BCG vaccine is priced too low – now, shortage for bladder cancer

bcg vaccine

You probably don’t know much about the BCG vaccine, because it isn’t used much these days. And no, it’s not one of the vaccines on the CDC immunization schedule for either adults or children. 

The Bacillus Calmette-Guerin vaccine, or BCG vaccine, was initially developed to prevent tuberculosis. The disease is caused by bacteria called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but they can also damage other parts of the body. Tuberculosis is treatable with advanced medicines, but it takes a long time and can be expensive. Without treatment, the patient will die.

So, why does it matter that the BCG vaccine is priced too low or that we have a shortage of it? Well, it has a couple of important uses (one current, and one potential) that has driven demand for the vaccine. And it’s not because there’s a sudden worldwide epidemic of tuberculosis. Continue reading “BCG vaccine is priced too low – now, shortage for bladder cancer”

Vaxxed producer Del Bigtree – not credible on vaccines

vaxxed del bigtree

Over the past few months, Vaxxed producer Del Bigtree, who formerly worked on the show The Doctors, has made numerous statements about vaccines and vaccine safety. His claims about fraud by the CDC have been addressed in the past, and the evidence doesn’t support his beliefs. But the claims he makes about vaccines go beyond the movie, and he makes an effort to present himself as an authority on the issue.

Mr. Bigtree’s statements are consistently inaccurate, suggesting he is not a good source of information about vaccines. It’s impossible to address every single wrong claim Mr. Bigtree has made about vaccines, of course. But these problems should demonstrate that Mr. Bigtree’s claims about vaccines cannot be relied on. Continue reading “Vaxxed producer Del Bigtree – not credible on vaccines”

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

Another study supports the Gardasil long-term safety

Gardasil long-term safety

I’ve written more than almost 200 articles about the safety and effectiveness of various versions of the HPV vaccine. As a result, I have focused a lot of those 200 articles on Gardasil long-term safety.

There have been huge studies, one that includes over 200,000 patients and another that includes over 1 million patients, that have provided solid and nearly incontrovertible evidence that support the Gardasil long-term safety – nevertheless, the anti-vaccine tropes and memes about the HPV cancer-preventing vaccine persist.

Though it is frustrating that some researchers publish “evidence” from small studies that are poorly designed in an attempt to invent issues with HPV vaccines if you look at the best designed unbiased studies, the facts are clear–Gardasil is safe and effective. It could be one of the safest and most effective vaccines since it was developed and studied in the era of harsh, and mostly unfounded, criticisms of vaccines by certain antivaccine activists.

Continue reading “Another study supports the Gardasil long-term safety”

Syracuse University mumps outbreak – bad anti-vaccine math

Syracuse University mumps outbreak

Partially because I’m an alumnus, and partially because I watch new reports about infectious disease outbreaks all over the world, I’ve been following the recent Syracuse University mumps outbreak. As of 13 November 2017, Syracuse University (SU) Health Services has reported 41 confirmed cases and 78 probable cases of the mumps on the SU campus.

One of the age-old tropes of the anti-vaccine statistics world is that kids who have been vaccinated against the mumps (or measles or any disease) are more likely to get mumps (or any disease) than those who are not vaccinated. I squashed this myth before, but you know what happens – the anti-vaccine zombie tropes tend to reappear over and over and over and over again.

Now, the anti-vaccine statistics deniers have jumped into the Syracuse University mumps outbreak with their alternative facts, or should I say alternative math. So, once more unto the breach, dear friends, once more. We will take down this trope. Continue reading “Syracuse University mumps outbreak – bad anti-vaccine math”

HPV vaccine safety – another massive scientific study (UPDATED)

HPV vaccine safety

In a 2013 study of over 1 million girls, the overall HPV vaccine safety for teenage girls was reaffirmed. There appear to be no links between serious adverse events and the HPV vaccines. This is in line with numerous other large size epidemiological studies of HPV vaccines.

Let’s take a look at the HPV vaccine safety that is supported by this trial.
Continue reading “HPV vaccine safety – another massive scientific study (UPDATED)”

Paul Offit MD – debunking the anti-vaccine tropes and myths

Paul Offit

I have long considered Paul Offit MD as one of heroes and leaders of the public discussion of how vaccines save lives, and how they have made the lives of the world’s children healthier and better. Dr. Offit, together with Edward Jenner (the father of immunology), Jonas Salk (discoverer of the polio vaccine), and Maurice Hillman (inventor of the MMR vaccine against measles, mumps and rubella), should have statues place outside of every pediatric hospital in the country for the number of lives that they have saved.

Unfortunately, since Dr. Offit is considered one of the “leaders” of the pro-vaccine majority, his name has been demonized by the anti-vaccine cult. These people use the Big Lie, a Nazi propaganda technique where a known falsehood is repeatedly stated, then treated as if it is self-evidently true in hopes of swaying the course of an argument in a direction that takes the big lie for granted rather than critically questioning it or ignoring it.

The vaccine deniers constantly repeat untruths about Dr. Offit so that those lies eventually evolve into apparent truths, at least for those who hold onto their pseudoscientific anti-vaccine beliefs.

The problem is, of course, that if you’re a new parent who is confused by what vaccines may or may not do, you’d assume you could not accept anything that Dr. Offit says because of those Big Lies, and many of the ridiculous tropes and memes of the vaccine denialists. And this is sad.

Let’s counter the Big Lie with the Big Facts.

Continue reading “Paul Offit MD – debunking the anti-vaccine tropes and myths”

Merck shingles vaccine lawsuit – what are the facts?

Merck shingles vaccine lawsuit

In 2016, a Merck shingles vaccine lawsuit was filed in the Court of Common Pleas in Philadelphia claiming that the plaintiff was injured by the Merck’s shingles vaccine. Since the shingles vaccine is not administered to children, it’s not covered by the National Childhood Vaccine Injury Compensation Act. Injury claims, therefore, do not go through the National Vaccine Injury Compensation Program (NVICP) before going to court.

That is a mixed bag for plaintiffs: on one hand, they can go directly to state courts, something anti-vaccine activists clamor for in relation to all suits.  On the other hand, they need to meet the more demanding requirements of regular courts, including showing that there was fault on the part of the manufacturer with one of the tools lawyers use to sue product manufacturers, meet the more demanding causation requirements that govern the process in state courts, and follow the rules of evidence in those courts.

To remind readers, in NVICP, a petitioner (as they are referred to, while claimants in state courts are “plaintiffs”) would only need to show that the vaccine caused their harm, and their damages, and pretty much any evidence is allowed, though the Special Masters may give unreliable evidence little weight. This Merck shingles vaccine lawsuit can suggest what these claims would have to demonstrate if they actually had to go to regular courts. Continue reading “Merck shingles vaccine lawsuit – what are the facts?”

Vaccine lawsuits – overview of litigation across the USA

vaccine lawsuits

The goal of this overview is to tell you about vaccine lawsuits in the federal and state courts (but not in the National Vaccine Injury Compensation Program). As an overview, the discussion of each case will be very short. If you want more information, please let me know in the comments section. If you know of cases I have missed, also mention that in the comments.

The vaccine lawsuits overview is arranged by topic, and without topic by states, and within states in alphabetical order. I have chosen August 1, 2016 as a starting point to keep this manageable.

Note that the “claims” section provides a summary of what a complaint is claiming – what it is trying to do – and not an analysis of the claims’ validity. Where available, I link to a post discussing the claim’s merits more in detail. Where not, I add some comments about the validity. But the claims section just provides what the plaintiffs are claiming – it doesn’t mean their claims, hold water. Continue reading “Vaccine lawsuits – overview of litigation across the USA”

Index of articles by Prof. Dorit Rubinstein Reiss

Professor Dorit Rubinstein Reiss

Editor’s note – this index of articles by Dorit Rubinstein Reiss has been updated and published here. The comments here are closed, and you can comment at the new article. 

 

Dorit Rubinstein Reiss – Professor of Law at the University of California Hastings College of the Law (San Francisco, CA) – is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines (generally, but sometimes moving to other areas of medicine), social policy and the law. Her articles usually unwind the complexities of legal issues with vaccinations and legal policies, such as mandatory vaccination and exemptions, with facts and citations. I know a lot of writers out there will link to one of her articles here as a sort of primary source to tear down a bogus antivaccine message.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination–she really is a well-published expert in this area of vaccine policy, and doesn’t stand on the pulpit with a veneer of Argument from Authority, but is actually an authority. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

Below is a list of articles that Dorit Rubinstein Reiss has written for this blog, organized into some arbitrary and somewhat broad categories for easy reference. Of course, she has written articles about vaccines and legal issues in other locations, which I intend to link here at a later date. This article will be updated as new articles from Dorit are added here.

Continue reading “Index of articles by Prof. Dorit Rubinstein Reiss”