New law mandates informed consent for COVID-19 vaccines

As of September 1, 2025, physicians and other health care providers must obtain written informed consent from patients before administering a COVID-19 vaccine. During the 89th Texas Legislature, lawmakers passed House Bill 4535, which adds another layer to the informed consent process for the vaccine and requires doctors to provide a standardized information sheet developed by the Texas Department of State Health Services.

Physicians and other health care providers can find the new Texas COVID-19 information sheet on the DSHS website.

The legislation requires that the sheet include details on:

• risks and potential side effects associated with the vaccine,
• the expedited development process of the COVID-19 vaccine,
• the status of long-term scientific studies related to the vaccine,
• civil liability status of vaccine manufacturers for vaccine-related injuries, and
• the federal Vaccine Adverse Event Reporting System, including how to report adverse reactions.

Under the new law, physicians who fail to comply with the informed consent requirements could face penalties, including fines or disciplinary action by the Texas Medical Board. Health care providers will be required to keep documentation of both the signed consent form and the provision of the information sheet in their patients' medical records.

For more information and to access a list of all available vaccine information statements, visit the Texas DSHS website.