Tag: hexavalent vaccine

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

What Is a Hexavalent Vaccine?

Most folks know that we have combination vaccines that help reduce the number of injections that kids have to get at one visit.

You might not think of it as a combination vaccine, but one of the first, DPT, simply combines protection against diphtheria, pertussis, and tetanus into one shot.

Of course, we have come a long way since the days when DPT and MMR were considered combination vaccines.

Wait, why aren’t they considered combination vaccines anymore?

It’s not part of any conspiracy. It’s simply because you can’t get their individual components separately anymore. There is no measles or rubella shots anymore. Just the MMR. There is no tetanus shot.

Combination Vaccines

Not surprisingly, it is now becoming routine for kids to get combination vaccines instead of separate shots.

That’s because while the great majority of us want our kids vaccinated and protected, few enjoy shots and needles.

“The use of licensed combination vaccines is preferred over separate injection of their equivalent component vaccines.”

AAP on Combination Vaccines for Childhood Immunization

Does this mean more vaccines at one visit?

Nope.

“So, at a doctor’s visit, your child may only get two or three shots to protect him from five diseases, instead of five individual shots. Fewer shots may mean less pain for your child and less stress for you.”

CDC on Combination Vaccines

It just means fewer injections.

Combination vaccines combine the vaccines that you are already getting into one injection.

What Is a Hexavalent Vaccine?

And they might get even fewer with the latest hexavalent vaccines (six-in-one).

This is the next step up from our current pentavelent vaccines (five-in-one), like Pediarix (combines DTaP, Hep B, and IPV) and Pentacel (combines DTaP, IPV, and Hib).

The hexavalent vaccines combine protection against diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type B, poliovirus and hepatitis B (DTaP-Hib-IPV-HepB) into one injection.

Sounds good, right?

Although not approved in the United States, hexavalent vaccines, including Infanrix Hexa have been used in many other countries since 2000! Another, Hexavac was withdrawn from the market because of issues with waning hepatitis B antibody titers (kids had levels that were still protective, but were on the low side).

When will get a hexavalent vaccine in the United States?

Obviously, the early problems with Hexavac kept us from getting a hexavalent vaccine, at least before the next generation of vaccines was developed.

Hexavalent vaccines are widely available in most parents of the world.
Hexavalent vaccines are widely available in most parents of the world.

Two new hexavalent vaccines, Vaxelis and Hexyon, have recently been licensed in Europe, after many studies showed that they worked and were safe when given with all of the other vaccines on the schedule, including Prevnar, rotavirus, Men C, and MMRV.

And one of these might soon be coming to the United States.

Vaxelis

V419 (Vaxelis), which was developed in collaboration between Merck and Sanofi Pasteur, has been under review by the FDA since 2014 has already received a Complete Response Letter that was “deemed complete and acceptable for review.”

And it was approved by the FDA on December 21, 2018.

Remember, that could mean just two shots at infant well check ups, but continued protection against eight vaccine-preventable diseases, as they get a hexavalent vaccine, Prevnar and the rotavirus vaccine!

It may be at least another year before Vaxelis makes it way to your pediatrician’s office though.

More on the Hexavalent Vaccine