Category Archives: vaccines

Gardasil Information

Centers for Disease Control Gardasil reporting, here

A Homeopathic Perspective, here

Gardasil Human Papillomavirus (HPV) Vaccine

On June 8, 2006, the FDA licensed Gardasil®, the first vaccine developed to prevent cervical cancer caused by certain kinds of human papillomavirus (HPV). Since then, more than 12 million doses of Gardasil vaccine have been distributed. In 2006, a total of 2,151,000 doses were distributed and in 2007, another 11,317,902. At this time, the U.S. does not have a national registry for immunization and vaccination and therefore cannot report the total number of people who have received Gardasil.

The FDA has licensed the vaccine as safe and effective. This vaccine has been tested in thousands of females (9 to 26 years of age) around the world. These studies have shown no serious side effects. The most common side effect is brief soreness at the injection site. CDC, working with the FDA, will continue to monitor the safety of the vaccine after it is in general use.

CBS News story, here

Age for HPV vaccination.
Harper DM, Paavonen J.

Dartmouth College, Department of Women’s and Gender Studies, Obstetrics and Gynecology, Community and Family Medicine, Hanover, NH, USA. Diane.M.Harper@Dartmouth.edu

HPV vaccination of pre-pubescent girls will be effective for many girls. Vaccinating girls and women older than 12 years of age may accelerate the reduction in cervical cancer rates. Currently HPV vaccines are effective for at least 5 years in the prevention of HPV 16 and 18 associated precancerous lesions however the duration of vaccine protection is unknown. The need for booster shots must therefore be addressed with patients as unknown. Continued cervical cancer screening is necessary regardless of vaccination. Vaccination alone will not eliminate cervical cancer.

Vaccine. 2008 Mar 14;26 Suppl 1:A7-11

EMEA Statement On The Safety Of Gardasil, Europe

Article Date: 25 Jan 2008

The European Medicines Agency (EMEA) has received reports of deaths in women who had previously received Gardasil, including two reports concerning the sudden and unexpected deaths of two young women in the European Union (EU). Gardasil is a vaccine approved in the EU for the prevention of cervical cancer and other diseases caused by human papillomavirus (HPV) types 6, 11, 16 and 18. It is estimated that about 1.5 million patients have been vaccinated with this HPV vaccine in Europe.

The two European cases were reported as part of the continuous monitoring of the safety of medicines. One of the cases occurred in Austria and the other in Germany. In both cases, the cause of death could not be identified. No causal relationship has been established between the deaths of the young women and the administration of Gardasil.

On the basis of the currently available evidence, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) is of the opinion that the benefits of Gardasil continue to outweigh its risks and that no changes to its product information are necessary.

The EMEA will continue to closely monitor the safety of Gardasil and take appropriate actions should new information emerge that has an impact on the benefit-risk profile of Gardasil.

Notes:

1. The approved indication in the EU for Gardasil is: “Gardasil is a vaccine for the prevention of high-grade cervical dysplasia (CIN 2/3), cervical carcinoma, high-grade vulvar dysplastic lesions (VIN 2/3), and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil should be in accordance with official recommendations.” For more information on Gardasil, please see here.

2. HPV types 6, 11, 16 and 18 vaccine is also marketed in the EU as Silgard. For more information on Silgard, please see here.

The Gardasil Vaccination, A Study in Tragedy?

The info posted below is from this young lady’s blog. In an attempt to pass the word about what she is currently dealing with. Visit her blog (here), medical professionals should check it out also and of course teens, young women and their mothers.

Her blog has additional information on other cases in where Gardasil is implicated. We can keep her in our prayers.

Welcome to the Family Blog for Jenny.

Jenny is a 14 year-old girl who lives in Northern California.

Over the last year, she has gone from being a fully healthy 13 year-old to being nearly completely paralyzed. She retains movement only in her neck and mouth and faintly in her left hand.This rapid decline in motor ability has understandably shocked and concerned us [her family]. We have responded by working with the best doctors in the field, fighting continuously to reach a diagnosis and find treatments.

Despite the best efforts of an extremely talented array of medical professionals, we have not been able to stop her decline. Doctors don’t know for sure why Jenny got so sick but some think it may be connected to the Gardasil vaccinations she got (last one in March, 2007) and the weakening that seemed to start in spring and gradually built up. One sign was in April 2007 when everyone in her PE class laughed at her because she couldn’t jump a hurdle they considered really puny. It is hard to say when the weakening started but by summer she had a terrible limp.

One of the major things that would help her doctors figure out what to do is to find other people like Jenny (called “comparables”)–people that share her medical condition and perhaps have had luck with certain treatments.

We are creating this blog to aid us in our search for comparables. If you think you may know a comparable, we urge you to check out the comparable traits in the sidebar and email us at jenjensfamily@gmail.com. Even if you do not know a comparable, feel free to leave a comment of support or link to any information you think might be helpful for us.

CDC Reports, More Kids Fainting After Shots

CDC on Thursday recommended that health-care providers observe young patients after vaccination, following a spike in the number of syncope, or fainting, reports in recent years.

According to CDC, at least 463 people fainted after getting immunized over an 18-month period from 2005 to 2007. While such fainting is not uncommon and is not in itself dangerous, some of the youngsters fell and hit their heads on the floor. At least one had a car accident, CDC said, and a 15-year-old boy died after striking his head.

Cases of syncope have risen as new vaccines, notably those against human papillomavirus (HPV) and meningitis (MCV4), have become routine among adolescents and teens. US infants and very young children receive a battery of vaccinations, but immunizations for older children and teenagers were not common until recently.

“A girl aged 13 years fainted within 10 minutes of receiving HPV and MCV4 vaccinations,” reported CDC. “She fell backward and hit her head on the carpeted floor of the clinic.” Though the girl had a fractured skull and bleeding on the brain, she eventually recovered.

“Providers should strongly consider observing patients for 15 minutes after they are vaccinated,” CDC urged.

The report, “Syncope After Vaccination, United States, January 2005-July 2007,” was published in CDC’s Morbidity and Mortality Weekly Report (2008;57(17):457-460).

Influenza Vaccine in Infants Younger Than 6 Months of Age

This study, see below, assesses the need for infants less than 6 months old to receive influenza vaccine. The study is funded, designed and carried out by a vaccine manufacturer. Bias could be construed in the entire study.

There is on going discussion of how allergic reactions continue to rise in the population. Overuse of antibiotics is seen as a contributing factor (mind you, they were once hailed as ‘wonder drugs’), could the indiscriminate use of vaccines also be a contributing factor? The entire human race has lived without the need of vaccines at birth and throughout life at least since recorded history. Young children used to get sick and there is evidence it made them healthier. Mumps, measles, chicken pox were for the most part lived through. The body developed immunity against the ailment and life went on. Now, it is seen as a constant source of fear and on going threat. Why?
Here is the ‘study’ why healthy infants need influenza vaccine:

Safety and Tolerability of Cold-Adapted Influenza Vaccine, Trivalent, in Infants Younger Than 6 Months of Age

Timo Vesikari, MDa, Aino Karvonen, MDa, Helen M. Smith, BScb, Andrew Dunning, PhDc, Ahmad Razmpour, PhDc, Melanie K. Saville, MB, BSb, William C. Gruber, MDc and Bruce D. Forrest, MDc a Vaccine Research Center, University of Tampere Medical School, Tampere, Finland
b Wyeth Vaccines Research, Taplow, United Kingdom
c Wyeth Vaccines Research, Pearl River, New York

OBJECTIVE. Young children are at high risk for influenza-related complications. Vaccination of close household contacts is recommended to provide indirect protection to children <6 months of age. Studies have shown that live, cold-adapted influenza vaccine, trivalent, is efficacious in children. To assess the risks associated with inadvertent exposure of infants to vaccine viruses from vaccinated contacts, this study was designed to evaluate the safety and tolerability of cold-adapted influenza vaccine, trivalent, administered intranasally to healthy children 6 to <24 weeks of age.

METHODS. Healthy infants aged 6 to <16 weeks and 16 to <24 weeks, respectively, were randomly assigned to receive 2 doses of influenza vaccine, or placebo intranasally 35 ± 7 days apart. Reactogenicity events were monitored for 11 days after each dose. Other adverse events were monitored through 28 to 35 days after dose 2.

RESULTS. Of the infants aged 6 to <16 weeks, 31 received influenza vaccine and 28 received placebo, and of those aged 16 to <24 weeks, 30 received influenza vaccine and 31 received placebo. In the 6- to <16-week cohort, more influenza vaccine, recipients experienced irritability (66.7% vs 35.7%) and runny nose or nasal congestion (63.3% vs 33.3%) after dose 1 but not dose 2. There were no significant increases in any other reactogenicity events or adverse events in the vaccine recipients compared with the placebo group.

CONCLUSIONS. Although there was an increase in mild reactogenicity events in children 6 to <16 weeks of age, cold-adapted influenza vaccine, trivalent, was generally well tolerated in infants 6 to <24 weeks of age. These findings support further evaluation of cold-adapted influenza vaccine, trivalent, in infants <6 months of age.

HPV vaccine mandates

Viruses are not the cause per se of cervical cancer. There has to be exposure to the virus and their has to a susceptibility to it. Their are many factors involved and by changing those inputs (behavior, diet,nutrition, life focus, spiritual focus of an individual, teaching wise choices vs. risky behaviors, etc.) outcomes can be changed. There are healthier approaches beyond vaccination.

A Research Study

HPV vaccine mandates: just say ‘no’ to the “great big public health experiment”

While many states are seriously considering requiring vaccination of pre-teen girls as a condition of middle school admission, the case for mandatory human papillomavirus (HPV) vaccine is very weak. Such a requirement lacks the traditional justification for vaccine mandates and therefore represents an unjustified usurpation of parental authority. Moreover, serious questions remain as to whether the vaccine is effective in preventing cervical cancer. The vaccine is the most expensive pediatric vaccine in history. Given the uncertainties surrounding the vaccine, Missouri lawmakers and taxpayers should reject this expensive and intrusive “public health experiment”.

Washington University School of Medicine, St. Louis, USA. Bob.Onder@house.mo.gov

Vaccines – Flu Shots and Mercury Content

A law went into effect on April 1, 2006 that changed the amount of mercury allowed in vaccines for certain groups.

After April 1, it is illegal for children under three and knowingly pregnant women to receive vaccines with more than a trace amount of mercury (one microgram of mercury per 0.5 milliliter dose, according to the FDA).

The mercury found in some multi-dose vials of vaccine is commonly called “thimerosal,” and is used as a preservative for the vaccine. In the 1990s, thimerosal was removed from all vaccines, except for multi-dose vials of influenza and Td.

Within the Vaccines for Children Program, the only vaccines containing thimerosal are:

  • Multi-dose vials of Henry Schein Td Vaccine (for adults only)
  • Multi-dose vials of Fluzone (Influenza vaccine)
  • Multi-dose vials of Fluvirin (Influenza vaccine)
  • Discover your state laws on this issue, click here.
  • American Teenage Girls, One in Four May Have an Sexually Transmitted Disease

    “What we found is alarming,” Dr. Sara Forhan, from the U.S. Centers for Disease Control and Prevention, said during a teleconference Tuesday. “One in four female adolescents in the U.S. has at least one of the four most common STDs that affects women.”"These numbers translate into 3.2 million young women nationwide who are infected with an STD,” Forhan said. “This means that far too many young women are at risk of the serious health effects of untreated STDs, including infertility and cervical cancer.”

    These common STDs include human papillomavirus (HPV), chlamydia, herpes simplex virus and trichomoniasis, Forhan said.

    Forhan announced the results as part of the CDC’s 2008 National STD Prevention Conference, in Chicago.

    “These findings are really giving us a lot of pause about how we provide care to adolescent girls who are sexually active,” said Dr. Elizabeth Alderman, an adolescent medicine specialist at Children’s Hospital at Montefiore in New York City and chairperson of the Executive Committee of the Section of Adolescent Health of the American Academy of Pediatrics. “The numbers are really astonishing.”

    Forhan noted that most of the burden of STDs falls on young African-American women. “Among African-American teenagers, about one in two were affected compared to one in five white teens,” she said.

    In terms of the racial disparity, “it’s what we’ve always seen, which is very unfortunate,” Alderman said.

    In the study, Forhan’s team collected data on 838 girls aged 14 to 19 who took part in the 2003-2004 National Health and Nutrition Examination Survey. The study did not include syphilis, gonorrhea or HIV, as earlier studies found very low prevalence of these diseases in this age group.

    HPV and chlamydia are the most common STDs found among teenage girls, Forhan said. “Almost one in five overall had a strain of HPV associated with cervical cancer or genital warts,” she said.

    “We need to be screening adolescent girls who are sexually active and providing them with HPV vaccine,” Alderman said. “The recommendations are to screen sexually active girls, but many girls don’t disclose to their health-care provider that they are sexually active, even when asked,” she said.

    As for chlamydia, 4 percent of teenaged girls had this STD, Forhan said. “The majority of chlamydia infections do not have symptoms. If left untreated, it can lead to pelvic inflammatory disease, which leaves these young women at risk for atopic pregnancy, chronic pelvic pain or infertility,” she said.

    In addition, the study found that 2.9 percent of young women had trichomoniasis, and 2 percent were infected with genital herpes, Forhan said.

    According to Forhan, about 50 percent of the teens reported having sex, and the prevalence of STDs in this group was 40 percent. “Even for young women with only one reported lifetime sexual partner, one in five had an STD,” she noted.

    “If you choose to be sexually active, you need to protect yourself and be screened for these infections,” Alderman said. “And all girls between the ages of 11 and 26 should get vaccinated for HPV.”

    Among women with an STD, 15 percent had more than one infection, Forhan added.

    “These data provide a clearest picture to date of the overall burden of STDs in adolescent women in the United States,” Forhan said. “The study also underscores the importance of addressing racial disparities in STD rates among young women.”

    Race itself is not a risk factor for STDs, Forhan said. However, factors such as limited access to health care, poverty, community prevalence of STDs, and misperceptions about individual risk are some of the reasons that STD rates are particularly high among African-Americans, she said.

    Comments:

    The female population in the United States ages 0-19 is estimated to be 40,328,895. This sample consisted of slightly over 800 girls. Who were they? What is their way of life? Based on this sample, it is recommended to vaccinate all girls. There are less risky ways to foster the health (if that is the goal) of young girls.

    Autism Vaccine Case – Be Informed

    JusticeFULL TEXT: AUTISM VACCINE CASE

     

    IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS

    CHILD, a minor, by her Parents and Natural Guardians, MOM & DAD,

    Petitioners,

    v.

    SECRETARY OF HEALTH AND HUMAN SERVICES,

    Respondent.

    RESPONDENT’S RULE 4(c) REPORT
    In accordance with RCFC, Appendix B, Vaccine Rule 4(c), the Secretary of Health and
    Human Services submits the following response to the petition for compensation filed in this
    case.

    FACTS
    CHILD (“CHILD”) was born on December –, 1998, and weighed eight pounds, ten ounces. Petitioners’ Exhibit (“Pet. Ex.”) 54 at 13. The pregnancy was complicated by gestational diabetes. Id. at 13. CHILD received her first Hepatitis B immunization on December 27, 1998. Pet. Ex. 31 at 2.

    From January 26, 1999 through June 28, 1999, CHILD visited the Pediatric Center, in Catonsville, Maryland, for well-child examinations and minor complaints, including fever and eczema. Pet. Ex. 31 at 5-10, 19. During this time period, she received the following pediatric vaccinations, without incident:

    Vaccine Dates Administered
    Hep B 12/27/98; 1/26/99
    IPV 3/12/99; 4/27/99
    Hib 3/12/99; 4/27/99; 6/28/99
    DTaP 3/12/99; 4/27/99; 6/28/99

    Id. at 2.

    At seven months of age, CHILD was diagnosed with bilateral otitis media. Pet. Ex. 31 at 20. In the subsequent months between July 1999 and January 2000, she had frequent bouts of otitis media, which doctors treated with multiple antibiotics. Pet. Ex. 2 at 4. On December 3,1999, CHILD was seen by Karl Diehn, M.D., at Ear, Nose, and Throat Associates of the Greater Baltimore Medical Center (“ENT Associates”). Pet. Ex. 31 at 44. Dr. Diehn recommend that CHILD receive PE tubes for her “recurrent otitis media and serious otitis.” Id. CHILD received PE tubes in January 2000. Pet. Ex. 24 at 7. Due to CHILD’s otitis media, her mother did not allow CHILD to receive the standard 12 and 15 month childhood immunizations. Pet. Ex. 2 at 4.

    According to the medical records, CHILD consistently met her developmental milestones during the first eighteen months of her life. The record of an October 5, 1999 visit to the Pediatric Center notes that CHILD was mimicking sounds, crawling, and sitting. Pet. Ex. 31 at 9. The record of her 12-month pediatric examination notes that she was using the words “Mom” and “Dad,” pulling herself up, and cruising. Id. at 10.

    At a July 19, 2000 pediatric visit, the pediatrician observed that CHILD “spoke well” and was “alert and active.” Pet. Ex. 31 at 11. CHILD’s mother reported that CHILD had regular bowel movements and slept through the night. Id. At the July 19, 2000 examination, CHILD received five vaccinations – DTaP, Hib, MMR, Varivax, and IPV. Id. at 2, 11.

    According to her mother’s affidavit, CHILD developed a fever of 102.3 degrees two days after her immunizations and was lethargic, irritable, and cried for long periods of time. Pet. Ex. 2 at 6. She exhibited intermittent, high-pitched screaming and a decreased response to stimuli. Id. MOM spoke with the pediatrician, who told her that CHILD was having a normal reaction to her immunizations. Id. According to CHILD’s mother, this behavior continued over the next ten days, and CHILD also began to arch her back when she cried. Id.

    On July 31, 2000, CHILD presented to the Pediatric Center with a 101-102 degree temperature, a diminished appetite, and small red dots on her chest. Pet. Ex. 31 at 28. The nurse practitioner recorded that CHILD was extremely irritable and inconsolable. Id. She was diagnosed with a post-varicella vaccination rash. Id. at 29.

    Two months later, on September 26, 2000, CHILD returned to the Pediatric Center with a temperature of 102 degrees, diarrhea, nasal discharge, a reduced appetite, and pulling at her left ear. Id. at 29. Two days later, on September 28, 2000, CHILD was again seen at the Pediatric Center because her diarrhea continued, she was congested, and her mother reported that CHILD was crying during urination. Id. at 32. On November 1, 2000, CHILD received bilateral PE tubes. Id. at 38. On November 13, 2000, a physician at ENT Associates noted that CHILD was “obviously hearing better” and her audiogram was normal. Id. at 38. On November 27, 2000, CHILD was seen at the Pediatric Center with complaints of diarrhea, vomiting, diminished energy, fever, and a rash on her cheek. Id. at 33. At a follow-up visit, on December 14, 2000, the doctor noted that CHILD had a possible speech delay. Id.

    CHILD was evaluated at the Howard County Infants and Toddlers Program, on November 17, 2000, and November 28, 2000, due to concerns about her language development. Pet. Ex. 19 at 2, 7. The assessment team observed deficits in CHILD’s communication and social development. Id. at 6. CHILD’s mother reported that CHILD had become less responsive to verbal direction in the previous four months and had lost some language skills. Id. At 2.

    On December 21, 2000, CHILD returned to ENT Associates because of an obstruction in her right ear and fussiness. Pet. Ex. 31 at 39. Dr. Grace Matesic identified a middle ear effusion and recorded that CHILD was having some balance issues and not progressing with her speech. Id. On December 27, 2000, CHILD visited ENT Associates, where Dr. Grace Matesic observed that CHILD’s left PE tube was obstructed with crust. Pet. Ex. 14 at 6. The tube was replaced on January 17, 2001. Id.

    Dr. Andrew Zimmerman, a pediatric neurologist, evaluated CHILD at the Kennedy Krieger Children’s Hospital Neurology Clinic (“Krieger Institute”), on February 8, 2001. Pet. Ex. 25 at 1. Dr. Zimmerman reported that after CHILD’s immunizations of July 19, 2000, an “encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness.” Id. He noted a disruption in CHILD’s sleep patterns, persistent screaming and arching, the development of pica to foreign objects, and loose stools. Id. Dr. Zimmerman observed that CHILD watched the fluorescent lights repeatedly during the examination and would not make eye contact. Id. He diagnosed CHILD with “regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development.” Id. At 2. Dr. Zimmerman ordered genetic testing, a magnetic resonance imaging test (“MRI”), and an electroencephalogram (“EEG”). Id.

    Dr. Zimmerman referred CHILD to the Krieger Institute’s Occupational Therapy Clinic and the Center for Autism and Related Disorders (“CARDS”). Pet. Ex. 25 at 40. She was evaluated at the Occupational Therapy Clinic by Stacey Merenstein, OTR/L, on February 23, 2001. Id. The evaluation report summarized that CHILD had deficits in “many areas of sensory processing which decrease[d] her ability to interpret sensory input and influence[d] her motor performance as a result.” Id. at 45. CHILD was evaluated by Alice Kau and Kelley Duff, on May 16, 2001, at CARDS. Pet. Ex. 25 at 17. The clinicians concluded that CHILD was developmentally delayed and demonstrated features of autistic disorder. Id. at 22.

    CHILD returned to Dr. Zimmerman, on May 17, 2001, for a follow-up consultation. Pet. Ex. 25 at 4. An overnight EEG, performed on April 6, 2001, showed no seizure discharges. Id. at 16. An MRI, performed on March 14, 2001, was normal. Pet. Ex. 24 at 16. A G-band test revealed a normal karyotype. Pet. Ex. 25 at 16. Laboratory studies, however, strongly indicated an underlying mitochondrial disorder. Id. at 4.

    Dr. Zimmerman referred CHILD for a neurogenetics consultation to evaluate her abnormal metabolic test results. Pet. Ex. 25 at 8. CHILD met with Dr. Richard Kelley, a specialist in neurogenetics, on May 22, 2001, at the Krieger Institute. Id. In his assessment, Dr. Kelley affirmed that CHILD’s history and lab results were consistent with “an etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression.” Id. at 7. He continued to note that children with biochemical profiles similar to CHILD’s develop normally until sometime between the first and second year of life when their metabolic pattern becomes apparent, at which time they developmentally regress. Id. Dr. Kelley described this condition as “mitochondrial PPD.” Id.

    On October 4, 2001, Dr. John Schoffner, at Horizon Molecular Medicine in Norcross, Georgia, examined CHILD to assess whether her clinical manifestations were related to a defect in cellular energetics. Pet. Ex. 16 at 26. After reviewing her history, Dr. Schoffner agreed that the previous metabolic testing was “suggestive of a defect in cellular energetics.” Id. Dr. Schoffner recommended a muscle biopsy, genetic testing, metabolic testing, and cell culture based testing. Id. at 36. A CSF organic acids test, on January 8, 2002, displayed an increased lactate to pyruvate ratio of 28,1 which can be seen in disorders of mitochondrial oxidative phosphorylation. Id. at 22. A muscle biopsy test for oxidative phosphorylation disease revealed abnormal results for Type One and Three. Id. at 3. The most prominent findings were scattered atrophic myofibers that were mostly type one oxidative phosphorylation dependent myofibers, mild increase in lipid in selected myofibers, and occasional myofiber with reduced cytochrome c oxidase activity. Id. at 7. After reviewing these laboratory results, Dr. Schoffner diagnosed CHILD with oxidative phosphorylation disease. Id. at 3. In February 2004, a mitochondrial DNA (“mtDNA”) point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C). Id. at 11.

    CHILD returned to the Krieger Institute, on July 7, 2004, for a follow-up evaluation with Dr. Zimmerman. Pet. Ex. 57 at 9. He reported CHILD “had done very well” with treatment for a mitochondrial dysfunction. Dr. Zimmerman concluded that CHILD would continue to require services in speech, occupational, physical, and behavioral therapy. Id.

    On April 14, 2006, CHILD was brought by ambulance to Athens Regional Hospital and developed a tonic seizure en route. Pet. Ex. 10 at 38. An EEG showed diffuse slowing. Id. At 40. She was diagnosed with having experienced a prolonged complex partial seizure and transferred to Scottish Rite Hospital. Id. at 39, 44. She experienced no more seizures while at Scottish Rite Hospital and was discharged on the medications Trileptal and Diastal. Id. at 44. A follow-up MRI of the brain, on June 16, 2006, was normal with evidence of a left mastoiditis manifested by distortion of the air cells. Id. at 36. An EEG, performed on August 15, 2006, showed “rhythmic epileptiform discharges in the right temporal region and then focal slowing during a witnessed clinical seizure.” Id. At 37. CHILD continues to suffer from a seizure disorder.

    ANALYSIS
    Medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC) have reviewed the facts of this case, as presented by the petition, medical records, and affidavits. After a thorough review, DVIC has concluded that compensation is appropriate in this case.

    In sum, DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder. Therefore, respondent recommends that compensation be awarded to petitioners in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii).

    DVIC has concluded that CHILD’s complex partial seizure disorder, with an onset of almost six years after her July 19, 2000 vaccinations, is not related to a vaccine-injury.

    Respectfully submitted,

    PETER D. KEISLER
    Assistant Attorney General

    TIMOTHY P. GARREN
    Director
    Torts Branch, Civil Division

    MARK W. ROGERS
    Deputy Director
    Torts Branch, Civil Division

    VINCENT J. MATANOSKI
    Assistant Director
    Torts Branch, Civil Division

    s/ Linda S. Renzi by s/ Lynn E. Ricciardella
    LINDA S. RENZI
    Senior Trial Counsel
    Torts Branch, Civil Division
    U.S. Department of Justice
    P.O. Box 146
    Benjamin Franklin Station
    Washington, D.C. 20044
    (202) 616-4133
    DATE: November 9, 2007

    Vaccines After Age 50: Another Point of View

    Vaccines, Depression and Neurodegeneration After Age 50: Another Reason to Avoid the Recommended Vaccines.By Russell L. Blaylock, M.D., CCN

    It has been estimated that 14.8 million Americans suffer from major depressive disorder and of this number 6 million are elderly. If we include anxiety disorders, which commonly accompany depression, the number jumps to 40 million adults. At a cost of $44 billon dollars a year just for care of the seniors, this impacts the national budget as well. Depression later in life tends to last longer and be more severe than at younger ages. It is also associated with a high rate of suicide.

    Previously, it was thought that major depression was secondary to a deficiency in certain neurotransmitters in the brain, particularly the monoamines, which include serotonin, norepinephrine and dopamine. While alterations in these important mood-related neurotransmitters is found with major depression, growing evidence indicates that the primary culprit is low-grade, chronic brain inflammation. In addition, we now know that inflammatory cytokines can lower serotonin significantly and for long periods by a number of different mechanisms.

    Researchers have also discovered that most people with major depressive disease (MDD) have higher levels of the neurotransmitter glutamate in their spinal fluid (CSF) and blood plasma. This is the same glutamate found as a food additive-for example, MSG (monosodium glutamate), hydrolyzed proteins, calcium or sodium casienate, soy protein isolate, vegetable protein concentrate or isolate, etc. Much of the free glutamate in the brain of depressed people comes from within, that is it escapes from special cells within the brain itself (microglia and astrocytes). Free glutamate, that is, existing outside the neurons, is very toxic to brain connections and brain cells themselves — mainly by a process called excitotoxicity.

    This connection between high brain glutamate levels and major depression was discovered quite by accident, when researchers observed that the anesthetic drug ketamine could relieve depression for a prolonged period. Ketamine is a powerful blocking drug for a class of glutamate receptors (NMDA receptors).

    For quite some time it was known that depression could cause a loss of neurons in the hippocampus of the brain-the area most important for recent memory (declarative memory or working memory), the form of memory most affected in Alzheimer’s disease. This shrinkage of the brain usually occurred with long-term depression, yet it was shown, using sophisticated testing, that even without brain shrinkage, memory could be adversely affected. Some antidepressants could not only reverse the memory loss but could reverse the shrinkage as well.

    The implication was that the elevated brain glutamate, via excitotoxicity, was destroying brain connections and later killing brain cells in the hippocampus and that the antidepressants were lowering brain glutamate levels. Subsequent studies have confirmed that drugs that block excitotoxicity also reduce depression and that some antidepressants reduce brain glutamate levels.

    The Link Between Elevated Brain Glutamate and Inflammation

    A tremendous amount of research has now demonstrated the link between chronic low-level brain inflammation, elevated brain glutamate levels and major depression. We know that as we age, the level of inflammatory immune cytokines increase (such as interleukin-1ß (IL-1), IL-6 and TNF-a). That is, the level of inflammation in our body increases, with high levels being seen at the extremes of life — the 80s and 90s.

    This progressive elevation in the body’s inflammation increases our risk of a number of inflammation-linked diseases, such as cancer, arthritis, muscle weakness, fatigue, sleep disturbances, memory loss and confusion. People with Alzheimer’s and Parkinson’s disease have even higher levels of these inflammatory cytokines — much higher.

    When inflammatory chemicals are elevated in the brain it makes brain cells more vulnerable to a number of toxins, many of which are in the environment. One study demonstrated, using a series of sophisticated techniques, that if brain cells were exposed to low levels of a pesticide there was little toxicity seen and that if you exposed these same brain cells to an immune stimulant alone, little damage occurred. But if you first exposed the brain cells to the immune stimulant, the same low dose of pesticide could destroy a great number of brain cells.

    The importance of this observation was that the vaccine made the brain cells hypersensitive to the toxin so that even in concentrations that normally would do not cause harm, could wiped out most of the neurons. One of the strongest connections between an environmental toxin (pesticides) and a neurological disorder is with Parkinson’s disease. The reason it is more common in the elderly is that they have the highest levels of inflammatory cytokines. This also explains the high incidence of Alzheimer’s disease, which reaches incidences of 50% after age 80.

    The link depression was also by accident. Doctors using immune cytokines to treat patients with cancer or hepatitis found that one third of the patients developed major depressive illness within days of the treatment and that it resolved only when the treatment was terminated. Other studies, in which inflammatory cytokine levels were measured in people with major depressive illness, also found most had high levels of these inflammatory chemicals.

    To their surprise, they found that many of the antidepressant medications commonly used lowered inflammatory cytokines levels and that patients who failed to respond had the highest level of the cytokines.

    So, how is this linked to excitotoxicity? Neuroscientists have known for some time that inflammatory cytokines cause the brain to release higher levels of glutamate — the more intense the inflammation, the higher the brain glutamate level. The highest levels are found in the prefrontal lobes and limbic system, the areas most related to mood control. MSG also increases brain inflammation.

    Vaccination and Brain Inflammation

    A great number of studies have shown that when you vaccinate an animal, the body’s inflammatory cytokines not only increase dramatically, but so do the brain’s inflammatory chemicals. The brain has its own immune system that is intimately connected to the body’s immune system. The main immune cell in the brain is called a microglia. Normally, these brain cells are lying throughout the brain in a resting state (called ramified). Once activated, they can move around, traveling between brain cells like amoeba (called amoeboid microglia).

    In the resting state, they release chemicals that support the growth and protection of brain cells and their connections (dendrites and synapses). But when activated, they secrete a number of very harmful chemicals, including inflammatory cytokines, chemokines, complement, free radicals, lipid peroxidation products, and two excitotoxins — glutamate and quinolinic acid.

    In essence, these brain immune cells are out to kill invaders, since the body’s immune system sent an emergency message that an invasion had occurred. With most infections, this phase of activation last no more than a few days to two weeks, during which time the immune system successfully kills off the invaders. Once that is accomplished, the immune system shuts down to allow things to cool off and the brain to repair what damage was done by its own immune system.

    What researchers knew was that during this period of activation, people generally feel bad and that what they experience closely resembles depression — a condition called “sickness behavior”. Most of us have experience this when suffering from a viral illness — such things as restlessness, irritability, a need to get away from people, trouble sleeping, fatigue and difficulty thinking.

    Studies have shown that there are two phases to this “sickness behavior”; one in which we have the flu-like symptoms and a later onset of depression-like symptoms that can last awhile. They have also shown that all of these symptoms are due to high levels of inflammatory cytokines in the brain, which come from activated microglia.

    A number of studies have also shown that after age 50, people have exaggerated and prolonged “sickness behavior”, much more so than younger people. This is one of the reasons why many elderly hang onto flu symptoms for months after exposure.

    There is also another immune phenomenon that plays a major role in vaccine-related brain injury. Researchers discovered that when you vaccinate an animal, the brain microglia immune cells turn on partially (called priming), that is, they are in a state of high readiness. If the immune system is activated again soon after (days, weeks to months), these microglia explode into action secreting levels of their destructive chemicals far higher than normal. This overreaction can be very destructive and make you feel very depressed.

    Stimulating the immune system with a vaccine is far different than contracting an infectious illness naturally. Vaccines are made of two components — the agent you wish to vaccinate against — for example, the measles virus; and an immune system booster called an immune adjuvant. These adjuvants are composed of such things as aluminum compounds, MSG, lipid compounds and even mercury. Their job is to make the immune system react as intensely as possible and for as long as possible.

    Studies have shown that these adjuvants, from a single vaccine, can cause immune overactivation for as long as two years. This means that the brain microglia remain active as well, continuously pouring out destructive chemicals. In fact, one study found that a single injection of an immune activating substance could cause brain immune overactivation for over a year. This is very destructive.

    Flu Vaccines and An Expanding Vaccine Schedule for the Elderly

    Public health authorities and physician societies are in an all out campaign to have every elderly person vaccinated every year with the flu vaccine as well as a growing number of newer vaccines. When I was practicing neurosurgery, the hospitals had an automatic written order on all older patients’ charts mandating a flu vaccine, unless it was countermanded by the physician, which I always did. Now, they are giving the shots in malls, tents and every available site they can muster. And worse still, using lies and scare tactics to frighten the elderly onto getting the shots (such as the bold lie of 36,000 elderly dying of the flu every year).

    As you age your immune system, including that special immune system in your brain, releases significantly more inflammatory immune cytokines than when you were younger. This serves to prime the microglia, as discussed. So, when you get your first flu shot your microglia overreact and does so for a very long period — perhaps years. Many elderly report that the flu shot gave them the flu. Proponents of vaccines, retort with a condescending laugh, that it is impossible because the flu vaccine contains killed flu viruses. In truth, what these people are reporting is a prolonged, intense “sickness behavior” response to the vaccine. To the body, it is worse than getting the flu. Remember, no one is recording the number of elderly who die after getting the flu shot, especially if they die months later, which can happen with sickness behavior, especially if they have a preexisting chronic illness or are infirm.

    Here is the shocking truth. With the elderly already having increased inflammatory cytokine levels both systemically and in their brain, stimulating these primed microglia so that a chronic overstimulation of the brain’s immune system is triggered, will not only increase their risk of developing one of the neurodegenerative diseases, but will also substantially increase their risk of developing major depression. Remember, this also increases their risk of suicide and even homicide dramatically.

    Anxiety is a major problem with depression, and vaccinations will greatly worsen the condition. In fact, vaccination, especially multiple vaccinations, will maintain the brain in a state of inflammation that will be self-perpetuating, because the excess release of glutamate in the brain, as well as glutamate in the diet, will further enhance microglial activation and excitotoxicity.

    Those who are prone to developing one of the neurodegenerative diseases, such as Alzheimer’s disease or Parkinson’s disease will be at a drastically increased risk as we have seen experimentally when even animals exposed to subtoxic concentrations of environmental toxins and vaccinated develop neurologic worsening.

    Most people use pesticides in their home and studies have shown that the concentrations in homes are sufficient to trigger Parkinson’s disease in susceptible people. Vaccinations, as these studies have shown, will greatly increase risk. Most doctors are completely unaware of this important research.

    You must keep in mind that “health authorities” urge the elderly to get the flu vaccine each and every year. This will keep the microglia in a primed and even activated state continuously. Recently, neurologists announced that the incidence of neurodegenerative disease had been grossly underestimated and that neurological diseases of aging were increasing at a frightening rate. They have no explanation. Over the last three decades the number of elderly receiving yearly flu vaccines has risen from 20% before 1980 to over 60% today.

    If this were not depressing enough, now the public health authorities and medical specialty societies are adding a whole new set of vaccines for those above 50 years of age, including the pneumococcal and meningiococcal vaccines. What is being completely ignored by the promoters of these vaccines is the effect of multiple doses of immune adjuvant that accompany each of these vaccines.

    Lets, say you see your doctor and he talks you into getting the flu vaccine, the pneumococcal and meningiococcal vaccine all during the same office visit. That way, he can save you extra office visits. What your doctor ignores is that he is giving you three doses of powerful immune adjuvant all in one sitting, which means that your body and brain are assaulted by a massive dose of powerful immune activators, which have been proven to activate the brain’s immune system to dangerous levels, even when given as a single dose. Proof of this mechanism exists not only in animal studies, but in humans as well.

    Mercury and Aluminum

    There are other ways that vaccines can cause havoc in the brain. Most vaccines contain aluminum compounds. A multitude of studies have shown that aluminum, especially if combined with fluoride, is a powerful brain toxin and that it accumulates in the brain. With each vaccine injection, a dose of aluminum is given. These yearly aluminum inoculations accumulate not only at the site of the injection, but travel to the brain, where it enters neurons and glial cells (astrocytes and microglia). A number of studies have shown that aluminum can activate microglia and do so for long periods. This means that the aluminum in your vaccination is priming your microglia to overreact. The next vaccine acts to trigger the enhanced inflammatory reaction and release of the excitotoxins, glutamate and quinolinic acid.

    You must also appreciate that any infection, stroke, head injury or other toxin exposure will also magnify this inflammatory brain reaction initially triggered by your vaccines. Studies have now indicated that the more one’s immune system is activated the more like he or she will suffer from one of the neurodegenerative diseases.

    Mercury is also a powerful activator of brain microglia and can do so in extremely low concentrations-in nanomolar amounts. Because of its numerous reactions with sulfhydral compounds in the body (which are ubiquitous), mercury can poison a number of enzymes both systemically and in the brain. Of special concern is the ability of mercury, especially ethylmercury (the kind found in vaccines called thimerosal) to inhibit the regulation of brain glutamate levels. (It does this by inhibiting the glutamate transfer proteins that control the removal of glutamate from outside the neuron, where it does its harm.)

    In essence, mercury, in the concentrations being injected with vaccines, triggers excitotoxicity, increases brain free radicals and lipid peroxidation products, inhibits critical brain enzymes, inhibits antioxidant enzymes and impairs DNA repair ability. The flu vaccine contains enough mercury to do all of these things. You must keep in mind that each flu vaccine adds to the mercury supplied by your last vaccine, that is, it is progressively accumulating in your brain.

    In addition, the aluminum in the vaccines also primes microglia and when combined with mercury is infinitively more toxic to the brain. Now, if this is not enough, we also have to consider the contamination of vaccines with foreign viruses and viral components. Studies have shown that this is not a rare occurrence, with up to 60% of vaccines being contaminated in one study of several major manufactured vaccines. When confronted with this fact, vaccine proponents just shrug their shoulders and say — “We don’t think these things are harmful.”

    Yet, the studies say otherwise. It has been found that insertion of viral fragments, not even the whole virus, is sufficient to trigger the brain’s microglial system and subsequent excitotoxicity, leading to progressive brain degeneration. This is accepted to be the mechanism by which the HIV virus causes dementia in a great number of AIDS victims. Fragments of the virus (gp140 and Tat) are engulfed by the microglia and this triggers chronic brain inflammation and excitotoxicity. The herpes virus and measles virus can do the same thing.

    Danger of Live Virus Vaccines

    A number of studies have shown that live viruses used in vaccines can enter the brain and reside there for a lifetime. One such study, in which autopsied elderly were examined for the presence of the measles virus, found that 20% of the brains had live measles viruses and 45% of other organs were infected. These viruses were highly mutated, meaning that they could be just as potent as other measles viruses, but could be even more virulent. Worse, is that in most cases they cause a smoldering destruction of tissues without the obvious symptoms of infection, which has been shown in a number of studies.

    Live virus vaccines are made using a process to attenuate the pathogenic or disease-causing virus by passing it through a series of cultures. The problem is that the reverse can also happen within the body. A number of studies have shown that when we produce free radicals in our body (and we produce tons of such radicals over a lifetime), it mutates the viruses residing in our tissues. This is what was found in the autopsy study I referred to above.

    Likewise, these viruses can trigger brain inflammation and degeneration, which has been shown in a number of studies-that is, there exist a chronic degeneration of the brain over years or decades. Because it is so far separated from the time of the original vaccine, physicians just attribute it to old age or heredity, anything but the vaccines.

    Virologists are also concerned that such mutated live viruses can also infect other people, leading to outbreaks of disease totally unsuspected by health authorities.

    Conclusion

    Current recommendations by the CDC for adult vaccinations include a total of 14 separate inoculations with infectious agents and powerful immune adjuvants. To be fair, some of these are for special medical risks and conditions, such as high-risk behaviors, illegal drug use and HIV infected individuals. If we eliminate these, women will be exposed to 10 inoculations and men 7, should they follow CDC guidelines, which doctors follow.

    According to CDC recommendations, multiple vaccinations for a single disease are separated by no more than 4 weeks, which is close enough together to produce priming and subsequent hyperactivation of brain microglia. We have seen that this can trigger a smoldering process of brain inflammation and excitotoxicity that can not only result in depression, anxiety and high suicide rates, but can increase one’s risk of developing one of the neurodegenerative diseases as well.

    We have also seen that in many cases a person will be injected with several vaccines during a single office visit and that this means their body is exposed to a very large dose of immune adjuvant. Compelling studies, using many animal species as well as humans, have shown that this overactivates brain inflammatory mechanism that can last for years.

    In addition, several additives to vaccines, such as mercury and aluminum, are powerful brain toxins that are known to accumulate in the brain over years and can trigger brain inflammatory/excitotoxic mechanisms. Vaccine contaminants, such as bacteria, mycoplasma and viral fragments can also produce prolonged brain inflammation and neurodegeneration.

    Because the elderly already have high levels of inflammatory cytokines, they are at a special risk. The very young (babies and small children) are at a high risk because their brains are undergoing the most rapid development at the very time they receive the greatest number of vaccinations — the first two years of life. In fact, they receive 22 vaccines during the first year of life, one of which contains a full pediatric dose of mercury. Like adults, they receive many inoculations (up to 9 inoculations) in one office visit. This is insane and in my estimation, criminal.

    Nasal flu vaccines are even worse, because they introduce a live virus into the nasal passages, which can then travel along the olfactory nerves, which leads to the very part of the brain first and most severely affected by Alzheimer’s disease. A number of studies have shown that viruses and bacteria can pass along this route to the brain. In fact, in one study scientists sprayed a bacterium into the nose of mice and observed a rapid development of Alzheimer’s type plaques in the mouse’s brain.

    So, what should older people do? First, studies have shown that the primary cause of immune deficiency in the elderly is purely dietary. The carotenoids, such as beta-carotene, alpha-carotene, canthaxanthin, lutein and lycopene significantly enhance the immunity of the elderly. Zinc, magnesium and selenium are also essential. One should also avoid omega-6 oils (the vegetable oils-corn, safflower, sunflower, canola, soybean and peanut oils), since they greatly enhance inflammation and depress immunity. The EPA component of fish oils (omega-3 oils) is also a powerful immune suppressant. DHA is not. A healthy immune system means that you can fight infections efficiently and rapidly.

    Regular exercise, such as brisk walking or weight exercises three to five times a week also boost immunity, while extreme exercise suppresses immunity. Sugar and refined carbohydrates also suppress immunity and inflame the brain. Exercise protects the brain from aging effects and from degeneration.

    Adequate sleep is also vital to both brain health and good immune function. Pubic health officials and spokesmen for the major medical societies are lying to the public concerning vaccine safety. We now possess sufficient information from a great number of studies to halt this disastrous vaccine policy. We are facing a medial disaster in this country, which is already well on its way.

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