Why Vaccine Policy Reform is Critical

  • In the past decade, there have been many advances in the understanding of genetics, epigenetics, and the immune system; the neurotoxicity of aluminum adjuvants; the biological mechanism of thimerosal toxicity; common medicines that impair mitochondria and suppress the immune system, but this science is not incorporated into current vaccine design, schedules, or policies.

    “. . .the fact that vaccines are delivered to billions of people without preliminary screening for underlying susceptibilities is thus of concern. Indeed, it is naïve to believe that all humans are alike.” Vaccines and Autoimmunity Yehuda Shoenfeld 2015

    “CBER’s Office of Vaccines Research and Review together with the Genomics Evaluations Team for Safety (GETS) are involved in several research collaborations that focus on identification of genetic risk factors associated with adverse reactions to vaccines.” PAVING THE WAY FOR INDIVIDUALIZED MEDICINE, October 2013, FDA

  • There is a seventeen-year delay from medical discovery to community-level practice. The delay can be much longer. The 1986 National Childhood Vaccine Injury Act removed liability from vaccine makers and declared vaccines “unavoidably unsafe.” In effect, this removed the financial incentive to improve designs, and increased incentive to add more vaccines to the pediatric schedule. No liability; all profit.
  • In 2011, the Bruesewitz v. Wyeth decision resulted in even flawed vaccines being protected. Justice Sotomayor and Ginsberg dissented, writing:

    “Its decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”

  • Despite AAP claims about the pediatric schedule, in 2013, “the [IOM] committee generally found a paucity of information, scientific or otherwise, that addressed the risk of adverse events in association with the complete recommended immunization schedule . . .”
  • Drugs commonly given to children impair mitochondria and can lead to injury if vaccinated before full mitochondria/immune/biome recovery: Tylenol, Aleve, aspirin, antibiotics, anxiety meds, steroids.

    Medical exemptions do not cover the diversity of conditions that may lead a parent and/or pediatrician to delay, space, or decline one or more vaccines.?

    Philosophical exemptions are required to give the flexibility needed to avoid injury.

    One-size-for-all school requirements do not respect individual susceptibility factors.

    With all that is now known about individual risk,
    a personalized approach to vaccine administration is the only ethical choice.

A few VACCINE FACTS

Responsible use of vaccines as part of public health management requires understanding and communicating caution about protection limits and known individual risks, as well as incorporating the latest science into vaccination decisions to minimize vaccine injury.

Because of the limitations of current vaccine designs, even 100% vaccination rates would not completely eliminate incidence of disease. Emphasis should not be on complete disease elimination but on keeping the population healthy so that minor outbreaks are experienced without complication.

  • Pertussis: Waning immunity to whooping cough increasing outbreaks. “. . .protection from disease after a fifth dose of DTaP among children who had received only DTaP vaccines was relatively short-lived and waned substantially each year.” Waning Protection after Fifth Dose of Acellular Pertussis Vaccine in Children. N Engl J Med 2012; 367
  • Pertussus: The acellular pertussis vaccine does not prevent the colonization or transmission of pertussis. “These data provide a plausible explanation for pertussis resurgence and suggest that attaining herd immunity will require the development of improved vaccination strategies that prevent B. pertussis colonization and transmission.” Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. Proc Natl Acad Sci U S A. 2014 Jan 14;111(2)
  • Mumps: Mumps outbreaks are occurring among fully vaccinated populations. “The most likely explanations of this epidemiological change are (1) the ability of certain mumps virus strains to escape vaccine-induced immune responses, or (2) waning immunity.” FDA: Determining the Safety and Efficacy of Vaccines to Protect Against Viruses that Infect the Central Nervous System
  • Mumps: “Stephen A. Krahling and Joan A. Wlochowski, former Merck virologists blew the whistle by filing a qui tam action lawsuit in August 2010. The scientists allege that the efficacy tests for the measles, mumps, rubella vaccine (MMR) were faked. The document was unsealed in June, 2012.” Former Merck Scientists Sue Merck Alleging MMR Vaccine Efficacy Fraud
  • Varicella: In 2000, varicella[chickenpox] incidence declined 70% from the prevaccine rate, and “HZ [shingles] reports significantly increased among adults aged 20–69 years from 2000 to 2001. ► Children with a prior history of varicella demonstrated HZ rates similar to adults. ► By 2002, the efficacy of the varicella vaccination had declined well below 80%. ► HZ morbidity costs have exceeded the cost savings from varicella-disease reductions.” Review of the United States universal varicella vaccination program

Aluminum Adjuvants

Abstract: Aluminum vaccine adjuvants: are they safe? Curr Med Chem. 2011;18(17):2630-7.

“Aluminum is an experimentally demonstrated neurotoxin and the most commonly used vaccine adjuvant. Despite almost 90 years of widespread use of aluminum adjuvants, medical science’s understanding about their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. In spite of this, the notion that aluminum in vaccines is safe appears to be widely accepted. Experimental research, however, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. In particular, aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation and associated neurological complications and may thus have profound and widespread adverse health consequences. In our opinion, the possibility that vaccine benefits may have been overrated and the risk of potential adverse effects underestimated, has not been rigorously evaluated in the medical and scientific community.”

A few of the many Aluminum Toxicity Studies

2002 “Neurological adverse events associated with vaccination.

2007 “Neurological adverse events of immunization: experience with an aluminum adjuvanted meningococcal B. . .

2007 “Inflammation, neurodegenerative diseases, and environmental exposures.

2009 “Long-term persistence of vaccine-derived aluminum hydroxide is associated with chronic cognitive dys. . .

2009 “Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration.”

2009 “Aluminum-induced defective mitochondrial metabolism perturbs cytoskeletal dynamics in human astroc….

2011 “Aluminum toxicity and astrocyte dysfunction: a metabolic link to neurological disorders.”

2011 “Aluminum vaccine adjuvants: are they safe?

2011 “Metal ions affecting the neurological system.

2013 “Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA syndrome) in commercial sheep.

2013 How aluminum, an intracellular ROS generator promotes hepatic and neurological diseases: the metabolic. .

2014 “Aluminum-induced entropy in biological systems: implications for neurological disease.”

2014 “Are there negative CNS impacts of aluminum adjuvants used in vaccines and immunotherapy?

2014 A sudden onset of a pseudo-neurological syndrome after HPV-16/18 AS04-adjuvated vaccine:. . .

2014 “Prolonged exposure to low levels of aluminum leads to changes associated with . . .neurodegeneration.

2014 Administration of aluminium to neonatal mice in vaccine-relevant amounts is associated with adverse long. .

2014 “Oxidative stress and mitochondrial dysfunction in aluminium neurotoxicity and its amelioration: a review

2014 “Aluminum in the (CNS): toxicity in humans and animals, vaccine adjuvants, and autoimmunity.

2015: “Biopersistence and brain translocation of aluminum adjuvants of vaccines

2016:Insight into cellular fate & toxicity of aluminum adjuvants used in clinically approved human vaccinations

2016 “Behavioral abnormalities in female mice following administration of aluminum adjuvants and Gardasil.”

“Vaccine adjuvants and vaccines may induce autoimmune and inflammatory manifestations in susceptible individuals. To date most human vaccine trials utilize aluminum (Al) adjuvants as placebos despite much evidence showing that Al in vaccine-relevant exposures can be toxic to humans and animals. We sought to evaluate the effects of Al adjuvant and the HPV vaccine Gardasil versus the true placebo on behavioral and inflammatory parameters in female mice.”

2016 “Aluminum adjuvants of vaccines injected into the muscle: Normal fate, pathology and associated disease.”

“Although generally well tolerated on the short term, it has been suspected to occasionally cause delayed neurologic problems in susceptible individuals. In particular, the long-term persistence of aluminic granuloma also termed macrophagic myofasciitis is associated with chronic arthromyalgias and fatigue and cognitive dysfunction. . . .These novel insights strongly suggest that serious re-evaluation of long-term aluminum adjuvant phamacokinetics and safety should be carried out.”

Excerpt from FDA on live, attenuated vaccines

Determining the Safety and Efficacy of Vaccines to Protect Against Viruses that Infect the Central Nervous System

Principal Investigator: Steven Rubin, PhD
Office / Division / Lab: OVRR / DVP / LMD

General Overview

FDA regulators at CBER are now reviewing several live, attenuated (weakened versions of viruses) vaccines that are derived from neurotropic wild-type viruses (viruses that infect the central nervous system).

There are as yet no reliable markers (biological evidence) that can be used to determine whether such viruses have been successfully attenuated–other than the failure of the vaccine to produce obvious symptoms of disease in recipients. This problem is based on the lack of knowledge of 1) virus virulence factors (molecules that help viruses infect cells and cause disease); 2) characteristics of cells targeted by such viruses; and 3) how these viruses spread in the host. In addition, for many of these vaccines there are as yet no known markers of efficacy (measurable responses of the body that accurately signify that the vaccine is working effectively). This lack of markers of efficacy, such as a specific level of antibody, makes it difficult to interpret immune response data collected during clinical trials of these vaccines.

Our laboratory uses the mumps virus as a model to identify markers of successful virus attenuation as well as to identify markers in the blood that signify that the vaccine is providing significant protection. The present lack of sufficient knowledge in areas of mumps vaccine safety and efficacy is highlighted by the licensure of some mumps vaccines that have caused a complication called aseptic meningitis (inflammation of the membranes covering the brain and spinal cord) and the occurrence of mumps outbreaks in highly-vaccinated populations.

Problems with vaccine safety can be linked to an inadequate understanding of the infection process. Therefore, our research efforts are focused on identifying 1) cells that the virus naturally infects; and 2) mechanisms the virus uses to facilitate its spread in the infected host.

To help identify markers of vaccine efficacy, our laboratory is studying the ability of vaccine-induced antibodies to inactivate a broad range of variations of the virus obtained from different patients. Our goal is to determine the level of antibody that signifies that the immune response to the vaccine is providing protection against the virus.

We chose mumps virus as the model to study because, for the first time in over 40 years, new live attenuated mumps vaccines are being submitted to FDA for approval. Therefore, FDA regulators must understand what to test for in vaccines based on attenuated mumps virus to demonstrate that they are safe and effective. In response to these challenges, we are trying to learn more about mumps virus vaccine safety and efficacy and to apply this to other viral vaccines.

Scientific Overview

Identification of markers of virus neuroattenuation

Understanding viral pathogenesis is key to successful development of attenuated virus vaccines. In these studies we are trying to identify cell types infected following a natural route of inoculation (intranasal or intra-tracheal) in an animal model and follow the subsequent dissemination of the virus to other sites in the body, including the central nervous system. We inoculate animals via the respiratory route with recombinant mumps viruses expressing enhanced green fluorescent protein (eGFP). The viruses used for these studies include a highly attenuated mumps virus strain, a highly neurovirulent mump virus strain, and chimeric viruses consisting of mixtures of genes from these two viruses.

Disease-relevant host cells identified from the animal studies will then be used for in vitro testing to identify functional differences in the gene products (proteins) of both virulent and attenuated viruses. Our goal is to identify biomarkers of mumps virus neurovirulence, e.g., specific cellular targets of infection or functional properties of specific viral proteins, and to apply this knowledge to efforts at attenuating other neurotropic viruses, in order to facilitate the development and use of safer vaccines.

Examination of vaccine-induced protective efficacy

Over the past decade numerous mumps outbreaks have been reported in highly vaccinated populations in several countries. Widespread use of only one of the two recommended doses of vaccine was believed to be largely responsible. In 2006 the US experienced its largest mumps outbreak in 20 years. Multiple independently performed outbreak investigations found that between 70% and 99% of cases had received the recommended 2 doses of mumps-containing vaccine, indicating lower vaccine efficacy than previously estimated. While mumps was historically a disease of childhood, now mumps primarily occurs among young adults. The most likely explanations of this epidemiological change are (1) the ability of certain mumps virus strains to escape vaccine-induced immune responses, or (2) waning immunity.

To address the virus escape mutant theory, serum samples from recent vaccinees will be assessed for neutralizing antibody titer against a panel of phylogenetically distinct mumps virus strains, including an isolate from the 2006 US mumps outbreaks. The ability of serum to effectively neutralize all virus strains would argue against the virus escape mutant theory.

To address the waning theory, serum samples from individuals at 1 month to 15 years post vaccination will be assessed for neutralizing antibody titer against the vaccine virus itself as well as an isolate from the 2006 US mumps outbreaks. The anti-viral activity in serum will be assessed as a function of time post vaccination.

Finally, to identify a protective titer of mumps antibody, serum samples acquired via the CDC from a Red Cross blood drive at a university prior to a mumps outbreak will be assessed for pre-exposure mumps virus neutralizing antibody titer. The pre-exposure mumps virus neutralizing antibody titer in subjects who later developed or did not develop mumps during the outbreak will inform us of non-protective and protective levels of antibody.

Note from OAMF:

Former Merck Scientists Sue Merck Alleging MMR Vaccine Efficacy Fraud

“Stephen A. Krahling and Joan A. Wlochowski, former Merck virologists blew the whistle by filing a qui tam action lawsuit in August 2010. The scientists allege that the efficacy tests for the measles, mumps, rubella vaccine (MMR) were faked. The document was unsealed in June, 2012.”

Links to Printable PDFs

Vaccine Reform and Vaccine Facts

Aluminum Data

FDA on live attenuated Vaccines