Tag: vaccine pipeline

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

Why Do We Only Fear Vaccine Preventable Diseases?

How many diseases can be prevented with vaccines?

Would you believe that there are about 29 vaccine-preventable diseases, from adenovirus and anthrax to typhoid fever and yellow fever?

That’s a lot more than the 16 that kids today routinely get vaccinated against

Diseases That Are Not Vaccine Preventable

Whether you think about 16 or 29 vaccine-preventable diseases, they are a drop in the pocket when you think about all of the diseases that can’t be prevented with a vaccine.

Just consider all of the viruses and bacteria that can get you sick during cold and flu season:

  • group A Streptococci – strep throat and scarlet fever
  • Human metapneumovirus (HMPV) – bronchiolitis, colds, and viral pneumonia
  • Human parainfluenza viruses (HPIVs) – bronchiolitis, bronchitis, colds, croup, or viral pneumonia
  • norovirus – diarrhea and vomiting
  • respiratory adenovirus – bronchitis, colds, croup, viral pneumonia, pink eye, and diarrhea
  • Respiratory syncytial virus (RSV) – wheezing and bronchiolitis in younger children, but colds in older kids and adults
  • rhinovirus – the classic common cold
  • rotavirus – diarrhea and vomiting, was much more common in the pre-vaccine era
  • seasonal coronavirus – colds, bronchitis, and viral pneumonia
  • Streptococcus pneumoniae – ear infections, meningitis, sinus infections, and pneumonia

In addition to the flu, only rotavirus and Streptococcus pneumoniae (pneumococcal vaccines) are vaccine preventable.

And there are still thousands of other diseases that aren’t vaccine preventable, including African trypanosomiasis, Chagas disease, Chikungunya, Cytomegalovirus (CMV), Dengue fever, Ebola, Herpes Zoster, HIV, Hookworm disease, Leishmaniasis, Malaria, Schistosomiasis, and Zika, some of the most deadly diseases around.

Why Do We Only Fear Vaccine-Preventable Diseases?

So is it true that we only fear vaccine-preventable diseases and that’s why folks get vaccinated?

“Why aren’t you walking around concerned about leprosy every day? Why aren’t you concerned about someone from another country bringing leprosy into Australia or the US and somehow exposing all of our most vulnerable to this illness? I’ll tell you why. Because there’s no vaccine for leprosy. You are afraid of what we vaccinate for because these illnesses are hyped up all of the time. It’s propaganda. You are told what to fear, so they can then sell you an alleged solution.
The only diseases we fear are the ones that a vaccine has been developed and marketed for. We never feared measles and mumps in the early 20th century… Because its what the media tells us to do.”

Learn the Risk – Why aren’t we afraid of all diseases?

Did you know that there actually is a vaccine for leprosy? Don’t expect it to be added to our immunization schedule any time soon or to increase your fears about leprosy, as leprosy is not highly contagious and it can be cured.

Forget about leprosy though… If folks didn’t fear measles and mumps in the early 20th century, before we had vaccines to control these diseases, then why did epidemics so often lead to newspaper headlines, quarantines, and school closings?

Quarantines were routine in the pre-vaccine era.
Quarantines were routine in the pre-vaccine era.

And if we only fear diseases that a vaccine has been developed and marketed for, then why are so many parents afraid of RSV and herpes?

How many new parents won’t even let family members kiss their newborns because they are worried about herpes, even if they don’t have a cold sore? How many parents get panicked if they hear RSV, which can cause severe disease in high risk babies, but typically only causes cold symptoms in most others.

Anyway, fear doesn’t drive most of us to vaccinate and protect our kids. We just understand that vaccines are safe and necessary and that getting vaccinated is a smart decision.

It is the diseases that aren’t vaccine preventable that might scare us a little bit…

What to Know About Fearing Vaccine-Preventable Diseases

Anti-vaccine folks push propaganda to make parents afraid of vaccines and to scare them away from vaccinating and protecting their kids. The idea that we are only afraid of vaccine preventable diseases is a good example.

More on Fearing Vaccine Preventable Diseases

Can Vaccines Cause Multiple Sclerosis?

Multiple Sclerosis is thought to be an autoimmune disease, with symptoms typically starting when you are between 20 to 40 years old.

“MS symptoms are variable and unpredictable. No two people have exactly the same symptoms, and each person’s symptoms can change or fluctuate over time. One person might experience only one or two of the possible symptoms while another person experiences many more.”

National Multiple Sclerosis Society on MS Symptoms

From fatigue, weakness, and problems walking to vision problems, including the onset of blurred vision, MS can have many different symptoms.

What Causes Multiple Sclerosis?

Some people may be surprised that doctors have known about Multiple Sclerosis since the 1870s. They recognized people with the symptoms of MS even earlier.

Unfortunately, we still don’t know what causes it.

Can Vaccines Cause Multiple Sclerosis?

Without a known cause, it is easy to understand why some folks blame vaccines.

How many infants got hepatitis B in France because of low levels of vaccination after they blamed the vaccine for causing MS?
How many infants got hepatitis B in France because of low levels of vaccination after they blamed the vaccine for causing MS?

We see the same thing with many other conditions.

Remember though, just because you don’t know what causes something doesn’t mean that you can’t eliminate things that don’t cause it.

“Concern about hepatitis B vaccination arose from France in the mid 1990s. Following a mass hepatitis B vaccination program in France there were reports of MS developing in some patients a few weeks after receiving the vaccine. In 1998, the French government stopped the school-based hepatitis B component of the vaccination program while they investigated a possible relationship between hepatitis B vaccine and demyelinating disease. When studies of the French vaccine recipients were completed they showed that there was not a significant increase in the number of vaccinated people who developed MS as compared with those who had never received hepatitis B vaccine.”

Hepatitis B and multiple sclerosis FactSheet

And more than a few studies have shown that vaccines do not cause Multiple Sclerosis.

From the hepatitis B vaccine to the HPV vaccines, it has been shown that vaccines do not cause Multiple Sclerosis.

It has also been shown that vaccines don’t increase the risk of relapses for people who already have MS.

“…vaccines are able to prevent some infections in MS patients known to accelerate the progression of the disease and increase the risk of relapses.”

Mailand et al on Vaccines and multiple sclerosis: a systemic review

And yes, since new infections may trigger MS relapses, vaccines have an added benefit for MS patients.

And that’s why it is recommended that patients with MS follow the standard Centers for Disease Control immunization schedule. They may need to avoid getting live vaccines while taking specific MS medications though, as some of these can suppress their immune system.

“In the last few years a number of MS-focused vaccines have shown promising results in early phase clinical trials, and with each success the technology is closer than ever to offering a viable treatment option.”

Dr. Karen Lee on MS vaccines: Thinking outside the box for new treatments

While everyone hopefully now understands that any talk about MS being associated with vaccines is just another myth or scare tactic of the anti-vaccine movement, vaccines may one day really be associated with MS – therapeutic vaccines are in development that can treat people with Multiple Sclerosis!

What to Know About Vaccines and Multiple Sclerosis

Although it is still not known what does cause Multiple Sclerosis, we do know that it is not vaccines, which may actually reduce the risk of relapses for folks who already have MS.

More on Vaccines and Multiple Sclerosis

Four Generations of Vaccines and Vaccine Preventable Diseases

This image that has been floating around the Internets conveys a lot of information, both about vaccines and vaccine-preventable diseases. And about the propaganda being pushed by the anti-vaccine movement.

Four generations of vaccines or vaccine misinformation?
Four generations of vaccines or vaccine misinformation?

A lot has changed over the last four generations…

Four Generations of Vaccine Preventable Diseases

In the United States, we have seen:

  • 1949 – the last smallpox outbreak
  • 1970s – the last outbreak of respiratory diphtheria
  • 1979 – endemic polio was declared eliminated
  • 1979 – smallpox was declared eradicated
  • 2000 – endemic measles was declared eliminated
  • 2000- neonatal tetanus was declared eliminated
  • 2004 – endemic rubella and congenital rubella syndrome were declared eliminated
  • 2009 – endemic respiratory diphtheria was declared eliminated

But there hasn’t been as much change as some folks think.

Four Generations of Vaccines

For one thing, kids don’t get 69 vaccines today as part of the recommended immunization schedule.

We don’t even have 69 vaccines available to give children today!

And while 200+ vaccines are being tested or are in the “pipeline,” very few will end up on the childhood immunization schedule. For example, many of these are therapeutic vaccines to treat cancer, allergies, and other conditions. And a lot of the other pipeline vaccines are for the same infectious disease, including 36 vaccines being tested to prevent or treat HIV and 25 to prevent the flu.

So how many vaccines do kids actually get?

Kids today routinely get 13 vaccines to protect them from 16 vaccine-preventable diseases. More than 13 vaccines are available, but some aren’t used in the United States and some are only used in special situations or for high risk kids.

Also, looking at historical immunization schedules, it is clear that folks in the 1940s and 50s didn’t get just two vaccines.

schedule1940s
A schedule of immunizations from a 1948 AAP Round Table Discussion on the Practical and Immunological Aspects of Pediatric Immunizations

Did some kids really get annual tetanus and typhoid vaccine boosters back then?

It’s possible, after all, by the 1930s, we did have individual vaccines against diphtheria, tetanus, pertussis, typhoid, and smallpox.

This was followed by:

  • 1948 – the individual diphtheria, tetanus, and pertussis vaccines become combined in a single DTP vaccine
  • 1955 – first polio vaccine – IPV
  • 1962 – change to oral polio vaccine – OPV
  • 1963-68 – first measles vaccines
  • 1967 – first mumps vaccine
  • 1969 – first rubella vaccine
  • 1971 – the individual measles, mumps, and rubella vaccines become combined in a single MMR vaccine
  • 1972 – routine vaccination with smallpox vaccines end in the US

The next big change was the addition of the Hib vaccine to the schedule in 1985.

“…for those trained in pediatrics in the 1970s, Hib (Haemophilus influenzae type b) was a horror.”

Walter Orenstein, MD

This was followed in 1989, with the addition of the hepatitis B vaccine, expanded age ranges for Hib, and the start of the switch to DTaP.

By 2000, kids got protection against 11 vaccine-preventable diseases, and routinely got the DTaP, MMR, IPV, Hib, chicken pox, Prevnar, hepatitis B, and Td vaccines.

Over the years, vaccines and protection against rotavirus, hepatitis A, meningococcal bacteria, HPV, and a yearly flu shot were added to the schedule.

We still haven’t gotten to 69 vaccines though.

Looking at the latest immunization schedule from the CDC and AAP, it should be clear that kids don't get 69 vaccines.
Looking at the latest immunization schedule from the CDC and AAP, it should be clear that kids don’t get 69 vaccines.

Kids today do routinely get:

  • 13 vaccines, including DTaP, IPV (polio), hepatitis B, Hib, Prevnar 13, rotavirus, MMR, Varivax (chicken pox), hepatitis A, Tdap, HPV, MCV 4 (meningococcal vaccine), and influenza
  • protection against 16 vaccine-preventable diseases, including diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, chicken pox, pneumococcal disease, hepatitis A, hepatitis B, meningococcal disease, HPV, rotavirus, Hib, and flu
  • about 28 doses of those vaccines by age two years
  • about 35 doses of those vaccines by age five years
  • as few as 23 individual shots by age five years if your child is getting combination vaccines, like Pediarix or Pentacel and Kinrix or Quadracel and Proquad
  • about 54 doses of those vaccines by age 18 years, with a third of that coming from yearly flu shots

How do you get a number like 69?

You can boost your count to make it look scarier by counting the DTaP, MMR, and Tdap vaccines as three separate vaccines each (even though they aren’t available as individual vaccines anymore). That quickly turns 8 shots into “24 vaccines.”

And that’s fine – as long as you are consistent. You can’t count them each as three vaccines today, but just as one when mom, grandma and great-grandma got them. If you are counting individual components of those vaccines, then great-grandma didn’t just get two vaccines, especially when you consider that she almost certainly would have gotten multiple doses of the DPT vaccine.

Paradoxically, even more antigens have been taken off the schedule with the removal of the smallpox and DPT vaccines. In 1960, kids got exposed to 3,217 different antigens from the smallpox, polio, diphtheria, tetanus and whole cell pertussis vaccines. All of today’s vaccines on the schedule expose them to just 177 different antigens!

Why does that matter? It is the antigens that are stimulating the immune system, so if you were really concerned about a number, that would be the one to look at.

More Vaccines Equal More Protection

Of course, the number of vaccines kids get and how they have increased over time is very important. But not in they way anti-vaccine folks like to think.

It is important because kids today are protected against and don’t have to worry about the consequences of many more life-threatening diseases, like bacterial meningitis (Hib and the pneumococcal bacteria), epiglottitis (Hib), liver failure and liver cancer (hepatitis B), severe dehydration (rotavirus), and cervical cancer (HPV), etc.

If you think kids get too many vaccines today, then you have no idea what things were like in the pre-vaccine era.

More on The Evolving Immunization Schedule

Vaccine-Preventable Diseases

The latest immunization schedule from the CDC and AAP.
The latest immunization schedule from the CDC and AAP.

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.

Vaccine-Preventable Diseases

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:

  1. adenovirus – a military vaccine
  2. anthrax – vaccine only given if high risk
  3. chicken pox – (Varivax, MMRV)
  4. cholera – vaccine only given if high risk
  5. dengue – vaccine not available in the United States
  6. diphtheria – (DTaP/Tdap)
  7. hepatitis A – (HepA)
  8. hepatitis B – (HepB)
  9. hepatitis E – vaccine not available in the United States
  10. HPV – (Gardasil)
  11. Haemophilus influenzae type b – (Hib)
  12. influenza
  13. measles – (MMR, MMRV)
  14. meningococcal disease – (MCV4 and MenB and MenC)
  15. mumps
  16. pneumococcal disease – (Prevnar13 and PneumoVax23)
  17. pertussis – (DTaP/Tdap)
  18. polio – (bOPV and IPV)
  19. Q-fever – vaccine not available in the United States
  20. rabies – vaccine only given if high risk
  21. rotavirus – (RV1, RV5)
  22. rubella – (MMR, MMRV)
  23. shingles – vaccine only given to seniors
  24. smallpox – eradicated
  25. tetanus – (DTaP/Tdap)
  26. tick-borne encephalitis – vaccine not available in the United States
  27. tuberculosis – (BCG) – vaccine only given if high risk
  28. typhoid fever – vaccine only given if high risk
  29. 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.

More About Vaccine Preventable Diseases

Updated June 16, 2018