Properly evaluating vaccine mortality

The public’s concern about adverse events, especially death, immediately or soon after vaccinations is very disruptive to vaccine uptake, leading to increased morbidity and mortality of vaccine-preventable diseases. For example, a 2009 Japanese study that showed 107 deaths following H1N1 influenza A vaccination, assumed a causality between the vaccine and the deaths without any evaluation of background rates of of deaths, which would help indicate whether there was any significance to the death rate or even if its related to the vaccination. 

Chen RT. Evaluation of vaccine safety after the events of 11 September 2001: role of cohort and case-control studies. Vaccine. 2004 May 7;22(15-16):2047-53. Review. PubMed PMID: 15121321.

Chen RT. Evaluation of vaccine safety after the events of 11 September 2001: role of cohort and case-control studies. Vaccine. 2004 May 7;22(15-16):2047-53. Review. PubMed PMID: 15121321.

It has been demonstrated that passively reported data, that is data that isn’t actively investigated by trained researchers, cannot be used to assess causality. In an active investigation, it was found that only 2 of the 107 deaths had an autopsy performed, and most of the others had other underlying diseases and conditions that were causally related to the mortality events. Furthermore, 15 million people were vaccinated with the H1N1 seasonal vaccine, and it would be expected that there would be >8000 deaths during the 20 days after vaccination using a crude mortality rate in Japan. Though it would still be a misuse of statistics, but there really is more evidence that the H1N1 vaccination lowered the death rate from 8000 to 107 post vaccination. 
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Mandatory flu vaccinations cause healthcare workers to quit–a myth

Bones fluOne of the many myths of the vaccine denialism movement is that healthcare workers will quit if there is a mandatory vaccination, usually the flu. Many of the healthcare worker vaccine deniers base their opposition to vaccines based on thoroughly debunked lies about vaccinations. Their invented opposition to vaccines is in direction contradiction to their obligation to protect the health of patients. However, more and more healthcare systems are mandating the flu vaccine for their employees.

A four-year analysis of mandatory influenza (flu) vaccinations, which are a condition of employment at Loyola University Health System in Chicago, IL, showed no statistical increase in voluntary terminations of employees. In the first year of Loyola’s mandatory policy (2009-10 flu season), 99.2% of employees received the vaccine, 0.7% (yes, 0.7%) were exempted for religious/medical reasons, and 0.1% refused vaccination and chose to terminate employment with Loyola. In 2012, the last year of the study, the vaccination uptake rate at Loyola remained steady: 98.7% were vaccinated, 1.2% were exempted and 0.06% refused vaccination.

According to Dr. Jorge Parada, study author and professor of medicine at Loyola University Chicago Stritch School of Medicine, reported that ”in reality our numbers were even better than that, of the 5 persons who refused vaccination in the mandatory period, 3 were unpaid volunteers, who later reconsidered, received vaccine and returned to Loyola. The two other persons were part-time staff, each with only 10% time commitment at Loyola…truly reflecting a 0.002 vaccine refusal rate” reports Parada. The study showed that, over the course of four years, less than 15 staff, including volunteers, out of approximately 8,000 healthcare workers in the system, chose termination over vaccination. Loyola has sustained a 99 percent compliance average since adopting the mandatory flu vaccination protocol four years ago.
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Japan Health Ministry pulls recommendation for HPV vaccination

gardasil-ad1I was going to put some snarky comment in the title like, “but wait, what about the statistics.” Because we know that this isn’t a good decision, and that the vaccine deniers will be all over it like MrAndy Wakefield’s fraudulent and retracted study claiming that vaccines cause autism. But let’s move on to what happened.

According to a English newspaper in Japan,

The health ministry decided June 14 to withdraw its recommendation for a vaccination to protect girls against cervical cancer after hundreds complained about possible side effects, including long-term pain and numbness.

The Ministry of Health, Labor and Welfare is not suspending the use of the vaccination, but it has instructed local governments not to promote the use of the medicine while studies are conducted on the matter.

So far, an estimated 3.28 million people have received the vaccination. However, 1,968 cases of possible side effects, including body pain, have been reported.

The ministry’s task force discussed 43 of those cases. However, a cause-and-effect relationship between the vaccination and the pain and numbness could not be established, so the task force members called for further studies by the ministry.

The ministry’s investigation is expected to take several months. It will then decide whether to reinstate or continue to withhold its recommendation for the vaccination.

So, the health ministry is going to withhold recommendation of the HPV vaccination because they notice 43 cases for which they couldn’t establish a causal relationship to the vaccine. In other words, 0.0013% of cases, a number so small that it’s pretty close to impossible to affix any statistical significance to it. In fact, random background “noise” (that is that some whole body pain could be expected in any random sampling of vaccinated or unvaccinated individuals) of this type of observation is as plausible as correlation (let alone causation) to the vaccine. In fact, the Health Ministry failed to provide us with data concerning the level of these side effects in the general population. Nor how soon after vaccination. Nor anything potentially useful in a scientific analysis.

What’s worse is that, according to the same article, about 2700 women in Japan die every year from HPV related cancers. So, because of complaints from the antivaccination lunatics in Japan (didn’t know they had any, but I shouldn’t be surprised), and bad statistics (43 potential cases of “body pain” out of 3,280,000 vaccinations), the Health Ministry stops recommending the vaccine. Exactly what were these people thinking?

Finally, let’s be clear here. The vaccine hasn’t been pulled from the market nor has it been outlawed; teenagers can still get the vaccine. And this was a very unusual move, since only 3 years ago, Japan’s parliament added the HPV vaccine to the mandatory schedule. Hopefully, this committee will look at the numbers from a statistical and scientific point of view and fix this stupidity.

By the way, the World Health Organization still recommends the HPV vaccine.  Because the HPV vaccine saves lives by preventing future cervical cancers. 

 

Use the Science-based Vaccine Search Engine.

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The proper definition of a skeptic-once more with feeling

conspiracyPropagandists everywhere misappropriate words to use in manners that benefit them and their agendas. For me, looking out at the natural world in a scientific manner, the most misappropriated word is skeptic (or for those of you who prefer the Queen’s English, sceptic). I previously disliked the word, actually quite a bit, because it had a negative connotation. But I’ve embraced it over the past few years, and I now get offended when it’s misused.

The problem with the word “skeptic” is that it is used differently in different circumstances, much like the word “theory” has a different meaning in a formal scientific context than it does in common vernacular. To the average person, a skeptic is  a person inclined to question or doubt all accepted opinions. In other words, this type of skeptic just doubts everything, whether or not that doubt is backed by any type of evidence. It’s not very meaningful in terms of scientific discussion, and it it carries little weight in a debate about the scientific merits of an idea or a scientific hypothesis. In ordinary usage, this type of skepticism has one of three meanings:

  1. an attitude of doubt or a disposition to incredulity either in general or toward a particular object;
  2. the doctrine that true knowledge or knowledge in a particular area is uncertain; or
  3. the method of suspended judgment, systematic doubt, or criticism that is characteristic of skeptics.
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New 13-valent pneumococcal vaccine is safe

pneumonia_355pxA recent study, published in the journal Vaccine, provided evidence that the new 13-valent pneumococcal conjugate vaccine (PCV13) is as safe as the previous version, the 7-valent pneumococcal conjugate vaccine (PCV7). The newer version of the vaccine, introduced in 2010 after clinical trials, protects against a broader range of pneumococcus (Streptococcus pneumoniaea significant human pathogenic bacterium) subtypes. These studies show that the new version did not increase  the risk for any serious adverse events related to the vaccine.

Pneumococcal disease is a serious health care issue, especially for children and adults with certain risk factors. Pneumococcal disease can lead to various serious diseases like pneumonia and bacterial meningitis, or less serious ones like otitis media. Unfortunately, pneumococcal disease can be fatal. In some cases, it can result in long-term problems, like brain damage, hearing loss, and limb loss.
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“False balanced” reporting of autism-vaccine manufactroversy

In the real world of science-based medicine, the link between autism and vaccines (particularly, the MMR vaccine for measles, mumps and rubella) has been thoroughly debunked, quashed, and discredited. In the delusional world of the vaccine denialists, the link between autism and vaccines is based on MrAndy Wakefield‘s paper alleging a connection between MMR and autism that has been retracted by the Lancet medical journal.

Then why is there even a debate about this manufactroversy (a manufactured or invented controversy)? Well, researchers actually examined this false controversy in a recently published article, by Graham Dixon and Christopher Clarke of Cornell University, in Health Education Research. They investigated how the news media and journalists try to “falsely balance” their reporting about the debunked link between vaccines and autism. The journalists create this false balance, “despite a strong medical and scientific consensus backed by rigorous epidemiological studies indicating no link between autism and vaccines.” Dixon and Clarke also state that “research suggests that journalists in the United Kingdom and United States often report this controversy by presenting claims both for and against a link in a relatively ‘balanced’ fashion. In some cases, so-called ‘falsely balanced’ reporting fails to mention which claim is supported by a scientific consensus.” An overwhelming scientific consensus, by the way.
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New Mexico removes fake religious objections from vaccine exemptions

As I discussed previously, the pendulum is swinging against the so-called “philosophical exemption” against vaccination, which allows parents to not vaccinate their children based on the “just because I don’t want to” principle. They don’t even have to support their exemption with a discussion with a healthcare worker who might explain the risks of their decision.

According to an article in the Las Cruces Sun-News, New Mexico state law says that residents can exempt their children from immunization for two reasons: 1) medical issues that might make the vaccination unsafe (often called medical exemptions) or 2) vaccinations conflict with the family’s religious beliefs (religious exemptions). Apparently, according to the article, “the New Mexico Department of Health wants to keep it that way.”
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Court says that fake religious vaccine exemptions are not protected by the First Amendment

In April, 2010, a Federal District Court in New York denied a mother’s bid for a religious exemption to New York state’s mandatory vaccination rules. According to the article in the New York Law Journal, “Martina Caviezel, a self-proclaimed pantheist, sought a preliminary injunction allowing her to enroll her 4-year-old daughter in a Great Neck, N.Y., pre-kindergarten without getting the shots the state says the child needs. Caviezel relied on Public Health Law §2164(9), which exempts children from the requirement whose parents or guardians “hold genuine and sincere religious beliefs which are contrary” to vaccination.”

Around September 2009, Caviezel submitted the New York exemption form to the school  requesting that her youngest child be exempt from the requirement that children be vaccinated against measles, mumps, rubella and other diseases. The school principal told her that her request would likely be denied. Caviezel  declined to meet with school superintendent to further discuss the exemption. She then sued after her request was denied, alleging civil rights violations.
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Religious exemptions to vaccines elevates whooping cough rates

 

©Centers for Disease Control and Prevention, 2012

©Centers for Disease Control and Prevention, 2012

According to a new study published in Pediatrics, the number of New York state parents who skipped at least one required vaccine for religious reasons has increased over the past decade. And New York counties that had this increase in religious exemptions to vaccinations also had more  whooping cough (Bordetella pertussis, or simply pertussis) cases, even among children that had been fully vaccinated.

For this study, the researchers tracked data from the New York State Department of Health on both religious exemptions and new whooping cough cases. Children were reported as having a religious exemption if they had been allowed to skip at least one required vaccine for non-medical reasons. 

The key results from the study were:

  • The overall state annual mean rate of religious exemptions increased significantly from 0.23 % in 2000 to 0.45% in 2011, almost doubling the rate over the decade.
  • The prevalence of religious exemptions varied greatly among counties with no obvious trends, although all of the counties around New York City showed large increases in religious exemptions.
  • Counties with mean religious exemption rates of >1% reported a higher incidence of pertussis. For counties with higher exemption rates, the rate of pertussis was 33 per 100,000 compared to counties with lower exemption rates, which had a pertussis infection rate of 20 per 100,000. The researchers determined that this difference was statistically significant.
  • In addition, the risk of pertussis among vaccinated children living in counties with high exemption rate increased with increase of exemption rate among exempted children, also statistically significant.

The increase in whooping cough rates is particularly troubling since unvaccinated children not only put themselves at risk, but also those who have been vaccinated (as result of the lower effectiveness of the currently available pertussis vaccine). Also, as the exemption rate increases and there is a lower than expected effectiveness of the vaccine, the herd immunity becomes weaker.
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Court decides parent’s refusal to vaccinate kids is not “free exercise of religion”

©friendlyatheist.com, 2012

©friendlyatheist.com, 2012

The US District Court for the Northern District of Ohio has ruled (pdf) that a parent’s refusal to vaccinate her children against diseases is not a “free exercise” of religion, and is tantamount to neglect.

 

In April 2010,  the Tuscarawas County (Ohio) Jobs and Family Services (TCJFS) took custody of the children of Charity and Brock Schenker as a result of a domestic violence matter between the parents. TCJFS determined that the children were “neglected and dependent” and worked out case plans for the parents which included psychiatric evaluations, drug testing and supervised visitation of their children. When TCJFS asked about the children’s immunizations, according to Secular News Daily, “Mrs. Schenker claimed she had religious objections to immunizations. The court informed her that the immunizations would be ordered.”

As a result of recommendations of court-ordered psychiatric evaluations and positive random drug tests, Mrs. Schenker (who subsequently divorced her husband) visitations were terminated, and TCJFS filed a motion for permanent custody of her children in August 2011. According to the Secular News Daily, “the county laid out as evidence a number of instances in which Schenker did not comply with orders, refused home inspections, and more. But Schenker sued with eight claims, including conspiracy claims and, most significantly, claims that her First Amendment right to free expression of religion was violated.”
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Vaccine denier claims sanitation ended diseases, not vaccines

And here we go again. Over the Memorial Day weekend, I was catching up on some reading, which sometimes leads me to reading pseudoscience claims of some random vaccine denier. In this case, it was an article that claimed that it had “irrefutable evidence” that vaccines had any impact on preventing infectious diseases. Well, I am always one to read up on “irrefutable evidence”, but it’s possible that my standard for “irrefutable evidence” is different than most others. And in fact, real science assumes that most evidence can be scientifically refuted, so it never speaks in such absolutes. So that’s hint #1 that I’m going to be disappointed.

The author of this article, Dave Mihalovic, is a naturopathic doctor (typically someone who eschews science-based medicine in favor of pseudoscience like homeopathy and acupuncture), who claims to be a “vaccine researcher.” If he’s a vaccine researcher, he has published exactly zero indexed articles about vaccines, or any other field of real medicine. In other words, his research probably means he spent a few hours on Google and thinks he’s now as smart as anyone who actually has a bachelor’s and doctoral degree in immunology, virology, biochemistry or some other biomedical science along with a decade or two research in a world class laboratory. Mihalovic is as much a vaccine researcher as I am an NBA basketball player. I can say that I play basketball. I can claim that I can dunk over LeBron James. But there’s no evidence of it, and you’d just think I was being silly. Mihalovic, of course, isn’t being silly, he thinks he’s as smart as real researchers. But let’s see what Mihalovic has to say:

A summary review of data on neurological adverse events and the historical role of vaccination in the natural course of infectious disease in Switzerland and Germany, supports data from other regions with evidence that vaccines had no impact on disease prevention efforts from the early-mid to late 20th century. The data contradicts widespread misinformation campaigns by mainstream medicine which claim that vaccination led to immunization and a subsequent decline in infectious disease. The review supports other data around the world and mounting evidence that vaccine effectiveness is unproven, unjustified and lacking evidence-based medicine.
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Comparing effectiveness of two types of pertussis vaccines

whooping-cough-cocoonOver the past year or so, there have been several outbreaks of whooping cough (Bordetella pertussis), including one that reached epidemic levels in Washington state, which has been considered one of the worst pertussis outbreaks in the USA during the past several decades. The disease lead to 18 infant deaths from whooping cough during 2012.

The original DTP vaccine (diphtheria, tetanus and pertussis) became available in the USA in 1948 and was critical to dropping the number of cases of whooping cough from 260,000  in 1934 to less than a few thousand per year in the 1990′s. The original vaccine contained what was called “whole-cell” pertussis, which includes all of the antigens of the pertussis bacterium, partially because it wasn’t understood (and to some extent still not fully understood) which antigens on the bacteria actually induce the proper immune response to have the body destroy a pertussis infection. 
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Flu during pregnancy is associated with bipolar disorder in children

pregnant-flu-vaccineA recent article published in a leading psychiatry journal, JAMA Psychiatry, has shown that pregnant mothers’ exposure to the influenza (flu) was associated with a nearly 4X increase in risk to their child eventually developing bipolar disorder in adulthood. These findings add to mounting evidence of possible shared underlying causes and illness processes with schizophrenia, which some studies have also linked to prenatal exposure to influenza. Bipolar disorder, historically called manic depressive disorder, is a mood disorder where the sufferer can experience episodes of a frenzied state known as mania (or hypomania), typically alternating with episodes of depression. It can be treated with medications and psychotherapy (especially cognitive therapy), but more difficult cases require the individual to be voluntarily or involuntarily institutionalized until the mood changes can be reduced or eliminated.

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Big Pharma supports the antivaccine movement–the real conspiracy

Expensive medicineOne of the ongoing memes, beliefs and fabrications of the vaccine deniers is somehow, somewhere, in some Big Pharma boardroom, a group of men in suits choose the next vaccine in some magical way, and foist it upon the world just to make billions of dollars. And while magically concocting the vaccine brew, these pharmaceutical execs ignore ethics and morals just to make a profit on hapless victims worldwide.

The vaccine deniers pollute the internet with their screeds about the profits of vaccines. One of them said, “measles expert Offit has already made millions of dollars profit from his ties to vaccines and the measles MMR vaccine maker Merck.” Using a childish ad hominem, the article calls him, Dr. Paul “For Profit” Offit. Seriously, that’s how you’re going to “prove” that vaccines are a Big Pharma conspiracy? 

You can find whole threads of tedious commentary about vaccine profits on any typical anti-vaccine forum. One of the more illogical claims is that “maybe vax companies see vaccines as more of an investment? Break mostly even on what the vaxes cost to make and sell, but make a bank load of money on treating all the chronic problems they cause!” Of course, that would be a business strategy that would be laughed out of the secret Big Pharma boardroom, because they know that vaccines don’t cause chronic problems. The vaccines prevent it. 
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Updated: make religious vaccine exemptions more difficult to obtain

flu church vaccineA recent report indicated that US state legislatures are beginning to pass laws that make it more difficult for parents to obtain so-called personal exemptions to vaccinations before children attend public schools. According to the author, Tara Haelle, “Each US state sets its own vaccination policies, and most will not generally allow children to attend public school unless they have been vaccinated against diphtheria, tetanus and pertussis (whooping cough)hepatitis B; the Haemophilus influenzae bacteriummeasles, mumps and rubellapolio; and varicella (chicken pox).” In general, most states require that students meet the Centers for Disease Control and Prevention schedule (pdf) for children between 0 and 6 years old, which is set by the Advisory Committee on Immunization Practices.

All states allow legitimate medical exemptions from the immunization schedule before a child enters school, because of certain medical conditions that might make vaccinations problematic for young children. Some of these medical issues are: allergies to some of the components in the vaccines, immunocompromised conditions, family history of seizures, and other issues outlined in the General Recommendations on Immunization of the Advisory Committee on Immunization Practices. These medical exemptions are extremely rare, but are very important. A licensed medical doctor is the only one that should provide this exemption.
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Consequences of not vaccinating–Report 5

A baby died in Florida from whooping cough (Bordetella pertussis) last week. According to the report, “officials said the family chose not to vaccinate their child. Some parents are choosing not to fully vaccinate their children because they worry there is a link between the vaccinations and autism.” Of course, there is no evidence that vaccines cause autism.

Let’s place the blame for this death right where it belongs, right at the feet of  MrAndy Wakefield, the de-licensed physician, who caused the drop in MMR vaccine uptake through his fraudulent claim that MMR caused autism. Wakefield is a horrible excuse for a human being, and probably should take responsibility for this and many other deaths that resulted from his fraudulent and retracted study claiming that vaccines cause autism.

Parents have a moral obligation to vaccinate their children.

We have a moral responsibility for the health of our children and this has to dominate any other belief systems we hold. Even worse, by not vaccinating children, we are putting other people’s children at risk, as well as our own. If another child dies of measles, or whooping cough, or meningitis, and was infected by our own, non-vaccinated child, are we partly responsible?

And they should start by ignoring Wakefield’s lies. Because vaccines would have saved this baby’s life.

 

Use the Science-based Vaccine Search Engine.

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Vaccines saves lives–HPV scientific evidence part 2

 

© Copyright CSL, 2013. All Rights Reserved.

© Copyright CSL, 2013. All Rights Reserved.

Human papillomavirus (HPV) is a virus from the papillomavirus family that is capable of infecting humans. Like all papillomaviruses, HPVs establish productive infections only in keratinocytes of the skin or mucous membranes, making it easily transmitted sexually or through other intimate contact. While the majority of the known types of HPV cause no symptoms in most people, some types can cause warts (verrucae)HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced analvulvarvaginal, and penile cancers. The HPV quadrivalent vaccine, also known as Gardasil (or Silgard in Europe), is marketed by Merck. The vaccine prevents the transmission of certain types of HPV, specifically types 6, 11, 16 and 18

 

 

 

 

 

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Waterloo, Ontario deals with unvaccinated students

The Waterloo Region (an area of southern Ontario, Canada) health department is responsible for the enforcement of a new law (pdf) that requires parents to provide immunization records for their children by 7 May 2013. And according to the CBC, over 1700 high school students received suspensions notices, hand delivered by school principles, this week unless their vaccination records are updated by 7 May.

Of course, the department of health allows medical exemptions for vaccinations, along with the unconscionable religious and personal exemptions to getting children vaccinated. Can’t win them all, but at least this part of Canada is attempting to deal with unvaccinated students by making them provide the records. 

Vaccines save lives.

Use the Science-based Vaccine Search Engine.

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Vaccination myths and facts from the World Health Organization

© Copyright World Health Organization (WHO), 2013. All Rights Reserved.

© Copyright World Health Organization (WHO), 2013. All Rights Reserved.

For those of you who track these things, this past week is World Immunization Week, an annual awareness campaign for immunizations worldwide sponsored by the World Health Organization. As part of of their efforts to increase awareness of the need to vaccinate worldwide, they put together an online question and answer session last week in an attempt to debunk some of the myths surrounding vaccinations. In other words, some of the greatest minds in worldwide healthcare issues, including infectious diseases and vaccinations, answered and debunked some of the craziest myths about vaccines across the world.

 

 

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Consequences of not vaccinating–Report 4, meningitis and education

college_meningitisThis is the fourth in a series of reports about actual consequences from not vaccinating against infectious diseases. The reports are all based on verifiable reports from health agencies and/or articles published in high impact peer-reviewed journals. 

Bacterial meningitis is a usually severe inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. While most people with meningitis recover, it can cause serious complications, such as brain damage, hearing loss, or learning disabilities. For example, in the United States, about 4,100 cases of bacterial meningitis, including 500 deaths, occurred each year between 2003–2007.

There are several pathogens that can cause bacterial meningitis including Haemophilus influenzae (most often caused by type b, often called Hib), Streptococcus pneumoniae, group B StreptococcusListeria monocytogenes, and Neisseria meningitides. Depending on the pathogen, bacterial meningitis is highly contagious, especially among groups that are in enclosed areas such as schools, college dormitories and other such situations. There are other types of meningitis, viral, fungal, parasitic and non-infectious, but they are significantly different than bacterial meningitis, about which is the focus of this article.
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