Patient Care

Age 5-11 COVID Vaccine: Everything You Need to Know on Safety, Efficacy, and Distribution

Oct. 12, 2022

Updated on October 12, 2022.

Children 5 to 11 years old are now eligible to receive the Pfizer and BioNTech SE and Moderna COVID-19 vaccine. The CDC unanimously authorized its use, after extensive review of safety and efficacy data from vaccine studies completed across the country, including at the University of Rochester Medical Center. Additionally, the FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. Per the FDA: The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.

We spoke with URMC infectious disease expert Jennifer Nayak, M.D., as well as pediatrician Stephen Cook, M.D., M.P.H, about why this COVID vaccine is continuously proven to be safe and effective.

Why do younger children need to be vaccinated?
We are still seeing younger children admitted to the hospital with COVID-19 and respiratory disease. There have been 1.8 million COVID cases in 5- to 11-year-olds in the United States. Additionally, we’re seeing children hospitalized with multisystem inflammatory syndrome (MIS-C), which is a common illness that occurs post-COVID infection. Record numbers of children have been hospitalized in the Omicron wave, including here in Rochester. There are 28 million children in this age group and the best protection is to be vaccinated and continue with masking and distancing as recommended. It’s important to protect children, and prevention strategies and vaccinations are our best methods.

The Delta variant has hit young children especially hard, sickening more kids than were diagnosed earlier in the pandemic. Additionally, the Omicron wave has seen record numbers of pediatric hospitalizations throughout the country, with vaccinated children being less likely to be hospitalized during the wave. Vaccination will help prevent those infections, keep kids in school, and help stop COVID’s spread.

Are the vaccines safe and effective for my children?
Yes. Safety is a top priority for any clinical trials for children.

The vaccines were well tolerated in the studies, and children experienced similar effects that teens and adults do: mild to moderate pain in the arm, mild headache, and fatigue were reported in a small number of cases after the first dose. And a small percentage of children experienced fever and chills after the second dose. There were no cases of myocarditis or pericarditis through three months of follow-up. And they are very effective in protecting youngsters.

Researchers followed more than 3,000 children enrolled in the vaccine trials for 126 days. During that time, there were 17 COVID cases in the placebo group, versus 3 COVID cases in the vaccinated groups. That’s a 91 percent vaccine efficacy rate when measured at a week post second dose.

Some children may still have break-through infections, because the shot does not provide complete protection, but they will have milder symptoms.

What are the long-term effects of the vaccines?
Long-term effects are continuously being studied for COVID vaccines. In general, any vaccine side effect from prior vaccines occurred within the first few weeks after vaccination. This is why the safety studies collected data for a few months, well beyond the time period that a reaction has ever been seen for existing vaccines.

How were COVID vaccines evaluated and tested in this age group?
The studies were completed in two parts. Initially researchers focused on dosage, starting with very low doses and gradually increasing them to find the appropriate amount for this age group.

In the trials, two-thirds of the kids received the vaccine and others were given a placebo (saline.) That ratio makes it easy to understand the safety of these vaccines.

In all, 4,500 children were enrolled across the nation, including 75 children in URMC research studies.

Scientists/researchers are also continuously updating and reviewing data to continue to monitor the efficacy and safety of vaccination. This is a good thing because it means scientists are always looking to improve how things are done.

Is the dosage different for younger children?
Quite different, actually. The dose for children is one-third of the dosage for adults. And it is based on age, not weight. And, most importantly it provides a similar immune response in kids that we’ve seen in adolescents and adults.

Are variants spreading in children, teens, and young adults?
Yes, the variants are spreading, which is expected. Whenever there is infection, the virus replicates very rapidly and potentially creates variants. Some of those variants can cause more severe disease or possibly be more transmissible. The best way to prevent variants is to prevent infection. The best way to prevent infection is through vaccination.

How can I get my children vaccinated?
Your child's pediatrician should be able to provide the vaccine. If your doctor is not able to provide the shot, they should be able to point you in the right direction. 

Will the vaccine change testing/quarantine requirements for schools?
The CDC has not changed its guidance on testing and quarantine requirements. Anyone who is fully vaccinated who comes in close contact with someone with suspected or confirmed COVID infection should be tested 5 to 7 days after exposure. If the results are negative, there is no need to isolate.

Can these vaccines give you COVID?

Getting a coronavirus vaccine will not give you COVID. None of the vaccines currently being developed, tested and distributed in the U.S. use the live virus that causes COVID-19; they use other methods to stimulate our bodies to recognize and fight the virus. Learn about how COVID-19 vaccines work.

Are mRNA vaccines gene therapy?

The Pfizer and Moderna COVID vaccines are composed of short-lived messenger RNA, which is not the same thing as DNA. The RNA will not enter the nucleus of the cell (the command center of the cell and location of the DNA) and cannot change a cell’s genetic material in any way. Therefore, the vaccine is NOT gene therapy. Upon providing the “message” to make the protein that will protect from infection, the RNA contained in the vaccine is broken down by the body.

In addition, vaccines are not medications, medications are taken daily and are continuously being processed by your body. They are designed to change how your body works. Vaccines provide the blueprint for your immune system to respond to a very specific situation. Once that blueprint is created, there is not more response.