Technically Speaking — Federal Documents to Assist In Informed Consent: Required Or Not, Here They Come!

Editor’s Note: This article was based on articles previously published in IZ Express, a weekly newsletter published by Immunize.org.

A Vaccine Information Statement (VIS) is a document produced by the Centers for Disease Control and Prevention (CDC) that informs the reader about vaccine-specific benefits and risks. Immunize.org posts them in English and 46 other languages.

Requirements

• All public and private vaccine providers are required by the National Childhood Vaccine Injury Act of 1986 (NCVIA) to give the appropriate VIS to the patient (or parent or legal representative) before every dose of vaccine is given if that vaccine is covered by NCVIA.
• The VIS must be given regardless of the age of the recipient. So, for example, because the nasal spray influenza vaccine (LAIV) is covered by NCVIA, the LAIV VIS must be given before LAIV administration to a person of any age.
• Many formats are permitted. For example, recipients may be shown the VIS as a paper copy, laminated office copy, version displayed on a computer monitor or other video display, or version on a phone or other digital device.

For more on the VIS-related requirements, see You Must Provide Patients with Vaccine Information Statements (VISs) – It’s Federal Law! To see if your office is distributing the most current VISs, check this document: Dates of Current Vaccine Information Statements (VISs).

COVID-19 information documents and requirements

Two types of sheets are available to share when it comes to COVID-19 vaccines. One is required and one is not. The nuance is due to the remaining product distinctions related to licensing versus emergency use authorization.

1. Emergency Use Authorization (EUA) Fact Sheet — Healthcare providers continue to be required to provide the product-specific “Emergency Use Authorization (EUA) Fact Sheet” when administering a COVID-19 vaccine under conditions of EUA. This means EUA Fact Sheets for COVID-19 vaccination are required:

• When vaccinating children 6 months through 11 years of age
• Before giving Novavax COVID-19 Vaccine (2023-2024 formula) to any eligible recipient

Current EUA Fact Sheets are listed on Immunize.org’s popular “Checklist of Current Versions of U.S. COVID-19 Guidance and Clinic Support Tools.”

2. COVID-19 mRNA VIS — The new “COVID-19 mRNA VIS” may be used when vaccinating people 12 years and older who will receive one of the licensed mRNA vaccines (Pfizer’s Comirnaty^® or Moderna’s Spikevax^®). Even though at this time adverse events following COVID-19 vaccines are covered by the Countermeasures Injury Compensation Program (CICP) rather than the Vaccine Injury Compensation Program (VICP), use of the VIS is still required.

Respiratory syncytial virus (RSV) information documents and requirements

Two types of documents are available for RSV products, a traditional VIS and a newer “Immunization Information Statement” or “IIS.”

1. RSV VIS — The first RSV VIS, issued earlier in 2023, covered vaccination of adults 60 and older. However, it was recently updated to include information about vaccination of pregnant people between 32 weeks and 36 weeks, 6 days of gestation, following the September 2023 CDC recommendations.
2. RSV Immunization Information Statement (IIS) — On Sept. 25, 2023, the CDC released a new IIS for the Respiratory Syncytial Virus (RSV) Preventive Antibody, called nirsevimab. The IIS is similar in format to a VIS and contains important information about the new monoclonal antibody product. The IIS can be accessed as file formats similar to VIS from this page of the CDC’s website. ​Immunize​.org has also added the nirsevimab IIS to their website and will provide translations in the future.
   
   Currently, the RSV preventive antibody is not part of the Vaccine Injury Compensation Program; therefore, use of the IIS is not required by federal law. However, as a condition of participating in the Vaccines for Children (VFC) program, providers must give the IIS to parents in the same way that a VIS is provided.

Wrap-up

As the velocity of change increases, it is difficult to keep up! This article summarizes some of the newest modifications to the requirements for informed consent before vaccination. To keep an eye out for future changes, you can subscribe at no charge to ​IZ Express.