Vaccine Information Statements (VISs)
Frequently Asked Questions
Should the VISs be used for adults getting vaccines as well as for children
Yes. Under the National Childhood Vaccine Injury Act, anyone receiving a covered vaccine should be given the appropriate VIS. VISs are worded so they may be used by adults as well as children. Exceptions are VISs for vaccines that are not licensed for adults, such as DTaP or rotavirus.
Are VISs "informed consent" forms?
No. People sometimes use the term “informed consent” loosely when referring to VISs. But even when vaccine information materials had tear-off sheets for parents to sign, they were not technically informed consent forms. The signature was simply to confirm that the "Duty to Warn" clause in the vaccine contract was being fulfilled.
There is no Federal requirement for informed consent. VISs are written to fulfill the information requirements of the National Childhood Vaccine Injury Act. But because they cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed. Some states have informed consent laws, covering either procedural requirements (e.g., whether consent may be oral or must be written) or substantive requirements (e.g., types of information required). Check your state medical consent law to determine if there are any specific informed consent requirements relating to immunization. VISs may be used for informed consent as long as they conform to the appropriate state laws.
The law states that vaccine information materials be given to a child's legal representatives. How is "legal representative" defined?
A "legal representative" is a parent or other individual who is qualified under state law to consent to the immunization of a minor. There is not an overriding Federal definition.
Does the National Childhood Vaccine Injury Act specify an age at which a child becomes an adult for purposes of distributing VISs? For example, if an 18-year old is considered a child, would it be illegal to give a VIS to him or her directly, as opposed to the parent or guardian?
The National Childhood Vaccine Injury Act does not provide a definition of child for purposes of the Act. "Legal representative" is defined as "a parent or an individual who qualifies as a legal guardian under State law." A reasonable interpretation is that State law, and specifically the State medical consent law, should be deferred to for purposes of defining who is a minor. Therefore, if an 18 year old can consent to immunization under a State's law, that 18 year old is the person who must be provided a copy of the VIS.
Must the patient, parent, or legal representative physically take away a copy of each VIS, or can we simply let them read a copy and make sure they understand it?
Ideally the person getting the shot, or their representative, should actually take each VIS home. They contain information that may be needed later (e.g., the recommended vaccine schedule, information about what to do in the case of an adverse reaction). Patients may choose not to take the VIS, but the provider should offer them the opportunity to do so.
When do providers have to start using a new VIS?
The date for a new VISs required use is announced when the final draft is published in the Federal Register. Ideally, providers will begin using a new VIS immediately. This is particularly important for a VIS for a new vaccine, or it is a revision of an existing VIS, if the vaccine’s contraindications or adverse event profile have changed significantly.
How should we comply with the law for patients who cannot read the VISs (e.g., those who are illiterate or blind)?
The NCVIA requires providers to supplement the VISs with "visual presentations" or oral "explanations" as needed. If patients are unable to read the VISs, it is up to the provider to ensure that they have that information. VISs can be read to these patients, or videotapes can be used as supplements. At least one CD-ROM is being produced on which users can hear the VIS's read. Versions of VISs that are compatable with screen reader devices are available on the NIP website.
Why are the dates on some of the VISs so old? Are they obsolete? Why can't they be updated every year?
VISs are updated only when they need to be. For instance, a VIS would be updated if there were a change in ACIP recommendations that affects the vaccine’s adverse event profile, indications, or contraindications. It’s true that some people might be concerned that a VIS that is several years old might be outdated. On the other hand, knowing that VISs posted on the NIP website will always be the current versions should help alleviate that concern. Annually changing the dates on VISs that haven’t changed otherwise could be confusing too, because there could be multiple VISs in circulation that were identical but would have different dates.
Some VISs contain recommendations that are at odds with the manufacturer's package insert. Why?
VISs are based on the ACIP’s recommendations, which occasionally differ from those made by the manufacturer. These differences may involve adverse events. Package inserts generally tend to include all adverse events that were temporally associated with a vaccine during clinical trials, whereas ACIP tends to recognize only those believed to be causally linked to the vaccine.
What is the reading level of VISs?
Defining the readibility of a VIS by a traditional “grade level” measure can be difficult and misleading. Two of the criteria used by standard readibility formulas are word length and sentence length. Word length is not necessarily a reliable measure of readibility, as there are multi-syllable words that are widely understood (e.g., “individual”) and short words that are not (e.g., “spiv”). VISs are often unavoidably saddled with long words (“Haemophilus influenzae” for instance, or “vaccination” or “compensation” or “polysaccharide”) which drive the reading level up. Sentence length can be a problem with VISs because they incorporate bulleted lists, which may be read as very long sentences (no period), while they are actually quite easy to understand.
Applying a Fletch-Kincaid test to a VIS usually reveals about a 10th grade reading level, but this should be taken with the caveats in the preceeding paragraph.
In what may be a more useful measure of readability, several VISs were the subject of a series of focus groups among low-literacy parents in a variety of racial and ethnic groups (some not native English speakers) in 1998, and the participants overwhelmingly rated them easy to read and understand. A survey using the influenza VIS in 2002 came to the same conclusion.
How should we distribute VISs when the parent or legal representative of a minor is not present at the time the vaccination is given, for example during a school-based adolescent vaccination program?
CDC’s legal advisors have proposed two alternatives for this situation:
(1) Consent Prior to Administration of Each Dose of a Series. With this alternative the VIS must be mailed or sent home with the student around the time of administration of each dose. Only those children for whom a signed consent is returned may be vaccinated. The program must place the signed consent in the patient's medical record.
(2) Single Signature for Series. This alternative is permissible only in those States where a single consent to an entire vaccination series is allowed under State law and in those schools where such a policy would be acceptable. The first dose of vaccine may be administered only after the parent or legal representative receives a copy of the VIS and signs and returns a statement that a) acknowledges receipt of the VIS and provides permission for their child to be vaccinated with the complete series of the vaccine (if possible, list the approximate dates of future doses); and b) acknowledges their acceptance of the following process regarding administration of additional doses:
prior to administration of each dose following the initial dose, a copy of the VIS will be mailed to the parent (or legal representative) who signs the original consent at the address they provide on this statement, or the VIS will be sent home with the student; and
the vaccine information statements for the additional doses will be accompanied by a statement notifying the parent that, based on their earlier permission, the next dose will be administered to their child (state the date), unless the parent returns a portion of this statement by mail to an address provided, to arrive prior to the intended vaccination date, in which the parent withdraws permission for the child to receive the remaining doses.
The program must maintain the original consent signature and any additional dose veto statements in the patient's medical record. A record must be kept of the dates prior to additional doses that the VIS was mailed, or sent home with the adolescent.
Prior to administration of each additional dose, the provider should ask the adolescent whether he/she experienced any significant adverse events following receipt of earlier doses. If yes, the provider should consider consulting the parent or delaying the vaccination. The adolescent's response to questions about adverse reactions to previous doses should be kept in the medical record.
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Content last reviewed on December 6, 2010
Content Source: National Center for Immunization and Respiratory Diseases