GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2025 H 1 HOUSE BILL 803 Short Title: 3-Year FDA Approval for New Childhood Vaxx. (Public) Sponsors: Representatives Blackwell, Biggs, Potts, and Rhyne (Primary Sponsors). For a complete list of sponsors, refer to the North Carolina General Assembly web site. Referred to: Health, if favorable, Education - K-12, if favorable, Rules, Calendar, and Operations of the House April 8, 2025 *H803 -v-1* A BILL TO BE ENTITLED 1 AN ACT PROHIBITING THE COMMISSION FOR PU BLIC HEALTH FROM ADD ING 2 ANY NEW VACCINES TO THE STATE'S CHILDHOOD IMMUNIZATION SCHED ULE 3 UNLESS THE VACCINE HAS EITHER BEEN APPROVED BY THE UNITED STATES 4 FOOD AND DRUG ADMINI STRATION (FDA) FOR A MINIMUM OF THREE YEARS 5 OR, IF FDA-APPROVED FOR LESS THAN THREE YEARS, UPON THE 6 RECOMMENDATION OF BO TH THE NORTH CAROLIN A MEDICAL SOCIETY 7 BOARD OF DIRECTORS A ND THE NORTH CAROLIN A PEDIATRIC SOCIETY 8 BOARD OF DIRECTORS. 9 The General Assembly of North Carolina enacts: 10 SECTION 1. G.S. 130A-152 reads as rewritten: 11 "ยง 130A-152. Immunization required. 12 (a) Every child present in this State shall be immunized against diphtheria, tetanus, 13 whooping cough, poliomyelitis, red measles (rubeola) and rubella. In addition, except as 14 provided in subsection (f) of this section, every child present in this State shall be immunized 15 against any other disease upon (i) a determination by the Commission that the immunization is 16 in the interest of the public health. health and (ii) confirmation by the Commission that the 17 vaccine used for immunization has been approved by the United States Food and Drug 18 Administration (FDA) for a minimum of three years. The Commission may, however, add to the 19 State's childhood immunization schedule an FDA-approved vaccine that has been approved for 20 less than the minimum three-year period specified in this subsection upon recommendation by 21 both the North Carolina Medical Society Board of Directors and the North Carolina Pediatric 22 Society Board of Directors. 23 (a1) Every parent, guardian, person in loco parentis and person or agency, whether 24 governmental or private, with legal custody of a child shall have the responsibility to ensure is 25 responsible for ensuring that the child has received the required each immunization required by 26 this section at the age required specified by the Commission. If a child has not received the a 27 required immunizations immunization by the specified age, the responsible person shall obtain 28 the required immunization for the child as soon as possible after the lack of the required 29 immunization is determined. 30 (b) Repealed by Session Laws 2002-179, s. 10, effective October 1, 2002. 31 (c) The Commission shall adopt and the Department shall enforce rules concerning the 32 implementation of the an immunization program. program that meets the requirements of this 33 Part. The rules shall provide for:delineate all of the following: 34 General Assembly Of North Carolina Session 2025 Page 2 House Bill 803-First Edition (1) The child's age at administration of each vaccine;vaccine. 1 (2) The number of doses of each vaccine;vaccine. 2 (3) Exemptions from the immunization requirements where medical practice 3 suggests that immunization would not be in the best health interests of a 4 specific category of children;children. 5 (4) The procedures and practices for administering the vaccine; andvaccine. 6 (5) Redistribution of vaccines provided to local health departments. 7 (6) Reasonable fees health care providers may charge for the administration of 8 vaccines provided by the State, in accordance with subsection (b) of 9 G.S. 130A-433. 10 (7) Limitations on the requirements that can be placed on children and their 11 parents, guardians, or custodians as a condition for receiving vaccines 12 provided by the State. 13 (c1) The Commission for Public Health shall, pursuant to G.S. 130A-152 and 14 G.S. 130A-433, adopt rules establishing reasonable fees for the administration of vaccines and 15 rules limiting the requirements that can be placed on children, their parents, guardians, or 16 custodians as a condition for receiving vaccines provided by the State. These rules shall become 17 effective January 1, 1994. 18 (d) Only vaccine preparations which that meet the standards of the United States Food 19 and Drug Administration or its successor in licensing vaccines and are approved for use by the 20 Commission may be used. 21 (e) When the Commission requires immunization against a disease not listed in paragraph 22 subsection (a) of this section, or requires an additional dose of a vaccine, the Commission is 23 authorized to exempt from the new requirement children who are or who have been enrolled in 24 school (K-12) on or before the effective date of the new requirement. 25 (f) Notwithstanding this section or other applicable State law, the Commission for Public 26 Health, public school units, community colleges, constituent institutions of The University of 27 North Carolina, and any private colleges or universities receiving State funds are prohibited from 28 requiring a student to (i) provide proof of vaccination against the coronavirus disease of 2019 29 (COVID-19) or to (ii) submit to a COVID-19 vaccination or series of COVID-19 vaccinations 30 unless the requirement for vaccination or proof of vaccination is required for participating in a 31 program of study, or fulfilling education requirements for a program, that requires working, 32 volunteering, or training in a facility certified by the Centers for Medicare and Medicaid 33 Services." 34 SECTION 2. This act is effective when it becomes law and applies to new vaccine 35 requirements established for children in this State on or after that date. 36