The state Department of Health Services (DHS) is promulgating a rule which would require an additional vaccine for school students entering the seventh grade, but the agency is facing pushback from a state lawmaker and an advocacy group for parental choice after DHS shut down a required public hearing after only an hour, denying dozens the right to speak.
Among other things, the revised rule would require students entering the seventh grade to get a meningitis vaccine, as well as a booster for students entering the 12th grade.
According to DHS, bacterial meningitis is a serious but vaccine-preventable disease, and the Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices has recommended that the vaccine be administered at the 11-12 year old health care visit, along with other routine vaccinations such as Tdap.
The rule, DHS 144, would do just that, along with other vaccine policy changes. Those changes include moving the Tdap vaccine from sixth to seventh grade and adding Varicella (chicken pox) as a part of its definition of a substantial outbreak.
Some opponents of the rule say the vaccine's effectiveness has not been scientifically demonstrated, and the vaccine has led to thousands of vaccine injuries nationwide and to hundreds in Wisconsin.
More immediately, say both state Rep. Chuck Wichgers (R-Muskego) and the group Wisconsin United for Freedom (WUF), the agency has not given those who disagree with the rule a fair hearing. Both Wichgers and WUF have called for a second hearing.
Wichgers, who attended the hearing, said citizens were cut off from petitioning the government and there appeared to be an element of partisanship on the issue.
"I attended the hearing and witnessed the agency's efforts to stifle discussion," Wichgers said. "A number of Wisconsinites who had wished to speak were sent away, unfortunately some of those citizens traveled three or four hours and were abruptly dismissed. People were only given two minutes to speak and at the two-minute mark, the microphone was literally ripped from the hands of a person testifying."
The hearing went exactly 60 minutes and then the hearing was immediately shut down, Wichgers said.
"I shared my concerns regarding the lack of openness and lack of public input during the hearing," he said. "However, my opinion, like so many attending the hearing, left us with a feeling of indifference by the members of DHS. One of the fundamentals of good government is the ability for citizens to petition their government. A second principal is that of recourse - neither offered by this state agency."
In addition, Wichgers added, DHS began the hearing by taking testimony from those attending by Skype rather than those who traveled long distances to speak. And while the people who participated via Skype spoke, the lawmaker said they could not be heard because of technical difficulties.
What's more, Wichgers said, addressing those technical difficulties wasted valuable time for everyone in the room. Accordingly, Wichgers called for a second hearing.
Wisconsin United for Freedom (WUF) also requested a second hearing.
"A second hearing is needed because the public was not given adequate time to express their concerns," Amber Psket, a co-founder of WUF, said in a statement to The Times. "While written comment was also accepted, people drove for hours to speak and were denied the opportunity. Also, DHS was well aware of the public interest in this particular hearing and because of that we feel better accommodations should have been made. The public called and emailed DHS prior to the hearing to inquire on several things."
However, Psket said, DHS has refused the request for another hearing.
On its Facebook page, WUF said the agency had stacked the deck of the rule-making process.
"This rule-making process had an advisory committee which consisted of all medical organizations and not one parent," the Facebook post stated. "With parents being the largest stakeholders that would be affected by this change it is only fitting the parents should be consulted prior to rule making."
Reasons for the addition
The DHS said it was promulgating the rule for several reasons.
"This provision will ease the burden on families, providers, and schools by ensuring that both meningococcal and Tdap vaccines are administered at the same visit and the same grade level," the agency stated in its statement of scope for the rule.
DHS also proposed a booster dose for students entering 12th grade, according to CDC recommendations. The CDC says the booster dose gives teens continued protection during the ages when they are at highest risk.
"This will help to ensure students are fully vaccinated prior to leaving school," the agency stated.
The CDC stresses the seriousness of bacterial meningitis.
"Bacterial meningitis is very serious and can be deadly," the CDC states. "Death can occur in as little as a few hours. Most people recover from meningitis. However, permanent disabilities (such as brain damage, hearing loss, and learning disabilities) can result from the infection."
DHS also points to other states. Illinois, Iowa, Michigan, and Minnesota all require students to get a meningitis vaccination, the agency states.
The requirements in Wisconsin would take effect for the 2021-22 school year.
The changes, including the imposition of the meningitis vaccine, were backed by the Wisconsin Medical Society, which said in testimony the revisions would bring Wisconsin's immunization requirements and guidelines in line with those recommended by the CDC and the Advisory Committee on Immunization Practices.
"Overall, the changes proposed by DHS are modest revisions that bring the state's requirements in line with both national and regional practices," WMS stated on its website. "The Society unequivocally supports these updates as the immunizations called out by the regulation are effective evidence-based treatments necessary to ensure the health and well-being of Wisconsin's students."
In its testimony, the WMS said immunizations contribute enormous benefits to overall public health, and that WMS takes an active role in promoting them.
"It also promotes the participation of its members in immunization efforts in conjunction with local, state, and federal government agencies and other private service organizations," the group stated. "Additionally, the Society supports efforts to overcome immunization hesitancy brought about by misinformation, and also advocates for utilizing government funds to purchase and administer vaccines at no cost to those in need."
The WMS said it supported Wisconsin's immunization schedule for infants and preschoolers as well as making vaccination rates of public and private schools publicly available, and it also supports and promotes routine immunization for children while encouraging physicians to promote the adolescent immunization schedule.
Lastly, the WMS emphasized, the group opposes philosophic, moral, and personal belief exemptions from state vaccine requirements.
WUF: Choice, safety, evidence
Wisconsin United for Freedom sees it much differently. Its members have concerns not only about the specific vaccine mandates of DHS rule 144, but about the larger issue of parental choice and the ability to make decisions about their children's health care.
"I think parental choice is important, period," Psket told The Times. "I know my child better than anyone and if I feel that something is a danger to them I should be able to do my best to protect them. Vaccines are a medical procedure that carry serious risks. They are not safe and effective for everyone."
In fact, Psket said, there is a compensation plan set up by the government (funded by taxpayers), the National Vaccine Injury Compensation Program, that to date has paid out over $4 billion for vaccine injury and death.
In a paper developed for the DHS hearing, WUF cited multiple reasons why the meningitis vaccine should not be a mandatory vaccine for students in DHS rule 144.
First, the group states, meningococcal disease is extremely rare. Indeed, according to the CDC's 2017 data, there were only 350 cases (0.11 per 100,000 people) and 45 deaths. In Wisconsin, there were four cases of meningococcal disease. Of those, WUF points out, only one case was attributed to a serogroup found within the proposed vaccine.
"The last noted epidemic of meningococcal disease occurred in 1943-1944," the group states in its hearing points. "In 1943, there were 18,223 reported cases of meningococcal disease, however, by 1950, the disease rate had significantly decreased with only 3,788 reported cases. The vaccine is not responsible for reduction of disease rates."
From 1998 to 2007 and prior to the introduction of four major meningococcal conjugate vaccines, WUF continued, meningococcal disease rates continued to decrease. By 2007, there were 1,077 reported cases of meningococcal disease, down significantly from the 2,725 cases reported in 1998, and disease rates dropped from 0.92 cases per 100,000 population in 1998 to only 0.33 cases per 100,000 population by 2007.
"Researchers reported that while they could not offer any explanation for the significant decrease in the number of cases of meningococcal disease, they acknowledged that the newly licensed meningococcal conjugate vaccine was not responsible for the reduction in disease rates," WUF stated.
Indeed, in "Changes in Neisseria meningitidis Disease Epidemiology in the United States, 1998-2007," published in Clinical Infectious Diseases, researchers concluded, "Before the introduction of the quadrivalent meningococcal conjugate vaccine, the incidence of meningococcal disease in the United States decreased to a historic low."
In addition, the hearing points state, meningococcal disease is not spread through casual contact.
"It is not highly contagious," WUF stated. "Meningococcal disease is not easily spread. People do not catch the disease through casual contact. Transmission of the disease requires one to be susceptible to the disease and to have direct close and lengthy contact, such as kissing or sharing a toothbrush, with a person who is colonizing the bacteria."
Then, too, WUF states, the effectiveness of the vaccine wanes rather quickly.
"The CDC estimates five years after vaccination, it is only 50% effective," the hearing points state. "The booster dose recommendation was made in 2010 after studies noted that only 50% of adolescents vaccinated at age 11-12 had sufficient vaccine acquired antibodies to protect them against meningococcal disease five years post-vaccination."
What's more, the talking points continued, the booster shot at age 16 does not cover meningococcal group B, which accounts for over a third of all cases in 16-23 year olds. Finally, the group states, while meningococcal vaccines may provide protection to vaccinated individuals, they do not offer herd immunity.
"According to the CDC, the meningitis vaccine has not been proven effective, and has not been tested against placebos, and clinical effectiveness has not been determined," WUF states. "Therefore mandatory use of this vaccine in all Wisconsin schoolchildren cannot be justified."
There are two Meningococcal conjugate or MenACWY vaccines available, Menactra and Menveo, and WUF says neither have been proven safe or effective.
"In the spring of 2005, when the CDC's Advisory Committee on Immunization Practices (ACIP) voted that all 11-12 year olds be administered (Menactra), it acknowledged that immunogenicity data was not sufficient enough to determine the vaccine's effectiveness," WUF stated. "... While the committee recommended that Menactra be administered at the same time as the newly licensed Tdap vaccine, no clinical trials had examined whether administering both vaccines simultaneously would be effective or even safe."
Menveo received FDA approval in 2010 based on safety and immunogenicity studies reporting the vaccine to be non-inferior to Menactra.
"As with Menactra vaccine, no vaccine efficacy studies had ever been completed nor had any studies determined whether or not the vaccine could reduce or eliminate nasopharyngeal carriage," the hearing points state.
On the other side of the safety coin, WUF states, the meningococcal vaccine has caused severe side effects, including death.
"As of April 30, there have been more than 32,408 reports of meningococcal vaccine reactions, hospitalizations, injuries and deaths following meningococcal vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 186 related deaths, 3,267 hospitalizations, and 461 related disabilities," the hearing points state. "Such injuries greatly outpace incidence of this disease."
In Wisconsin, as of April 30, there have been 462 reports of meningococcal vaccine reactions.
"Since 1998 to April 2019 the federal Vaccine Adverse Event Reporting System (VAERS) has received 21 Wisconsin reports of serious meningococcal vaccine reactions," the hearing points state. "Of these serious reports, 10 were life threatening; 15 required hospitalization with two requiring prolonged hospitalization; three reported permanent disability; and three deaths were reported."
The deaths were reported to be related to meningococcal disease from strains covered within the vaccine received, WUF stated. What's more, the hearing points state, the VAERS database is a passive reporting system and is estimated by HHS to capture only 1% of vaccine injuries and deaths.
According to the CDC, as many as 50% of individuals receiving meningococcal vaccines targeting meningococcal serogroups A, C, Y, and W-135 (Menactra or Menveo) experience mild side effects such as pain or redness at the injection site and a small number also report joint pain and muscle aches following vaccination.
Additionally, the hearing points points continue, the CDC warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, severe pain and limited mobility to the vaccinated limb, and even serious injury and death.
The hearing points cited a 2017 published study of Menveo vaccine by researchers who examined adverse reaction reports submitted to the Vaccine Adverse Events Reporting System (VAERS) between 2010 and 2015, which found that medical conditions following vaccination included Guillain-Barre syndrome, facial nerve palsy, seizures, intracranial hypertension, acute disseminated encephalomyelitis, migraine, headache, hypotonia/motor delay, neuromyopathy, anaphylaxis, allergic reactions, myocarditis and pericarditis, appendicitis, viral meningitis, streptococcal pneumonia, and others.
In a 2012 study by the Institute of Medicine (IOM) evaluating the adverse effects of vaccines, the IOM could not reject or support a causal relationship between meningococcal vaccine and the reported adverse event, due either to an absence of methodologically sound published studies or too few quality studies to make a determination, the hearing points asserted.
But, as the hearing points state, the IOM committee did conclude that the scientific evidence "convincingly supports" a causal relationship between anaphylaxis and meningococcal vaccine.
Finally, the hearing points assert, the meningitis vaccine has not been tested or proven to be safe in combination with other vaccines. According to one study, persons receiving Menveo concomitantly with HPV, Tdap and influenza vaccines are at greater risk for developing Bell's palsy within 84 days of vaccination.
All the evidence points against mandating the meningitis vaccine, the talking points conclude.
"While parents may choose to vaccinate their child against meningococcal disease, given the low prevalence and non-contagiousness of meningitis, as well as the lack of safety, lack of efficacy of this vaccine, and increased risk when this shot is given at the same time as other vaccines, a mandate for meningitis is neither warranted nor advisable," the talking points state. "Mandating this vaccination is not supported by valid research and data."
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