“The case-fatality ratio of meningococcal disease is 10% to 15%, even with appropriate antibiotic therapy. The case-fatality ratio of meningococcemia is up to 40%. As many as 20% of survivors have permanent sequelae, such as hearing loss, neurologic damage, or loss of a limb.”
Epidemiology of Vaccine Preventable Diseases (PinkBook)
Of course, that doesn’t stop anti-vaccine folks from spreading misinformation about these vaccines to try and scare parents away from vaccinating and protecting their kids.
Is the Meningococcal Vaccine More Dangerous Than Meningococcal Disease?
And there are different types of meningococcal vaccines, including those that protect against Neisseria meningitidis serogroups A, C, W, Y and Men B.
So routine vaccinations likely prevent up to 500 meningitis deaths each year, just in the United States, including many deaths from Hib meningitis, pneumococcal meningitis, and meningococcal disease.
“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.”
Epidemiology of Vaccine Preventable Diseases (PinkBook)
What about the idea that 1 in 100 people will have a serious reaction to the vaccine?
“The most frequently reported adverse events for MenACWY-D include fever (16.8%), headache (16.0%) injection site erythema (14.6%), and dizziness (13.4%). Syncope was reported in 10.0% of reports involving MenACWY-D. Of all reported MenACWY-D events, 6.6% were coded as serious (i.e., resulted in death, life-threatening illness, hospitalization, prolongation of hospitalization, or permanent disability). Serious events included headache, fever, vomiting, and nausea. A total of 24 deaths (0.3%) were reported.”
Epidemiology of Vaccine Preventable Diseases (PinkBook)
The serious events listed above were from the clinical trials for the vaccine and didn’t differ between the vaccine and placebo.
Although meningococcal vaccines can have frequent mild side effects, they very rarely have serious side effects.
Here is another meningococcal study in which a few of the participants died – one in a car accident and the other a drug overdose.
Unfortunately, vaccines can’t protect you from everything…
Like a few other vaccines, Gardasil underwent Fast Track approval by the FDA.
“This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults.”
Jesse Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research
But that doesn’t mean that any corners were cut in getting it quickly approved or that the vaccine isn’t safe.
Vaccine Fast Tracking
The Fast Track process can help get new drugs and vaccines approved more quickly by the FDA because they have:
more frequent meetings with the FDA to discuss the drug’s development plan and to help ensure the collection of appropriate data needed to support drug approval
more frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers
eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
a Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
In very simple terms, it is kind of like having a VIP pass at an amusement park. It gets you a guide and helps you jump to the front of many of the lines, but you still don’t get to operate the rides yourself.
Others that have Fast Track designation include vaccines for anthrax (NuThrax anthrax vaccine adsorbed with CPG 7909 adjuvant), chikungunya, Clostridium difficile (Clostridium difficile toxoid vaccine), malaria, RSV, Zika, Ebola, Invasive Staphylococcus aureus infections in surgical populations, Shigella (Flexyn2a), and Lyme disease. None are approved yet though.
And that all of these vaccines have Fast Track designation is a good reminder that it isn’t a guarantee of approval.
“With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.”
Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century
It just puts them on a Fast Track to get approved if they meet all of the FDA requirements for safety and efficacy.
The ability to develop and approve new vaccines quickly is also important as we continue to face new emerging disease threats. Faced with a deadly global pandemic, everyone will be glad that we have the ability to Fast Track vaccines and other drugs.
Specifically, there is a risk for severe infections from the Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis bacteria.
Fortunately, there are vaccines that protect against many subtypes of these bacteria, including:
Hib – protects against Haemophilus influenzae type B
Meningococcal conjugate vaccines – Menactra or Menveo, which protect against 4 common types of the Neisseria meningitidis bacteria – serogroups ACWY
Serogroup B Meningococcal vaccines – Bexsero or Trunemba, which protect against Neisseria meningitidis serogroup B
Prevnar 13 – protects against 13 subtypes of Streptococcus pneumoniae
Pneumovax 23 – protects against 23 subtypes of Streptococcus pneumoniae
Although Prevnar, Hib, and the meningococcal vaccines (Menactra or Menveo and Bexsero or Trunemba) are part of the routine immunization schedule, there are additional recommendations that can change the timing for when kids get them if they have asplenia.
According to the latest recommendations, in addition to all of the other routine immunizations that they should get according to schedule, children with asplenia should get:
one dose of the Hib vaccine if they are older than age 5 years “who are asplenic or who are scheduled for an elective splenectomy” and have not already vaccinated against Hib. Unvaccinated younger kids should get caught up as soon as possible. In general though, Hib is given according to the standard immunization schedule. This recommendation is about kids who are behind on the shot.
two doses of a meningococcal conjugate vaccine, either Menactra or Menveo, two months apart once a child with asplenia is at least two years old and a booster dose every five years. Infants with asplenia can instead get a primary series of Menveo at 2, 4, 6, and 12 months, with a first booster dose after three years, and a second booster after another five years. Older infants can get Menactra at 9 and 12 months, again, with a first booster dose after three years, and a second booster after another five years. While these vaccines are recommended for all kids, those with asplenia get them much earlier than the standard age.
either a two dose series of Bexsero or a three dose series of Trunemba, once they are at least 10 years old. The Men B vaccines are only formally recommended for high risk kids, others can get it if they want to be protected.
between one to four doses of Prevnar, depending on how old they are when they start and complete the series. Keep in mind that unlike healthy children who do not routinely get Prevnar after they are 5 years old, older children with asplenia can get a single dose of Prevnar up to age 65 years if they have never had it before. Like Hib, this recommendation is about kids who are behind on the shot.
a dose of Pneumovax 23 once they are at least two years old, with a repeat dose five years later and a maximum of two total doses. Kids who are not high risk typically don’t get this vaccine.
Ideally, children would get these vaccines at least two to three weeks before they were going to get a planned splenectomy. Of course, that isn’t always possible in the case of the emergency removal of a child’s spleen, in which case they should get the vaccines as soon as they can.
More About Asplenia
In addition to these vaccines, preventative antibiotics are typically given once a child’s spleen is removed or is no longer working well. Although there are no definitive guidelines for all children who have had a splenectomy, many experts recommend daily antibiotics (usually penicillin or amoxicillin) until a child is at least 5 years old and for at least 1 year after their splenectomy.
Other less common bacteria that can be a risk for children with asplenia can include Escherichia coli, Staphylococcus aureus, Salmonella species, Klebsiella species, and Pseudomonas aeruginosa. Vaccines aren’t yet available for these bacteria, so you might take other precautions, such as avoiding pet reptiles, which can put kids at risk for Salmonella infections.
Children with asplenia are at increased risk for severe malaria and babesiosis (a tickborne illness) infections. That makes it important to take malaria preventative medications and avoid mosquitoes if traveling to places that have high rates of malaria and to do daily tick checks when camping, etc.
A medical alert type bracelet, indicating that your child has had his spleen removed, can be a good idea in case he ends up in the emergency room with a fever and doctors don’t know his medical history.
Keep in mind that since there are many different causes of asplenia, the specific treatment plan for your child may be a little different than that described here. Talk to your pediatrician and any pediatric specialists that your child sees.
What to Know about Vaccines for Children with Asplenia
Children with asplenia typically need extra vaccines and protection against pneumococcal disease, Hib, and meningococcal disease.
A lot of folks, even some pediatricians, are still confused about the recommendations for the meningococcal B vaccines.
Remember, two vaccines, Bexsero and Trumenba, are approved to protect against serogroup B meningococcal disease.
The Men B Vaccine for High Risk Kids
There is no confusion about the recommendation that high risk kids should get vaccinated against meningococcal B disease.
“Certain persons aged ≥10 years who are at increased risk for meningococcal disease should receive MenB vaccine.”
ACIP on Use of Serogroup B Meningococcal Vaccines in Persons Aged ≥10 Years at Increased Risk for Serogroup B Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices, 2015
Who’s high risk?
In addition to microbiologists who work with the Neisseria meningitidis bacteria, you are considered to be high risk if you are at least 10 years old and:
have a persistent complement component deficiency, including inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, or factor H
have anatomic or functional asplenia, including sickle cell disease, children with congenital asplenia, and children who’s spleen was removed (splenectomy) to prevent complications of other conditions, such as ITP, hereditary spherocytosis, pyruvate kinase deficiency, Gaucher disease, and hypersplenism, etc.
are taking the medication eculizumab (Soliris), which is used to treat two rare blood disorders, atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH)
And, if high risk, you should either get a 3 dose series of Trumenba or a 2 dose series of Bexsero.
Keep in mind that traveling is not usually a risk factor for Men B, but can be for the other meningococcal vaccines.
The Men B Vaccine for Healthy Teens
But what if you aren’t at high risk?
While teens should routinely get vaccinated with other meningococcal vaccines, Menactra or Menveo, that provide protection against serogroups A, C, W, Y, the recommendation for Men B vaccination is more permissive.
“A MenB vaccine series may be administered to adolescents and young adults aged 16–23 years to provide short-term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16–18 years.”
ACIP on Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015
When given to healthy teens who are not at high risk for meningococcal disease, both Bexsero and Trumenba can be given as a two dose series.
A Permissive Recommendation for Men B Vaccines
This permissive recommendation for Men B is what has got folks confused…
“The recommendation is labeled as “Category B,” meaning that individual clinical decision-making is recommended. A Category A recommendation means a vaccine is recommended for everyone in an age-group or risk factor group.”
ACIP endorses individual choice on meningitis B vaccine
So there is a recommendation for older teens to get vaccinated with the Men B vaccines, it just isn’t the clear cut, get the vaccine, kind of recommendation that we are used to. The recommendation instead says that you can get the vaccine if you want to be vaccinated and protected against meningococcal B disease.
And that’s where the confusion comes from, as over 75% of doctors don’t even know what a category B recommendation really means! That’s not surprising though, as the Advisory Committee on Immunization Practices doesn’t often make category B recommendations for vaccines.
Things that factored into the decision for a permissive recommendation seemed to include that:
routine vaccination of all teens would prevent about 15 to 29 cases of Men B and two to five deaths each year, as there are about 50 to 60 cases and five to 10 deaths each year in children and young adults between the ages of 11 and 23 years, and giving it only to kids going to college would only prevent about nine cases and one death each year
there are some concerns about how effective the MenB vaccines might be, but only because vaccine effectiveness “was inferred based on an immunologic marker of protection,” as it is difficult to otherwise test how well the vaccine works because the disease has a low prevalence and there is no data yet about how long the protection will last, as they are new vaccines. Still, from 63 to 88% of people get protective levels of antibodies after getting the MenB vaccines and the protection should last for at least two to four years.
data on safety was limited, but there were no “no concerning patterns of serious adverse events”
the vaccine likely won’t reduce the nasopharyngeal colonization by MenB bacteria, so might not contribute to herd immunity
If you are still confused, you will hopefully be reassured that a combination, pentavalent MenABCW-135Y meningococcal vaccine is in the pipeline and once available, will almost certainly be recommended for all teens, replacing the need to get separate meningococcal vaccines for protection.
Making a Decision About the MenB Vaccines
So do you get your kids the Men B vaccine series?
“Pediatricians are encouraged to discuss the availability of the MenB vaccines with families.”
AAP on Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older
The one thing that is very clear is that you should make your decision after talking to your pediatrician about the risks and benefits of getting vaccinated.
Although many people think that there is no recommendation for healthy teens to get a Men B vaccine, that isn’t really true. There just isn’t a recommendation for routine vaccination of all teens.
It is true that the Men B vaccines aren’t required by most colleges, although some are starting to require them, just like they do Menactra or Menveo.
“The treating clinician should discuss the benefits, risks, and costs with patients and their families and then work with them to determine what is in their best interest.”
AAP on Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older
What are the benefits? Your child doesn’t get Men B disease, a disease that is often life-threatening.
What are the risks? In addition to extremely rare risks that you can see with any vaccine, like anaphylaxis, there are the risks that the vaccine doesn’t work, as no vaccine is 100% effective, pain from the shot, or that your child is never exposed, so didn’t actually need the shot, since Men B disease is pretty rare.
“The CDC has estimated the risk of anaphylaxis is 1.3 cases/1 million doses following administration of any vaccine. Thus, the vaccine benefit from prevention of death from MenB disease is approximately equal to the risk of anaphylaxis from MenB vaccine administration.”
H. Cody Meissner, MD on MenB vaccines: a remarkable technical accomplishment but uncertain clinical role
Although thinking about it this way, the risk of anaphylaxis vs the benefit of preventing Men B deaths seems to be equal, remember that anaphylaxis is often treatable.
What are the costs? Men B vaccines are expensive, but are covered by insurance and the Vaccines for Children Program. Still, someone is always paying for them.
What other factors come into play? Some teens are getting caught up on their HPV vaccines and are getting a booster dose of the other meningococcal vaccine at around this same time. While they can certainly all be given together, some pediatricians prioritize getting kids vaccinated and protected with Gardasil and Menactra or Menveo, and so don’t focus on the Men B vaccines.
Still, the vaccine is safe and it works, so the question really may come down to – is it necessary? Or is Men B so rare, that it is worth taking a chance and skipping this vaccine.
What to Know About the Recommendations to Get a Men B Vaccine
Talk to your pediatrician and see if your child should get the Men B vaccine series.
More on Understanding the Recommendations to Get a Men B Vaccine
“Well, here are the numbers. And the numbers change every year. I think in 2012, there were 185 million doses of flu doses manufactured in this country. And I think fewer than 10 million were thimerosal-free. Over 90 percent had huge, huge doses of mercury.”
An interview with Robert Kennedy Jr. on vaccines
Huge, huge doses of mercury?
Although it was never actually linked to any significant side effects, as a “precautionary measure,” the AAP recommended that thimerosal (mercury) be removed from childhood vaccines in 1999.
Thimerosal was removed from the hepatitis B, DTaP, and Hib vaccines, the only routinely used, non-flu vaccines that ever had thimerosal, in 2001. It is important to note that thimerosal-free versions of the DTaP and Hib vaccines were already available in the late 1990s though.
By January 2003, remaining stocks of vaccines with thimerosal expired.
Also in 2003, thimerosal-free flu vaccines became available, including thimerosal-free flu shots and FluMist, the nasal spray flu vaccine.
Is he right about the number of thimerosal-free flu vaccines in 2012?
Let’s do the math.
Ever since thimerosal-free flu vaccines became available in 2003, the supply has increased each year.
2007-08: 112 million doses, with 10-12 million doses of thimerosal-free flu vaccine from Sanofi Pasteur, 7 million doses of thimerosal free FluMist, plus Afluria was thimerosal-free, and flu vaccines with trace thimerosal from Novartis and GSK
2008-09: 110 million doses, with 50 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine and only 25% infants and toddlers are fully vaccinated against flu
2009-10: 114 million doses, with 50 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine
2010-11: 155 million doses, with 74 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine
2011-12: 132 million doses, with 79 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine
2012-13: 134 million doses, with 62 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine, including 13 to 14 million doses of FluMist. While 76% of infants and toddlers were vaccinated, only 50% of pregnant women got a flu shot.
2013-14: 134 million doses, with 62 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine. 13 million doses of FluMist.
2014-15: 147 million doses, with 98 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine. 14 to 15 million doses of FluMist.
2015-16: 146 million doses, with 116-118 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine
2016-17: 145 million doses, with 120 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine
2017-18: 155 million doses, with 130 million doses of thimerosal-free or preservative-free (trace thimerosal) influenza vaccine
So Kennedy was wildly wrong about the number of thimerosal-free flu vaccines that were available in 2012. And he is certainly wrong about the number of thimerosal-free flu vaccines that are available today.
“Over 90 percent had huge, huge doses of mercury. Not trace amounts as the industry likes to claim. Trace amounts means less than 1 microgram. They contain 25 micrograms, which is 25 times trace amount and over 100 times what EPA’s safe exposure levels are. … So today, in the last three or four years, that number has been reduced to 48 million.” Which number has been reduced to 48 million?
“I believe this year there were 150, around 150 million flu doses manufactured and 48 million of those, or a third, were loaded with mercury.”
An interview with Robert Kennedy Jr. on vaccines
What about his theory about the way the “industry” uses the term trace amounts?
There has never been a conspiracy to hide the thimerosal content of flu shots or any other vaccines. Those with trace amounts of thimerosal clearly have less than or equal to 1mcg per dose. Others were either thimerosal free or contained a standard amount of thimerosal, 25mcg.
Not surprisingly, this isn’t the first time Kennedy has tried to mislead people about vaccines.
“There is no question that meningococcal meningitis is a serious disease that can cause death and disability, but we need to ensure that the solution is not worse than the problem. There is every reason to believe that mandatory meningococcal B vaccines for every college student could kill more students than the disease they protect against. Before we relinquish our rights, pay millions and sicken students, we should do the math.”
Robert F. Kennedy, Jr.: Doing the math on meningitis vaccinations
A few years ago, Kennedy responded to a resolution that had been passed by the University of Colorado-Boulder student government about new meningococcal B vaccines.
For some reason, he devoted a good deal of time talking about the “hefty mercury load” that kids could get from Menomune, a vaccine that doesn’t cover the meningococcal B strain and which has largely been replaced by the newer Menactra (2006) and Menveo (2010) vaccines. In fact, Menomune was discontinued last year.
What to Know About Robert F Kennedy, Jr
Kennedy seems to mislead people about thimerosal and vaccines at every opportunity he can.
Bexsero and Trumenba – serogroup B meningococcal vaccines
But just because your child has been vaccinated doesn’t mean that you are in the clear if they are exposed to someone with meningitis. They might still need preventative antibiotics if they are exposed to someone with Hib or meningococcal meningitis.
Still, getting fully vaccinated on time is the best way to prevent many of these types of meningitis and other life-threatening diseases.
What to Know About Meningitis Vaccines
Learn which vaccines are available to provide protection against bacterial and viral meningitis.
Today, in the United States, children typically get:
36 doses of 10 vaccines (HepB, DTaP, Hib, Prevnar, IPV, Rota, MMR, Varivax, HepA, Flu) before starting kindergarten that protect them against 14 vaccine-preventable diseases
at least three or four more vaccines as a preteen and teen, including a Tdap booster and vaccines to protect against HPV and meningococcal disease, plus they continue to get a yearly flu vaccine
So by age 18, that equals about 57 dosages of 14 different vaccines to protect them against 16 different vaccine-preventable diseases.
While that sounds like a lot, keep in mind that 33% of those immunizations are just from your child’s yearly flu vaccine.
Of course, kids in the United States don’t get all available vaccines and aren’t protected against all possible vaccine-preventable diseases. Some vaccines are just given if traveling to a high risk area or in other special situations.
Vaccine-preventable diseases (in the United States, children and teens are routinely protected against the diseases highlighted in bold) include:
adenovirus – a military vaccine
anthrax – vaccine only given if high risk
chicken pox – (Varivax, MMRV)
cholera – vaccine only given if high risk
dengue – vaccine not available in the United States
diphtheria – (DTaP/Tdap)
hepatitis A – (HepA)
hepatitis B – (HepB)
hepatitis E – vaccine not available in the United States
HPV – (Gardasil)
Haemophilus influenzae type b – (Hib)
measles – (MMR, MMRV)
meningococcal disease – (MCV4 and MenB and MenC)
pneumococcal disease – (Prevnar13 and PneumoVax23)
pertussis – (DTaP/Tdap)
polio – (bOPV and IPV)
Q-fever – vaccine not available in the United States
rabies – vaccine only given if high risk
rotavirus – (RV1, RV5)
rubella – (MMR, MMRV)
shingles – vaccine only given to seniors
smallpox – eradicated
tetanus – (DTaP/Tdap)
tick-borne encephalitis – vaccine not available in the United States
tuberculosis – (BCG) – vaccine only given if high risk
typhoid fever – vaccine only given if high risk
yellow fever – vaccine only given if high risk
Discontinued vaccines also once protected people against Rocky mountain spotted fever, plague, and typhus.
These vaccine-preventable diseases can be contrasted with infectious diseases for which no vaccines yet exist, like RSV, malaria, norovirus, and HIV, etc., although vaccines are in the pipeline for many of these diseases.
What To Know About Vaccine Preventable Diseases
Available vaccines are helping to eliminate or control a number of vaccine-preventable diseases, like polio, measles, and diphtheria, but a lot of work is left to be done.