New hexavalent vaccine protects children against 6 diseases

hexavalent vaccine

On 26 December 2018, Sanofi and Merck jointly announced (pdf) FDA approval for a new hexavalent vaccine called Vaxelis. The new vaccine was developed to vaccinate children aged 6 weeks to 4 years old to protect them against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and Haemophilus influenzae type B (also known as Hib). Sanofi and Merck stated that the companies are setting up production, and the vaccine should be available in the USA by 2020.

This new (for the USA) hexavalent vaccine is intended for intramuscular injection as a 3-dose series given at 2, 4, and 6 months of age. However, the initial dose may be given to infants as early as 6 weeks. The vaccine may be used to complete the hepatitis B immunization series. However, one additional dose of a pertussis-containing vaccine must be added to the 3-dose hexavalent vaccine schedule to complete the immunization against pertussis.

This vaccine will reduce the number of separate vaccinations from at least 4 down to 1. Reducing the number of times an infant needs to receive a shot is a benefit to the child, the parents, and the healthcare workers who perform the vaccinations.

Sanofi, Merck, and GSK have produced various formulations of this hexavalent vaccine outside of the USA since 2000. Merck and Sanofi submitted the application for this vaccine to the FDA in 2014 after completion of phase III clinical trials, which included over 1400 infants. The clinical trial showed that the new vaccine was equivalent, in terms of safety and effectiveness, to the older series of individual vaccines.

As discussed previously, spurious claims that hexavalent vaccines lack antigens and other nonsense have been debunked.

I am not sure why this vaccine took nearly two decades to reach the US market, but I’m sure someone in the anti-vaccine religion will invent some ridiculous conspiracy theory to say why. Nevertheless, this hexavalent vaccine is a very important addition to the list of vaccines available in the USA.

In spite of the FDA approval, the CDC’s Advisory Committee on Immunization Practices will need to review all of the data again before making a recommendation to change the US vaccination schedule. That will probably happen during the next couple of years.

This new hexavalent vaccine is a great benefit to preventing diseases that harm our children. I’m glad it’s coming to the USA.

Citations

Debunking the claim that vaccines kill people using real scientific evidence

Vaccines kill

The anecdotal beliefs from the anti-vaccine religion that vaccines kill babies, children, and adults (warning, the link is from Natural News, one the worst websites for scientific credibility) is frustrating. Dorit Rubinstein Reiss and I have written two articles, about Nick Catone and Colton Berrett, that refute parental claims that vaccines killed their children. Those boys deaths were tragic, but according to the best evidence we have, neither were the result of vaccines.

Deaths attributed to vaccines are often not causally related. It may feel like one event that follows another event is related, which is the post hoc ergo propter hoc fallacy. There may not be any correlation, let alone causality, that would make us accept that vaccines kill.

Those of us who accept the fact that vaccines are very safe, and indeed, not really a risk for causing death, have found no evidence that there has been a single death attributed to vaccines over the past couple of decades. But that’s just examining the high quality scientific and medical literature, which may or may not be 100% inclusive of all post-vaccination mortality.

Now, I’ve always contended that there is no evidence that there has ever been a death attributed to vaccines. I never agreed with the old adage that “science can’t prove a negative,” but I do think that the burden of proof is on those making that claim. Where is the evidence of a link between vaccines and mortality? Sometimes, the absence of evidence can be evidence of absence, Carl Sagan’s claims notwithstanding, especially if we look very carefully for that evidence.

Let’s move on to this pivotal study in our understanding of whether vaccines kill. They don’t.

Continue reading “Debunking the claim that vaccines kill people using real scientific evidence”

Anti-vaccine scientists (cough, cough) republish a retracted article

Anti-vaccine scientists

Here we go with the same old story that I’ve pursued for years – the one about University of British Columbia researchers, Christopher Shaw and Lucija Tomljenovic, who are amongst the most laughable anti-vaccine scientists (and I use the word “scientist” very loosely) to ply their pseudoscientific nonsense onto the world. Their articles are regularly retracted by even minor journals, but like zombies, those articles return to life in even more obscure, minor journals.

Despite the utter junk that Shaw and Tomljenovic publish, the anti-vaccine religion embraces them like they are prophets of the impending apocalypse of vaccines. Every time one of their pseudoscientific papers gets published, even after devastating critiques, the anti-vaccine zealots embrace it without reservation.

So one more paper by the University of British Columbia team gets retracted, and then comes back to life in some other obscure journal. Do you really think I’m going to ignore piling on to Shaw and Tomljenovic? Oh hardly. This is why I have this website. Continue reading “Anti-vaccine scientists (cough, cough) republish a retracted article”

Anti-vaccine pseudoscience – Shaw, Tomljenovic, and tetanus vaccine

anti-vaccine pseudoscience

I’m beginning to feel some deja vu, since I am criticizing another anti-vaccine pseudoscience paper foisted onto the world by Christopher Shaw and Lucija Tomljenovic. These two University of British Columbia (UBC) researchers in the Department of Ophthalmology (you know, the study of eyes) have no background or training in any area vaccine research, including immunology, epidemiology, microbiology, virology or anything else remotely related. Yet they keep publishing anti-vaccine pseudoscientific junk medicine.

Yet, every time these anti-vaccine shills publish anti-vaccine pseudoscience articles in low ranked journals, the reactionaries jump all over it and try to use those articles as “science” to dismiss the scientific fact of vaccine safety and effectiveness. Except for one small matter – Shaw and Tomljenovic have a long record of retracted articles (here and here), publishing their “research” in low impact factor, predatory “pay-to-play” journals, and pushing anti-vaccine pseudoscience that has been hammered by respected scientific organizations like the World Health Organization (WHO).

Yes, many of us are wondering why UBC hasn’t tossed both of them out of the university for research malfeasance, but that’s not the point here. We’re just going to rip apart the anti-vaccine pseudoscience presented in another article from Shaw and Tomljenovic.  Continue reading “Anti-vaccine pseudoscience – Shaw, Tomljenovic, and tetanus vaccine”

RFK Jr and vaccine safety – using a bad study to come to bad conclusions

RFK Jr and vaccine safety

Yesterday, Dorit Rubinstein Reiss explained why most experienced journalists ignore Robert F. Kennedy Jr’s views on vaccines. He gets simple facts about vaccines completely wrong again and again. She was referencing an interview Kennedy had given on Fox News – as a part of that interview, Kennedy misused a small study about the DTaP vaccine (for diphtheria, tetanus and pertussis, or whooping cough). Unfortunately, RFK Jr and vaccine safety of DTaP has continued – he has doubled down on misusing this study in an article by him published today.

I thought we would take a look at the issues specific to this new version of RFK Jr and vaccine safety – we’ll analyze his comments and then take a detailed look at the published article that forms the basis of Kennedy’s comments. Continue reading “RFK Jr and vaccine safety – using a bad study to come to bad conclusions”

Freedom to ignore French vaccination program – a court case

french vaccination program

Samia and Marc Larère, parents to a three year old and fifteen months old, have decided not to vaccinate them. A criminal charge was brought against them, by the government of France, for not giving their three year old the required vaccines against diphtheria, tetanus and polio according to the French vaccination program.

They were charged under two legal provisions–a provision in the Code of Public Health (le code de la santé publique, art. L.3116-4) that imposes a find of 3750 euros and up to six months in jail for those who do not receive, or allow those under their guardianship to receive, mandatory vaccinations, including parents (“Le refus de se soumettre ou de soumettre ceux sur lesquels on exerce l’autorité parentale ou dont on assure la tutelle aux obligations de vaccination prévues aux articles L. 3111-2, L. 3111-3 et L. 3112-1 ou la volonté d’en entraver l’exécution sont punis de six mois d’emprisonnement et de 3 750 Euros d’amende”).

And a provision in the criminal code that criminalizes neglect of parental duties “to the point of risking the health… of a minor child”, with a fine of 30,000 euros and up to two years in prisons as penalty (article 227-17: “Le fait, par le père ou la mère, de se soustraire, sans motif légitime, à ses obligations légales au point de compromettre la santé, la sécurité, la moralité ou l’éducation de son enfant mineur est puni de deux ans d’emprisonnement et de 30 000 euros d’amende”).

The reason the Larères initially gave for declining to vaccinate their child was that they could not give her only the required vaccines–the only available vaccines, they said, had the required vaccines in combination with others, like Hepatitis B and meningococcal, which are not legally required and they were not willing to give the combination vaccine to their child.  Upon further probing, however, the couple admitted they received a vaccine containing only the required vaccines from Sanofi Pasteur, but still refused to vaccinate claiming that the vaccine contained a “toxic product”.

It may have been this vaccine (pdf). It’s unclear which ingredients they were referring to. The product contains a number of ingredients that may be used to raise concern among those unfamiliar with their role in vaccines and the principle that the dose makes the poison. In fact, in the tiny amounts in vaccines (pdf), none of these ingredients is toxic (pdf). Continue reading “Freedom to ignore French vaccination program – a court case”

Pertussis vaccine reduced length and severity of whooping cough

Except for the evidence that says it's not a failure.
Except for the evidence that says it’s not a failure.

I know, there are just so many tropes and outright lies pushed by the vaccine deniers, it’s really hard for this writer to keep up with it all. But there’s one that has always bothered me, but I didn’t have quite enough evidence to lustfully debunk in my usual manner.

As has been shown in few studies, the vaccine against whooping cough (Bordetella pertussis), either  DTaP or Tdap (which also protect against tetanus and diphtheria), isn’t as effective in providing long-term protection as our expectations, based on other vaccines. Although the antivaccination cult has misinterpreted and misstated the actual numbers, an analysis of the data from the Washington State pertussis epidemic in 2011-2012 provided us with the following information:

  • Ages 5-9 unvaccinated or under vaccinated children are 6 times more likely to become infected with pertussis than fully vaccinated. 
  • Ages 10-13 unvaccinated or under vaccinated are 25 times more likely to become infected with pertussis than fully vaccinated. 
  • Ages 14-18 unvaccinated or under vaccinated  are 6 times more likely to become infected with pertussis than fully vaccinated.

In other words, not getting the vaccine made it easier to get infected with whooping cough. Continue reading “Pertussis vaccine reduced length and severity of whooping cough”

How vaccines saved millions of lives

Infographic: How People Died In The 20th Century

 

Over 5.2 billion people died in the 20th Century. Although the 20th Century ended a mere 13 years ago, from a statistics standpoint, we know we will probably die of different diseases (and other less natural causes) than our forebears. The causes of death evolve over time as medicine improves, science ameliorates risk, lifestyles change, environments shift, and politics reshape our world. British data journalist David McCandless (of Information is Beautiful) created this fascinating infographic based on a project, commissioned by the Wellcome Trust, a U.K. charity devoted to human health, called Death in the 20th Century, which shows us, graphically, the leading causes of mortality from 1900 to 2000, worldwide. 

Some of the numbers are shocking. Humanity is the cause of nearly 1 billion (or just short of 20%) of the deaths in the 20th Century. These numbers include war, murders, religious intolerance, suicide, and other deadly crimes that humans perpetrate against one another. Maybe the 21st Century will knock that number down, though I doubt any of us are optimistic given the way this century has started.

But the most interest information is in the Infectious Disease section. Nearly 1.7 billion people have died from infectious diseases. Some of the more interesting numbers are:

In the 21st Century, the numbers of deaths from these diseases will probably be in the few thousand worldwide. Why? Because of vaccines. Not better sanitation. Not better health care facilities. But because of vaccines.

And in the 21st Century, as more vaccines are developed and brought to market, many of these infectious diseases will be less of a problem. 

Vaccines saves lives. Literally hundreds of millions of lives.

Use the Science-based Vaccine Search Engine.

 

Debunking the “vaccines aren’t tested” myth

There are so many silly memes that have arisen from the anti-vaxxers, all of which have been thoroughly debunked. Everything from the well-worn (and worn-out) “vaccines cause autism” fable, quashed here, to the “these diseases aren’t dangerous”, which, of course, couldn’t be farther from the truth. One of the more annoying of the tales pushed by the vaccine denialists is that vaccines aren’t tested thoroughly before being used on unsuspecting infants. I do not know where this started, or why it started, but like much in the anti-vaccination world, it really doesn’t matter. It just passes from one person to another across google, and individuals with no research background hold this particular belief as if it were the Truth™. Continue reading “Debunking the “vaccines aren’t tested” myth”

Whooping cough: Kansas outbreak grows (update)

Tdap vaccine. ©CNN, 2012

On June 11, it was reported that the recent outbreak of whooping cough (Bordetella pertussis) in Johnson County, Kansas, has grown by 65 cases to a total of 175 cases since the beginning of the year. The Johnson County health department has issued a warning (pdf) about the outbreak, requesting that children and adults get the vaccine and to be aware of symptoms. To prevent the spread of the disease, the health department is requesting that people who are being treated for the disease with antibiotics stay home for 5 days, and those we are refusing to be treated, stay home for 3 weeks. Continue reading “Whooping cough: Kansas outbreak grows (update)”