Coronavirus disease 2019 (COVID-19) vaccines are now available to children ages 5 and up in the U.S. Here’s what parents and kids need to know about the safety and effectiveness of the vaccine, the possible side effects, and the benefits of getting vaccinated.
If children don’t frequently experience severe illness with COVID-19, why do they need a COVID-19 vaccine?
A COVID-19 vaccine can prevent your child from getting and spreading the virus that causes COVID-19.
If your child gets COVID-19, a COVID-19 vaccine could prevent him or her from becoming severely ill or experiencing short-term or long-term complications. Children with other health conditions, such as obesity, diabetes and asthma, might be at higher risk of serious illness with COVID-19.
Getting a COVID-19 vaccine can also help keep your child in school and more safely have playdates and participate in sports and other group activities.
What COVID-19 vaccines have been approved for kids in the U.S.?
In the U.S., COVID-19 vaccines are available to children by age group:
- Ages 5 through 11. The U.S. Food and Drug Administration (FDA) has given emergency use authorization to a Pfizer-BioNTech COVID-19 vaccine for this age group. This vaccine involves two injections, given three weeks apart. It contains a lower dose than the Pfizer-BioNTech COVID-19 vaccine used for people age 12 and older. Research shows that this vaccine is about 91% effective in preventing COVID-19 in children ages 5 through 11.
- Ages 12 through 15. The FDA has given emergency use authorization to a Pfizer-BioNTech COVID-19 vaccine for this age group. This vaccine involves two injections, given three weeks apart. It contains the same dose as the Pfizer-BioNTech COVID-19 vaccine for people ages 16 and older. The second dose can be given up to six weeks after the first dose, if needed. Research has shown that this vaccine is 100% effective in preventing COVID-19 in children ages 12 through 15.
- Ages 16 and older. The FDA has approved a Pfizer-BioNTech COVID-19 vaccine, now called Comirnaty, for this age group. This vaccine involves two injections, given three weeks apart. The second dose can be given up to six weeks after the first dose, if needed. This vaccine is 91% effective in preventing severe illness with COVID-19 in people age 16 and older. Early research also suggests that the vaccine is 96% effective at preventing severe disease with COVID-19 caused by the delta variant, the most common COVID-19 variant in the U.S right now.
How did the FDA determine the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccines for use in kids?
For kids ages 5 through 11, the FDA reviewed a vaccine study of more than 4,600 children in this age range. Of this group, about 3,100 were given the Pfizer-BioNTech COVID-19 vaccine. The other children were given an inactive (placebo) shot. Children who were given the vaccine were monitored for side effects for at least 2 months after the second dose. Side effects were generally mild to moderate.
The FDA also took an early look at cases of COVID-19 that occurred one week after children were given a second dose of the vaccine. None of the children in this analysis had been previously diagnosed with COVID-19. Among 1,305 children given the vaccine, there were 3 cases of COVID-19. Among 663 children given the placebo, there were 16 cases of COVID-19. The results suggest that the vaccine is about 91% effective in preventing COVID-19 in this age group.
For kids ages 12 through 15, the FDA reviewed a vaccine study of more than 2,200 U.S. children in this age range. Of this group, about half were given the Pfizer-BioNTech COVID-19 vaccine. The other children were given a placebo shot.
A week after the second dose was given, there were no cases of COVID-19 in the 1,005 children given the Pfizer-BioNTech vaccine. Among 978 children given the placebo, there were 16 cases of COVID-19. None of the children had previously been diagnosed with COVID-19. The results suggest that the vaccine is 100% effective at preventing COVID-19 in this age group.
What are the side effects of the Pfizer-BioNTech COVID-19 vaccines for kids?
Children given the Pfizer-BioNTech COVID-19 vaccines had side effects similar to those experienced by people age 16 and older. The most commonly reported side effects include:
- Pain where the shot was given
- Muscle pain
- Joint pain
- Swollen lymph nodes
- Decreased appetite
Similar to adults, children have side effects within 2 days after vaccination that typically last 1 to 3 days. More children reported these side effects, except for injection site pain, after the second dose of the vaccine. However, some people have no side effects.
After your child is given a COVID-19 vaccine, he or she will be monitored for 15 to 30 minutes to see if he or she has an allergic reaction that requires treatment.
It isn’t recommended that you give your child an over-the-counter pain reliever before vaccination to prevent side effects. It’s OK to give this kind of medication after your child gets a COVID-19 vaccine.
Can COVID-19 vaccines affect the heart?
In the U.S., there has been an increase in reported cases of myocarditis and pericarditis after mRNA COVID-19 vaccination, particularly in males ages 12 through 17. Myocarditis is the inflammation of the heart muscle, while pericarditis is the inflammation of the lining outside the heart. These reports are rare. One study suggests that the risk of myocarditis in the week after being fully vaccinated with the Pfizer-BioNTech vaccine is about 54 cases per million doses given to males ages 12 to 17.
Of the cases reported, the problem happened more often after the second dose of the COVID-19 vaccine and typically within several days after COVID-19 vaccination. Most of the people who received care quickly felt better after receiving medicine and resting. Symptoms to watch for include:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering or pounding heart
If you or your child has any of these symptoms within a week of getting a COVID-19 vaccine, seek medical care.
Is there any research on the long-term effects of the Pfizer-BioNTech COVID-19 vaccines?
Because COVID-19 vaccine clinical trials only started in the summer of 2020, it’s not yet clear if the vaccines will have long-term effects. However, vaccines rarely cause long-term effects.
A portion of the children in each age group were monitored for safety for at least two months after being given the second dose of the COVID-19 vaccine.
As part of its first request for emergency use authorization of its COVID-19 vaccine in 2020, Pfizer Inc. created a safety monitoring plan. The plan now includes the monitoring of children and adolescents given the COVID-19 vaccine.
In addition, in the U.S. all vaccination providers are required to report serious adverse events, such as allergic reactions, to a national program called the Vaccine Adverse Event Reporting System.
How do the Pfizer-BioNTech COVID-19 vaccines work?
The Pfizer-BioNTech COVID-19 vaccines use messenger RNA (mRNA). Researchers have been studying mRNA vaccines for decades.
Coronaviruses have a spikelike structure on their surface called an S protein. COVID-19 mRNA vaccines give instructions to immune cells for how to make a harmless piece of an S protein. After vaccination, cells begin making the protein pieces and displaying them on cell surfaces. The immune system recognizes the protein and begins building an immune response and making antibodies. After delivering instructions, the mRNA is immediately broken down. It never enters the nucleus of the cell, where DNA is kept.
Is there any difference in the ingredients or dosing of the Pfizer-BioNTech COVID-19 vaccines for younger children, older children or adults?
The Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 contains a lower dose (10 micrograms) than the vaccine used for older children and adults (30 micrograms). Smaller needles are being used to deliver the vaccine to children ages 5 through 11.
The Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 also contains a different buffer than the vaccine used for older children and adults. This different buffer, which is used in other
FDA-approved vaccines, will help keep the vaccine stable in refrigerated temperatures for longer.
The ingredients and dosing of the Pfizer-BioNTech COVID-19 vaccine are the same for children ages 12 through 15 and people age 16 and older.
Are there any children who shouldn’t get the Pfizer-BioNTech COVID-19 vaccine?
This vaccine is not yet available to children younger than age 5. Clinical trials involving younger children are in progress.
The vaccine also shouldn’t be given to a child with a known history of a severe allergic reaction to any of its ingredients. If this is the case, your child might be able to get another COVID-19 vaccine in the future.
Can a COVID-19 vaccine give a child COVID-19?
No. The COVID-19 vaccines currently being developed in the U.S. don’t use the live virus that causes COVID-19.
Can a COVID-19 vaccine affect fertility or menstruation?
There is no evidence that any COVID-19 vaccines cause fertility problems.
A small number of women have reported experiencing temporary menstrual changes after getting a COVID-19 vaccine. A small study has also shown that some women experienced temporary menstrual changes after getting COVID-19. It’s not clear if getting COVID-19 or a COVID-19 vaccine causes these changes. Further research is needed.
Keep in mind that many things can affect menstrual cycles, including infections, stress, sleep problems and changes in diet or exercise.
Can children who get COVID-19 experience long-term effects?
Anyone who has had COVID-19 can develop a post-COVID-19 condition. Research suggests that children with both mild and severe COVID-19 have experienced long-term symptoms. The most common symptoms in children include:
- Tiredness or fatigue
- Trouble sleeping
- Trouble concentrating
- Muscle and joint pain
These symptoms could affect your child’s ability to attend school or do his or her usual activities. If your child is experiencing long-term symptoms, consider talking to your child’s teachers about his or her needs.
How can children get a COVID-19 vaccine?
Consult your local health department, pharmacy or your child’s doctor for information on where your child can get a COVID-19 vaccine. When making an appointment for your child to get a COVID-19 vaccine, consider asking these questions:
- Does a parent or guardian need to be present at the appointment?
- What information will need to be provided during the appointment?
- Is there a limit on how many family members, such as siblings, can attend the appointment?
How soon can a child get a COVID-19 vaccine before or after getting another vaccine?
A COVID-19 vaccine and other vaccines can be given on the same day.
Previously, due to the newness of COVID-19 vaccines, the CDC had recommended against getting any other vaccines two weeks before and after getting a COVID-19 vaccine. The CDC changed its recommendation based on safety data gathered in recent months.
Remember, COVID-19 vaccination will protect most people from getting sick with COVID-19. If you have questions or concerns about your child getting a COVID-19 vaccine, talk to your child’s doctor. He or she might be able to help you weigh the risks and benefits.
Nov. 16, 2021
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