Tag: ACIP

Did Dr. Bob Uncover a CDC Plot to Give Adult Flu Shots to Babies?

Have you heard the news?

Uh, the ACIP can't request a license for a vaccine...
Uh, the ACIP can’t request a license for a vaccine…

Dr. Bob and his new podcasting side kick think that the “CDC wants the FDA to approve adult doses of the flu vaccine for babies, because the normal half-doses approved for babies don’t work well enough.”

Did Dr. Bob Uncover a CDC Plot to Give Adult Flu Shots to Babies?

This is likely going to surprise Dr. Bob, but many infants already get the same dose of flu vaccine as adults.

Both FluLaval and Fluarix are given at the same 0.5ml dose, containing 15 µg of HA per vaccine virus, to infants, older children, and adults.

Fluzone, on the other hand, is still given at a 0.25ml dose, containing 7.5 µg of HA per vaccine virus, to children between the ages of 6 months to three years, and a larger 0.5ml dose to older kids and adults.

Why the differences?

“In a randomized trial comparing immunogenicity and safety of 0.5 mL FluLaval Quadrivalent with 0.25 mL Fluzone Quadrivalent, safety and reactogenicity were similar between the two vaccines.”

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

Because they are just as safe at the lower doses and might actually work better.

Then why did we ever use a lower dose for infants?

That recommendation was based on the older, whole-virus version of the flu shot, which did cause more side effects for infants when given at a full dose. We now use split-virus flu shots that don’t have this problem.

And now, the manufacturer of Fluzone has done a study, and not surprisingly, they have also found that “safety profile of a 0.5 ml (full-dose) is similar to 0.25 ml (half-dose) and may be more immunogenic.”

So they are submitting a BLA to the FDA for the use of the 0.5ml dose of their flu vaccine for infants.

What about the idea of an “adult dose of mercury” for infants?

Over 80% of flu vaccines were thimerosal free this year. You almost have to go out of your way to get your kids a flu vaccine with thimerosal, so no, this won’t mean an “adult dose of mercury” for your infant.

Most importantly though, if you understand how vaccines work, you know that the dose of vaccines for kids and adults is not calibrated by weight or age, so none of this really matters. The immune reaction that helps antibodies travel all through your body starts locally, near where the vaccine was given, so a 20-pound infant and a 200-pound adult can get the same dose of flu shot and both can be protected.

More on Dr. Bob’s CDC Plot to Give Adult Flu Shots to Babies

Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.
Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

  • Public Health Service Act (42 USC 262-63) §351
  • Food, Drug, and Cosmetic Act (21 USC 301-392)
  • Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
  • Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
  • Title 21 CFR 312 – investigational new drug application (IND)
  • Title 21 CFR 210-211 – good manufacturing practices
  • Title 21 CFR 58 – good laboratory practices
  • Title 21 CFR 56 – institutional review boards
  • Title 21 CFR 50 – protection of human subjects
  • Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
  • Food and Drug Agency Modernization Act (FDAMA) of 1997
  • Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

  • Center for Biologics Evaluation and Research (CBER) – vaccines
  • Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation

Retired Hospital Worker’s Flu Shot Speech at the ACIP Meeting

Did you see the video of the retired hospital worker, an emergency room technician, at the ACIP meeting earlier this year?

A retired emergency room technician gave a speech at an ACIP meeting because she is upset that hospital workers have to get yearly flu shots.
A retired emergency room technician gave a speech at an ACIP meeting because she is upset that hospital workers have to  either get yearly flu shots or wear a face mask.

Although brief, and emotional, she hit a lot of anti-vaccine talking points and managed to somehow talk about adult autistics walking around the mall with diapers and helmets at least four times.

Retired Hospital Worker’s Flu Shot Speech at the ACIP Meeting

Praised by anti-vaccine folks for being “explosive” and a “bombshell,” all the speech really does is reveal how easily influenced some folks are by the modern anti-vaccine movement.

“I don’t come here with any degree.”

The only true and one of the most important things she says comes at the beginning. Although it certainly isn’t a requirement to have a degree to speak your mind, in a room full of scientists and doctors who study health policy and vaccines as their life’s work, she was there to tell them that they were wrong.

“No one believes in the flu shots. My colleagues. I didn’t. Because the efficacy – and I won’t give you data, you created the data. 10% one year. 18% another year. 40% at best. And the FluMist you gave to our children from 2 to 8 years for almost 4 years – it never worked. 3%. Oh well.”

Most people actually understand that flu vaccines are important and many get a flu shot each year. Even more get their kids vaccinated and protected each year.

In most years, the flu vaccine is at about 40 to 50% effective at preventing the flu, but has other benefits, including preventing a severe case of the flu, getting hospitalized, and keeping you from dying with the flu!

Did a drop in flu vaccine coverage help contribute to a rise in flu deaths?
Did a drop in flu vaccine coverage help contribute to a rise in flu deaths?

The idea that “no one believes in flu shots” is silly. It is certainly possible that no one this speaker knows believes in flu shots, as many anti-vaccine folks exist in an echo chamber and only hear and read negative things about vaccines.

Her statements about flu vaccine efficacy are also way off, especially about FluMist, as there was only evidence that it didn’t work well against H1N1 flu strains for a few years.

“And then came your mandates. And then came your recommendations. So you know what, for four years before I retired I put a mask on. 12 hour shifts. It wasn’t easy to breath. But that’s how much I didn’t believe in your efficacy.”

Neither the CDC or ACIP mandate that hospital workers get a yearly flu shot.

It is recommended and it is the ethical thing to do, so that we protect our most vulnerable patients, including those who can’t be vaccinated, but the CDC doesn’t issue mandates.

“But the truth. The public’s truth. My observation – which is the first step in scientific theory – they didn’t believe in your shot.”

Making an observation is actually the first step in the scientific method. But you don’t stop there. Why don’t they believe in flu vaccines? Are they scared about all of the anti-vaccine propaganda that they see and read on the Internet or even from anti-vaccine friends or coworkers?

“This year I retired. I’m grateful for that, because my soul was sick about what I saw go on. That flu shot was crazy. First it was 10%. How can you do data? Which 10 got the shot out of a 100?”

How do they know which 10 got the shot?

Believe it or not, when they tell us about flu vaccine effectiveness, they are not basing that number on each and every person who got a flu vaccine. They do a study, enroll patients, see if they get flu, see if they had a flu vaccine, compare them to other patients, etc. It’s actually very easy to tell which ones got the shot…

“I’m looking around, some of you are my age. And if I’m mistaken, I apologize. But I’m in a generation where I got 7 shots. 26 years later, my daughter got 10. Her son got, maybe 60. My new grandson is expected to get maybe 72, and I just watched you add more.”

Yes, a lot has changed from her generation.

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

Our now vaccinated kids don’t die from Hib meningitis, Hib epiglotittis, pneumococcal disease, rotavirus, chicken pox, hepatitis A, hepatitis B, measles, etc., and they don’t get congenital rubella syndrome!

And for the record, her new grandson won’t need 72 shots or more.

They didn’t add any more at that ACIP meeting she gave her speech at either.

“Robert Kennedy, Jr – do you know what he says? His family started Special Olympics – there were no autistic kids. He says, where are the 40 year olds wearing diapers with helmets on at the mall if you misdiagnosed them. If you missed them, because you say it’s not vaccines,  where were the special ed classes for people in my generation – there weren’t any. Because they didn’t exist.”

Special education classes didn’t exist back then, because we didn’t start getting things like that until passage of the Education for All Handicapped Children Act in 1975. Before that, many states actually had laws excluding special needs children from school!

So there weren’t any special ed classes because they weren’t available, not because they weren’t needed.

And as the first school for autistic children, the Sybil Elgar School, was established in 1965, it should be obvious that her comments about autistic adults are not only wrong, they are offensive.

“I don’t care what you say that the autism and vaccines don’t exist – it does. I watched a perfectly healthy beautiful 2-year-old get those shots and become a severe autistic child. And guess what, he will be 40 and walking around the mall with a diaper on and helmet.”

This is everything that is wrong with the modern anti-vaccine movement.

Continuing to push the idea that vaccines are associated with autism and being locked into a deficit model of thinking about autism, so that when you look at your child, all you see is an adult with a “diaper on and helmet,” instead of beautiful autistic 2-year-old.

Ironically, she ended her speech with this quote by William Wilberforce.

“Having heard all of this you may choose to look the other way but you can never again say you did not know.”

William Wilberforce

Nothing she said was true and some of it was actually offensive.

You can’t say you don’t know now.

More on the Retired Hospital Worker’s Flu Shot Speech at the ACIP Meeting

Did the FDA Approve a New HPV Vaccine for Adults?

What do you know about the HPV vaccine?

Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.

Did the FDA Approve a New HPV Vaccine for Adults?

News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.

The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.

The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.

They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.

“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”

Why the new age indication?

“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?

Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.

Except FDA approval doesn’t automatically mean that your insurance company will pay for it.

That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.

“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”

Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System

And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.

Will Gardasil 9 be added to the immunization schedule for adults?

The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.
The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.

We should know sooner, rather than later. It is on the agenda for the next ACIP meeting on October 25…

More on Gardasil for Older Adults

Flumist Is Not Just a Last Resort

The return of FluMist has hit a slight snag.

Most folks will remember that on February 12, 2017, at a meeting of the Advisory Committee on Immunization Practices (ACIP), members voted to once again recommended FluMist Quadrivalent to prevent the flu. So it will be available for this year’s flu season.

Many parents and pediatricians welcomed the news, as it meant that many kids could avoid getting a shot and could get the nasal spray flu vaccine instead.

Why did flu vaccine rates drop in younger school age kids when Flumist wasn't available?
Why did flu vaccine rates drop in younger school age kids when Flumist wasn’t available?

It was especially good news for those kids who skipped getting a flu vaccine because they didn’t want to get a shot when Flumist wasn’t available.

Flumist as a Last Resort?

So what’s the problem?

“The Academy recommends pediatricians give children inactivated influenza vaccine in the upcoming season and use live attenuated vaccine only as a last resort.”

American Academy of Pediatrics

Members of the AAP Committee on Infectious Diseases (COID) are concerned that FluMist, even after it has been changed to address previous issues, may not work as well as a standard flu shot.

“Influenza is unpredictable from year to year, so we really want to immunize as many kids as we can against the flu with what we think will be the most effective product. That’s why we’re recommending the flu shot this coming season.”

Henry H. Bernstein, D.O., M.H.C.M., FAAP

While many of us were surprised by the “last resort” phrasing from the AAP, maybe we shouldn’t have been.

In addition to being an ex officio member of the AAP Committee on Infectious Diseases (COID), Henry H. Bernstein was one of only two members of the ACIP who voted against bringing FluMist back, going against the opinion of twelve other members who voted in favor of FluMist.

Dr. Henry H. Bernstein is also the “leading voice on AAP’s annual policy statement on preventing flu in children with flu vaccines.”

“The data reviewed showed that receiving the nasal spray vaccine is better than not getting any vaccine at all,” said Flor Munoz, MD, FAAP, member of the AAP Committee on Infectious Diseases. “If you get the nasal spray vaccine, just be aware that, depending on the performance of the new vaccine formulation, there might be a chance you will not be fully protected against H1N1 strains of flu. The efficacy of this new formulation has not yet been determined.”

It is important to note that the AAP is not saying that Flumist won’t work though.

“The effectiveness of this new formulation of LAIV4 has not been confirmed, since A/H1N1 virus has not widely circulated recently.”

AAP influenza immunization recommendations revised for 2018-’19 season

They are basically saying that if the reformulated version of Flumist doesn’t work as it is predicted to work, then your kids might not be protected. They are concerned that we haven’t seen the new version of Flumist work in real world studies against the H1N1 strain of the flu.

Flumist Is Not Just a Last Resort

Fortunately, the AAP has somewhat rephrased their message about Flumist (LAIV4). While they still recommend that the inactivated influenza vaccine (flu shots) be the primary choice for children, they now say that:

“LAIV4 may be offered for children who would not otherwise receive an influenza vaccine (and for whom it is appropriate by age and health status).”

AAP influenza immunization recommendations revised for 2018-’19 season

Importantly though, parents and pediatricians should note that the recommendations of the Advisory Committee on Immunization Practices (ACIP) for the 2018–19 flu season very clearly make no preferential recommendation for the use of any influenza vaccine product over another.

“Following two seasons (2016–17 and 2017–18) during which ACIP recommended that LAIV4 not be used, for the 2018–19 season, vaccination providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). LAIV4 is an option for those for whom it is appropriate.”

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

And the ACIP and CDC aren’t the only ones who disagree with the AAP’s decision.

“So I think the AAP was wrong, frankly, to say that FluMist should only be used as a last-resort vaccine for influenza. Rather, they should have gone along with what the ACIP said, which was that these vaccines can now be used interchangeably for persons aged 2-49 years.”

Paul Offit, MD on FluMist: Reasonable Vaccine Option or ‘Last Resort’ for the Upcoming Flu Season?

So what should you do?

If it is going to be a battle getting your kids a flu shot and you might you might have even skipped it the last few years because Flumist wasn’t available, then your choice is very clear.

Get vaccinated with Flumist, as long as your child is at least two years old and otherwise meets the requirements.

And don’t feel bad or worried that your decision is leaving your child unprotected. Remember that Flumist is recommended by the ACIP and CDC and has been used continuously in most other countries (under the name Fluenz).

Your next battle might simply be finding Flumist. Because of the AAP’s “last resort” comment, some pediatricians didn’t even bother ordering any doses.

More on the Latest Flumist Recommendations

Did the US Government Lose a Landmark Vaccine Lawsuit?

Have you heard the big news in the anti-vaccine world?

The anti-vaccine world thinks that they won some landmark lawsuit.

Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.

It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.

The 1986 National Childhood Vaccine Injury Act includes a mandate for safer vaccines.
The National Childhood Vaccine Injury Act of 1986 includes a mandate for safer vaccines.

Really?

Which ones?

Did the US Government Lose a Landmark Vaccine Lawsuit?

While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.

The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.

It should be clear that the HHS has done plenty to promote vaccine safety though.

HHS Secretary Donna Shalala reported to the Senate Committee on Health Education Labor and Pensions in 1998.
HHS Secretary Donna Shalala actually reported to the Senate Committee on Health Education Labor and Pensions in 1998.

Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, has commissioned almost a dozen reports about vaccine safety over the years.
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, has commissioned almost a dozen reports about vaccine safety over the years.

And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.

Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?

The Assistant Secretary for Health leads development of HHS-wide public health policy recommendations, oversees 11 core public health offices — including the Office of the Surgeon General and the U.S. Public Health Service Commissioned Corps, which has approximately 6,500 uniformed health officers who serve in nearly 600 locations around the world to promote, protect and advance the health and safety of our nation and our world. He also oversees three Presidential and 11 Secretarial advisory committees.
The Assistant Secretary for Health leads development of HHS-wide public health policy recommendations, oversees 11 core public health offices and three Presidential and 11 Secretarial advisory committees. We have had a National Vaccine Plan since 1994.

And also consider that:

Most importantly, new vaccines have been approved that protect our kids against many more now vaccine-preventable diseases.

HHS Settles Lawsuit Over Vaccine Safety Reporting

But wait, did the HHS even lose the lawsuit?

Not saying I'm surprised, but even Dr. Bob has bought into the idea that this lawsuit against HHS means something big.
Not saying I’m surprised, but even Dr. Bob has bought into the idea that this lawsuit against HHS means something big.

They actually didn’t.

They did settle a lawsuit though, a lawsuit which was then dismissed.

So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.

Vaccines are still safe. And they are still necessary.

What to Know About the HHS Vaccine Lawsuit

Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.

More on the HHS Vaccine Lawsuit

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