BILL ANALYSIS Ó
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2832
(Travis Allen) - As Introduced 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),
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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
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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.
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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.
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CDC recommends routine vaccination to prevent 17
vaccine-preventable diseases that occur in infants, children,
adolescents, or adults.
3)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.
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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.
4)VAERS. The NCVIA requires health care providers to report
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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.
5)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
---------------------------
<1>
https://vaers.hhs.gov/resources/VAERS_Table_of_Reportable_Events_
Following_Vaccination.pdf
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report an adverse reaction to VAERS, and information regarding
the NVCIP.
6)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.
7)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.
8)POLICY COMMENTS.
a) DPH already posts the requested information. It should
be noted that the information required by this bill is
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already "conspicuously available" on the DPH Website
( https://www.cdph.ca.gov/programs/immunize/Pages/VaccineSafe
ty.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.
b) 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.
c) 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
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A Voice for Choice
Hundreds of individuals
Opposition
California Immunization Coalition
Analysis Prepared by:Paula Villescaz / HEALTH / (916) 319-2097