Tag: thimerosal

Alleged Fraud in the Vaccine Court Omnibus Autism Proceedings

Have you heard about the alleged fraud in the Vaccine Court Omnibus Proceedings?

Alleged by who?

Guess?

Alleged Fraud in the Vaccine Court Omnibus Autism Proceedings

Yup. The usual suspects.

The usual suspects are alleging fraud during the in the Vaccine Court Omnibus Proceedings.

Most folks remember that the Vaccine Court Omnibus Autism Proceedings were a series of cases that were used to test theories that vaccines could contribute to or cause autism.

The conclusion?

Vaccines are not associated with autism.

So what’s the problem?

“Robert F. Kennedy Jr., Chairman of Children’s Health Defense (CHD), and Rolf Hazlehurst, parent of a vaccine-injured child, petitioned the Department of Justice (DOJ) Office of Inspector General (OIG), and the Senate and House Judiciary Committees today to investigate actions taken by federal personnel during the “Vaccine Court” Omnibus Autism Proceedings (OAP).”

Kennedy and Hazlehurst claim to have evidence of “obstruction of justice and appallingly consequential fraud by two DOJ lawyers who represented the Department of Health and Human Services (HHS) in 2007.”

What evidence?

Kennedy and Hazlehurst claim that “that the leading HHS expert, whose written report was used to deny compensation to over 5,000 petitioners in the OAP, provided clarification to the DOJ lawyers that vaccines could, in fact, cause autism in children with underlying and otherwise benign mitochondrial disorders.”

Who is this expert?

It is Andrew Zimmerman, MD, a pediatric neurologist.

There is also a claim that Dr. Zimmerman, along with Dr. Richard Kelley, who was also an expert witness in the Vaccine Court Omnibus Autism Proceedings, served as expert witnesses in a medical malpractice case against a pediatrician who vaccinated a child, supposedly causing him to become autistic.

Which child?

Yates Hazlehurst, who was the second test case in the Vaccine Court Omnibus Proceedings.

Confused?

Dr. Zimmerman settles any fraud issue when he answers this clear question in his deposition in a malpractice against Yates Hazlehurt's pediatrician.
Dr. Zimmerman settles any fraud issue when he answers this clear question in his deposition in a malpractice against Yates Hazlehurt’s pediatrician.

Dr. Zimmerman admits that there is no evidence that vaccines cause autism, but also believes that there are some exceptions, and that vaccines can cause regressive autism in some kids with mitochondrial disorders.

Dr. Zimmerman also clarified that it is not just immunizations, but infections, fever, and other inflammatory responses that can lead to regressive autism.

Dr. Zimmerman clarified that infections can lead to regressive autism too - not just vaccines.
Dr. Zimmerman clarified that infections can lead to regressive autism too – not just vaccines.

And Dr. Zimmerman would have testified to it in the Cedillo case (the first test case in the Vaccine Court Omnibus Proceedings), if he had been allowed to.

Except that upon review of the Cedillo case, Dr. Zimmerman had concluded that “there is no evidence of an association between autism and the alleged reaction to MMR and Hg, and it is more likely than not, that there is a genetic basis for autism in this child.”

Apparently, he had changed his mind later, even though he continues to say that all evidence points to the fact that vaccines don’t cause autism.

“Dr. Zimmerman subsequently submitted a second expert opinion on behalf of Hannah Poling, which in effect states that she suffers autism as a result of a vaccine injury. The same government officials, who submitted and relied upon Dr. Zimmerman’s first expert opinion as evidence in the O.A.P., secretly conceded the case of Hannah Poling and placed it under seal so that the evidence in the case could not be used in the O.A.P. or known by the public.”

Memorandum Regarding Misconduct By The United States Department Of Justice And The United States Department Of Health And Human Services During The Omnibus Autism Proceeding As To The Expert Opinions Of Dr. Andrew Zimmerman

But what about the “second expert opinion” from Dr. Zimmerman?

Zimmerman deposition on Hannah Poling.

According to Poling’s mother, “Dr. Zimmerman was not an expert nor was he asked to be an expert on Poling’s case. The government conceded her case before ANY opinion was rendered or given.”

What about Dr. Richard Kelley?

“As noted above, an important consideration for treatment of AMD is that “normal” inflammation can impair mitochondrial function. Although most infections cannot be avoided, certain measures can limit the risk of injury during infection or other causes of inflammation… We believe it is much better to immunize with DTaP than risk infection with highly inflammatory and potentially damaging community-acquired pertussis.”

Dr. Richard Kelley on Evaluation and Treatment of Patients with Autism and Mitochondrial Disease

While he seems to believe that vaccines can trigger regressive autism in some kids with mitochondrial disease, he admits that other kinds of inflammation can do it too, including vaccine-preventable diseases.

“We believe it is much better to immunize with DTaP than risk infection with highly inflammatory and potentially damaging community-acquired pertussis.”

Andrew Zimmerman

And again, so does Dr. Zimmerman, to the point that in many cases, he thinks that even kids with mitochondrial disorders should be vaccinated.

“…the MMR vaccine has been temporally associated, if rarely, with regressions — with regression in AMD and other mitochondrial disease when given in the second year. Doubtless some of these regressions are coincidental, since the usual age for giving the MMR falls within the typical window of vulnerability for AMD regression.”

Andrew Zimmerman

If rarely associated…

Coincidental…

That doesn’t sound very convincing.

Although a lot of Dr. Zimmerman’s deposition makes it into J.B. Handley’s new autism book. What’s missing is that there were many other experts that testified against the idea that vaccines could be associated with autism during the Vaccine Court Omnibus Proceedings and that their testimony and their reports were relied upon more than Zimmerman’s.

“The undersigned has reviewed and considered the filed reports from these experts and finds that the opinions of the experts lend support to the conclusions reached in this decision. In reaching the conclusions set forth in this decision, however, the undersigned relies more heavily on the testimony and reports of the experts who were observed and heard during the hearings.”

Hazlehurst v. Secretary of HHS

So where is the fraud in the Vaccine Court Omnibus Proceedings?

Is it that the Poling case files have been kept under seal and hidden from public view?

“Finally, and perhaps for purposes of Rolf’s request that Poling’s records be released to the public, Jon and I have not allowed the release of Hxxxx’s records nor will we ever willingly allow third parties to tear apart her medical history which includes other close family members as well as things that should have never been in the record to begin with.”

Terry Poling

While we should all care about fraud in our court system, we should all also care about folks who push misinformation about vaccines and try to scare parents away from vaccinating and protecting their kids, especially when they use autistic kids to do it.

Don’t believe them.

It is telling that Dr. Zimmerman, the hero in this story, discredits the other heroes of the anti-vaccine movement, from the Geiers to Andrew Wakefield.

“I do think that — that there was much information — misinformation brought about by Dr. Wakefield and it’s — this has set the field back. I think that — that we — we have worked very hard to try to reassure the public  and I agree with doing that because I am very supportive of vaccinations, immunizations in general.”

Andrew Zimmerman

While Dr. Zimmerman truly believes that future research might find a way to identify a very small subset of kids with mitochondrial disorders that worsen after they get their vaccines (or infections or other types of inflammation), this doesn’t apply to the great majority of autistic kids or even the great majority of kids with regressive autism.

Different answers to a very similar question? They are from different lawyers in the Zimmerman deposition...
Different answers to a very similar question? They are from different lawyers in the Zimmerman deposition…

Even Dr. Zimmerman only seems to speak of an “uncommon relationship” that “is not evident in studies that have been done to date.”

And none of the researchers he mentions, including Richard Frye, Shannon Rose, Joe (Jill?) James, or Dmitriy Niyazov seem to have actually studied vaccines, only possible relationships between autism and mitochondrial conditions.

“The claims by RFK Jr. and Handley draw on something that was not, in fact, a fraud, that is misrepresented as having a dramatic impact on the Omnibus Autism Proceedings when it had little to no effect.”

Plus ça change – anti-vaccine activists revive the Hannah Poling case

So there is nothing really new here.

And while it might be news to folks like Bob Sears, vaccines are safe and necessary and still don’t cause autism.

More on the Alleged Fraud in the Vaccine Court Omnibus Proceedings

Do Vaccines Cause Tics or Tourette Syndrome?

One thing to understand when talking about tics and Tourette Syndrome is that tics are not Tourette Syndrome.

Instead, Tourette Syndrome is a type of tic disorder.

What Causes Tics and Tourette Syndrome?

You should also understand that tics are common.

In fact, about 20% of school age kids get tics, although few have them for more than a year. These motor or vocal tics (involuntary eye blinking, head jerking, shoulder shrugging, humming, sniffing, grunting, throat clearing, or yelling out a word or phrase) are most common when kids are between the ages of 10 to 12 years old, but may start as early as age 6 to 7 years.

Not only are these tics common, but they are thought to be normal and very often go away without treatment. About 97% of kids have complete resolution of their tics within a year or so.

The rest might go on to have a persistent motor or vocal tic disorder though.

And some kids with persistent motor and vocal tics might have Tourette Syndrome.

Why?

“While environmental factors and illness may influence ticcing, the weight of evidence argues that tic disorders and their comorbidities are inherited/genetic. The inheritance pattern can be subtle and unexpected. In clinic, we often see a parent, while either indicating that they experienced childhood tics that remitted or that no one in the immediate family ever had tics, demonstrating frequent subtle tics.”

Kids and Tics: What’s “Normal” and When to see a Specialist

That’s right. Genetics.

Tics and Tourette Syndrome often run in families.

Do Vaccines Cause Tics or Tourette Syndrome?

As you might suspect, vaccines do not cause tics or Tourette Syndrome.

Neither does thimerosal, which used to be a common preservative in vaccines.

That’s not surprising, as neither tics nor Tourette Syndrome are new conditions.

Why can you find studies that try to link thimerosal and vaccines to tics and Tourette Syndrome? Because they are poorly done studies by folks who routinely do studies that try to make it look like vaccines cause everything from autism and tics to ADHD.

Other studies have found no link between thimerosal and tics, including the study Neuropsychological Performance 10 Years After Immunization in Infancy With Thimerosal-Containing Vaccines.

Even the studies that found some association weren’t very convincing.

“With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.”

Andrews et al on Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association.

One study, for example, did actually find some association between thimerosal and tics.

Maybe.

Infants who received one dose of DTP with thimerosal had a higher rate of tics than infants who didn’t. The strange thing about the study though is that infants who had two or three doses also had a higher rate than getting just one dose and a similar rate as kids who didn’t get any vaccines with thimerosal.

“We did find one statistically significant association between exposure to thimerosal-containing vaccines and the presence of tics among boys, however, this association was not replicated in girls. Previous associations between thimerosal containing vaccines and tics were found by Verstraeten et al. (2003) and Andrews et al. (2004) but the findings were not sex specific. Our tic finding was also consistent with the tic finding reported in the original study (Thompson et al., 2007).”

John Barile et al on Thimerosal Exposure in Early Life and Neuropsychological Outcomes 7–10 Years Later

None of this sounds like evidence that vaccines cause tics, does it?

No.

None of these studies found clinically significant evidence that vaccines cause tics or Tourette Syndrome.

What about other thimerosal-free vaccines? There have been no reports of increased rates of tics or Tourette Syndrome with any thimerosal-free vaccines either.

“There were 17 reports of Tourette’s disorder. Two patients developed movement disorders following 4vHPV with symptoms similar to Tourette’s, but did not have a definitive clinical diagnosis of Tourette’s disorder from a specialist (i.e., a neurologist or psychiatrist). In three additional reports, patients had a Tourette’s diagnosis or displayed symptoms of Tourette’s prior to vaccination. The remaining 12 reports were submitted by one physician who read on internet websites about possible Tourette disorder occurring after vaccines, but he had no firsthand information on any patient. None of these 12 reports could be verified.”

Arana et al on Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.

There is no evidence that vaccines cause tics or Tourette Syndrome.

In fact, at the December 2017 meeting of the Advisory Committee on Childhood Vaccines, there was a petition to add tics as a vaccine table injury. After reviewing all available evidence, including the work of William Thompson, the so-called CDC Whistleblower, the committee voted 5-1 for the option to not add tics as an injury to the Table. They also didn’t add asthma or PANDAS to the vaccine injury table, despite some folks petitioning them to do so.

Tics have not been added as a table injury.
Tics have not been added as a table injury.

That’s likely not a surprise to folks who know that vaccines are safe.

What to Know About Tics and Tourette Syndrome

Why Are You Still Worried About the MMR Vaccine?

We know why most folks got scared of the MMR vaccine.

Who's to blame for low immunization rates and continuing outbreaks?
Who’s to blame for low immunization rates and continuing outbreaks?

And most of us remember when most folks welcomed the MMR vaccine the end of endemic measles in the United States.

Why You Were Worried About the MMR Vaccine

Of course, that all changed when Andrew Wakefield spoke at the press conference for his 1998 Lancet paper and said:

“And I have to say that there is sufficient anxiety in my own mind of the safety, the long term safety of the polyvalent, that is the MMR vaccination in combination, that I think that it should be suspended in favour of the single vaccines, that is continued use of the individual measles, mumps and rubella components… there is no doubt that if you give three viruses together, three live viruses, then you potentially increase the risk of an adverse event occurring, particularly when one of those viruses influences the immune system in the way that measles does. And it may be, and studies will show this or not, that giving the measles on its own reduces the risk of this particular syndrome developing… the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines…. People have been saying for some time, people on the periphery of autism, have been saying for some time that this may well be related to bowel damage.”

Although there was no evidence for any of that, vaccination rates went down and measles rates went up – the Wakefield Factor.

MMR vaccination rates had dropped below 80% by 2003, when the first measles outbreaks in the UK began. They didn't fully recover until 2012.
MMR vaccination rates had dropped below 80% by 2003, when the first measles outbreaks in the UK began. They didn’t fully recover until 2012.

But no, it wasn’t one person at a press conference that us lead down a decade of worry about the MMR vaccine.

“And then the nurse gave my son that shot. And I remember going, “Oh, God, no!” And soon thereafter I noticed a change. The soul was gone from his eyes.”

Jenny McCarthy on Oprah

Andrew Wakefield had plenty of help!

Not only from anti-vaccine celebrities, but from the media and their scare stories.

Why Are You Still Worried About the MMR Vaccine?

But that is all old news.

Over and over again, we see new studies that show that the MMR vaccine is safe and is not associated with autism.

Andrew Wakefield’s work was never replicated.

The MMR vaccine never contained thimerosal and doesn’t even contain aluminum, which I mention only because those are ingredients that some folks get scared about, not because they are harmful.

Vaccines are safe. The MMR vaccine is safe.

And more and more, as predicted, we are seeing why vaccines are necessary – more and more outbreaksOutbreaks that are proving to be deadly.

Why are you still worried about the MMR vaccine?

Because anti-vaccine folks are still scaring you away from vaccinating and protecting your kids!

Don’t listen to them!

More on MMR Vaccine Fears

Which Flu Vaccine Should You Get?

After decades with a single type of flu vaccine – the flu shot – there are now many different kinds of flu vaccines that many of us can choose from. And your choices are not just between the nasal spray flu vaccine vs a flu shot. There are also a lot of different kinds of flu shots available now.

Everyone needs a flu shot. When will you get yours?
Everyone needs a flu shot. When will you get yours? Photo by Gabriel Saldana (CC BY-SA 2.0)

Having choices is nice.

It would be also be nice to have a little more guidance on what to do with these choices.

Are any of the flu vaccines better than others?

Which Flu Vaccine Should You Get?

This year, we will have:

  • quadrivalent flu shots – Afluria, Fluarix, FluLaval, Fluzone, Fluzone Pediatric Dose
  • quadrivalent flu shots that are cell-culture based – Flucelvax
  • quadrivalent flu shots that can be given intradermally – Fluzone Intradermal
  • trivalent flu shots – Afluria
  • trivalent flu shots that are adjuvanted – Fluad
  • high dose trivalent flu shots – Fluzone High-Dose
  • quadrivalent flu shots that are made with recombinant technology – Flublok
  • nasal spray flu vaccine – Flumist

Which one should you get?

It is actually easy to start by asking which one you should get for your kids, as many of these flu vaccine options are only available for adults and seniors.

Flu Vaccine Options

Before you start thinking too long and hard about potential options, keep in mind that you might not have as many options as you think.

“Not all products are likely to be uniformly available in any practice setting or locality. Vaccination should not be delayed in order to obtain a specific product when an appropriate one is already available.”

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

Doctors and clinics might not stock multiple brands or types of flu vaccines, so you might have to get whatever flu vaccine that they have available.

“Within these guidelines and approved indications, where more than one type of vaccine is appropriate and available, no preferential recommendation is made for use of any influenza vaccine product over another.”

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

And that’s okay. In most cases, there haven’t been head to head studies showing that one flu vaccine is better than another.

Flu Vaccine Options for Kids

Still, since these options might be available to you, it is good to know about them.

This year, younger kids, between the ages of 6 months and 3 years, can either get:

  • FluLaval Quadrilvalent
  • Fluarix Quadrivalent
  • Fluzone Quadrivalent Pediatric

While you are unlikely to notice a difference, both FluLaval and Fluarix are given at a 0.5ml dose containing 15 µg of HA per vaccine virus, while Fluzone is given at a 0.25ml dose containing 7.5 µg of HA per vaccine virus. Why the difference? “Safety and reactogenicity were similar between the two vaccines,” even at the different doses.

Basically, these are just different brands of the same type of flu shot.

There are even more options as your kids get older though, including  Fluzone Quadrivalent (age three and above), Afluria Quadrivalent or Trivalent (age five and above), Flucelvax Quadrivalent (age four and above), FluLaval and Fluarix.

Of these, some folks wonder if Flucelvax, since it isn’t made in chicken eggs, might be more effective than the others. Remember, one of the things that are thought to make the flu vaccine less effective than most other vaccines is that they are made in eggs, leading to mutations. And there is actually some evidence that those flu vaccines that are not made in eggs might be more effective.

“And the University of Pittsburgh Medical Center is taking that a step further, saying it will only be buying the two egg-free vaccines on the market: Flucelvax and FluBlok. That’s because there is some evidence these two formulations may work better than the older vaccines grown in eggs, said Dr. Richard Zimmerman, who advises the UPMC Influenza Committee.”

Guidance on which flu vaccine to get: Shots for kids, maybe go egg-free

Again, remember that the CDC has made “no preferential recommendation” for one flu vaccine over another. Why not? We don’t have enough information to make that kind of recommendation.

Should parents only ask for Flucelvax? That would only work if they made enough doses for every kid to get vaccinated, which they didn’t. Should you hold out until you can find FluceIvax for your kids? No, since doing that might leave them unvaccinated once flu season hits.

What else should you know about your flu vaccine options? While over 80% of flu vaccines are now thimerosal free, most of these flu vaccines are still available in multi-dose vials with thimerosal.

Also thimerosal free, this year, Flumist is back as an option. It is available for healthy kids who are at least two years old. Although the AAP has issued a preference for flu shots this year, the ACIP says that kids can get either Flumist or a flu shot.

What about if your kids are allergic to eggs?

“Persons who report having had reactions to egg involving symptoms other than urticaria (hives), such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, may similarly receive any licensed, recommended, and age-appropriate influenza vaccine (i.e., any IIV, RIV4, or LAIV4) that is otherwise appropriate for their health status.”

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

Unless they had a severe allergic reaction to a previous flu vaccine, they can get any available flu vaccine, especially if the previous reaction was only hives or they are able to eat eggs.

What if you want a flu vaccine without aluminum? Take your pick. While it would be safe it was, aluminum is not an ingredient in flu vaccines.

Flu Vaccine Options for Adults

In addition to all of the flu vaccines available for older kids, adults have a few more options:

  • Afluria Quadrivalent or Trivalent can be given by jet injector  to those between the ages of 18 and 64 years
  • Flublok Quadrivalent – a recombinant flu shot that can be given to those who are at least 18 years old
  • Fluzone High-Dose – a trivalent flu shot with a higher dose of flu virus antigens (4 times the amount of antigen as a regular flu shot) that is available for seniors who are at least 65 years old
  • Fluad – a trivalent flu shot with an adjuvant that is available for seniors who are at least 65 years old

Why get a flu vaccine with a jet injector instead of a standard needle? High-pressure jet injectors don’t use needles!

Like FluceIvax, Flublok is not made in chicken eggs. The recombinant hemagglutinin(HA) proteins are made in insect cell lines. Does Flublok work better than egg based flu vaccines? That’s the theory, but again, there is no preference for one of these vaccines over another.

Seniors have even more choices.

Should they get Fluzone High-Dose, Fluad, or one of the other flu vaccines? Both have been shown to be more effective than standard flu vaccines in seniors, but they have not been compared against each other.

“In a Canadian observational study of 282 people aged 65 years and older conducted during the 2011-12 season, Fluad was 63% more effective than regular-dose unadjuvanted flu shots.”

CDC on People 65 Years and Older & Influenza

But neither Fluzone High-Dose nor Fluad are quadrivalent, so only protect against three flu virus strains.

Is there a quadrivalent flu shot for older adults that might work better than standard flu shots?

Yes. FluceIvax and Flublok are non-egg based quadrivalent flu shots that might be more effective than standard flu vaccines.

So are you more confused now that you know you have so many options? Just remember that for most people, the mistake isn’t about choosing the right flu vaccine, it is about not getting vaccinated.

What to Know About Your Flu Vaccine Options

While it might seem like you have a lot more options in a flu vaccine this year and that some might be more effective than others, keep in mind that availability will likely greatly limit these “options.”

And the best flu vaccine is the one that you actually get, as it will be the one that reduces your risk of getting the flu. Missing your chance to get vaccinated and protected because you are waiting for a specific brand or type of flu vaccine isn’t going to help keep the flu away.

More on Your Flu Vaccine Options

Flumist Is Not Just a Last Resort

The return of FluMist has hit a slight snag.

Most folks will remember that on February 12, 2017, at a meeting of the Advisory Committee on Immunization Practices (ACIP), members voted to once again recommended FluMist Quadrivalent to prevent the flu. So it will be available for this year’s flu season.

Many parents and pediatricians welcomed the news, as it meant that many kids could avoid getting a shot and could get the nasal spray flu vaccine instead.

Why did flu vaccine rates drop in younger school age kids when Flumist wasn't available?
Why did flu vaccine rates drop in younger school age kids when Flumist wasn’t available?

It was especially good news for those kids who skipped getting a flu vaccine because they didn’t want to get a shot when Flumist wasn’t available.

Flumist as a Last Resort?

So what’s the problem?

“The Academy recommends pediatricians give children inactivated influenza vaccine in the upcoming season and use live attenuated vaccine only as a last resort.”

American Academy of Pediatrics

Members of the AAP Committee on Infectious Diseases (COID) are concerned that FluMist, even after it has been changed to address previous issues, may not work as well as a standard flu shot.

“Influenza is unpredictable from year to year, so we really want to immunize as many kids as we can against the flu with what we think will be the most effective product. That’s why we’re recommending the flu shot this coming season.”

Henry H. Bernstein, D.O., M.H.C.M., FAAP

While many of us were surprised by the “last resort” phrasing from the AAP, maybe we shouldn’t have been.

In addition to being an ex officio member of the AAP Committee on Infectious Diseases (COID), Henry H. Bernstein was one of only two members of the ACIP who voted against bringing FluMist back, going against the opinion of twelve other members who voted in favor of FluMist.

Dr. Henry H. Bernstein is also the “leading voice on AAP’s annual policy statement on preventing flu in children with flu vaccines.”

“The data reviewed showed that receiving the nasal spray vaccine is better than not getting any vaccine at all,” said Flor Munoz, MD, FAAP, member of the AAP Committee on Infectious Diseases. “If you get the nasal spray vaccine, just be aware that, depending on the performance of the new vaccine formulation, there might be a chance you will not be fully protected against H1N1 strains of flu. The efficacy of this new formulation has not yet been determined.”

It is important to note that the AAP is not saying that Flumist won’t work though.

“The effectiveness of this new formulation of LAIV4 has not been confirmed, since A/H1N1 virus has not widely circulated recently.”

AAP influenza immunization recommendations revised for 2018-’19 season

They are basically saying that if the reformulated version of Flumist doesn’t work as it is predicted to work, then your kids might not be protected. They are concerned that we haven’t seen the new version of Flumist work in real world studies against the H1N1 strain of the flu.

Flumist Is Not Just a Last Resort

Fortunately, the AAP has somewhat rephrased their message about Flumist (LAIV4). While they still recommend that the inactivated influenza vaccine (flu shots) be the primary choice for children, they now say that:

“LAIV4 may be offered for children who would not otherwise receive an influenza vaccine (and for whom it is appropriate by age and health status).”

AAP influenza immunization recommendations revised for 2018-’19 season

Importantly though, parents and pediatricians should note that the recommendations of the Advisory Committee on Immunization Practices (ACIP) for the 2018–19 flu season very clearly make no preferential recommendation for the use of any influenza vaccine product over another.

“Following two seasons (2016–17 and 2017–18) during which ACIP recommended that LAIV4 not be used, for the 2018–19 season, vaccination providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). LAIV4 is an option for those for whom it is appropriate.”

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

And the ACIP and CDC aren’t the only ones who disagree with the AAP’s decision.

“So I think the AAP was wrong, frankly, to say that FluMist should only be used as a last-resort vaccine for influenza. Rather, they should have gone along with what the ACIP said, which was that these vaccines can now be used interchangeably for persons aged 2-49 years.”

Paul Offit, MD on FluMist: Reasonable Vaccine Option or ‘Last Resort’ for the Upcoming Flu Season?

So what should you do?

If it is going to be a battle getting your kids a flu shot and you might you might have even skipped it the last few years because Flumist wasn’t available, then your choice is very clear.

Get vaccinated with Flumist, as long as your child is at least two years old and otherwise meets the requirements.

And don’t feel bad or worried that your decision is leaving your child unprotected. Remember that Flumist is recommended by the ACIP and CDC and has been used continuously in most other countries (under the name Fluenz).

Your next battle might simply be finding Flumist. Because of the AAP’s “last resort” comment, some pediatricians didn’t even bother ordering any doses.

More on the Latest Flumist Recommendations

Does the Vitamin K Shot Contain 100mcg of Aluminum?

The vitamin K shot is not a vaccine.

That doesn’t keep anti-vaccine folks from pushing misinformation about it and scaring parents away from protecting their babies from vitamin K deficiency bleeding.

Does the Vitamin K Shot Contain 100mcg of Aluminum?

Newborns have been routinely getting vitamin K shots since at least since 1961.

Babies do not get 100mcg of aluminum from a shot of vitamin K.
Babies do not get 100mcg of aluminum from a shot of vitamin K.

And except for a brief “vitamin K brouhaha” in the early 1990s, when a study suggested that vitamin K shots might be associated with childhood cancer (they aren’t), these shots have helped to nearly eradicate hemorrhagic disease of the newborn.

So why would someone want to skip it?

The photo above suggests that they think newborns get too much aluminum from the shot. If you look closely though, you can see why they are wrong.

The vial and package insert of vitamin K clearly states that it contains no more than 100 mcg/L of aluminum.

What’s a baby’s dose of vitamin K? They don’t get a liter! They get a single IM shot of 1mg of vitamin K, or 0.5ml.

So they are obviously not getting 100mcg of aluminum.

Do you see why?

With a concentration of 100 mcg/L or 100 mcg/1000ml (remember that one liter is equal to 1000 milliliters), since they are only getting a 0.5ml dose of vitamin K, they are getting, at most, only 0.05 mcg of aluminum.

That’s 0.00005 mg of aluminum, as compared to the 0.225mg of aluminum in the Hib vaccine.

Why is aluminum even added to vitamin K?

It’s not.

Keep in mind that aluminum isn’t even listed as an ingredient of vitamin K. But according to FDA rules, “Applicants and manufacturers must use validated assay methods to determine the aluminum content in parenteral drug products.” .

And like many other IV fluids, another ingredient of vitamin K, 5% dextrous hydrous (sugar water), does often contain some aluminum, about 17.3mcg/L. These small amounts of aluminum are present “because practically all materials used to manufacture containers for pharmaceuticals contain Al.” From aluminum oxide in glass components to aluminum used as catalysts to make plastics, it is hard to avoid aluminum. But as we have learned that premature babies could get total parenteral nutrition for prolonged periods of time and be exposed to too much aluminum, the FDA has taken steps to limit this exposure.

Vitamin K shots also don't contain mercury!
Vitamin K shots also don’t contain mercury!

Unfortunately, some of those steps, like the labeling of aluminum in vitamin K ampules is used to scare parents.

What to Know About Aluminum in the Vitamin K Shot

Neither the trace amounts of aluminum  or any other ingredient in your baby’s vitamin K shot shouldn’t keep you from protecting him from vitamin K deficiency bleeding.

More on Aluminum in the Vitamin K Shot

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

There is a new meme going around suggesting that folks have no business telling anyone to vaccinate and protect their kids unless they can answer a series of questions.

I bet answers from anti-vaccine folks aren't the same as the answers from the rest of us...
I bet answers from anti-vaccine folks aren’t the same as the answers from the rest of us…

While it is certainly good to be educated about vaccines, their questions seem rather loaded.

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

Since it is immoral and dangerous to push misinformation that scares parents away from vaccinating and protecting their kids, it would be nice if anti-vaccine folks would answer these questions before they tried to persuade anyone to not get vaccinated:

  1. Name 5 vaccine ingredients that you think are toxic and how exactly they can be toxic at the amounts present in vaccines.
  2. Name 5 possible complications of a vaccine-preventable disease.
  3. Are doctors and alternative health care providers who push non-standard, parent-selected, delayed protection vaccine schedules able to be held liable if their intentionally unvaccinated child suffers a vaccine-preventable disease or starts an outbreak, infecting other people?
  4. How many children died of vaccine-preventable diseases in the early 1980s, before the vaccine schedule grew to include the new vaccines we give today?
  5. Is it true that no one can force you to get vaccinated?
  6. What percentage of reports to VAERS are actually caused by vaccine reactions?
  7. How many doses of vaccines have been given since the Vaccine Court began paying for vaccine injury cases?
  8. Which vaccines must be avoided because of shedding or other concerns if you have a child with an immunodeficiency in your home?
  9. Why do some folks think that many vaccines still contain thimerosal?
  10. If today’s vaccines already contain far fewer antigens than they did in the old days, what would be the extra benefit of splitting them up even further into separate shots for each vaccine-preventable disease?
  11. Have you read all of studies on the safety and effectiveness of combination vaccines, including those that are double-blinded and placebo controlled, and the current vaccine schedule?
  12. Can you give me one other interesting fact about vaccines or vaccine-preventable diseases that was not already asked or discussed?

What’s my interesting fact?

Many on-the-fence and vaccine hesitant parents do change their mind about vaccines and decide to make the right choice and get their kids vaccinated and protected.

More Things Anti-Vaxxers Should Know