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Discussion Starter · #1 · (Edited)
This was published in July, but just noticed it in my newsfeed today.

http://www.medpagetoday.com/infectiousdisease/vaccines/59237

One-third of college students vaccinated for group B meningococcal disease during an outbreak on campus produced no immune response to the outbreak strain, though nearly all responded to the two strains included in the vaccine, researchers examining the December 2013 outbreak at Princeton University found.
Moreover, among the two-thirds who did develop antibody titers against the outbreak strain, many showed very weak responses, according to a report appearing Wednesday in the New England Journal of Medicine.
I know there's some of us who were thinking about the Men B vaccine and had questions about the effectiveness.

Overall, geometric mean concentrations of antibody titers against the disease strain were low, even among students who had received two doses of the vaccine (7.6, 95% CI 6.7 to 8.5), the authors wrote. With only about two-thirds of vaccinated students producing an immune response, that left 33.9% of vaccinated students who did not respond to the 4CMenB vaccine.
"I think receiving a vaccine that induces a response in a majority of people, even if not everyone develops an immune response to every strain of the pathogen, is really a better idea than skipping vaccination altogether," she said. "For many years, we didn't have any vaccines against meningococcal B disease in the U.S., so this is really a revolutionary development to now be able to protect against meningococcal B with a vaccine."
I guess the question is, if we are paying out of pocket for it (it's not recommended in Canada at this time and in Australia, it's only recommended for teens, but not covered, so parents have to pay anywhere from $450 to $600 for the series), is it "worth it" to pay for a vaccine that induces weak immunity or that doesn't generate an immune response at all?

Also, how will parent know unless they run titres afterwards? Is there not a false sense of security in thinking you "did the right thing" and your child is protected, but she is actually not?

I'm very much of the "wait and see" with Bexsero etc. But this is concerning. If the efficacy is questionable, and we have to pay out of pocket for it, this will affect if we get this one (and when).
 

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Discussion Starter · #2 · (Edited)
The other interesting question is how do these findings then relate to Australian consumer law? There are some pretty stringent consumer laws here in Australia. A product must perform as advertised or be liable for penalty if it does not. The consumer is entitled to a refund or replacement. Medications must perform as advertised. If the manufacturers claim that it protects against meningococcal B and induces immunity, especially as consumers are paying hundreds of dollars for this product, and titre results indicate no immunity generated for almost 34%, what does that mean legally with regards to Australian law?

Here's what happened with Nurofen last year...

https://www.accc.gov.au/media-release/court-finds-nurofen-made-misleading-specific-pain-claims

“Truth in advertising and consumer issues in the health and medical sectors are priority areas for the ACCC, to ensure that consumers are given accurate information when making their purchasing decisions.”
“Any representations which are difficult for a consumer to test will face greater scrutiny from the ACCC,” Mr Sims said.
 

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The other interesting question is how do these findings then relate to Australian consumer law? There are some pretty stringent consumer laws here in Australia. A product must perform as advertised or be liable for penalty if it does not. The consumer is entitled to a refund or replacement. Medications must perform as advertised.
How much burden of proof do they require to support claims about the pharmaceutical product? Is a healthy experimental sample plus a healthy pseudo-placebo group enough for the government? I can think of a couple of vaccines that should have been called out in Australia by now.
 

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Discussion Starter · #4 ·
I think the legality only comes into play with claims about what the product can do. I haven't read the fine print on the manuacturer's insert, but if it's written with enough waffle in the language "may prevent infection," "efficacy not established," then they won't run afoul of consumer law. As to whether it's ethical though to charge hundreds of dollars to families for a product that may or may not work is another question.
 
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