Tag: ACIP

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

Does the CDC Own Any Patents on Vaccines?

Have you heard the CDC owns patents on vaccines?

“The CDC is a subsidiary of the pharmaceutical industry. The agency owns more than 20 vaccine patents and purchases and sells $4.1 billion in vaccines annually. Congressman Dave Weldon has pointed out that the primary metric for success across the CDC is how many vaccines the agency sells and how successfully the agency expands its vaccine program—regardless of any negative effects on human health.”

Robert F Kennedy, Jr

Wait, the CDC sells vaccines?

To who?

Myths About the CDC Selling Vaccines

The CDC doesn’t sell vaccines. That’s not their mission.

“The Centers for Disease Control and Prevention (CDC) works 24/7 to protect America from health, safety, and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities to do the same.”

CDC Mission, Role and Pledge

They do buy vaccines. A lot of vaccines.

In 2017, the CDC immunization program spent just over $4.8 billion dollars, including $4.1 billion on the Vaccines for Children program.

“…from March through December 2016, over 13,000 doses of meningococcal conjugate vaccine, purchased using CDC funding, were used to respond to a deadly outbreak of meningitis in Southern California.”

Department Of Health And Human Services Fiscal Year 2018

Did they sell all of those vaccines?

If they did, then they wouldn’t have to request money from Congress each year to buy more vaccines, now would they?

“CDC buys vaccines at a discount and distributes them to grantees—i.e., state health departments and certain local and territorial public health agencies—which in turn distribute them at no charge to those private physicians’ offices and public health clinics registered as VFC providers.”

The VFC Program: At a Glance

Instead, the vaccines that the CDC buys, at big discounts, since they are buying so many, are offered free to those kids who can’t afford vaccines in the Vaccines for Children (VFC) program and through Section 317 grants.

What About the CDC Vaccine Patents?

Is Kennedy right about the CDC vaccine patents?

“In the course of performing our mission, many CDC researchers identify novel technologies which may be of interest to commercial partners. Some of these technologies are available as a biological or other tangible material for licensing, whereas others are protected under patent.”

Office of the Associate Director for Science (OADS)

OK, so the CDC has patents…

Well, not exactly the CDC. The United States of America as represented by the Secretary of the Department of Health and Human Services has patents…

Patents of vaccines and vaccine technology are not the big deal that anti-vaccine folks make them out to be.
Patents of vaccines and vaccine technology are not the big deal that anti-vaccine folks make them out to be.

When you think of Kennedy’s claim, do you think that the CDC has the patent on 20 new vaccines? After all, that’s how it sounds, doesn’t it?

They don’t. Instead, they mostly own patents on vaccine technology.

“This technology describes a method for inactivating rotavirus. Traditional inactivation strategies use chemicals that reduce antigenicity (by altering rotavirus proteins), leading to less protection against the virus. Conversely, this method preserves and/or maintains the integrity of viral particles, leading to greater protection against rotavirus. This strategy has been validated in mice, piglets and cattle and further clinical studies are underway.”

A Novel Thermal Method to Inactivate Rotavirus for Use in Vaccines

Why patent these technologies?

Because they were discovered by CDC researchers and if their intellectual properly is not patented, then someone else could patent it, use it or sell it, and keep others from using it.

“After a license is negotiated, post-license compliance must be maintained to ensure the scheduled development of the technology, payment of royalties, and compliance to the license agreement. Based on the terms negotiated in the agreement, a percentage of royalties will go to the inventor, while a portion will go to the originating laboratory for that technology. This allows funding to be reinvested into CDC for the development of additional technologies that can meet other public health needs.”

What is the Process of Technology Transfer?

Should it be a surprise that these patents might generate money?

“Certain people are not considered for ACIP membership. For example, people who are directly employed or have an immediate family member directly employed by a vaccine manufacturer, hold a patent on a vaccine or related product, or serve on a Board of Directors of a vaccine manufacturer are excluded from ACIP membership.”

The Advisory Committee on Immunization Practices (ACIP) and the Childhood Immunization Schedule

Is it a surprise that the CDC and Advisory Committee on Immunization Practices (ACIP) has taken steps to make sure these patents don’t generate any conflicts of interest among those making decisions about vaccines?

“Dr Offit did not sit on the FDA committee that approved any rotavirus vaccine and he was not a member of ACIP, as RFK Jr claims, at the time they voted to recommend adding rotavirus vaccine to the immunization schedule.”

The Truth about vaccines 6: rotavirus

Is it a surprise that Kennedy is just trying to scare folks with all of this talk about selling vaccines and vaccine patents?

What to Know About the CDC’s Vaccine Patents

While the CDC does own and license some patents related to vaccines and vaccine technologies, they don’t actually sell any vaccines.

More on the CDC’s Vaccine Patents