Children as young as 5 years old are eligible for COVID-19 vaccination.
In May 2021, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorized the use of Pfizer-BioNTech’s COVID-19 vaccine in children aged 12-15. The FDA and CDC then authorized the vaccine for children between the ages of 5 and 11 in November 2021.
Vaccines developed by Moderna and Johnson & Johnson/Janssen are available only for adults age 18 and older.
Before the FDA authorized the Pfizer vaccine for use in children, it had to meet standards for safety and effectiveness. According to reported data, the vaccine is safe and effective for children.
Here’s what you need to know about the vaccine’s safety for children.
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Were the COVID-19 Vaccines Tested in Children?
Before receiving EUA, the Pfizer vaccine went through months of clinical trials in children. The trials measured the safety and effectiveness of the vaccine in the child participants.
The authorization process worked the same way as it did for adults. For a vaccine to receive EUA, data must show that the vaccine’s benefits outweigh the risks.
Data from the clinical trials showed the Pfizer vaccine was safe for use in children ages 12 to 15, according to the FDA. It also showed the vaccine was effective in preventing COVID-19.
“All of the evidence so far says that the vaccine is extremely safe in kids,” says John Williams, MD, chief, Pediatric Infectious Diseases, UPMC Children’s Hospital of Pittsburgh. “The vaccine has been given to over 100 million adults with essentially no serious side effects. There’s no reason to think that younger children will be any different.”
COVID-19 Vaccine Side Effects in Children
Children who received the Pfizer vaccine reported common side effects. These side effects are generally minor and typically subside within 1 to 3 days after receiving the vaccine. The side effects are a result of the immune system’s response to the vaccine.
According to the FDA, the most commonly reported side effects in children included:
- Pain, redness, and swelling at the injection site.
- Muscle/joint pain.
- Swollen lymph nodes.
These side effects are consistent with side effects reported in people age 16 and older.
Side effects were more common after the second dose. Side effects are possible after both doses, and it’s also possible to experience no side effects. Most side effects appear within two days after vaccination and typically go away after one or two days.
The Centers for Disease Control and Prevention (CDC) is monitoring reports of the heart conditions myocarditis and pericarditis in people who received the Moderna and Pfizer vaccines, especially adolescents and young adults.
According to the CDC, the reported cases were rare and happened mostly in male adolescents and young adults 16 and older. Symptoms usually presented within days of vaccination, and patients typically responded well to rest and medications.
The CDC continues to recommend vaccination for Americans 5 and older.
Is the COVID-19 Vaccine Effective in Children?
According to the FDA, clinical trials of the Pfizer vaccine in children showed it was effective in preventing COVID-19. It is especially effective in preventing severe illness. It is also effective against COVID-19 variants.
While more data is needed to evaluate the vaccine’s effectiveness in preventing the spread of the virus from person to person, to date studies of vaccinated adults show that vaccinated people rarely transmit SARS-CoV-2 to others. It is not clear at this time how long the vaccine provides protection.
Why Do Kids Need the COVID-19 Vaccine?
Although fewer children than adults have gotten COVID-19, it is possible for children to become infected.
As of Oct. 28, 2021, nearly 6.4 million children had tested positive for COVID-19 since the start of the pandemic, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. As of Oct. 17, 2021, nearly 700 children had died from COVID-19, the FDA reported.
“It’s terrific news, as a parent and pediatrician, that our kids can be vaccinated,” Dr. Williams says. “Although severe COVID-19 is rare in young kids, it does happen, and the vaccine will protect them. Young people can also spread COVID-19 to vulnerable family members, and we know that the vaccine is extremely effective at preventing this.”
Most children experience mild illness from COVID-19 or are asymptomatic. But a severe illness, hospitalization, and death are possible. The numbers of hospitalizations and deaths from COVID-19 among children are greater than the number of hospitalizations and deaths from seasonal flu.
Some children who have had COVID-19 have developed a condition known as Multisystem Inflammatory Syndrome in Children (MIS-C). MIS-C is a rare but serious condition that can affect different body parts and cause serious symptoms.
Other children who have had COVID-19 have experienced long-term symptoms.
“While most children who are infected with SARS-CoV-2 have mild disease, some kids have a severe disease such as MIS-C, long-term symptoms consistent with long COVID, or require monitoring by a cardiologist for effects on the heart prior to returning to sports,” says Megan Freeman, MD, PhD, fellow, Pediatric Infectious Diseases, UPMC Children’s Hospital of Pittsburgh. “Vaccination can help protect the individual and the community as well.”
Editor's Note: This video was originally published on , and was last reviewed on .
Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. Link
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