Tag: Infanrix Hexa

The Latest Anti-Vaccine Bombshell on Infanrix Hexa is Just Another Dud

There are a lot of things about the latest anti-vaccine bombshell that won’t surprise you

For one thing, the “bombshell” isn’t recent. Anti-vaccine folks are just re-posting it now because a new hexavalent vaccine just got FDA approval.

The Latest Anti-Vaccine Bombshell on Infanrix Hexa is Just Another Dud

What about the 1,271 page confidential GSK document that was leaked to the press?

It was actually a document that was submitted as part of an Italian court case.

What about the idea of “missing deaths” and under-reporting of vaccine deaths?

“Before specifically addressing your analysis, it’s important to note that the issue of whether there is an increased risk of Sudden Infant Death following vaccination generally and following vaccination with DTP-containing vaccines more specifically is one that has been considered and thoroughly evaluated not only by GSK but also by a number of world-renowned regulatory agencies and public health authorities, including the European Medicines Agency, the US Centers for Disease Control and Prevention and the World Health Organization. The clear consensus amongst such agencies and authorities is that one cannot reasonably conclude, based on available data and information, that there is a causal relationship between vaccination generally or vaccination with Infanrix hexa and Sudden Infant Death.”

Dr. Norman Begg, Chief Medical Officer, GSK Vaccines on Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency

It’s no bombshell that this is all propaganda and these issues have been thoroughly investigated. Or that someone got a “study” that manipulated and misinterpreted data published in a predatory journal.

The idea that the hexavalent vaccines could be causing unexplained cases of sudden infant death shortly after vaccination began after a few case reports from Germany in 2003. Further studies, including a large study in Italy, found no risk.

What about the idea of “missing deaths” in safety reports from the manufacturer?

If there are so many "missing deaths," then why is the cumulative number of deaths higher in the latest report?
If there are so many “missing deaths,” then why is the cumulative number of deaths higher in the latest report?

Of course, there are no missing deaths.

I found the “missing deaths” that Puliyel talks about in his Infanrix hexa paper – in the GSK report he used to write his “study.”

The GSK report explains that twelve deaths were excluded from analysis, apparently eight from the first year (101 cumulative) and three from the second year (five cumulative), which is why the cumulative deaths dropped from eight to five.

Why?

“A cumulative review of Sudden Death (SD) since launch has been performed. Follow-up information received for older cases was taken into account. Design of the below observed to expected analysis was revisited in view of comments EMA expressed in the assessment report of PSUR 15-16 (dated 26 April 2012).”

GlaxoSmithKline Biological clinical safety and pharmacovigilance’s confidential report to the EMA: PSUR 19, page 440

Keep in mind that these are cumulative deaths since they began using the vaccine in 2000, and which are below the expected background rates of SIDS.

Vaccines are safe.

Hexavalent vaccines are safe.

Do your research before buying into the next anti-vaccine bombshell that try to throw at you to scare you away from vaccinating and protecting your kids.

More on the Latest Anti-Vaccine Bombshell

What is Corvelva?

Have you heard of Corvelva?

People are dying of measles in Italy and groups like Corvela are pushing anti-vaccine propaganda to further scare folks away from vaccinating and protecting their bambini.
People are dying of measles in Italy and groups like Corvela are pushing anti-vaccine propaganda to further scare folks away from vaccinating and protecting their bambini.

Probably not, but they are getting some attention in the anti-vaccine world because they think that they have uncovered a Vaccingate!

What is Corvelva?

Specifically, they analyzed the Infranix Hexa vaccine, and instead of finding DTaP-IPV-HepB/Hib antigens, they think that they found “65 signs of chemical contaminants of which only 35% is known” and “7 chemical toxins.”

Should you be worried?

“Coming back to the two basic principles that have been our topic on this analysis path, we reaffirm what we have said in the recent interview on the scientific journal Nature: we are inquiring the vaccines efficacy and safety and we can’t quite understand how it is possible to claim that this vaccine is even able to generate the 6 protective antibodies – reason why it is designed for – and furthermore to understand how this cluster made of 6 neurotoxic antigens bound together can be claimed as not toxic for newborns.”

Corvelva on Vaccingate: Initial results on Infanrix Hexa chemical composition

Although they might not understand it, Infranix Hexa has been proven to be safe and has been proven to work. You can read study after study in well respected peer reviewed journals that say so.

The Corvela Vaccingate “study” wasn’t published in a well respected peer reviewed journal. It wasn’t even published in one of the typical bottom-feeder, pay-to-publish journals that anti-vaccine researchers frequently use.

What Corvela did was more like a very poorly done science fair project by a kid who got too much help from his anti-vaccine parents.

Using the Surface Activated Chemical Ionization-Electrospray-NIST Bayesian model database search (SANIST) platform is pretty cool, to be sure. But why are we supposed to believe that their method would actually deconstruct the Infanrix Hexa vaccine? Because that’s why they were trying to do – separate out all of the combined vaccine ingredients so that they could be detected by SANIST. The combined vaccine ingredients, including one of which is an emulsifier that keeps the ingredients from separating, in a 6-in-1 combination vaccine.

So what’s more likely? That the unnamed ‘scientists’ at Corvela, which is basically an anti-vaccine website in Italy, did the experiment wrong or that the Infanrix Hexa vaccine, which is used in countries all over the world, doesn’t contain any of the antigens that it is supposed to contain?

A previous study on vaccines that they also have posted to their website and to an open peer review site was not approved, getting a lot of criticism.

Have you figured out what Corvela stands for yet?

It’s Italian for covfefe.

More on Corvelva