COVID-19 vaccine recommendations are rapidly shifting. Physicians and their staff should have the latest information addressing common questions about current COVID-19 vaccine recommendations, the expiration of the COVID vaccine Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA), the protections offered under the Public Readiness and Emergency Preparedness (PREP) Act going forward, and the differences between guidelines provided by the American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), and the Centers for Disease Control and Prevention (CDC).
The California Department of Public Health (CDPH) continues to recommend that everyone aged 6 months and older have access to the vaccine and the choice to receive COVID-19 vaccines. Groups at higher risk of severe illness should receive protection.¹ These groups include infants and toddlers, pregnant people, older adults, and others with risks of serious disease. The CDPH is working with partners, including the West Coast Health Alliance, to continue promoting vaccine access and provide science and fact-based information on vaccine safety and efficacy.
More information and resources are available at:
West Coast Health Alliance: https://www.gov.ca.gov/2025/09/03/california-oregon-and-washington-to-l…
CDPH: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Immunization/ncov2019.aspx
Q: The Covid-19 vaccine(s) emergency use authorization(s) have expired; how does this impact my liability?
On December 11, 2024, Health and Human Services (HHS) Secretary Xavier Becerra signed the 12th amendment to the PREP Act, extending its protections through December 31, 2029. The PREP Act went into effect January 1, 2025.²
The PREP Act extension maintains liability immunity for providers administering COVID-19 vaccines and other covered countermeasures, regardless of whether the vaccine is administered under CDC or AAP/AAFP guidance. Immunity includes claims for: death; physical, mental, or emotional injury, illness, disability, or condition or fear of any such injury, illness, disability, or condition; any need for medical monitoring; or property damage or loss, including business interruption loss.³
NOTE: The only exception to liability immunity under the PREP Act is a claim for willful misconduct, which is defined in the PREP Act as an act or omission that is taken (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. The PREP Act specifies that criteria for willful misconduct must be construed to establish a standard for liability that is more stringent than a standard of negligence in any form or recklessness.³
The amendment does not address or alter the scope of immunity based on differences in clinical recommendations between the CDC and AAP/AAFP.
Q: What are the implications of the PREP Act for those who immunize infants and children?
Physicians who follow AAP or AAFP recommendations—even if they differ from CDC guidance—are still covered under the PREP Act as long as the vaccine is FDA authorized, licensed, or approved and administered during the declared public health emergency period.3
Q: What are the key differences between the new guidelines for COVID-19 vaccination for infants and children between 6 months and 23 months old?
The key distinctions between the recommendations from the AAP, AAFP, and the CDC rest on the language between should receive, should be, and shared clinical decision-making, as follows:
- AAP Guidance: The AAP recommends that infants and children aged 6 through 23 months should―who do not have contraindications―receive the 2025–2026 COVID-19 vaccine. Their guidance includes specific recommendations based on vaccination status and risk categories.4
- AAFP Guidance: The AAFP recommends all children ages 6-23 months should be vaccinated against COVID-19 and use a risk-based single dose approach for children and teens 2-18 years.5
- CDC Guidance: The CDC’s updated guidance for individuals aged 6 months to 17 years who are not moderately or severely immunocompromised emphasizes shared clinical decision-making. This approach encourages healthcare providers to engage with patients and their families to make individualized vaccination decisions based on personal preferences and circumstances.6
- CDPH Guidance: The CDPH recommends vaccinations for COVID-19 for infants and toddlers aged 6 months to 23 months.¹
The AAP Immunization Schedule can be found at https://publications.aap.org/redbook/resources/15585/AAP-Immunization-S…. The Child and Adolescent Immunization Schedule, published by the CDC, which is not currently endorsed by the AAP, can be found at https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf.
Q: Does CAP recommend one guideline over the other for their members?
No, CAP does not endorse one guideline over the other and recommends that practices follow either AAP, AAFP or CDC guidance and clearly document which guideline is being followed.
- Moreover, if more than one (1) set of guidelines is discussed with the parent(s)/caregiver, document which guidelines were discussed.
- hese principles can apply to administration of any vaccine, not only COVID-19 vaccinations.
The decision regarding which guideline to adopt rests with the physician.
Q: Does CAP provide a specialized vaccination consent form for their members?
No, CAP does not currently provide specialized vaccination consent forms, as a standard consent form is sufficient. It is important to note that no consent form can fully eliminate liability or risk and that forms are only an adjunct to a proper informed consent discussion.
NOTE: California Department of Public Health (CDPH) Guidance―There are no federal or California state requirements for informed consent specifically relating to immunization. Federal law requires that healthcare staff provide a Vaccine Information Statement (VIS) to a patient, parent, or legal representative before each dose of certain vaccines.7
Q: What if I have a parent/caregiver/guardian who wants to receive a vaccination at the time of the visit with their child in my pediatric practice?
If your pediatric practice elects to vaccinate parents, caregivers, or guardians, the physician must follow standard intake/immunization procedures.
This includes, but is not limited to, documenting allergies, past medical history, obtaining informed consent or refusal, providing a VIS, and offering appropriate aftercare instructions.
Documentation for immunizations given to these individuals should be maintained in a separate, “confidential” section of the child’s medical record
Guidelines on this topic published by the AAP can be found at https://publications.aap.org/pediatrics/article/129/1/e247/31548/Immuni…. The AAP reaffirmed this technical report in November 2024.
Legal Disclaimer: The information provided herein is for general guidance only and does not constitute legal advice. Also note: While the PREP Act offers broad liability protections for providers administering COVID-19 vaccines, practices should consult legal counsel and review their malpractice liability coverage to ensure compliance with federal and state regulations. Differences in clinical guidance between the AAP and CDC do not affect the scope of PREP Act immunity, provided vaccines are administered in accordance with FDA authorization and applicable public health declarations.8
Deanna Spounias, Pharm.D., is a Senior Risk Management and Patient Safety Specialist. Questions or comments related to this article should be directed to DSpounias@CAPphysicians.com.
¹California Department of Public Health. Populations at Increased Risk Recommended for Vaccination Against COVID-19. September 2025. https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/Imm…
²American Association of Colleges of Osteopathic Medicine (AACOM). HHS Secretary Extends PREP Act for COVID-19. December 16, 2024. https://www.aacom.org/news-reports/news/2024/12/16/hhs-secretary-extend…
³U.S. Department of Health & Human Services, Administration for Strategic Preparedness and Response (ASPR). PREP Act Question and Answers. https://aspr.hhs.gov/legal/PREPact/Pages/PREP-Act-Question-and-Answers…
4American Academy of Pediatrics, Committee on Infectious Diseases. Recommendations for COVID-19 Vaccines in Infants, Children, and Adolescents: Policy Statement. Pediatrics, 156(5), e2025073924. November 2025. https://doi.org/10.1542/peds.2025-073924
5American Academy of Family Physicians. (n.d.). Immunizations & Vaccines. https://www.aafp.org/family-physician/patient-care/prevention-wellness/…
6Centers for Disease Control and Prevention. Staying Up to Date with COVID-19 Vaccines. November 19,2025. https://www.cdc.gov/covid/vaccines/stay-up-to-date.html
7California Department of Public Health. (n.d.). Laws and Regulations. https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Immunization/laws.aspx&…;
8U.S. Department of Health & Human Services, Administration for Strategic Preparedness and Response. Public Readiness and Emergency Preparedness (PREP) Act. https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx