Heather White

www.autismrawdata.net

June 27, 2013 Eric Lipman Administrative Law Judge Ofce of Administrative Hearings 600 North Robert Street P.O. Box 64620 Saint Paul, Minnesota 55164-0620 T 651 361-7842 F 651 361-7936 rulecomments.oah@ead.state.mn.us Judge Eric Lipman, I urge you to oppose the Minnesota Department of Healths decision to add the meningococcal meningitis (Neisseria Meningitidis) to the recommended pediatric vaccination schedule. The meningitis vaccine mandate is not necessary, the current vaccines are expensive ($125.00), have questionable effectiveness and there are outstanding safety questions surrounding the use of this specic vaccine. Here are the 12 points that argue against this mandate; 1. The Meningitis Vaccine Mandate Is Unnecessary Information about the disease and vaccine can be made available to every parent. The Minnesota Department of Health have and could continue to provide such information. There is ample access to these vaccines if parental concerns warrants the consent to said injections. 2. Invasive Meningococcal Disease Is Extraordinarily Rare, Deaths Exceedingly Rare There is not enough cases of meningitis to make the vaccine cost-effective. Looking at the available statistics from the Minnesota Department of Health regarding the cases and deaths attributed to Neisseria meningitidis we nd in the year 2010 there were nine cases mainly affecting persons over the age of 20 and one death from an infant (Minnesota Department of Health, pg 30). Under careful investigation of the available statistics the cases per 100,000 persons is 0.17, which is at a 10 year low. The cases and deaths documented by the Minnesota Department of Health do not show if these patients had any underlying pathology that exacerbated the disease pathology. 3. The Meningococcal Vaccine is Not Cost Effective. In determining whether a given vaccine program can be cost-effective, the factors that need to be considered are: (a) The disease must be common and have a signicant mortality rate, this disease is not. (b) The estimated number of disease cases prevented; the vaccine must be highly effective providing true disease protection to more than 90% of those inoculated for their lifetime. This vaccines has not proven this type of effectiveness according to the available data (further described below).

(c) The serious adverse reactions (death, permanent disability and life-threatening events) caused by the vaccine must be signicantly rarer than those caused by the disease before the vaccine approval and the other vaccination-associated costs (e.g., emergency room visits, hospitalizations and extended hospitalizations) must be sufciently low so that there population costs are some small fraction of the population administration costs and , collectively, are much less then the costs associated with the disease in the absence of any effective vaccine. All of these points are consistently ignored when mandates such as this are implemented to a broad population. 4. Most Students Are Already Naturally Protected Without Vaccination. According to a peer-review study in The New England Journal of Medicine, Colonization induces an immunologic response to N. Meningitides (as do certain organism in the enteric ora that have crossreacting antigens), so that by young adulthood, the majority of people in the United States have measurable antibody to the pathogenic serogroups of N. Meningitides (A, B, C, Y, and W-135) (Gardner, 2006). We need to ask are we trading the natural herd immunity our population has achieved for inferior vaccine acquired immunity that does not last. 5. The Meningococcal Vaccination Program Could Make Some Bacterial Strains More Deadly. Like with excessive antibiotic use, we just might be creating a nightmare scenario for meningococcal organisms to mutate into more lethal vaccine resistant bugs that will have all of us highly susceptible to invasive meningococcal infection and wishing we had taken the precautionary principle much more seriously. 6. Meningitis Is Not Casually Contagious According to the CDC; Fortunately, none of the bacteria that cause meningitis are as contagious as things like the common cold or the u. Also, the bacteria are not spread by casual contact of by simply breathing the air where a person with meningitis has been (CDC, n.d.). 7. Current Meningitis Vaccines Are Not Proven Effective According to a peer-review study in The New England Journal of Medicine, A major limitation of these vaccines is that neither provides immunity against serogroup B, which is responsible for approximately one third of cases of meningococcal disease (Gardner, 2006). This study was written prior to the creation of the Menveo vaccine which also does not prevent serogroup B infections. Please refer to the manufactures product insert; MENVEO dose not prevent N. Meningitidis serogroup B infections (MENVEO, 2010). According to the Menomune vaccine package insert; No studies have been conducted to evaluate the efcacy of meningococcal polysaccharide vaccines against disease due to serogroups Y and W-135 (Menomune, 1981). Further in April a Wisconsin-Madision senior died of bacterial meningitis and was documented as receiving the booster vaccine shortly before (Herzog, 2013). 8. Questionable Duration Of Protection According to the Menveo vaccine package insert; The duration of protection following immunization is not known (MENVEO, 2010).

9. The Vaccine Manufactures Advise Pregnant Women Caution and Discouragement When Considering Injection Of Their Products. So prior to administration of the Meningitis vaccine all childbearing females should be required to undergo lab conrmed pregnancy tests thereby increasing costs. 10. Safety Question Raised By Current Meningitis Vaccines Acknowledged serious side effects for all three current meningitis vaccines carry warning of GuillainBarre Syndrome, a serious and devastating neurological disease. According to the passive reporting system being our governments Vaccine Adverse-Event Reporting System (VAERS) there have been in a ve year period these associated adverse events with one meningococcal vaccine (MENACTRA); 20 Deaths 49 Permanent disability 98 Life Threatening Injuries 4,190 Not Serious Injuries 307 Hospitalizations 19 Extended Hospitalizations 2,412 Emergency Room Visits The CDC states that in January 14, 2005, through September 30, 2011, VAERS received 8,592 reports involving receipt of MenACWY-D in the United States; 89.0% reports involved persons aged 11 through 19 years (CDC, 2013). Balance that with the disease effects. According to the CDC; During 2005-2011, an estimated 800-1,200 cases of meningococcal disease occurred annually in the United States, representing an incidence of 0.3 cases per 100,000 population (CDC, 2013). 11. Incomplete Safety Testing All three current meningitis vaccines have not been evaluated for carcinogenic or mutagenic potential. Two (Menactra and Menomune) of the three have not been evaluated for impairment of fertility. The third current meningitis vaccine, Menveo is not tested regarding the impairment of male fertility according to the manufacturer; MENVEO has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility (MENVEO, 2010). 12. No Liability or Accountability For Vaccine Manufacturers February 2011, The Supreme Court took away the peoples right to sue the pharmaceutical industry or medical professionals for vaccine injury. Justice Sotomayer led a dissenting opinion in which Ginsburg, J. joined. Justice Kagan took no part in the consideration or decision of the case (Bruesewitz v. Wyeth, 2011). For the rst time in history product manufacturers are not accountable for product failure. Further it is these manufactures that are producing all the safety analysis for said products without any oversight from any independent scientic organization.

In closing the most prudent plan is to educate the parents and let them choose based on all available data what is best for their children. I strongly oppose the Minnesota Department of Healths decision to add the meningococcal meningitis (Neisseria Meningitidis) to the recommended pediatric vaccination schedule. Sincerely yours,

Heather White

References Bruesewitz v. Wyeth. (2011). SCOTUSblog. Retrieved from http://www.scotusblog.com/case-les/cases/ bruesewitz-v-wyeth/ CDC. (n.d.). Bacterial Meningitis. Retrieved from http://www.cdc.gov/meningitis/bacterial.html CDC. (2013). Prevention and control of meningococcal disease: recommendations of the advisory committee on immunization practices (ACIP). Retrieved from http://www.cdc.gov/mmwr/preview/ mmwrhtml/rr6202a1.htm Gardner, P . (2006). Prevention of Meningococcal Disease. N Engl J Med. Retrieved from https:// secure.muhealth.org/~ed/students/articles/NEJM_355_p1466.pdf Herzog, K. (2013). UW-Madison student who died of meningitis had vaccine booster. JSOnline. Retrieved from http://www.jsonline.com/blogs/news/202752191.html Menomune. (1981). Sano Pasteur. Retrieved from https://www.vaccineshoppe.com/image.cfm? doc_id=10447&image_type=product_pdf MENVEO. (2010). Highlights of Prescribing Information. Retrieved from http://www.fda.gov/downloads/ BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM201349.pdf Minnesota Department of Health. (n.d.). Incidence of Invasive Neisseria meningitidis Disease, Minnesota, 2000-2010. Retrieved from http://www.health.state.mn.us/divs/idepc/dtopics/invbacterial/nmen.pdf