Tag: MenB

Is the Meningococcal Vaccine More Dangerous Than Meningococcal Disease?

No one who has ever seen a child with meningococcal disease would ever think that it was even remotely possible that getting a meningococcal vaccine was more dangerous than getting the disease.

“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?

We actually vaccinate against meningitis with many different vaccines, including Hib, Prevnar, MMR, and the meningococcal vaccines.

And there are different types of meningococcal vaccines, including those that protect against Neisseria meningitidis serogroups A, C, W, Y and Men B.

Meningococcal vaccines are safe and effective against meningococcemia and meningococcal meningitis, both terrible diseases.
Meningococcal vaccines are safe and effective against meningococcemia and meningococcal meningitis, both terrible diseases.

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.

Not everything that happens during a clinical trial is related to the vaccine, even though it still gets reported. Another Menactra trial reported no deaths and the serious adverse events that were reported weren’t related to getting vaccinated.

Here is another meningococcal study in which a few of the participants died – one in a car accident and the other a drug overdose.

These deaths were not related to getting vaccinated, but were listed because they occurred during the study.
These deaths were not related to getting vaccinated, but were listed because they occurred during the study.

Unfortunately, vaccines can’t protect you from everything…

It would be especially nice if they could protect us from bad anti-vaccine memes.

More on Meningococcal Vaccine Safety

Vaccine Fast Tracking

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.

Vaccine fast tracking doesn't mean that a vaccine gets approved too fast.
It is a myth that vaccine fast tracking means that a vaccine gets approved too fast.

Which vaccines have had Fast Track approval?

They include Gardasil, Vaxchora, a cholera vaccine, the MenB vaccines, and FluBlock, the flu vaccine that is made in insect cells.

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.

More on Vaccine Fast Tracking

Vaccines for Kids with Asplenia

Asplenia means lack of a spleen or a spleen that doesn’t work.

Although the spleen is an important organ that helps your body fight infections, in addition to other functions, it is certainly possible to live without a spleen.

Asplenia

There are many reasons a child might have asplenia, including:

  • congenital asplenia (children born without a spleen), sometimes associated with severe cyanotic congenital heart disease, such as transposition of the great arteries
  • surgical removal (splenectomy) secondary to trauma or anatomic defects
  • surgical removal to prevent complications of other conditions, such as ITP, hereditary spherocytosis, pyruvate kinase deficiency, Gaucher disease, and hypersplenism, etc.

And some children simply have a spleen that doesn’t work (functional asplenia) or doesn’t work very well because of sickle-cell disease and some other conditions.

Vaccines for Children with Asplenia

Because the spleen has such an important function in helping fight infections, without a spleen, a child is at increased risk for infections.

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.

Some kids need extra protection from vaccines.
Some kids need extra protection from vaccines. Photo by Janko Ferlic.

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.

More about Vaccines for Children with Asplenia

Understanding the Recommendations to Get a Men B Vaccine

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:

  • MenB vaccines are routinely given during outbreaks on college campuses.
    MenB vaccines are routinely given during outbreaks on college campuses.

    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)
  • could be exposed in a serogroup B meningococcal disease outbreak

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.

So why did the Men B vaccines only get a permissive recommendation? After all, Bexsero is routinely given to all infants in the UK at 8 weeks, 16 weeks, and 1 year as part of their routine childhood immunization schedule.

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