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Discussion Starter · #1 · (Edited)
There's been a lot in social media this week about the Men B vaccine and the UK and an online petition to have the vaccine funded via the NHS. It is available to older children in the UK, if the parents want to pay for it privately.

Here in Australia, it is not on the schedule and not funded, available only by prescription and the cost varies from chemist to chemist, anywhere from $120 to $180 per dose.

So, over here it is recommended for certain age groups, but not funded.

Children aged <5 years, particularly infants aged <1 year, have the highest incidence of invasive meningococcal disease (IMD) caused by serogroup B meningococci (MenB). A lower, secondary peak in incidence is evident in late adolescence and early adulthood.
Bexsero® (4CMenB) is a recombinant multicomponent meningococcal B vaccine that induces specific bactericidal antibodies against a range of MenB strains. In Australia, based on laboratory tests, about 76% of MenB strains are predicted to be covered by this vaccine, but clinical effectiveness has not yet been shown.
http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi-advice-bexsero

4CMenB is recommended for these groups:
Infants and young children, particularly those aged <24 months
Adolescents aged 15 to 19 years
Children and adults with medical conditions that place them at a high risk of IMD, such as functional or anatomical asplenia or complement component disorders
Laboratory personnel who frequently handle Neisseria meningitidis.
Interestingly, Canada has a different perspective.

In developing the recommendations, NACI and MBPPTG considered the burden of illness from IMD, the safety and immunogenicity of the newly authorized 4CMenB vaccine, as well as other aspects of overall immunization strategies. MBPPTG further considered social and economic cost benefits, acceptability, feasibility, equity, ethical, and political considerations.
http://www.phac-aspc.gc.ca/naci-ccni/mening-4cmenb-exec-resum-eng.php

Recommendations of NACI and MBPPTG for the use of the multicomponent meningococcal B vaccine in Canada are limited by the lack of evidence and the range of uncertainty of the underlying assumptions, particularly those concerning vaccine’s coverage of circulating strains, herd immunity, effectiveness and potential adverse effects of vaccination at the population level. These recommendations will be updated at the time new data becomes available. Epidemiological, economic and other local programmatic/operational factors will be considered by provinces and territories when deciding on the inclusion of the following recommendations in publicly funded immunization programs.
So, according to the Canada's National Advisory Committee on Immunization (NACI)...

Who should receive this vaccine?

Immunization of individuals (≥2 months of age) should be considered under the following circumstances:

If they are at high risk of meningococcal disease caused by serogroup B N. meningitidis.
If they have been in close contact with a case of IMD caused by serogroup B N. meningitidis.
If they are at risk during IMD outbreaks caused by serogroup B N. meningitidis or the emergence of hyperendemic and/or hypervirulent N. meningitidis strains that are predicted to be susceptible to the vaccine based on Meningococcal Antigen Typing System (MATS) testing.

Currently, it is not recommended to include the multicomponent meningococcal serogroup B (4CMenB) vaccine in routine immunization programs for Canadian infants, children, adolescents and adults.
And their ultimate finding?

The scientific evidence regarding the novel multicomponent meningococcal serogroup B (4CMenB) vaccine Bexsero® has been reviewed in order to provide medical, scientific, and public health advice on the use of the vaccine in the Canadian population.

Given the current available information on the burden of IMD in Canada, as well as the lack of evidence and the range of uncertainty of the underlying assumptions, particularly those concerning the predicted level of strain susceptibility, duration of protection, impact on meningococcal carriage and herd immunity, and potential adverse effects of vaccination at the population level, a recommendation for the implementation of a routine immunization program for meningococcal serogroup type B in Canada cannot be made at this time.

Future research and surveillance activities should address the potential of 4CMenB vaccine to protect against Canadian meningococcal B strains and other meningococcal serogroups, as well as address issues around vaccine safety, vaccine efficacy, duration of protection, herd immunity, carriage, special populations and surveillance needs.
The CDC's Advisory Committee on Immunization Practices (ACIP) recommends that Trumenba and Bexsero be given to:

people 10 years or older who are at increased risk for serogroup B meningococcal infections, including:

People at risk because of a serogroup B meningococcal disease outbreak
Anyone whose spleen is damaged or has been removed
Anyone with a rare immune system condition called “persistent complement component deficiency”
Anyone taking a drug called eculizumab (also called Soliris®)
Microbiologists who routinely work with N. meningitidis isolates.

These vaccines may also be given to anyone 16 through 23 years old to provide short term protection against most strains of serogroup B meningococcal disease; 16 through 18 years are the preferred ages for vaccination.
http://www.cdc.gov/vaccines/hcp/vis/vis-statements/mening-serogroup.html

Finally, here was also the rationale behind ACIP's recommendation...

The available data suggest that MenB vaccines might be an important step for controlling serogroup B meningococcal disease. Although current data suggest they will protect against the majority of currently circulating strains, these vaccines are not expected to provide protection against disease caused by all serogroup B strains circulating in the United States. Additional studies assessing breadth of strain coverage are ongoing, and ACIP will review results as they become available. Immune responses following MenB vaccination in the studies described were evaluated after completion of the primary immunization series, but no data are available on vaccine effectiveness against clinical disease endpoints or duration of protection against clinical disease. On the basis of the limited available data, no concerning patterns of serious adverse events have been reported for MenB vaccines; additional safety data and postlicensure safety surveillance data are needed and will be reviewed by ACIP as they become available. In addition, the potential impact of MenB vaccines on nasopharyngeal carriage and herd protection is inconclusive, as is the potential impact vaccine introduction might have on the population of Neisseria meningitidis.
After reviewing the available data, ACIP supported consideration of vaccination of all adolescents rather than college students only, primarily because an important number of serogroup B meningococcal disease cases occurs in persons aged 18–23 years who are not attending college, and vaccinating college students only is estimated to prevent the fewest cases and deaths among all the options considered (Table 2). However, ACIP also acknowledges the impact that cases and outbreaks have on college campuses, both in terms of the cost for vaccination campaigns in response to these outbreaks as well as public concern. On the basis of the available antibody persistence data, ACIP concluded that a preference to administer the MenB series in later adolescence exists, preferably at age 16–18 years, to maximize the likelihood that protection would last into the highest age-related risk period.
The current low prevalence of disease, coupled with the fact that important data for making policy recommendations for MenB vaccines are not yet available, resulted in ACIP determining that insufficient evidence exists to make a routine public health recommendation that all adolescents be vaccinated with MenB vaccine. Given the seriousness of meningococcal disease and the availability of licensed vaccines, ACIP agreed that sufficient evidence exists to encourage individual clinical decision making.
Thus...

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 (recommendation Category B).
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6441a3.htm

It was interesting to observe one of the points made by one of the voting members of ACIP regarding the potential cost of instituting universal funded vaccination for Men B in light of the petition circulating in the UK:

Family physician and ACIP voting member Douglas Campos-Outcalt, M.D., M.P.A., of Phoenix, told AAFP News that another concern linked to the B recommendation was paying for universal vaccination of those ages 16-23, which he estimated would cost roughly $2 billion to $4 billion, while the number of infections and deaths prevented would be very few. The entire CDC budget is $6 billion to $7 billion, he pointed out.

"I do not want to downplay the significance of a death from meningitis -- each death takes a human toll -- I just want to put this debate on meningococcus B into perspective," Campos-Outcalt said.
http://www.aafp.org/news/health-of-the-public/20150701acipmtg.html

I think these divergent opinions highlight some key issues with the Men B vaccine(s) available, some issues that pertain to those of us who are S&D families. No doubt invasive meningococcal is a truly terrifying illness. However, the lack of data on effectiveness and duration of protection can't be just set aside. Canada notes that there is a "lack of evidence." The US keeps referring to its use as "short term protection." Thus, why the recommendation for it to be used on young children in Australia when we have no idea how long the protection will last and there has been no mention of what will be required as booster doses for this cohort once they reach their teens and the higher risk group again?

I have a child who is 12 this year and will start attending a Grade 7-12 high school next year, so this is not just some theoretical exercise. However, it's difficult for me to jump onboard with Bexsero when there's such a lack of data and evidence from which to make an informed decision. It's a bit concerning that Australia is recommending it for all 15-19 year olds when there's just no evidence for its effectiveness yet and the UK can't even recommend it for this age group using a cost effectiveness analysis.
 

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I have a lot of thoughts about this and a busy morning ahead of me--not a good combination. I hope to tackle a post with some insights later this evening.

Every time I hear dogma about "scientific consensus," I want to point the absolutists to the Bexsero issue.
 

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Meningitis is the only VPD I've seen in person. A friend was a track star, we were going into 8th grade. She got sick and died in less than 3 days. I'm getting it for my boys.
If my only meningitis b vaccine option is less effective than hoped or doesn't last as long as hoped, that's still no reason to dismiss the vaccine altogether for me.
 

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Discussion Starter · #5 ·
I have a lot of thoughts about this and a busy morning ahead of me--not a good combination. I hope to tackle a post with some insights later this evening.

Every time I hear dogma about "scientific consensus," I want to point the absolutists to the Bexsero issue.
I think something else that has been bothering me as well is the fact that since it is only available privately and each Australian family will have to pay anywhere from about $240 to $540 per child depending on the chemist's prices and the doses required, this is a pretty significant ask considering it's a product whose "clinical effectiveness has not been shown" in ATAGI's words. So, as consumers, we could be paying this amount of money per child on something that we hope works, but as yet, there's been no data that it actually does. As NACI noted, no evidence as yet on "duration of protection, impact on meningococcal carriage and herd immunity, and potential adverse effects of vaccination at the population level."

Australia has some serious consumer law. They've also been noted as leaning in on the supplements market in recent years, yet it's okay I suppose to recommend that parents pay hundreds of dollars for a product that we're not sure actually works yet to prevent invasive meningococcal B disease.
 

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Discussion Starter · #6 · (Edited)
Meningitis is the only VPD I've seen in person. A friend was a track star, we were going into 8th grade. She got sick and died in less than 3 days. I'm getting it for my boys.
If my only meningitis b vaccine option is less effective than hoped or doesn't last as long as hoped, that's still no reason to dismiss the vaccine altogether for me.
That's your choice by all means. One issue I have is that if the protection is short-lived as the US states it is, and there's only two or three doses on the schedule depending on age and no boosters scheduled, then by the time the kids vaccinated in early childhood reach the second critical risk period, they might be essentially, for all purposes, non-immune or presumably as susceptible as anyone not vaccinated. Right now, the information I have of Bexsero says "no boosters required." So, as to if kids vaccinated in primary school will still have immunity by high school is anyone's guess...and according to epidemiological data, that's apparently when they need it. The age group with the second highest risk of IMD is teens and young adults.

That is part of a problem with putting a vaccine out there with no data yet. Just questions and no answers. I keep rereading the same info about "we will learn more in years to come." Tough to make good policy on no evidence.
 

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That's your choice by all means. One issue I have is that if the protection is short-lived as the US states it is, and there's only two or three doses on the schedule depending on age and no boosters scheduled, then by the time the kids vaccinated in early childhood reach the second critical risk period, they might be essentially, for all purposes, non-immune or presumably as susceptible as anyone not vaccinated. Right now, the information I have of Bexsero says "no boosters required." So, as to if kids vaccinated in primary school will still have immunity by high school is anyone's guess...and according to epidemiological data, that's apparently when they need it. The age group with the second highest risk of IMD is teens and young adults.

That is part of a problem with putting a vaccine out there with no data yet. Just questions and no answers. I keep rereading the same info about "we will learn more in years to come." Tough to make good policy on no evidence.
I think that's why they're recommending it for 16-18, although I wish we could get it a bit earlier and just do boosters. My friend was 13, it would have been too early for her to have gotten it back then.
 

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Discussion Starter · #8 · (Edited)
I think that's why they're recommending it for 16-18, although I wish we could get it a bit earlier and just do boosters. My friend was 13, it would have been too early for her to have gotten it back then.
I'm so sorry for the loss of your friend. It is a terrifying and tragic illness, just because at the speed it strikes.

I think the questions about duration of protection and overall effectiveness are ones that we need answers to as soon as possible. That said, given the protection might be so short lived, it only makes sense if someone is planning to get Bexsero for their kids, to time it for the years when they are at highest risk. Although, like I mention, that presents a conundrum for parents whose children had the full schedule of it in their baby/toddler years, and there are then no boosters as yet on the schedule for their teen years. I guess we have 10-15 years for the cohort of infants and toddlers receiving it now to reach the next highest risk group and we'll see how it plays out in the data by then.
 

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Having seen meningitis in person yes, it's terrifying. I babysat a baby as a teen who had meningitis. I remember seeing her in the hospital, and babysitting her when she came home. It was heartbreaking.

That doesn't mean I would jump on board with this vaccine right away. There are still too many questions, like the Canadian government points out. It's not on our schedule anyway so it's a moot point because I don't have access to it, but I think japonica's point about it possible leaving kids vulnerable at the worst possible times is very valid.


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Having seen meningitis in person yes, it's terrifying. I babysat a baby as a teen who had meningitis. I remember seeing her in the hospital, and babysitting her when she came home. It was heartbreaking.

That doesn't mean I would jump on board with this vaccine right away. There are still too many questions, like the Canadian government points out. It's not on our schedule anyway so it's a moot point because I don't have access to it, but I think japonica's point about it possible leaving kids vulnerable at the worst possible times is very valid.


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It's totally valid, I wish they would start the series at 12 and do boosters at 16 and 18.
 

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It's totally valid, I wish they would start the series at 12 and do boosters at 16 and 18.

It doesn't really seem like we have the research to show that's safe though, unless I'm missing something. We can't just throw booster shots at everything and hope it's ok.


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Discussion Starter · #12 · (Edited)
It doesn't really seem like we have the research to show that's safe though, unless I'm missing something. We can't just throw booster shots at everything and hope it's ok.


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I think, Kait, that's the concern as well. The infant series was observed to often cause "systemic reactions" notably high fevers, to an extent that with every bit of official advice and product insert I read, there was a snippet on prophylactic acetaminophen/paracetamol dosage.

http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/1C08CC86CFF8FE00CA257E29000F7E06/$File/ATAGI-advice-bexsero.pdf

https://www.gov.uk/government/uploa...408/9413-paracetamol-menB-2page-A4-08-web.pdf

The teens seemed to fare a little better, but they reported more adverse effects compared to the "placebo" (likely the Men C vaccine)...

In adolescents, the incidence rates of local reactions were higher in the Bexsero group than in the placebo group. The most commonly reported local reaction after any Bexsero dose was pain, followed by erythema. The incidence rate of the individual systemic reactions was slightly higher in the Bexsero group than in the placebo group. The most commonly reported systemic reactions after any Bexsero dose were malaise, myalgia and headache. A higher percentage of subjects stayed home after each dose compared with the placebo group. Limited safety data were available in individuals from 18 to 50 years of age.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php

I'm a little bit concerned, reading the Canadian SBD, about the study group of adolescents and how that data may not adequately reflect the situation in Canada or Australia...

For adolescents (11-17 years), a study in Chilean adolescents supports at least a two-dose priming in this age group. However, most of the subjects live in an MenB endemic region and might be exposed to the MenB strains that cross-react to the reference strains. Health Canada requested data from Canadian adolescents and these were provided in the response to the NOD. The results confirmed the difference of pre-immune status between the two regions. Following immunization, the GMTs against all three tested antigens (fHbp, NadA and PorA) and the seropositive rate of PorA were lower in Canadian adolescents than in Chilean adolescents. However, the study supports the two-dose schedule in Canadian adolescents.
How does Men B being endemic in the region of the study group affect the results?

Antibodies against the three antigens in the Chilean adolescents were maintained at a high level (% seropositive rate) 18 to 23 months after two doses.
Could this be perhaps because the teens in this study are exposed to Men B at a much higher rate than what we would expect of teens who did not live in an endemic region? Or how did their pre-immunity factor in? It was noted in the quote above that the Canadian teens seroconverted in lower numbers to one of the antigens compared with the Chilean teens.

Anyway, again, lots of questions, but more data required. The Canadian SBD has a list of what they would like to see from the manufacturer post-market:

The persistence data of bactericidal antibodies after the administration of two catch-up doses of Bexsero in children 2 to 10 years of age.
The data from ongoing study V72_28 and its extension study V72_28E1 in infants 6-12 months of age.
The persistence data of bactericidal antibodies, including antibodies against Neisseria Heparin Binding Antigen in Canadian adolescents.
Explore possibilities for conducting observational post-market safety and effectiveness studies, and generate a bi-annual Periodic Benefit Risk Evaluation Report.
Health Canada has apparently also started a safety review of Bexsero to address the issue of "Safety of vaccination with Bexsero in older patients."

http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/new-nouveaux-eng.php

That's probably part of the reason Health Canada has been reluctant to make that recommendation for routine Men B immunisation...they cited in the paragraph I quoted in the first post that they had to take into account the "potential adverse effects of vaccination at the population level," so given that Bexsero seems to generate more adverse reactions than the placebo in the trials, health authorities have to ascertain if a primary 3 doses schedule followed by boosters at age 10, 13, and or 16 is feasible (given what we've seen so far of the questionable antibody persistence, we have to assume kids would be needing boosters every few years).
 
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