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.


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”

Another flu vaccine myth – Big Pharma profits

another flu vaccine myth

There is a more general article – about the myth of Big Pharma vaccine profits – which has recently been updated and republished. 

The 2015-16 flu season is upon us, and that means it’s flu vaccine time again. And flu vaccine myth time. There is another flu vaccine myth – Big Pharma profits – that needs to be debunked.

Despite the availability of several flu vaccines, many people think that the flu is a painless, harmless disease, a belief belied by evidence. Wrong.

To put flu in perspective, in the USA, depending on the severity of the flu season, from 3,000 (which happened 25 years ago, and hasn’t been that low since) to 49,000 people die every year. Worldwide, about 250,000 to 500,000 people die from the flu every year. A flu pandemic, like the one in 1918, killed 50-100 million humans, much more scary than Ebola.

Of course, a fairly large group of people, including some who are pro-science (read, pro-vaccine), will fall into the arms of their favorite flu vaccine myth, and then refuse to get the flu vaccine. Given the dangers of the flu, and given the loss in productivity, income, and lives, you’d think that the flu vaccine would be near the top of health care needs for the average person.

My fellow blogger, Tara Haelle, spent numerous hours putting together the Top Myths about the flu vaccine. She debunks these myths completely out of the water. But antivaccination myths are never static, there’s always a new variant. Continue reading “Another flu vaccine myth – Big Pharma profits”

The breadth and depth of vaccine research

I have frequently stated that the breadth and depth of vaccine research, which provides solid evidence on the safety and effectiveness of vaccines, overwhelms the misinformation, logical fallacies, and conspiracies pushed by the Society for Promotion of Vaccine Preventable Diseases (that is, the antivaccine cult).

In other words, there is so much evidence, published in generally respected, high quality journals, that it is the basis of a pure, 24-karat gold scientific consensus about vaccine safety and effectiveness. Using just one search parameter, vaccines + efficacy + safety, there are over 4200 articles published over the past 55 years on vaccines. Other search parameters show even more results.

As I’ve said time and again, the only thing that matters to science is the quality and quantity of repeated evidence derived from a broad range of different studies. We’ve got that. Continue reading “The breadth and depth of vaccine research”

Improved high dose flu vaccine for seniors

flu-vaccine-seniorIt’s that time of year again, early autumn, when flu experts recommend getting the seasonal flu vaccine, especially for children and individuals over 65. Of course, if you don’t think you should get the vaccine, there’s a description for a person like you.

One of the issues that has been observed in the past is that the traditional flu vaccines may not have a high effectiveness in older adults. In fact, recent research shows that, in patients over 65 years old, the effectiveness of the flu vaccines can be as low as 9% for some strains of the influenza A virus (but still strong effectiveness for that group for other strains of influenza A and all strains of the influenza B virus).

The lower effectiveness may not be a result of the vaccine itself, but because older individuals may require more antigen to induce a proper immune response. Because of these observations, Sanofi Pasteur developed a high dose version of their Fluzone vaccine specifically for seniors. The new high dose vaccine contains 60 μg of each of the three hemagglutinin antigens per vaccine dose compared to the 15 μg per antigen in the standard Fluzone dose. Continue reading “Improved high dose flu vaccine for seniors”

French court hands down a ludicrous decision about Gardasil

Marie-Oceane-Bourguignon-gardasil-France-lawsuiteA few months ago, I covered a story about a French teenager who had filed a lawsuit against a French vaccine manufacturer, Sanofi Pasteur (but the patents and trademarks are owned by Merck), along with French health regulators. The lawsuit claimed that side-effects from the HPV quadrivalent vaccine, known as Gardasil (or Silgard), induced multiple sclerosis (MS), a neurological disease that results from inflammation of neurons, in a teenage girl.

As with most of these antivaccination stories and tropes, I analyze them, debunk them, and then move on. I didn’t even bother check up to see if there was a legal decision, mainly because my French reading skills barely go beyond reading a menu and ordering a croque-monsieur at a sidewalk café in Lyon (headquarters of Sanofi Pasteur). But mostly, I just assumed it was one of those silly stories where the antivaccination cult tries to make a mountain out of a tiny pebble on the beach.

Well, I misjudged the desperation of the antivaccination world. Around 8 months ago, the court actually did hand down a decision about this case, but recently the vaccine fear mongering, anti-science websites are starting to push the story. I have no clue why these vaccine refusers are pushing this story eight months later, but it’s probably because they are desperate for anything that makes them relevant, given how irrelevant most of their ideas can be. Continue reading “French court hands down a ludicrous decision about Gardasil”

The beginning of the end of Gardasil–probably not


Safe. Prevents cancer.
Safe. Prevents cancer.

More fear mongering from the antivaccination forces, this time claiming that “mainstream news media is widely reporting today that a French teenager has filed a lawsuit against French pharmaceutical company, Sanofi Pasteur, and France’s health regulators, over side-effects that were caused by the Gardasil HPV vaccine.” The plaintiff is claiming that the vaccine induced multiple sclerosis (MS), a neurological disease that results from inflammation of neurons. The best available evidence is that MS is caused by a virus, which someday will be prevented with a vaccine!

Formally known as the HPV quadrivalent vaccine, Gardasil (or Silgard in Europe) is a vaccine that prevents infection by the human papillomavirus, a sexually transmitted disease. The vaccine specifically targets subtypes 16 and 18, that cause not only approximately 70% of cervical cancers, but they also cause most HPV-induced anal (95% linked to HPV), vulvar (50% linked), vaginal (65% linked), oropharyngeal (60% linked) and penile (35% linked) cancers. It also targets HPV6 and HPV11, which account for approximately 90% of external genital warts. The viruses are generally passed through genital contact, almost always as a result of vaginal, oral and anal sex. 

Let’s be clear here. Gardasil prevents cancers–serious, life threatening cancers.

Furthermore, the HPV quadrivalent vaccine has been shown to be extraordinarily safe in two different and large epidemiological studies, one with over 700,000 doses and the other with over 350,000 doses. The relative safety of the HPV vaccine is not in question except by those who engage in logical fallacies and anecdotes. The size of these two studies were so large, so impressive, that they would have uncovered extremely rare events, and there were none.

We  have discussed this issue before. Teenagers are at risk of many chronic diseases that are coincidental to vaccines. For example, the rate for MS in some populations in Europe is close to 200 per 100,000. Without any substantial and incontrovertible evidence that the HPV vaccine is linked to MS, and with substantial evidence that MS is caused by viruses and is fairly prevalent in Europe, one can only conclude scientifically that this child had a coincidental MS attack. That is sad, and I wish we could have prevented the disease, and someday we might–but blaming Gardasil is simply irresponsible, since we have evidence it saves lives

So, let’s debunk some of the crazy points made by the fear-mongering anti-Gardasil article:

  1. No, we have no evidence that Gardasil caused MS. In fact, we have evidence otherwise, since the background rate of MS in Europe is substantial.
  2. VAERS data (yes, the article decided to use VAERS) is merely observational. It is not controlled, it does not show causality, and it is abused by those who fail to understand the scientific and epidemiological value of the data.
  3. A lawsuit certainly does not imply causality, especially since nothing has been adjudicated so far. And even if the French legal system finds for the plaintiff, it does not provide evidence of causality. Courts are terrible evaluators of scientific data.
  4. Japan did not stop using Gardasil vaccine. The Japanese Health Ministry, under pressure from the anti-science crowd, withdrew its recommendation for the vaccine based on adverse events that were actually BELOW the rates of those same events in the general population. In other words, they failed to take any epidemiology courses.
  5. Oh, and the author blames Bill Gates in some complicated, nonsensical conspiracy theory about killing girls with HPV vaccines. It’s clear that for the vaccine deniers, since they don’t have real scientific evidence, they need to blame Bill Gates. And blame him again if that doesn’t work

Therefore, the HPV vaccine is safe, based on over 1 million doses in controlled studies. HPV vaccine prevents the virus that causes some serious, deadly cancers. Multiple sclerosis is probably not caused by the HPV vaccine (or any vaccine to be factual). Multiple sclerosis is probably caused by a virus that one day will be prevented by a vaccine developed by real scientists (and if I’m still writing then, rest assured the vaccine deniers will risk their children contracting MS to whine nonsensically about that new vaccine). 

Gardasil saves lives. And I’ve shown that scientific fact based on solid scientific, published evidence.

If you need to search for scientific information and evidence about vaccines try the Science-based Vaccine Search Engine.

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