S. 3323 — Family Vaccine Protection Act

This section codifies the Advisory Committee on Immunization Practices (ACIP), established under the Public Health Service Act, as a federal advisory committee subject to the Federal Advisory Committee Act (with exceptions) and specifies its duties. (As background, ACIP advises the Centers for Disease Control and Prevention (CDC) on vaccine use, influencing the Vaccines for Children program—which provides free vaccines to eligible children—and insurance coverage mandates under ACA sec. 2713.) The codified ACIP must (1) provide advice, guidance, and recommendations to the CDC Director, based on a preponderance of the best available peer-reviewed scientific evidence, on use of licensed vaccines to control vaccine-preventable diseases; (2) make immunization recommendations for ACA sec. 2713 coverage requirements for group and individual health plans; and (3) establish, review, and revise the list of vaccines, schedules, and contraindications for the Vaccines for Children program under SSA sec. 1928 (42 U.S.C. 1396s), which the Secretary and CDC Director must use for pediatric vaccine purchase, delivery, and administration. The CDC Director must review and adopt ACIP recommendations unless unsupported by evidence (publishing the basis if not adopted and notifying congressional committees within 48 hours); adopted recommendations become official HHS policy, are published online, and are provided in writing to the Secretary and Assistant Secretary for Health. ACIP must promptly consider newly licensed vaccines or indications (within 90 days of manufacturer notice or next meeting) and those designated as breakthrough therapies or for public health emergencies, with status updates to congressional committees. If the Secretary or CDC Director acts contrary to an ACIP recommendation (including on insurance coverage or Vaccines for Children listing), they must publish the evidence-based rationale and notify congressional committees within 48 hours.

This section requires that any removal of a vaccine from the Vaccine Injury Table, or other modification under current law (including additions to the list of covered injuries, disabilities, illnesses, conditions, and deaths), be supported by the preponderance of the best available scientific evidence regarding the vaccine's safety or efficacy. (As background, the National Vaccine Injury Compensation Program provides no-fault compensation to individuals injured by covered vaccines, with the table establishing a presumption of causation for listed injuries; this requirement does not limit the Secretary's authority to add new vaccines to the table.)