Do you need a signed consent form for flu vaccine for infants?

Answer 1

Depending on the age of the infant, they may not be able to have a flu vaccination at all. Until they are 6 months old, infants can not be vaccinated for the flu because their immune systems are too immature. Some types of flu vaccines can not be used for children under age 2.

In the US, there does need to be the standard form completed for all administrations of influenza vaccines, regardless of patient age.

There are no Federal requirements to get signed informed consent, however, many states do have such laws. Your state health department can provide you with all needed forms, both Federal and State, often online.

There is Federal law that applies to providing Vaccine Information Statements (VIS) to all patients or their parent or legal representative/guardian prior to the vaccination, regardless of age. The VIS is produced by the Centers for Disease Control and Prevention (CDC) that provides all state departments of health with the newest information and statements.

The VIS provision requirement is under the National Childhood Vaccine Injury Act (NCVIA) of 1986. The VIS must include specific information about the vaccine, with both the benefits and risks of vaccination. The VIS must be provided every time a vaccination is to be given before the administration of the vaccine. Children under age 10 need a booster approximately 1 month after the initial vaccination to help their young immune systems produce the correct response. They must be given a second VIS before the booster is given.

Each provider of vaccinations is required to record and keep specific patient information about the vaccination and the vaccine used (lot number, etc.) in the medical record. Or, the office can keep a permanent log of the administrations.

Under Federal law, although providers are permitted to ask for signatures on Informed Consent forms, this is not a Federal requirement. Some states do have specific requirements, including signed consent.