Vaccine Information Statement

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A Vaccine Information Statement (VIS) is a document designed by the Centers for Disease Control and Prevention (CDC) to provide information to a patient receiving a vaccine in the United States. The National Childhood Vaccine Injury Act requires that medical professionals provide a VIS to patients before receiving certain vaccinations. The VIS includes information about the vaccine's benefits and risks, a description of the vaccine, indications and contraindications, instructions for patients experiencing an adverse reaction, and additional resources.[ citation needed ]

Contents

History

In the 1974 case of Reyes v. Wyeth Laboratories, the US Fifth Circuit Court of Appeals decided that vaccine manufacturers were responsible for warning patients of the risks associated with their vaccine. This created concern among manufacturers, since they were reliant on the healthcare professionals administering their vaccines to convey these risks, and the companies could be liable for mistakes made by healthcare providers. [1] Consequently, vaccine prices increased to cover the costs of litigation. In response, the CDC added "duty to warn" clauses in their contracts, which required either the individualized judgement of a physician or "meaningful warnings related to the risks and benefits of vaccination" for all publicly purchased vaccines. This gave way to an early version of the VIS known as the "Important Information Statement" (ISS), the first of which was developed for "Swine and Victoria Influenza" vaccine in 1976. Over the following decade, more than 50 ISSs were created for various vaccines. [2]

An increase in vaccine-related lawsuits and fear of manufacturers withdrawing vaccines from the market led to the 1986 National Childhood Vaccine Injury Act (NCVIA). The act established the National Vaccine Injury Compensation Program (VICP) and the Vaccine Adverse Event Reporting System (VAERS) to take liability for adverse reactions off vaccine manufacturers. [3] The act also required the development of written information about all vaccines included in the VICP, which were primarily routine childhood vaccinations. The act required that all patients, or their parents/legal representatives, be given this information before vaccination. The secretary of the Department of Health and Human Services gave the responsibility of developing these materials to the CDC. By 1991, the CDC developed four 12-page "Vaccine Information Pamphlets" (VIPs) for DTP, MMR, polio, and tetanus-diphtheria (Td) vaccines. These pamphlets fulfilled the requirements of the NCVIA, but were criticized for their length and the amount of time they took to develop. Concerns were raised that patients could not read the entire forms during their visit, and could be less informed due to a less thorough review of the information. [2]

A 1993 amendment to the NCVIA simplified the requirements for the document and simplified the process through which it was created. It removed the requirement for a public hearing in the development of the document and reduced the time period for public comment to 60 days. The simplified requirements led to the single sheet (two-sided) Vaccine Information Statements (VISs) that are still used. By 1997 VISs were available for all vaccines that required them under NCVIA and the CDC began creating VISs for additional vaccines. [2]

In 2008, the Pediatric Multi-Vaccine VIS was developed, which included information on the vaccines for diphtheria, tetanus, and pertussis(DTaP), polio, hepatitis B, pneumococcal conjugate, and Haemophilus influenzae type B (Hib). This allows caregivers to read one document during their visit instead of an individual document for each vaccine. [2] [4]

In 2013, a "provider information document" was developed to include information that was relevant to medical providers but not to patients, reducing the need to frequently update VISs. By 2016, the provider information was made available through a links to the CDC website. [2]

VISs are now available on the CDC website and can be provided in hard copies or electronically. [5] The Immunization Action Coalition (IAC), a partner organization to the CDC, also provides translations of VISs in over 40 languages. [2]

Contents

CDC Vaccine Information Statement for MMR Vaccine from April 2012 CDC Vaccine Information Statement for MMR Vaccine.pdf
CDC Vaccine Information Statement for MMR Vaccine from April 2012

According to the 1993 amended National Childhood Vaccine Injury Act (NCVIA), a VIS must contain at least the following four components: (1) a description of the benefits of the given vaccine, (2) a description of its risks, (3) information about the National Vaccine Injury Compensation Program (VICP), and (4) other relevant information as determined by the Secretary of Health and Human Services. [2]

Current VISs typically include the following sections: [6] [7] [8]

The Multi-Vaccine VIS (DTaP, Hib, hepatitis B, polio, and pneumococcal conjugate) includes the same sections listed above, with sub-headings in the first four sections for each of the vaccines included, as needed. [4]

Requirements for distribution

A VIS must be given prior to vaccination in the United States when a patient is being vaccinated for diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) according to the National Childhood Vaccine Injury Act (NCVIA). The VIS must be given to the person receiving the vaccine or to their parent/legal representative prior to each dose of the vaccine. [9] The "legal representative" is defined as the person who can consent to the vaccination under the laws of the state in which the vaccine is being given. [10] The CDC has also developed VISs for vaccines not covered by the NCVIA, which are recommended for use with these vaccines, and required if the vaccines are purchased under CDC contract under the "duty to warn" clause. [11]

VISs can be provided on paper, in electronic form, or on a laminated office copy. The VIS can be given in a prior appointment, but must also be offered at the visit in which the vaccination is occurring. The patient or parent/representative must be offered a copy of the VIS take home, since the document contains information about what to do in case of an adverse reaction. When a patient receives multiple vaccines in one visit or a combination vaccine, a VIS should be given for each vaccine or component. The Multi-Vaccine VIS can be used for children receiving DTaP, polio, Hib, hepatitis B, and pneumococcal conjugate vaccines. The Multi-Vaccine VIS is not designed for adults or adolescents. [9] [10]

To document the receipt of the VIS, the healthcare provider must record the edition of the VIS and the date it was provided, in addition to the documentation required for the vaccination (date of vaccination, the vaccine manufacturer and lot number, and the office address, name, and title of the person administering the vaccine). [11]

Special Circumstances

In some circumstances, the parent or legal representative of a patient may not be present for the vaccination, such as school-based clinics or long-term care facilities. In these cases, the parent or legal representative can be given the VIS at the time they provide consent or at the time of admission to a long-term care facility. In cases like school-based clinics where a VIS might be sent home to parents, it should be sent home as close to the time of the vaccination as possible, and the parent or legal representative must acknowledge receipt of the VIS, in writing or electronically, including the edition of the VIS and the date it was given. It can be included in the consent form for the vaccination. [10]

Accommodations

The NCVIA requires that healthcare providers use the CDC-produced VIS, unaltered (although they may add contact information for the office). For patients with visual impairments or other needs, the VIS may additionally be read aloud or supplemented with visuals, videos, explanations, or other materials. For patients who are not comfortable with English, translations into over 40 languages are available from the Immunization Action Coalition (IAC). [10] [11]

Related Research Articles

This is a timeline of the development of prophylactic human vaccines. Early vaccines may be listed by the first year of development or testing, but later entries usually show the year the vaccine finished trials and became available on the market. Although vaccines exist for the diseases listed below, only smallpox has been eliminated worldwide. The other vaccine-preventable illnesses continue to cause millions of deaths each year. Currently, polio and measles are the targets of active worldwide eradication campaigns.

<span class="mw-page-title-main">DPT vaccine</span> Class of combination vaccines

The DPT vaccine or DTP vaccine is a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis, and tetanus. The vaccine components include diphtheria and tetanus toxoids and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against in order to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either "DTwP" or "DTaP", where the lower-case "w" indicates whole-cell inactivated pertussis and the lower-case "a" stands for "acellular". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain the pathogen itself, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest. However, booster doses are recommended every ten years to maintain immune protection against these pathogens.

<span class="mw-page-title-main">Pneumococcal polysaccharide vaccine</span> Pneumonia vaccine in use since 1947

Pneumococcal polysaccharide vaccine (PPSV)—known as Pneumovax 23 (PPV-23)—is the first pneumococcal vaccine derived from a capsular polysaccharide.

<span class="mw-page-title-main">National Childhood Vaccine Injury Act</span> US law

The National Childhood Vaccine Injury Act (NCVIA) of 1986 was signed into law by United States President Ronald Reagan as part of a larger health bill on November 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters.

<span class="mw-page-title-main">Vaccination schedule</span> Series of vaccinations

A vaccination schedule is a series of vaccinations, including the timing of all doses, which may be either recommended or compulsory, depending on the country of residence. A vaccine is an antigenic preparation used to produce active immunity to a disease, in order to prevent or reduce the effects of infection by any natural or "wild" pathogen. Vaccines go through multiple phases of trials to ensure safety and effectiveness.

<span class="mw-page-title-main">Childhood immunizations in the United States</span>

The schedule for childhood immunizations in the United States is published by the Centers for Disease Control and Prevention (CDC). The vaccination schedule is broken down by age: birth to six years of age, seven to eighteen, and adults nineteen and older. Childhood immunizations are key in preventing diseases with epidemic potential.

A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event caused by vaccination. The World Health Organization (WHO) knows VAEs as Adverse Events Following Immunization (AEFI).

The MMRV vaccine combines the attenuated virus MMR vaccine with the addition of the chickenpox vaccine or varicella vaccine. The MMRV vaccine is typically given to children between one and two years of age.

<span class="mw-page-title-main">Pneumococcal conjugate vaccine</span> Vaccine against Strep pneumoniae

Pneumococcal conjugate vaccine is a pneumococcal vaccine and a conjugate vaccine used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children.

<span class="mw-page-title-main">National Vaccine Injury Compensation Program</span> U.S. no-fault system for litigating vaccine injury claims

The Office of Special Masters of the U.S. Court of Federal Claims, popularly known as "vaccine court", administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims, sitting without a jury.

<span class="mw-page-title-main">Pneumococcal vaccine</span> Vaccine to prevent infection by the bacteria Stretococcus pneumoniae

Pneumococcal vaccines are vaccines against the bacterium Streptococcus pneumoniae. Their use can prevent some cases of pneumonia, meningitis, and sepsis. There are two types of pneumococcal vaccines: conjugate vaccines and polysaccharide vaccines. They are given by injection either into a muscle or just under the skin.

<span class="mw-page-title-main">Hepatitis B vaccine</span> Vaccine against hepatitis B

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected.

<span class="mw-page-title-main">Hib vaccine</span> Haemophilus influenzae type B vaccine

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

NmVac4-A/C/Y/W-135 is the commercial name of the polysaccharide vaccine against the bacterium that causes meningococcal meningitis. The product, by JN-International Medical Corporation, is designed and formulated to be used in developing countries for protecting populations during meningitis disease epidemics.

<span class="mw-page-title-main">Pertussis vaccine</span> Vaccine protecting against whooping cough

Pertussis vaccine is a vaccine that protects against whooping cough (pertussis). There are two main types: whole-cell vaccines and acellular vaccines. The whole-cell vaccine is about 78% effective while the acellular vaccine is 71–85% effective. The effectiveness of the vaccines appears to decrease by between 2 and 10% per year after vaccination with a more rapid decrease with the acellular vaccines. The vaccine is only available in combination with tetanus and diphtheria vaccines. Pertussis vaccine is estimated to have saved over 500,000 lives in 2002.

<span class="mw-page-title-main">Vaccines for Children Program</span>

The Vaccines for Children Program (VFC) is a federally funded program in the United States providing no-cost vaccines to children who lack health insurance or who otherwise cannot afford the cost of the vaccination. The VFC program was created by the Omnibus Budget Reconciliation Act of 1993 and is required to be a new entitlement of each state's Medicaid plan under section 1928 of the Social Security Act. The program was officially implemented in October 1994 and serves eligible children in all U.S. states, as well as the Commonwealth of Puerto Rico, the U.S. Virgin Islands, American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands.

<span class="mw-page-title-main">Tetanus vaccine</span> Vaccines used to prevent tetanus

Tetanus vaccine, also known as tetanus toxoid (TT), is a toxoid vaccine used to prevent tetanus. During childhood, five doses are recommended, with a sixth given during adolescence.

DTaP-IPV-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated polio vaccine or DTaP-IPV-Hep B. It protects against the infectious diseases diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B.

<span class="mw-page-title-main">Vaccination policy of the United States</span> Overview of the vaccination policy in the United States of America

Vaccination policy of the United States is the subset of U.S. federal health policy that deals with immunization against infectious disease. It is decided at various levels of the government, including the individual states. This policy has been developed over the approximately two centuries since the invention of vaccination with the purpose of eradicating disease from the U.S. population, or creating a herd immunity. Policies intended to encourage vaccination impact numerous areas of law, including regulation of vaccine safety, funding of vaccination programs, vaccine mandates, adverse event reporting requirements, and compensation for injuries asserted to be associated with vaccination.

Live recombinant vaccines are biological preparations that improve immunity through the use of live bacteria or viruses that are genetically modified. These live pathogens are biologically engineered to express exogenous antigens in the cytoplasm of target cells, triggering immune responses as a result. This form of vaccine combines the beneficial features of attenuated and recombinant vaccines, providing the preparation with attenuated vaccines’ long-lasting immunity and recombinant vaccines’ genetically engineered precision and safety.

References

  1. ↑ Sanzo, Michael (15 December 1991). "Vaccines and the law". Pepperdine Law Review. 19 (1): 29–48. PMID   11659523 . Retrieved 30 December 2020.
  2. 1 2 3 4 5 6 7 "History of vaccine information statements" (PDF). Centers for Disease Control and Prevention. Retrieved 30 December 2020.
  3. ↑ "About the National Vaccine Injury Compensation Program". Health Resources & Services Administration. Retrieved 30 December 2020.
  4. 1 2 "Your child's first vaccines: What you need to know" (PDF). Immunization Action Coalition. Retrieved 30 December 2020.
  5. ↑ "Vaccine Information Statements (VISs): Instructions for using VISs". Centers for Disease Control and Prevention. Retrieved 30 December 2020.
  6. ↑ "Adenovirus vaccine: What you need to know" (PDF). Centers for Disease Control and Prevention. Retrieved 30 December 2020.
  7. ↑ "Varicella (chickenpox) vaccine: What you need to know" (PDF). Centers for Disease Control and Prevention. Retrieved 30 December 2020.
  8. ↑ "Polio vaccine: What you need to know" (PDF). Centers for Disease Control and Prevention. Retrieved 30 December 2020.
  9. 1 2 "You must provide patients with Vaccine Information Statements (VISs) – It's federal law!" (PDF). Immunization Action Coalition.
  10. 1 2 3 4 "Vaccine Information Statements (VISs): Frequently asked questions". Centers for Disease Control and Prevention. 15 November 2019. Retrieved 30 December 2020.
  11. 1 2 3 "Vaccine Information Sheets (VISs): Facts about VISs". Centers for Disease Control and Prevention. 14 December 2021.
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