A new state law effective Sept. 1 requires physicians to report serious adverse events for patients who receive emergency use-authorized (EUA) vaccines, but the recent termination of certain authorizations may narrow the bill’s impact going forward.
Senate Bill 269 directs physicians to submit a report to the Vaccine Adverse Event Reporting System (VAERS), a federal database of vaccine side effects, for certain vaccines and under certain circumstances. A physician must report to VAERS if a physician knows a patient has received an experimental, investigational, or EUA or approved vaccine, and, up to one year after the vaccine administration, the physician diagnoses the patient with a condition related to an event that results in:
- Death, or is considered life-threatening;
- Inpatient hospitalization or an extension of the duration of an existing hospitalization;
- A persistent or significant incapacity or substantial disruption of an individual’s ability to perform normal life functions;
- A congenital anomaly or birth defect; or
- A medically important condition that, based on the physician’s reasonable medical judgment, may require medical or surgical intervention to prevent an outcome described by the above.
The diagnosing physician’s reporting requirement is not limited to vaccines administered by that physician (i.e., it includes those administered by another physician or clinician). The law does not apply to vaccines administered as part of a clinical trial.
FDA has a current list of vaccines with emergency use authorization on its website. The U.S. Food and Drug Administration (FDA) terminated EUAs for COVID-19 vaccines in August, which going forward may minimize the number of vaccine administrations to which the law applies.
SB 269 also contains parallel requirements for an adverse event related to an experimental or EUA-approved drug. That reporting is made through the FDA MedWatch program. FDA maintains a current list of drugs with emergency use authorization on its website.
SB 269 is a refile of similar legislation from 2023 that failed to pass. The Texas Medical Association worked closely with the primary author, Sen. Charles Perry (R-Lubbock), to reduce physicians’ potential burden from the original version of the bill, clarifying the legislation’s language to not apply to FDA-approved vaccines, ensuring that it only applies to serious adverse events, and allows for corrective actions by the Texas Medical Board (TMB) before formal disciplinary action is taken. It was one of roughly 50 vaccine-related bills filed this legislative session, and one of only a handful to make it to law after TMA fought an arduous defensive battle.
For an initial violation of this requirement, a physician is subject to nondisciplinary corrective action by TMB. For each subsequent violation, TMB may take disciplinary action. TMB will retain information on each violation in the physician’s permanent record. However, the agency may not consider a violation if it is brought forward more than three years after occurring.
Physicians are already obligated under the National Childhood Vaccine Injury Act to report to VAERS any adverse events that vaccine manufacturers consider a contraindication to further doses, or any reactions listed in a table compiled by the U.S. Department of Health and Human Services.
SB 269 only requires physicians to report adverse events to VAERS and does not set requirements on the content of the report. VAERS forms have fields for the adverse event, treatment, and outcome, and TMA staff note physicians are also able to express their medical judgment, e.g., if the adverse event resulted from a prior condition or complication.
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