AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO ENHANCED INFORMED CONSENT FOR INFANT VACCINATIONS AND DOCUMENTATION IN SUDDEN UNEXPECTED INFANT DEATH INVESTIGATIONS.

Legislation Document

SPONSOR:

Rep. Hilovsky & Sen. Richardson

Reps. Shupe, Vanderwende; Sens. Lawson, Pettyjohn, Wilson

HOUSE OF REPRESENTATIVES

153rd GENERAL ASSEMBLY

HOUSE BILL NO. 422

AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO ENHANCED INFORMED CONSENT FOR INFANT VACCINATIONS AND DOCUMENTATION IN SUDDEN UNEXPECTED INFANT DEATH INVESTIGATIONS.

WHEREAS, the State of Delaware recognizes the profound grief experienced by families who lose a healthy infant following routine well-child vaccinations; and

WHEREAS, the peak incidence of Sudden Infant Death Syndrome (SIDS) and Sudden Unexpected Infant Death (SUID) occurs between 2 and 4 months of age, coinciding precisely with the timing of standard 2-month and 4-month vaccination visits; and

WHEREAS, parents of infants receiving vaccines at well-child visits deserve explicit information about common and rare side effects, the possibility that an unexplained death may be labeled SIDS due to age-related timing, the Vaccine Adverse Event Reporting System (VAERS), and the National Vaccine Injury Compensation Program (VICP); and

WHEREAS, current federal law requires provision of Vaccine Information Statements (VIS), but Delaware law does not mandate a signed acknowledgment of a discussion covering these specific topics or require documentation of vaccination history in every SUID investigation; and

WHEREAS, requiring enhanced informed consent and improved SUID documentation will promote transparency, empower families, support accurate cause-of-death determinations, and strengthen public trust without restricting access to recommended vaccines.

NOW, THEREFORE:

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend Title 16 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:

Chapter 8E. Enhanced Informed Consent for Infant Vaccinations and Document Information.

§ 801E. This Chapter shall be known as the Josie Petrone Enhanced Informed Consent for Infant Vaccinations and Document Information Act.

§ 802E. Enhanced informed consent for vaccinations administered to infants under 12 months of age.

(a) Before administering any vaccine or combination of vaccines to an infant under 12 months of age at a well-child visit, a health-care provider must:

(1) Engage in an explicit discussion with the parent or legal guardian regarding the benefits and possible side effects of the specific vaccines to be given, including the fact that SIDS/SUID peaks at 2–4 months of age, and that unexplained deaths in this window are frequently classified as SIDS even when they occur shortly after vaccination;

(2) Provide information on how to report adverse events to VAERS and how to file a claim with the VICP; and

(3) Obtain a signed acknowledgment from the parent or legal guardian confirming that the discussion occurred and that the parent or guardian understands the information provided.

(b) The Department of Health and Social Services shall develop and make available a standardized one-page informed consent form that satisfies the requirements of subsection (a) of this section. The form shall be in plain language and shall be used by all providers administering infant vaccines.

(c) Failure to comply with this section shall not constitute a separate cause of action for damages but may be considered by the Board of Medical Licensure and Discipline or other licensing boards in any disciplinary proceeding.”

§ 803E. Documentation of vaccination history in SUID investigations.

In every investigation of a sudden unexpected infant death (SUID), including those initially classified as SIDS, the medical examiner or investigating authority shall document the infant’s complete vaccination history, including dates, types, and manufacturers of all vaccines administered in the 30 days preceding death. If death occurs with the 7-day post vaccine time frame, the medical examiner shall consider a vaccine reaction as a cause of death and work to prove or disprove. This documentation shall be included in the autopsy report and forwarded to the Child Death Review Commission.

Section 2. This Act takes effect after its enactment into law.

SYNOPSIS

This Act requires enhanced informed consent before administering vaccines to infants under 12 months of age. Providers must discuss possible side effects, the overlap between the 2–4-month vaccination, and how to report events to VAERS or file VICP claims. A signed acknowledgment form (developed by DHSS) is required. The Act also mandates that vaccination history be documented in every SUID/SIDS investigation to support accurate cause-of-death determinations. These measures directly respond to families’ requests for greater transparency following the loss of healthy infants shortly after routine vaccinations, while preserving access to recommended immunizations.