are at a lower risk of having severe disease from the virus, children have been hospitalized as a result of getting COVID-19. According to the CDC, at least 731 children have died from COVID-19, including 160 deaths of children who were 5 to 11 years old. 

The amount of effort and work that has gone into studying this particular vaccine has been tremendous. In the U.S., approximately 245 million doses of this vaccine has been taken with very little side effects.

How can children receive vaccines?
Children can get vaccinated at pharmacies, mega sites, some pediatricians’ offices and in some schools. As with the adult vaccine, children will receive a second vaccine three weeks later. More research is needed on whether a booster will eventually be required.

How should parents talk to children who are nervous about the vaccine?
Be honest. Tell your children that they could get a little sick, but that they should be fine after a day or so. The vaccine will allow them and their family members to resume a more normal life. As a community, the more people who are vaccinated, the less the virus will be transmitted. This will also help provide safety for people who can get very sick from the virus.

Will the COVID-19 vaccine need to be spaced out from other vaccines or can they be taken at the same visit?
It is important for children to receive all vaccinations that are recommended by their pediatricians, including the annual flu vaccine. The American Academy of Pediatricians feels comfortable with the coadministration of the vaccine to prevent COVID-19 and other routine vaccinations.  

It is also reasonable for parents to want to separate the COVID 19 vaccine administration from others. The most important thing is to get vaccinated as soon as possible and return our kids to a full life. 

What is the status of the COVID-19 vaccine approval for children under age 5?
Pfizer expects to have some data for children ages 2 to 4 years old in the fourth quarter of this year and kids between 6 months and 2 years old sometime after that.