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.
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”).
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.
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).
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, recentresearch 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).
A 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.
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:
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.
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.
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.
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.