Existing law establishes the State Department of Public Health within the California Health and Human Services Agency. The department is vested with certain duties, powers, and responsibilities, including programs related to immunizations and communicable diseases.

This bill would require the California Health and Human Services Agency to maintain a conspicuous link to federal resources related to vaccine injuries, including, but not limited to, the Vaccine Adverse Event Reporting System and the National Vaccine Injury Compensation Program, on the agencys Internet Web site.

Date of Hearing: April 19, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2832

Author:(Travis Allen) – As Introduced Ver:February 19, 2016

SUBJECT: Immunizations: vaccine injury information.

SUMMARY: Requires the California Health and Human Services Agency (HHS) to maintain a conspicuous link to federal resources related to vaccine injuries, including, but not limited to, the Vaccine Adverse Event Reporting System (VAERS) and the National Vaccine Injury Compensation Program (NVICP), on the agency’s Internet Website.

EXISTING STATE LAW:

1. Establishes HHS to oversee departments and offices that provide a wide range of services in the areas of health care, mental health, public health, alcohol and drug treatment, income assistance, social services, and assistance to people with disabilities.​
2. Establishes the Cailfornia Departmentof Public Health (DPH), under HHS, which oversees various public health programs, including programs related to preventing disease, disability, and premature death of the residents of California.
   
3. Authorizes DPH to establish the Immunization Branch to provide leadership and support to public and private sector efforts to protect the population against vaccine-preventable diseases.
   

EXISTING FEDERAL LAW:

1. Establishes, under the National Vaccine Childhood Injury Act (NVCIA), the NVICP, a no-fault alternative to the traditional tort system which provides compensation to people found to be injured by certain vaccines.
2. Requires, under the NVCIA, healthcare staff to provide a vaccine information sheet (VIS) to a patient, parent, or legal representative before each dose of certain vaccines.
3. Requires health care providers to report certain adverse health events following vaccination to VAERS.

FISCAL EFFECT: This bill has not yet been heard by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, existing law establishes DPH within the HHS. DPH is vested with certain duties, powers, and responsibilities, including programs related to immunizations and communicable diseases. DPH provides pages of information about vaccines and their benefits. However, it provides virtually no information regarding vaccine injuries or federal resources, such as the Vaccine Injury Compensation Program (VICP) or VAERS, which exist to aid persons who suffer vaccine injuries. The author argues that the manner in which HHS and DPH disseminate information related to vaccines and vaccine safety directly contributes to the lack of awareness of vaccine injuries and of the federal resources available to assist vaccine-injured children and adults. DPH’s publication titled “Vaccine Safety: Answers to Parents’ Top Questions,” for example, provides no information regarding the existence of VAERS for adverse event reporting or VICP for vaccine injury claims. Similarly, within the DPH Website, links to VAERS and VICP are so obscure, that a person searching must know that these programs exist in order to find them. Indeed, a search for the terms “vaccine injury” on the DPH Website returns a page titled “Vaccine Safety,” with links to various California and federal resources discussing vaccines and their importance. Links to VAERS and VICP are buried at the bottom of the page among twelve other links under the heading “Additional Resources.” The author states that a parent of a child who suffers a post-vaccination adverse event would need to spend an inordinate amount of time to identify the resources available to them, resulting in an undue burden on a family already dealing with vaccine injury. The author concludes that without awareness of the VICP, individuals who might otherwise receive compensation for a vaccine-related injury or death will continue to be denied compensation because of a failure to file their claim within the statutory deadlines, being forced to solely bear the financial burden of dealing with health conditions resulting from a state-mandated medical procedure.
2. BACKGROUND. The diseases that vaccines prevent can be dangerous, or even deadly. According to the federal Centers for Disease Control and Prevention (CDC), vaccines reduce the risk of infection by working with the body's natural defenses to help it safely develop immunity to disease. When bacteria or viruses invade the body, they attack and multiply, creating an infection. The immune system then has to fight the illness. Once it fights off the infection, the body is left with a supply of cells that help recognize and fight that disease in the future. Vaccines contain the same antigens or parts of antigens that cause diseases, but the antigens in vaccines are either killed or greatly weakened. This exposure to the antigens teaches the immune system to develop the same response as it does to the real infection so the body can recognize and fight the disease in the future.

Public health experts agree that vaccines represent one of the greatest achievements of science and medicine in the battle against disease. Vaccines are responsible for the control of many infectious diseases that were once common around the world, including polio, measles, diphtheria, pertussis, rubella, mumps, tetanus, and Hib meningitis. Vaccine helped to eradicate smallpox, one of the most devastating diseases in history. Over the years, vaccines have prevented countless cases of infectious diseases and saved literally millions of lives.

Vaccine-preventable diseases have a costly impact, resulting in doctor's visits, hospitalizations, and premature deaths. Sick children can also cause parents to lose time from work. CDC recommends routine vaccination to prevent 17 vaccine-preventable diseases that occur in infants, children, adolescents, or adults.

1. National Childhood Vaccine Injury Act. During the mid-1970s, there was an increased focus on personal health and more people became concerned about vaccine safety. Several lawsuits were filed against vaccine manufacturers and healthcare providers by people who believed they had been injured by the TDaP vaccine. Damages were awarded despite the lack of scientific evidence to support vaccine injury claims. In 1976, a preemptive attempt to conduct a nationwide influenza vaccination campaign for the swine flu stoked peoples' fears. The predicted epidemic did not occur and there were some who argued this particular influenza vaccine resulted in serious side effects. As a result, potential liability costs and vaccine prices soared, and several vaccine manufacturers halted production. A vaccine shortage resulted and public health officials became concerned about the return of epidemic disease.

To reduce liability and respond to public health concerns, Congress passed the NCVIA in 1986. The NCVIA established the National Vaccine Program Office (NVPO) to coordinate immunization related activities among various federal agencies and requires health care providers who give vaccines to provide an information statement to the patient or guardian that contains a brief description of the disease as well as the risks and benefits of the vaccine. The NVICP was created to compensate those injured by vaccines on a "no fault" basis. The NVICP has been criticized by some for inefficient operations, and for providing legal immunity to the pharmaceutical industry.

The NCVIA established a committee from the Institute of Medicine (IOM Committee) to review the literature on vaccine reactions. The IOM Committee concluded that there are limitations in our knowledge of the risks associated with vaccines. The group looked at 76 health problems to see if they were caused by vaccines. Of those, 50 (66%) had no or inadequate research to form a conclusion. The IOM identified several specific problems, such as a limited understanding of biological processes that underlie adverse events, incomplete and inconsistent information from individual reports, poorly constructed research studies (not enough people enrolled for the period of time), inadequate systems to track vaccine side effects, and few experimental studies were published in the medical literature. The CDC states that in the time since the publication of the IOM reports in the 1990s, significant progress has been made to monitor side effects and conduct research relevant to vaccine safety. In 2011 the IOM published, “Adverse Effects of Vaccines: Evidence and Causality,” representing an extensive study of peer-reviewed vaccine related research to date. The IOM Committee reviewed eight vaccines given to children or adults (MMR, varicella, influenza, hepatitis A, hepatitis B, human papillomavirus, meningococcal, and DTP) and again found that vaccines are generally very safe and that serious adverse events are quite rare.

1. VAERS. The NCVIA requires health care providers to report certain adverse health events following vaccination to the VAERS. The VAERS system remains an important source of information for the CDC and others to monitor the vaccine program, but the system allows self-reporting by any citizen or healthcare provider what they believe to be an adverse vaccine-related event. The event numbers publicly available have not been medically verified or scientifically studied. Health care providers are subject to the adverse event reporting provisions of the NCVIA. This act mandates the reporting of any event set forth in the Reportable Events Table^[1] that occurs within the time period specified and any event listed in the manufacturer's package insert as a contraindication to subsequent doses of the vaccine. There are no penalties specified in the law for health care providers who do not report adverse events. However, the federal Food and Drug Administration takes active steps to educate physicians, nurses and other health care workers about the importance of reporting adverse vaccine events.
2. Vaccine Information Statements. A VIS is a document, produced by CDC, that informs vaccine recipients (or their parents or legal representatives) about the benefits and risks of a vaccine they are receiving. All vaccine providers, public or private, are required by the NCVIA to give the appropriate VIS to the patient (or parent or legal representative) prior to every dose of specific vaccines. The appropriate VIS must be given prior to the vaccination, and must be given prior to each dose of a multi-dose series. It must be given regardless of the age of the recipient. Every VIS contains, among other information, consistent and clear directions to the patient on where to find resources regarding vaccine injuries, how to report an adverse reaction to VAERS, and information regarding the NVCIP.
3. SUPPORT. Supporters argue that this measure will help the public access VICP, created as part of the 1986 National Childhood Vaccine Injury Act to compensate victims of vaccine injuries. All too often vaccine injury claim filing deadlines are missed as many patients are unaware of the program's existence. Supporters state that this undermines the very purpose of the VICP, which is to compensate vaccine-injured individuals and it erodes trust in the vaccine program. Supporters conclude that conspicuous and clearly labeled web links to VAERS on state agency websites will greatly enhance the accuracy and effectiveness of this essential research tool.
4. OPPOSITION. The California Immunization Coalition (CIC) states in opposition that despite the concerns voiced by the author, DPH has addressed these issues through their comprehensive Website which includes links, information, and resources on vaccines, vaccine preventable diseases and vaccine safety. CIC argues that this bill is unnecessary as links to vaccine safety information currently exist not only on the DPH website but it is federal law that patients are provided with a Vaccine Information Statement, a document that explains both the benefits and risks of a vaccine and includes information for VICP and VAERS.
5. POLICY COMMENTS.
   1. DPH already posts the requested information. It should be noted that the information required by this bill is already "conspicuously available" on the DPH Website (https://www.cdph.ca.gov/programs/immunize/Pages/VaccineSafety.aspx). This website is the first result returned for the search term "vaccine injury" on DPH main Website as. DPH states that provision of vaccine safety information is one of many public services provided voluntarily by DPH. The Committee may wish to consider whether this bill is necessary.
   2. Why HHS? HHS oversees departments and offices that provide a wide range of services in the areas of health care, mental health, public health, alcohol and drug treatment, income assistance, social services, and assistance to people with disabilities. DPH is responsible for executing Health and Safety Code statutory provisions and related regulations regarding public health activities, including immunizations. It is more likely that a consumer looking for vaccine injury information would end up on the Website of DPH, not HHS.
   3. What is "conspicuous"? The measure requires HHS to "maintain a conspicuous link to federal resources." It is not clear what characteristics of the link would qualify it as conspicuous.

REGISTERED SUPPORT / OPPOSITION:

Support

A Voice for Choice

Hundreds of individuals

Opposition

California Immunization Coalition

Analysis Prepared by: Paula Villescaz / HEALTH / (916) 319-2097

1. https://vaers.hhs.gov/resources/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf ↑