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Vaccine Controversies

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									Vaccine Controversies
                                         23 March 2010
 University of Wisconsin School of Medicine and Public Health
Synopsis
   Background on vaccines
   U.S. Smallpox program - 2002
   Cost Effectiveness
   Thimerosal – Neurodevelopmental issues
   MMR – Autism
   Fetal Tissue
Vaccine Controversies
Background on Vaccines
   US Birth Cohort ~ 4,000,000 children / year
   General vaccine coverage ~ 90%
   doses per vaccine per year = 3,600,000
   Financial Implications:
       $10 vaccine with universal recommendation
         $36,000,000 per year

       $108 vaccine with 4 dose
         $1,555,200,000 per year

   Global total profit from vaccines
       Less than profit from a single cholesterol drug
                                       HPV                           Number of Immunizations
                                       Tdap
                                       Meningococcal                   from Birth to Age 18
                                       Influenza
                                       Hep A
                    55                 Pneumococcal
                                       Varicella
                    50                 MMR
                    45                 Rota
Cumulative Number




                                       IPV
                    40                 Hib
                                       DTaP
                    35                 Hep B
                    30
                    25
                    20
                    15
                    10
                    5
                    0
                                 2-M
                                       4-M
                                             6-M




                                                                 3
                                                                     4
                                                                         5
                                                                             6
                                                                                 7

                                                                                     8
                                                                                         9
                         Birth




                                                                                             10
                                                                                                  11
                                                                                                       12
                                                                                                            13
                                                                                                                 14

                                                                                                                      15
                                                                                                                           16
                                                                                                                                17
                                                                                                                                     18
                                                   12-M
                                                          18-M




                                                                                 Age
                                                 HPV                             Cost of Immunizations
                                                 Tdap
                                                 Meningococcal                    from Birth to Age 18
                                                 Influenza
                                                 Hep A
                          2000                   Pneumococcal                                                 $541
                                                 Varicella
Cummunlative Cost (US$)




                          1750                   MMR
                                                 Rota
                                                 IPV        $223
                          1500                   Hib
                                                 DTaP
                          1250                   Hep B

                          1000
                                    $1060
                           750

                           500

                           250

                             0
                                 Birth
                                         2-M
                                               4-M
                                                     6-M




                                                                         2
                                                                             3
                                                                                 4
                                                                                     5
                                                                                         6
                                                                                             7
                                                                                                 8
                                                                                                     9
                                                                                                         10
                                                                                                              11
                                                                                                                   12
                                                                                                                        13
                                                                                                                             14
                                                                                                                                  15
                                                                                                                                       16
                                                                                                                                            17
                                                                                                                                                 18
                                                           12-M
                                                                  18-M




                                                                                         Age
Prevalence, Mortality and Cost
recommended childhood and adolescent vaccines
       Case Fatality Rate (per 1000 cases)   1000


                                             100                                                            $300

                                               10

                                                                                                            $100
                                                1


                                              0.1                                                           $50


                                             0.01


                                     0.001
                                                    0.1      1      10     100    1000   10000     100000

                                                          Pre-vaccine Prevalence (cases/100,000)
Comparative Costs to fully Immunize
all American Children
(77.9 million children: ages 0 – 18)

                         800
                         700
   Billions of Dollars




                         600                                             713
                         500
                         400
                         300
                         200
                         100
                                       134
                          0
                               Childhood Immunization           Iraq War (as of 3/22/10)
                                   Sources of population and cost information:
                               http://www.census.gov; http://www.costofwar.com
Vaccine Controversies
Smallpox (Variola major)
    Smallpox: Overview
   1949 - Last U.S. case
   1972 - End of routine childhood vaccination
   1980 - Global eradication
   U.S. and Russia maintain
        cultures of Variola
   History of weaponization
   Efficient person-to-person
    aerosol/contact transmission     CDC: Electron
                                     micrograph of
   Up to 30% mortality              Variola major
    Smallpox Vaccine

   Immunity not life-long
   old vaccine available
       Made from live Vaccinia
       14 million doses
       1:5 dilution = 70 million
                          Smallpox Vaccine
                          Complications




Eczema vaccinatum. Photo courtesy of John M. Leedom, M.D.
Rates of Complication from Vaccinia
Vaccine
   Autoinnoculation                                                        529.2
Generalized Vaccinia                            241.5
 Eczema Vaccinatum           38.5
         Encphalitis       12.3
 Vaccinia Necrosum 1.5
              Death 1.1
               WCP         5.25
               OPV 0.4

                       0          100     200      300     400       500      600
                                        Events per 1,000,000 doses


                                    Lane et al, J Infect Dis 1970: 122:303-9
                        Number of Smallpox citations
                        reported on MEDLINE per month
                        ( January 1999 -February 2004 )

                        80
                                                                                     “End of hostilities”
No. MEDLINE citations




                        70
                                                                                 Start of Iraq war
                        60

                        50
                                                 Start of civilian vaccination
                        40

                        30               Anthrax Attacks

                        20        September 11th, 2001

                        10

                         0

                             | 1999    | 2000        | 2001           | 2002            | 2003         |
Vaccine Controversies
Human Papillomavirus vaccine




 Source: http://rhino.bocklabs.wisc.edu/cgi-bin/virusworld/ictv8gallery.pl
HPV
School-entry mandates are essential to provide vaccine to
traditionally under-immunized individuals and populations
   Compulsory Vaccination can violate personal values
     Status of HPV School-entry Mandates
            National Conference of State Legislatures
       http://www.ncsl.org/programs/health/HPVvaccine.htm




 Passed

Introduced

 Conflict

Withdrawn
Now… for boys as well
HPV Questions
   What is the role of cost effectiveness in
    shaping vaccine policy?
   Is there a cost per life or cost per QALY that
    is too expensive?
   Who should pay for vaccines
   What are the ethics of a sex-based
    recommendation for HPV?
Vaccine Controversies
Thimerosal
Thimerosal History
   Thiomersal or sodium ethylmercurithiosalicylate, is commonly
    known in the United States as thimerosal.
   Organomercury compound (approximately 49% mercury by
    weight) used as an antiseptic and antifungal agent
   Developed and registered under the trade name Merthiolate in
    1928 by Eli Lilly and Company
   Used as a preservative in vaccines, immunoglobulin
    preparations, skin test antigens, antivenins, ophthalmic and nasal
    products, and tattoo inks
   In the U.S., E.U., and a few other affluent countries, the
    compound is being phased out from vaccines routinely given to
    children. Packaging the vaccines in single-dose vials
    eliminates the need for bacteriostatics such as thiomersal
Policy Effect - 1999
The American Academy of Family Physicians (AAFP),
American Academy of Pediatrics (AAP), and the Public
Health Service (PHS) in consultation with the Advisory
Committee on Immunization Practices (ACIP) established
a goal to remove or greatly reduce thimerosal from
vaccines as soon as possible for the following reasons:
 removal or substantial reduction of thimerosal is feasible
 progress in removal to date is substantial
 discussions between the FDA and the vaccine
  manufacturers in removing thimerosal are ongoing
 public concern about the use of mercury of any sort
  remains high
Thimerosal &
   Autism
“Fact Box”
   A typical flu shot contains 25 micrograms - or 50,000 parts per
    billion - of mercury.
   The EPA classifies a liquid with 200 parts per billion of mercury
    as hazardous waste. The limit for drinking water is 2 parts per
    billion.
   Using the standards set for the kind of mercury in fish, an
    average 130-pound person getting the flu shot would exceed the
    daily limit by more than four times. A 22-pound baby would get
    more than 25 times the amount of mercury considered safe.
    Doctors are recommending many babies and children get two flu
    shots this season.

                                     Source: RAQUEL RUTLEDGE
                                     Milwaukee Journal Sentinel
                                     Posted: Nov. 12, 2007
Flu-shot scare unjustified by
either evidence or science
By JONATHAN L. TEMTE
Posted: Nov. 24, 2007




“Legitimizing extreme points of view, without
  critical evaluation, not only is wrong but can
  lead to flawed, and sometimes deadly,
  personal and policy decisions.”
Suggestions for “Fair”
Evaluations
   Make numbers understandable.
      Mixing parts per billion and microgram amounts encourages
       readers to equate influenza vaccines with hazardous waste.

   Make chemistry understandable.
      Two forms of mercury often are often confused. Thimerosal, the
       preservative used in a limited number of vaccines, contains ethyl
       mercury. Exposure warnings are based on methyl mercury.

   Make sources of information understandable.
      The article quoted a publication from the Journal of American
       Physicians and Surgeons. This journal, however, is not
       included in the 5,146 medical journals listed by the National
       Library of Medicine as a recognized source of legitimate medical
       information.
Science vs. Dogma

                 “The committee also concludes that the body
                 of epidemiological evidence favors rejection
                 of a causal relationship between thimerosal
                 -containing vaccines and autism”



“Evidence of Harm is a gripping investigation.
Much like the 9/11 commission's report, it is
 an alarming page-turner. Keep your eye on
California, where autism cases are closely
tracked. If autism-related diagnoses decline
over the next year or two following the
introduction of thimerosal-free vaccines,
the finding will further fuel this simmering
controversy.” -- Newsday
Prevalence of autism in children aged 2 to 12 years by year
of birth from 1989 to 2003




  Schechter, R. et al. Arch Gen Psychiatry 2008;65:19-24.
Possible
Consequences of Action
   On December 12, 2007 Merck & Co. announced
    that it was recalling 13 Lots containing 1.2 million
    doses of HIB vaccine (PedvaxHIB and the
    combination COMVAX containing HIB and hepatitis
    B vaccines)
   Possible contamination with the common bacterium
    called Bacillus cereus (B. cereus).
   Problem due to a piece of equipment in Merck's
    West Point, PA manufacturing facility which failed a
    sterility test and yielding the bacterium
Increasing cases of
Haemophilus influenzae Type B
Mercury and Autism References

   Schechter R, Grether JK. Continuing increases in autism reported to
    California's developmental services system: mercury in retrograde. Arch
    Gen Psychiatry. 2008 Jan;65(1):19-24.
   Baker, JP Mercury, Vaccines, And Autism: One Controversy, Three
    Histories. Am J Public Health. 2008. Vol. 98
   Novella S. The Anti-Vaccination Movement. Skeptical Inquirer
    2007;31(6):25-31.
   Immunization Safety Review – Vaccines and Autism. Immunization
    Safety Review Committee, Board on Health Promotion and Disease
    Prevention, Institute of Medicine of the National Academies. 2004; The
    National Academies Press; Washington, D.C. www.nap.edu
Thimerosal Questions
   What is the role of alarmists and contrarians
    in vaccine policy?
   Are such cautions helpful or harmful?
   Do proponents of vaccine harm bear
    responsibility of vaccine related disease?
   Is the current system responsive to patients’
    needs?
Special Masters Ruling
   On Friday, March 12, special masters in the U.S.
    Court of Federal Claims ruled against the claims of
    parents of autistic children in three separate cases.
   The parents alleged that vaccines with thimerosal
    had triggered autism in their children, and they were
    seeking compensation from the National Vaccine
    Injury Compensation Program.
   The vaccine court was established to require a
    lower standard of proof than civil courts, so the
    forceful rejection of the vaccine-autism link is
    especially notable.
Special Masters Ruling
   Special Master George Hastings wrote, for example,
    that "The overall weight of the evidence is
    overwhelming contrary to the petitioners' causation
    theories."
   Another ruling noted that many parents had "relied
    upon practitioners and researchers who peddled
    hope, not opinions grounded in science and
    medicine."
   The rulings follow the same court's judgment last
    year against claims that measles-mumps-rubella
    shots in combination with other thimerosal-
    containing vaccines cause autism.
Vaccine Controversies
MMR and Autism
Autism Background
   Autism and autism spectrum disorders begin before
    the age of 3, and include a group of developmental
    disabilities marked by great difficulty in social
    interaction and communication.
   Difficulties on the spectrum range from mild to
    severe.
   The disorder is on the rise, with one in 150 children
    now diagnosed with autism spectrum disorders,
    according to the CDC.
   Suspicion of a vaccine link with autism has been
    ongoing at numerous advocacy groups
MMR – Autism Timeline
                       Apr – 2000
                                                Jan – 2001
                 Rep. Dan Burton chairs
                                            British Press runs
                  Congressional Panel
                                           Favorable articles on
                   On MMR - Autism
                                           MMR-Autism Theory

   Feb – 1998                                                Mar – 2004
Wakefield publishes                                      10 of 11 co-authors
MMR-Autism* Study                                         retract the claim




*Wakefield AJ et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis,
and pervasive developmental disorder in children. The Lancet, Volume 351,
Number 9103 28 February 1998
MMR – Autism Timeline
     May – 2004
Institute of Medicine         June - 2007               Sep - 2007
   releases report        Special Masters start   Jenny McCarthey’s
                           hearing test cases     book blaming MMR
                                                     for son’s autism
                  June – 2004                      featured on Oprah
              Rep. Dave Weldon
              derides IOM Report
                                                            Feb – 2008
               on MMR - Autism
                                                         Wakefield accused
                                                           of misconduct




                                                            Feb – 2010
                                                          Lancet Retracts
                                                          Wakefield paper
The Lancet fully retracts paper
Office of Special Masters
Decision
   March 6, 2008 - Federal officials say a Georgia girl is
    entitled to compensation from a federal vaccine injury
    fund because she developed autism-like symptoms
    after receiving childhood vaccines
   Her father said, "we showed there was a plausible
    mechanism. We showed that an injury occurred
    shortly after her vaccination. Her growth curve went
    flat for months."
   officials concluded that the vaccines given to the girl
    aggravated a pre-existing condition -- a
    mitochondrial disorder -- that then manifested as a
    regressive neurological disease with
    some symptoms of autism spectrum disorder.
Consequences of Action
   13% reduction in MMR coverage in UK since 1998
   Increasing cases of measles in England and Wales
Consequences of Action
Focused on Vaccines?
   January 16, 2009: Alison Singer, the executive vice president
    of communications and awareness at Autism Speaks, one of
    the nation's leading autism advocacy groups, announced her
    resignation, citing a difference of opinion over the organization's
    policy on vaccine research.
   "Dozens of credible scientific studies have exonerated vaccines
    as a cause of autism," she wrote in a statement. "I believe we
    must devote limited funding to more promising avenues of autism
    research."
   Singer, who has an 11-year-old daughter with autism, joined the
    organization when it launched in 2005. Singer praised Autism
    Speaks and its founders, Bob and Suzanne Wright, but said she
    could no longer work for a group that supports spending limited
    resources on vaccine research.
Office of Special Masters
Decision
   Feb. 12, 2009 - The Office of Special Masters of the U.S. Court
    of Federal Claims rejected claims that either the
    measles/mumps/rubella (MMR) vaccine or thimerosal in vaccines
    caused children's autism.
   The three cases addressed by the vaccine court were picked as
    test cases by a panel of lawyers representing all the families with
    vaccine-related autism claims. The main issue in all three test
    cases was whether thimerosal-containing vaccines and/or the
    MMR vaccine can cause autism.
   The ruling is a major setback for the more than 5,000 cases in
    which families claim that the mercury-based thimerosal -- a
    preservative no longer in wide use in vaccines -- or the MMR
    vaccine itself caused their children's autism
Office of Special Masters
Decision
   The three separate decisions by the court's "special masters"
    were not close
   "To conclude that [autism] was the result of [this child's] MMR
    vaccine, an objective observer would have to emulate Lewis
    Carroll's White Queen and be able to believe six impossible (or,
    at least, highly improbable) things before breakfast," wrote
    Special Master Denise K. Vowell.
   The vaccine court reviewed huge amounts of scientific evidence,
    including tens of thousands of pages of medical records and
    scientific literature and testimony from scores of medical experts.
   "I find that it is extremely unlikely that any of [this child's]
    disorders were in any way causally connected to her MMR
    vaccination, or any other vaccination," writes Special Master
    George L. Hastings, Jr.
MMR-Autism Questions
   Why do certain claims receive wide
    acceptance and persist?
   What is the difference between scientific
    proof and preponderance of evidence?
   Will the special masters’ rulings have any
    effect on the priorities of autism interest
    groups?
Vaccine Controversies
Fetal Tissue
Human Diploid Cell Lines
   Rubella vaccine
       produced using the WI-38 cell line
       derived from a 3-month female fetus
       UK - 1962
   Varicella vaccine
       produced using the MRC-5 cell line
       derived from a 14-week male fetus
       US -1966
Religious objection
[e-mail from a parent to Dr. Temte]

  “… has your group done any research on the
  manufacture of the Rubella and Varicella vaccines? I
  am concerned with the safety of both of these viruses
  knowing that they are propagated on medias of human
  fetal diploid fibroblasts (the source of these cell lines is
  aborted human babies). The Varicella vaccine insert
  directly states that a child who receives the shot will
  receive cell fragments including DNA and proteins
  (again, these are cell fragments from an aborted fetal
  tissue line that most parents have no idea is being
  injected into their child). As a parent I am concerned
  that not enough parents are educated about the
  contents and adverse events of vaccination.”
Religious objection
   Pontifical Academy for Life at the Vatican
       Encourages manufacturers to seek alternative
       In the absence of alternative:
           Vaccines may be used “to avoid serious risk not only
            for one’s own children, but also, and more specifically,
            for the health conditions of the population as a whole –
            especially for pregnant women.”
           “the parents who did not accept the vaccination for
            their own children become responsible for the
            malformations in question.”
Religious objection

“Catholic parents who wish to consent to its use can
 be assured that there is no general obligation to
 refuse permission for the vaccination to be given.
 Consenting does not condone abortion, nor
 amount to encouraging further abortions for this
 vaccine. The substantial benefits of this vaccine,
 for which there is no substitute available, may be
 accepted”
 Bishop Budd – Chair of the Department for Christian Responsibility and
 Citizenship and of the Committee fro Family Life
 http://www.cdc.gov/vaccines/vac-gen/laws/rubella-cathnews.html
Fetal Tissues Questions
   Is the ongoing use of human diploid cell
    culture justified for vaccine production?
   What are the potential effects of avoiding
    vaccines on religious grounds?
   Are there non-religious reasons for avoiding
    vaccination?
Breaking news…
Rotavirus vaccine
   Rotarix (GSK)
   ROTARIX is a live, attenuated rotavirus vaccine
    derived from the human 89-12 strain which belongs
    to G1P[8] type.
   This strain is propagated on Vero cells
       Vero lineage isolated from kidney epithelial cells
         extracted from an African green monkey
       developed on 27 March 1962
   independent U.S. academic research team found
    DNA from porcine circovirus 1 (PCV1) in Rotarix.
   PCV1 is not known to cause illness in humans or
    other animals
       PCV2 is associated with postweaning multisystemic
        wasting syndrome in pigs
Rotavirus background
   Worldwide sales in 2009 = $440,000,000
       US sales = 118,000,000
   Rotavirus can cause vomiting and watery
    diarrhea in infants and children.
   Significant across the globe
       rotavirus causes 500,000 deaths a year
   Pre-vaccine in the US
       < 100 deaths per year
       ~ 50,000 pediatric hospitalizations annually
Rotavirus Questions
   Is it appropriate to suspend distribution of an
    effective and safe rotavirus vaccine due to
    the finding of unexpected DNA?
   What are the benefits and costs of this
    suspension?
   What type of evidence is needed to re-enter
    the market?

								
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