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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 may be considered particularly for patients who receive the COVID-19 vaccine for “off label” indications; this includes patients who do not have high risk conditions. While signed informed consent forms aren't typically required for most off-label prescriptions or treatments, the unique public scrutiny surrounding the COVID-19 vaccine suggests practices might consider using them as an added safeguard against potential litigation, 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. 

Medical Record Documentation of Shared Clinical Decision Making

AAP recommends use of specific language related to shared clinical decision making in medical record documentation. 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.

Use the following dot phrase (template language) as a guide:

The patient/caregiver and I engaged in shared clinical decision-making about the benefits and risks of the _________ 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 vaccine was ordered in the context of shared clinical decision making and educational materials were provided. 

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

General Medical Liability Considerations

Am I legally required to share the Vaccine Information Statement (VIS) with patients or families/caregivers before I administer a vaccine?

Yes.  42 U.S. Code § 300aa-26 requires all providers who administer a vaccine included on the Vaccine Injury Table to provide the latest VIS developed by the CDC to the legal representative of any child the provider intends to vaccinate. VIS translations are available here. 
 
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?  

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 Affordable Care Act (ACA), payers and Vaccines for Children (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. For payers bound by ACA requirements,  Section 2713 of the ACA requires that plans must continue covering all vaccines without cost sharing as they appeared in the CDC schedule at the beginning of the plan year. 

Are adolescents allowed to consent to vaccine administration?

This is highly state-specific. 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. 

COVID-19 Vaccine Liability Considerations

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

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, providers administering COVID-19 vaccines through VFC or many state and local programs are legally required to disseminate the COVID-19 VIS to the patient (or parent or legal representative) prior to the vaccination.

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?

It is an unsettled legal question whether the immunity provisions of the PREP Act apply to uses not explicitly authorized by the FDA, such as administration of the COVID vaccine to healthy children. 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, an insurance carrier could maintain that this amounts to an exclusion.

Additional Resources

Practice Management Liability & Regulation

Clinical Liability Guide from Common Health Coalition