Why are different COVID-19 vaccine formulations needed to vaccinate the pediatric age group?

Infants and children younger than 12 years require smaller doses of COVID-19 vaccine based on the safety, tolerability, and immunogenicity profiles in children studied during clinical trials. If the same COVID-19 vaccine formulation used for adults was used for children at a lower dose, the injection volume would be reduced as well. These resulting injection volumes are considered too small for an I.M. injection.

Therefore, Pfizer-BioNTech and Moderna have made several formulations of their COVID-19 vaccines available. The formulation used should be selected based on the patient’s age to ensure accurate dosing. Access APhA’s “Guide to COVID-19 Vaccine Schedules” in our COVID-19 resources: Know the Facts library for a summary of the available options. It is important to note differences in dosing, dilution, and administration of each vaccine formulation.

Who is authorized to order and administer COVID-19 vaccines for the pediatric age group?

Pharmacists and other pharmacy team members have federal authority under the Public Readiness and Emergency Preparedness (PREP) Act to provide FDA-authorized or FDA-licensed COVID-19 vaccines according to CDC’s Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendations to patients 3 years or older, subject to certain requirements outlined in APhA’s practice resource. Pharmacists and other pharmacy team members may still order or administer vaccines to individuals ages 2 years or younger to the extent authorized under state law. To optimize these opportunities and increase access for the communities you serve, it is important to know what is expected and prepare for your expanded role as an immunizer.

Some pharmacies may not provide vaccines to all children, due to practice-specific factors, but can be important disseminators of information, guidance, and referral where appropriate. Pharmacy teams should determine and communicate the scope and age group(s) for vaccine administration within their practice.

What evidence is available to support the safety and efficacy of COVID-19 vaccines in adolescents and children?

Information about the safety and efficacy of COVID-19 vaccines is summarized in several reports. More information can be found about vaccine safety in children and teens and COVID-19 vaccine efficacy on CDC’s website.

Why might an 8-week interval between the first and second dose be beneficial for infants 5 months and older (through age 64 years)—who are not moderately or severely immunocompromised, and for whom there is not increased concern about community transmission or severe disease?

Recent safety and effectiveness data illustrate that a longer time interval between the first and second mRNA COVID-19 vaccine dose gives the body a chance to build a stronger immune response, increasing the effectiveness of these vaccines, and offering individuals greater protection against COVID-19. A longer interval between primary doses can also help lower the risk of myocarditis and pericarditis following vaccination. Although rare, some cases have been reported—mostly among adolescent and young adult males—after receiving the Pfizer-BioNTech or Moderna vaccines.

How should COVID-19 vaccines be administered to adolescents and children?

COVID-19 vaccines are administered intramuscularly. Smaller needle lengths may be needed for younger patients. Reference CDC’s resources below for a summary of the recommended needle gauges and lengths for patients based on age.

• Vaccine administration: I.M. injection infants 11 months of age and younger
• Vaccine administration: I.M. injection children 1 year through 2 years
• Vaccine administration: I.M. injection children 3 years through 6 years
• Vaccine administration: I.M. injection children 7 years through 18 years
• Vaccine administration: Needle gauge and length

APhA’s application-based learning activity, Pharmacy-based immunizations for pediatric patients, provides a thorough review of topics related to immunizing pediatric patients, including parent and patient preparation and immunization administration techniques for children.

Should other vaccines be coadministered with the COVID-19 vaccine?

All authorized COVID-19 vaccines may now be administered without regard to timing of vaccine administration with other vaccines. This includes simultaneous administration of COVID-19 vaccines and other recommended childhood and/or adult vaccines on the same day as well as administration within 14 days.

It is unknown whether the reactogenicity of COVID-19 vaccine is increased with coadministration, including with other vaccines known to be more reactogenic such as adjuvanted vaccines or live vaccines. When deciding whether to coadminister other vaccines with COVID-19 vaccines, providers should consider

• Whether the patient is behind, or at risk of falling behind, on recommended vaccines.
• The likelihood of the child returning for another vaccination.
• The patient’s risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures).
• The reactogenicity profile(s) of the vaccines.

Providers should inform the patient and parent or caregiver of the potential reactions to the vaccines, duration of symptoms, and how to manage those effects.

What steps should vaccine providers take when administering multiple vaccines during a single visit?

If multiple vaccines will be administered during a single visit, administer each vaccine at a different injection site. For adolescents and adults, the deltoid muscle can be used for more than one intramuscular injection. Best practices for multiple injections include

• Administering the vaccines in separate limbs, especially vaccines that may be more likely to cause a local reaction (e.g., tetanus-toxoid–containing and adjuvanted vaccines), if possible.
• Separating injection sites by 1 inch or more, if possible, when administering in the same limb.
• In situations when two or more vaccines need to be administered in the same limb for children aged 5 years to 10 years, the preferred muscle is the vastus lateralis because of the larger muscle mass compared with the deltoid muscle.

How should adolescents and children be monitored after vaccination?

The post-observation time and process is the same for adolescents and children as it is for adults. Individuals with no history of allergic reaction should be monitored for 15 minutes. Adolescents and children with a history of allergic reaction should be monitored for 30 minutes.

Adolescents and children may be at increased risk of experiencing a syncopal (fainting) episode after receiving any immunization, including COVID-19 vaccine. Providers should pay particular attention to potential syncope reactions in this age group and maintain proper facility space and seating options to minimize fall risk.

What should adolescents/children and their parents or caregivers expect after vaccination?

Post-vaccination symptoms such as a sore arm, redness at the injection site, fever, fatigue, headache, and chills, are common. Children may experience fewer adverse effects than adolescents or young adults. For all currently authorized COVID-19 vaccines, antipyretic, or analgesic medications (e.g., acetaminophen, other NSAIDs) can be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended.

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of heart lining) have been reported after mRNA vaccination in adolescents. The observed risk is highest in males aged 12 years to 29 years. A report found that the risk of myocarditis or pericarditis after receipt of an mRNA COVID-19 vaccine is lower than the risk of myocarditis associated with COVID-19 infection in adolescents and adults. The symptoms of myocarditis and pericarditis include acute chest pain, shortness of breath, and palpitations. Patients who sought medical care for these symptoms responded well to medication and rest in most cases.

There is no evidence that any vaccines, including COVID-19 vaccines, can cause female or male infertility.

Should people who have had COVID-19 infection get vaccinated?

Yes, CDC recommends vaccination regardless of whether a patient has already had COVID-19 infection. Substantial immunologic and an increasing body of epidemiologic evidence indicates that vaccination after infection significantly enhances protection and further reduces the risk of reinfection and one study showed that unvaccinated people who already had COVID-19 are more than two times likely than fully vaccinated people to get COVID-19 again.

What steps should parents and caregivers take to monitor children for safety related to COVID-19 vaccination?

V-safe has been updated to allow parental input and management. Parents or guardians can register their adolescents or children in v-safe and complete the health surveys on their behalf. CDC’s v-safe call center follows up on reports to v-safe that include possible medically significant health events to collect additional information for completion of a Vaccine Adverse Event Reporting System (VAERS) report. A parent or guardian can enroll the adolescent or child under their v-safe profile by clinking on “add a dependent.”

What steps should vaccination providers take to monitor for safety related to COVID-19 vaccination?

Vaccination providers are required to report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA.

Adverse events that occur after receipt of any COVID-19 vaccine should be reported to the VAERS. Information on how to submit a report to VAERS is available at their website or by calling 1 (800) 822-7967.

What additional requirements should pharmacies be prepared to meet?

If the patient is 18 years or younger, the vaccination provider must inform the patient and/or the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. The following materials were designed by APhA and others to help pharmacy teams meet this requirement:

• Well-child visit brochure
• Template referral form for well-child visit
• Well-child checkup letter

Last revised on July 7, 2022.