In May, the CDC’s ACIP recommended the Pfizer-BioNTech vaccine for individuals aged 12–15 in the U.S. following the FDA amending its EUA to include individuals 12 to 15 based on safety and efficacy data, which showed 100% effectiveness in the vaccine group (0 cases) compared to the placebo group (16 cases). The EUA Fact Sheets reflect the changes.
On Nov. 3, the CDC recommended the COVID-19 vaccine for children 5-11 years old. They agreed the clinical trial demonstrated the Pfizer-BioNTech COVID-19 vaccine is safe and effective in this age group, and that it can reduce the devastating impact of COVID-19 on children. The Pfizer-BioNTech vaccine (10ug) will now be available for all children in this age group under the FDA’s EUA.
AAFP's statement, AAFP Applauds FDA’s Emergency Use Authorization of COVID-19 Vaccines for Children Ages 5-11, emphasizes that children need equitable access to a safe, effective vaccine and they should be quickly distributed to primary care physicians.
On Oct. 29, the FDA authorized use of the Pfizer-BioNTech COVID-19 vaccine for children 5-11 years old. The authorized vaccine is at a different dose and will be shipped separately from adult doses. It will still be a 2-dose series with 3 weeks between doses. In data presented to the committee, this dose induced comparable antibody levels as seen in adolescents and young adults, and was 90% effective at preventing symptomatic COVID-19. Side effects were similar, if not lower, than those in adults. No cases of myocarditis, anaphylaxis, or death were observed.
Pediatric vials, which are different from those used for adolescents and adults, will need to be diluted per instructions for the correct dose (see table below). More information can be found in the Pfizer Quick Reference Guide.
Childhood (Pediatric) Vaccine
Adolescents and Adult Vaccine
|Vial description||Orange top||Purple top|
|Dose||10 mcg||30 mcg|
|Doses per vial||10 doses per vial||6 doses per vial|
Here is a list of frequently asked questions to aid you in discussing the vaccines with your patients and their parents/caregivers. Please refer to the CDC's Clinical Considerations for more detail.
What vaccines are available for children and adolescents?
Currently, the Pfizer-BioNTech mRNA vaccine has been authorized/recommended for children and adolescents aged 5-15. Adolescents (12-15) receive 2 doses of the adult formulation where as children (5-11) receive 2 doses of a different formulation at a lower dose. This lower dose resulted in a robust immune response and was seen to be 90% effective at preventing symptomatic disease. Children’s immune systems are much more responsive so this lower dose works well for them. Vaccines, unlike other medications, are recommended by age and not body weight.
Why should my child get the vaccine?
Children and adolescents can get COVID-19 just as easily as adults and can transmit it to others. There have been almost 2 million cases reported in children resulting in over 80,000 hospitalizations and 94 deaths in children aged 5-11. These rates are much higher than rates observed for diseases that we already routinely immunize children against. Vaccination is also important in protecting children from the potential of severe inflammatory disease (MIS-C) and “Long-COVID.” Children can also spread COVID-19 to others, so getting them vaccinated is another way to protect your family and community, especially those who are most vulnerable.
What if my child turns 12 before their 2nd dose?
The CDC is recommending that children get the vaccine that is recommended for their age on the day of vaccination. So they should receive a dose of the adolescent/adult vaccine if they have turned 12. However, the FDA authorization allows for flexibility and they can still receive a second dose of the child vaccine if needed and will be considered fully vaccinated. View the updated CDC Clinical Recommendations.
Should I get my child vaccinated if they have already had COVID-19?
Yes, the CDC is recommending all children aged 5 and older get vaccinated regardless of their past infection history. There is increasing evidence that vaccination after COVID-19 actually increases protection against reinfection including against the recent more infectious variants. In the clinical trial, there were no effects on the immune response or side effects in children who were seropositive (past infection). Additionally, there is extreme variability in immunity after infection and there is data showing lower antibody levels in people who had an asymptomatic infection.
Is the vaccine safe for children?
Yes. The vaccines will not give your child COVID-19. They do not cause fertility problems and do not contain tracking devices, microchips, or luciferase so your children will not glow after receiving the vaccine. As with all medications and vaccines, there are rare instances of allergic reactions. Talk with your family physician about these rare events, particularly if your child has a history of anaphylaxis or if they are allergic to any of the components of the vaccine. The vaccine formulation for children is different and uses a different buffer than the adult, but this buffer is used in other vaccines and is completely safe.
What are the side effects of the vaccine in children?
Children may experience fewer side effects than adolescents or young adults. Children with evidence of prior infection may have fewer side effects than those without evidence of prior infection. The clinical trial showed that children had similar, if not fewer, side effects than adults. You may see pain, redness, or swelling at the injection site. There is also a chance they may develop fever, fatigue, headache, chills, muscle or joint pain, or swollen lymph nodes. There were no serious side effects observed in the trial.
Should I be worried about them getting myocarditis?
Myocarditis, inflammation of the heart, has been observed in some individuals following receipt of one of the mRNA COVID-19 vaccines. However, these have been rare events—only around 700 out of almost 200 million people who have received at least one dose of the vaccine. Most cases were mild and resolved within a few days after vaccination. There were no cases of myocarditis/pericarditis observed in the clinical trial in children aged 5-11. Myocarditis is fairly common after viral infections, and the risk of myocarditis is 16-times higher with COVID-19.
Should I give my child/adolescent pain medications before getting the vaccine?
No. It is not recommended for people to take pain relievers before getting the vaccine as it is not known how these medications may affect how well the vaccine works. Get tips on relieving pain and discomfort AFTER the vaccine.
What does it cost to get the vaccine?
COVID-19 vaccines available at no cost to individuals, and clinicians administering the vaccine will be reimbursed for vaccine administration. See guidance on coding and payment.
How do I know where to find the child vaccine?
Many primary care offices are contacting patients to get them scheduled for the vaccine. You can also search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 to find locations near you. These services will be updated with information as soon as it is available.
What should I do to monitor my child after vaccination?
Enroll in V-Safe. It's a free, easy-to-use, and confidential smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after your child receives a COVID-19 vaccination. Through v-safe, you can report how your child is feeling after getting vaccinated. V-safe also reminds you when to get your child’s second dose.