COVID-19 Vaccine Frequently Asked Questions

2025-2026 COVID-19 Vaccine Recommendations

What are the new COVID-19 vaccine recommendations for Fall 2025-2026? Who is eligible to receive the updated vaccine?

Each year, updated formulations of COVID vaccines are manufactured to provide better protection against currently circulating variants and prevent serious consequences of COVID-19, including severe disease, hospitalization, death, and long COVID.
 
The AAP recommends COVID-19 vaccination as follows:

• Completion of an initial vaccination series for everyone ages 6 -23 months of age, or a single dose for those under age 2 years who previously completed their initial series.
• Two or more doses for children 6 months – 18 years of age who are moderately or severely immunocompromised.
• A single dose for all children and adolescents 2-18 years of age who are at high risk for severe COVID-19, residents of long-term care facilities or other congregate settings, persons who have never been vaccinated against COVID-19, or persons whose household contacts are at high risk for severe COVID-19
• Children 2-18 years of age whose parent or guardian desires protection from COVID-19 for their child should be offered a single dose. 

There are two types of COVID-19 vaccines recommended for use in the United States – mRNA vaccines (Moderna, Pfizer-BioNTech) and the protein subunit vaccine (Novavax, authorized for people 12 years and older). There is no preferential recommendation when multiple vaccine options are available.

Please see the AAP Pediatric COVID-19 Vaccine Dosing Quick Reference Guide for more details, including recommendations on the intervals between doses.

The most updated formulations of COVID vaccines that are available should be used.

Additional Resources:

AAP Policy Statement: Recommendations for COVID-19 Vaccines in Infants, Children, and Adolescents (August 2025)

Who is considered at high risk for severe COVID-19?

AAP recommends a single dose of COVID-19 vaccine for all children and adolescents 2-18 years of age who are at high risk for severe COVID-19 (other than moderately or severely immune compromised children, who are recommended to receive multiple doses). These risk groups are described in the AAP Policy Statement as follows:

^a List of examples is not exhaustive.
^b Children who are moderately or severely immunocompromised require 2 or more doses of COVID-19 vaccine. Refer to AAP Recommended Child and Adolescent Immunization Schedule for dosing guidance.  

Why does AAP recommend universal COVID-19 vaccination for ages 6 through 23 months of age?

Children younger than 2 years old are at high risk for severe COVID-19 disease and hospitalization and COVID-19 vaccines have been shown to be safe and effective for 6 through 23 month old children.

How do AAP recommendations differ from CDC recommendations for COVID-19 vaccination?

CDC recommends children ages 6 months through 18 years can receive a COVID-19 vaccine through shared clinical decision-making.  AAP’s recommendations are noted above and in the AAP Policy Statement. 

The CDC does not make a recommendation for pregnant adolescents; AAP recommends COVID-19 vaccination for pregnant adolescents. 

Both organizations recommend COVID-19 vaccination for children 6 months of age and older who are moderately or severely immunocompromised. 

The AAP will continue to monitor federal and state policy changes that impact liability protections for pediatricians and update this information regularly. Pediatricians are encouraged to report any liability-related concerns or issues related to vaccine administration to the AAP via this form. 

Medical Liability Considerations

Why is off-label use of COVID-19 vaccine different than off-label medication prescribing which is common in pediatrics? 

Given the intensifying politicization of COVID vaccines, the Secretary of Health’s overt statements about physician liability protection, as well as concerns that some malpractice carriers have indicated that they will exclude COVID related claims, there are additional liability concerns with COVID vaccines specifically.

Do malpractice protections in the PREP Act apply to off-label use of the COVID vaccine? 

There is a reasonable argument that the immunity provisions of the PREP Act would not apply because administration of the COVID vaccine to healthy children is not authorized by the FDA. The courts will have to rule on this key issue.

Is the malpractice risk the same for the pediatrician who writes a prescription for COVID vaccine for administration elsewhere versus a pediatrician who is administering COVID vaccine in their office? Should medical record documentation be the same in both situations?

Yes, the malpractice risk is the same, except for claims that relate specifically to the administration of the vaccine product. Clinical documentation by the ordering physician should be the same whether a prescription is provided or the vaccine is administered. 

If my state has a directive recommending administration and insurance coverage for COVID vaccines that goes beyond the FDA label, does this change my liability risk?  

Generally speaking, state laws or policies that affirm the decision to vaccinate strengthen the provider’s defense that they followed applicable standards of care. However, this does not preclude attempts by litigious parties to initiate potential civil litigation or disciplinary proceedings. It is also possible that a carrier may not cover these claims or provide a defense against them, unless state law explicitly states otherwise.

My liability carrier has a specific clause stating it only covers FDA approved treatments. Is there a difference in liability risk if a product is approved for use in children but for a different indication vs. not being approved in children at all?  Would you interpret a clause that “only covers FDA approved treatments” to apply to the current COVID vaccine recommendations in children who are not at higher risk for severe illness?

This is a very subjective analysis. While it is reasonable to argue that approval for one group could mean off-label use in this instance should be covered; however, an insurance carrier could maintain that this amounts to an exclusion.

Should pediatricians be obtaining informed consent prior to administration of COVID vaccine for patients who do not have high risk conditions? What about for patients who have high risk conditions?

Informed consent is necessary for all clinical interactions with patients including vaccines. Every procedure or medication prescription should include a discussion of the risks, benefits and alternatives to the proposed course of action. Signed informed consent should be considered particularly for patients who receive the vaccine for “off label” indications; this includes patients who do not have high risk conditions. For patients who have high risk conditions, there is alignment with FDA labels, so a signed informed consent is not needed. The clinician's discussion with the patient/family should be documented in the medical record whether or not a consent form is used. 

The AAP has developed this template as a resource for practices that are considering the use of written informed consent prior to off-label administration of COVID-19 vaccine for patients. It is not meant to imply that written informed consent is recommended or to provide legal advice, but to serve as an example of the content that an informed consent document for off-label prescribing of the COVID-19 vaccine may contain. The AAP recommends seeking advice from local legal counsel prior to implementing the use of such a document. 

Am I required to share the COVID-19 Vaccine Information Statement (VIS) with patients or families/caregivers when I administer a COVID-19 vaccine?

42 U.S. Code § 300aa-26 requires all providers who administer a vaccine included on the Vaccine Injury Table to provide a VIS developed by the CDC to the legal representative of any child the provider intends to vaccinate. 
 
While COVID-19 vaccines are not listed on the Vaccine Injury Table, providers are generally required to provide these, too, by state VFC provider agreements (see, e.g., California and New York, both stating, “I will distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA), which includes reporting clinically significant adverse events to the Vaccine Adverse Event Reporting System (VAERS).), and as stated on the CDC website: “VISs also exist for vaccines that are not covered by the NCVIA. CDC encourages healthcare providers to use these whenever they give one of these vaccines, but they must be used when the vaccine is purchased under CDC contract. The legal basis for this is not the NCVIA, but a "Duty to Warn" clause in CDC's vaccine contracts.”  Therefore, VFC providers are legally required to disseminate the COVID-19 VIS to the patient (or parent or legal representative) prior to the vaccination. 

Given the CDC signed off on the ACIP recommendations for shared clinical decision making for COVID vaccines in patients between 6 months – 64 years of age, does this lessen potential liability risk for pediatricians?  Is a signed informed consent still necessary?

This does lessen the risk of liability greatly; however, the FDA label does not include an indication for healthy children. It is important for a provider to consider risk tolerance when deciding whether to ask patients/caregivers to sign an informed consent. 

Is it important to call this an “informed consent” or can this be called something else such as a “waiver”?

Yes. The goal is to document informed consent to minimize the prospect of provider liability rather than to legally waive it. While a waiver would theoretically limit responsibility, it does not account for documenting patient/caregiver understanding of medical risks. It is also important to consider the appearance of impropriety in asking a patient to sign a liability waiver specifically for the COVID vaccine.

Is there any requirement about the type of provider that is allowed to have the conversation with the parent/caregiver to meet the definition for Shared Clinical Decision Making?  

This is entirely dependent on state scope of practice laws, specifically those laws dictating the parameters of patient counseling under standing orders or other arrangements. 

Will adolescents be allowed to consent to COVID vaccine administration?

In some states a minor can themselves consent while in others a parent or legal guardian must consent. Some states also require that a minor child of a certain age consent along with a parent or legal guardian. This is highly state-specific and forms should be designed accordingly.

Given the CDC recommendation for Shared Clinical Decision Making, do you recommend that specific language be included in medical record documentation? If so, is there any template language that can be provided.

Yes. Documentation is recommended that discussion about the vaccine occurred and a decision to vaccinate followed shared clinical decision making. The patient’s desire to receive the protection of vaccination should be adequate, however, notating any additional benefit to the patient is also helpful. The following dot phrase (template language) can be used as a guide:

The patient/caregiver and I engaged in shared clinical decision-making about the benefits and risks of the 2025-2026 COVID-19 vaccine. This discussion included an opportunity for them to ask questions. No contraindication to vaccination was identified, and the patient/caregiver and I collaboratively determined the patient would benefit from vaccination.  A COVID-19 vaccine was ordered in the context of shared clinical decision making and educational materials were provided. 

Where applicable for patients with underlying conditions add: The patient has ________(indicate underlying condition).

States have changed vaccine exemption laws and have released language regarding civil rights and vaccine requirements. Are there any concerns with practice policies that dismiss patients for not following the recommended vaccine schedule (not COVID-specific)?  

This is dependent on state requirements. A practice must carefully consider risks of dismissing patients based on their state guidance against the risks of retaining a patient who may put others in their practice at risk.

Currently under the ACA, payers and VFC must cover vaccines on the CDC schedule. Are they legally bound to cover these vaccines, even if they are not administered at the specific age that the CDC schedule recommends? For example, if the CDC schedule no longer recommends a Hepatitis B vaccine birth dose, but recommends it at a later age, would payers be legally bound to pay for this immunization if given shortly after birth?

ACA-regulated markets and VFC are different. Under VFC, participating providers are legally bound to follow the ACIP schedule when administering VFC doses. Payers bound by ACA requirements are permitted to manage utilization within the parameters of ACIP recommendations, so their payment policies typically align with the timing on the CDC schedule.

COVID Vaccine Dosing

What is the recommended interval between the doses of an mRNA COVID-19 vaccine series? How can I determine what my patient needs if they already received at least one COVID-19 dose?

Please the AAP Pediatric COVID-19 Vaccine Dosing Quick Reference Guide for dosing intervals. This resource offers the dosing intervals for unvaccinated children and previously vaccinated children. Also included is dosing information for children who are moderately or severely immunocompromised.

When a series of vaccines is recommended for a patient, an 8-week interval between the first and second doses (Moderna, Novavax, and Pfizer) doses might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis associated with these vaccines.

What are the vaccine recommendations for a child who turns 2 years old during their initial vaccine series?

A child should receive the recommended dosing based on their age at the START of their vaccine series. For example, a child who begins their initial series at age 23 months should receive two doses of Moderna Spikevax vaccine. 

Which vaccine dose should a child with moderate or severe immunocompromise receive if they have a birthday between doses?  

A child should receive age-appropriate vaccine product and dosage based on their age on the day of vaccination. For example, for children who turn 11 to 12 years of age , administer the recommended product/dosage for 12 year olds for all doses that are administered after the child turns 12 years of age See additional information in the AAP Pediatric COVID-19 Vaccine Dosing Guide. 

Can you “mix and match” vaccine products for one child?  

A multi-dose series is only recommended for children 6 -23 months of age, as well as for children who are moderately or severely immunocompromised. For these individuals, the same vaccine should be used to complete the initial series, whenever possible. 

Additional Resources:

• AAP Pediatric COVID-19 Vaccine Dosing Quick Reference Guide
• AAP Immunization Schedule

COVID Vaccine Products

Which COVID-19 vaccines have been approved for use in the US?

Moderna mRNA Vaccine

• Spikevax Package Insert (ages 6 months and up)
• mNEXSPIKE Package Insert (ages 12 years and up)

Pfizer-BioNTech mRNA Vaccine

• Comirnaty Package Insert (ages 5 years and up)

Novavax Protein Subunit Vaccine

• Nuvaxovid Package Insert (ages 12 years and up)

Can I still administer the 2024-2025 Pfizer-BioNTech, Moderna, and Novavax  COVID vaccine to my patients?

No. On August 27, 2025, FDA revoked the Emergency Use Authorizations (EUA) that were originally issued in December 2020 for pediatric COVID vaccine formulations (for < 12 year old patients) from Moderna and Pfizer-BioNTech, as well as the product for 12 years and up from Novavax.  Any products that were authorized under these EUAs may no longer be administered, including the 2024-2025 Pfizer-BioNTech COVID vaccine products for 6 month – 11 year olds; the 2024-2025 Moderna COVID vaccine for 6 month – 11 year olds; and the 2024-2025 Novavax COVID vaccine for 12 years and up. Please note that this relates to 2024-2025 COVID vaccine products and not to 2025-2026 COVID vaccine products.

What is the difference between Moderna’s Spikevax and mNEXSPIKE? Which should I administer to my patients who are 12 years of age and older?

mNEXSPIKE is a new formulation of the Moderna product designed to provide a more targeted immune response at a lower dose. It is approved for use in patients who are 12 years of age and older. While either Spikevax or mNEXSPIKE can be used in 2025-2026, only Moderna’s Spikevax will be available through the VFC program. 

Vaccinating Special Populations

What are the vaccine recommendations for children and adolescents who are moderately or severely immunocompromised?

Children and adolescents with certain immunocompromising medical conditions or who are receiving treatments that induce moderate or severe immune suppression should be vaccinated according to the schedule outlined in the AAP Pediatric Vaccine Dosing Quick Reference Guide.

Close contacts of immunocompromised individuals should also consider receiving COVID-19 vaccination to provide additional protection. 
 
Information on immunization and immunocompromised children and adolescents can be found in the Red Book chapter, Immunization and Other Considerations in Immunocompromised Children

Can I administer a COVID-19 vaccine to a patient who is currently sick with COVID-19? 

COVID-19 vaccination should be deferred for patients with a current SARS-CoV-2 infection until they recover from their acute illness.
 
Individuals who recently had SARS-CoV-2 infection may consider delaying COVID-19 vaccine by 3 months from symptom onset or positive test (if infection was asymptomatic). Studies have shown that increased time between infection and vaccination may result in an improved immune response to vaccination.

Side Effects/Safety

Are there any different side effects or safety concerns with the updated 2025-2026 formula mRNA vaccines?

No, the side effect and safety profile are the same as that of previous formulations. 

The side effects have been similar to other routine vaccines- sore arm or leg, redness, fatigue, fever, chills, headache, myalgia, and arthralgia. The side effects are temporary and mostly mild or moderate. Anaphylaxis has been observed following receipt of COVID-19 mRNA vaccines, but this has been rare. Rare cases of myocarditis or pericarditis have been reported – most often in males between 12-39 years of age.  Additional information on common side effects and rare adverse reactions can be found in the package inserts of the vaccine products:

Moderna mRNA Vaccine

• Spikevax Package Insert (ages 6 months and up)
• mNEXSPIKE Package Insert (ages 12 + years)

Pfizer-BioNTech mRNA Vaccine

• Comirnaty Package Insert (ages 5+ years)

Novavax Protein Subunit Vaccine

• Nuvaxovid Package Insert (ages 12+ years)

What is the safety testing that has been done on COVID-19 vaccines? How is vaccine safety monitored? How do we know it is safe long-term?

The safety follow-up during COVID-19 vaccine studies have been very similar to the follow-up done during other vaccine trials. All vaccines are determined to be safe and effective before they are licensed. 

Pediatric vaccine studies involve very close follow up and tracking of patient’s health status and medical care after vaccination (eg. monitoring side effects, medical visits, use of new medications or changes to previous medications, and other interactions post-vaccination). All reported medical events are recorded and reviewed by the study team, sponsor, an independent safety monitoring board, an ethics committee, and the FDA. Children in these studies are often being followed for one to two years post vaccination and their health status is monitored for vaccine safety. 
 
Even after licensure, safety data are collected through Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), Clinical Immunization Safety Assessment (CISA), and pharmacovigilance. VAERS and VSD are specifically designed to monitor safety signals from simultaneous administration of multiple vaccines (ie co-administration). These programs collect information on an even larger number of persons who get vaccinated than can be collected during clinical studies. 
 
Safety data beyond 2 years is captured through studies performed post licensure. No licensed vaccines have been found to have an unexpected long-term, or “delayed” safety problem that was found only years or decades after introduction. 

How do I report an adverse event related to administration of COVID-19 vaccine? 

Healthcare providers are required by law to report to Vaccine Adverse Event Reporting System (VAERS):

• Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination
• An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine

Healthcare providers are strongly encouraged to report:

• Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event
• Vaccine administration errors

Co-Administration

Can COVID-19 vaccine be co-administered with other childhood or adolescent immunizations?

Yes, the AAP supports co-administration (or vaccination in the days before and after) of routine childhood and adolescent immunizations and seasonal immunization (such as RSV immunization and influenza vaccine), with COVID-19 vaccines for children and adolescents who are behind on or due for immunizations (based on the AAP Recommended Child and Adolescent Immunization Schedule). 

When co-administering with other vaccines, it is recommended that a different injection site (at least 1 inch apart) be used. If co-administered with a more reactogenic vaccine (eg, adjuvanted or high-dose influenza vaccine and COVID-19 vaccine), consider using a different limb. 

Is co-administration acceptable for all populations of children and adolescents, including those who are immunocompromised?

Since the mRNA COVID-19 vaccines are not live vaccines, it is expected that the safety and efficacy will be similar to other vaccines that are co-administered. Immunocompromising conditions are not contraindications to receipt of the mRNA COVID-19 vaccines. In general, simultaneously administered vaccines are recommended to ensure optimal age-specific protection and fewer medical visits. As with all vaccines, patients should be informed about the likely timing of potential side effects and adverse events related to each vaccine.

Are there any differences or concerns with co-administration of COVID-19 vaccine with live attenuated vaccines?

No. The mRNA COVID-19 vaccines are not live vaccines, and no additional safety or efficacy issues are expected with co-administration with live attenuated vaccines. Co-administration is particularly important for children and adolescents who are behind on routinely recommended vaccines because it promotes timely receipt of vaccines and reduces the number of medical visits for the patient.

Vaccine Coding and Payment

Which CPT codes should I use? Will I get paid for vaccine administration?

A full listing of COVID-19 vaccine codes can be found on the Getting Paid page. 
 

Talking to Families

How can pediatricians build trust with families who may express vaccine hesitancy

Parents and caregivers trust pediatricians. Pediatricians should listen to families’ questions and provide clear, consistent information. They should state what is currently known and unknown. They should not overemphasize “potentials” – neither potential risks nor potential benefits. More information on how to communicate effectively can be found at Communicating with Families and Promoting Vaccine Confidence. 

Pediatricians can also utilize resources in the AAP COVID-19 Vaccine Communications Toolkit to promote vaccine confidence. Consider ways that patients and families in your practice like to receive information and use these mechanisms to debunk common myths and answer frequently asked questions.