Tag: Dravet syndrome

Should Parents Be Concerned About Combination Vaccines and Febrile Seizures?

Anti-vaccine folks have parents worried about everything and anything having to do with vaccines these days.

Unlike most of the ideas that anti-vaxxers push, febrile seizures really can occur after vaccines. Fortunately, they aren’t something to be worried about.

Should Parents Be Concerned About Combination Vaccines and Febrile Seizures?

While febrile seizures can be scary, it is important to know that without other risk factors, kids who develop febrile seizures after a vaccine are at the same small risk for developing epilepsy as other kids.

And know that vaccines aren’t the only cause of febrile seizures. Vaccine-preventable diseases can cause both febrile seizures and more serious non-febrile seizures.

What about the extra risk of febrile seizures following combination vaccines?

“Studies have shown a small increased risk for febrile seizures during the 5 to 12 days after a child has received their first vaccination with the measles, mumps, rubella (MMR) vaccine. The risk is slightly higher with the measles, mumps, rubella, varicella (MMRV) combination vaccine, but the risk is still small. Studies have not shown an increased risk for febrile seizures after the separate varicella (chickenpox) vaccine.”

Childhood Vaccines and Febrile Seizures

The small extra risk of febrile seizures for the measles, mumps, rubella, varicella (MMRV) combination vaccine vs the separate MMR and chicken pox vaccines is just for the first dose of these vaccines, so pediatricians and parents might choose to give the separate vaccines instead. And only use this combination vaccine for the second dose.

Are any other combination vaccines a concern for febrile seizures?

Nope, even though some anti-vaccine sites push that idea and that vaccines can cause epilepsy.

Parents will likely be reassured by one of the studies that anti-vaccine folks like to cite, which states that “vaccination with DTaP-IPV-Hib was not associated with an increased risk of epilepsy.”

We do know that there is a small increased risk for febrile seizures when the influenza vaccine is given at the same time as either the Prevnar13 vaccine or the DTaP vaccine, although “the risk of febrile seizure with any combination of these vaccines is small and CDC’s Advisory Committee on Immunization Practices (ACIP) does not recommend getting any of these vaccines on separate days.”

Is the risk really small though?

After all, an article by Sheri A Marino talks about a 6-fold extra risk in some cases.

Isn’t that a lot?

“Does this mean we should stop giving these vaccines together or stop giving them at all? We say, emphatically, no. With the results of this study, we can accurately calculate the risks and benefits of this practice. The risk is 1 febrile seizure per pediatric practice every 5 to 10 years. Febrile seizures, although frightening to parents, rarely have any long-term sequelae. The benefits of giving these vaccines simultaneously include decreased office visits associated with painful vaccines, decreased episodes of vaccine-associated fussiness, and, most important, the assurance that children will be fully immunized and protected from infections that carry real morbidity and mortality. It is well established that the vaccines we miss when we fail to give all the vaccines we can (simultaneously at each health care visit) may never be administered to some children, thus leaving them at risk for the diseases the vaccines prevent. It goes without saying that influenza, diphtheria, tetanus, pertussis, and pneumococcal infections may result in serious illness. These infections also have the potential to cause fevers and febrile seizures. Without vaccines to prevent these illnesses, pediatricians would see many more than 1 case of most of these infections each decade. In fact, they would see children in their practices with both febrile seizures and life-threatening infections. The risk from these diseases far outweighs the risk from the vaccines.”

Sawyer et al on Vaccines and Febrile Seizures: Quantifying the Risk

Because the risk of febrile seizures is so small, it remains small even with any extra risk.

What’s more concerning? The risks of following anti-vaccine propaganda and leaving your kids unvaccinated and unprotected.

Vaccines are safe, with few risks, and necessary.

More on Vaccines and Febrile Seizures

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

So you likely know that there were a bunch of lawsuits against manufacturers of the DPT vaccine in the early and mid 1980s.

“As the number of lawsuits grew to hundreds during the early 1980s, the pharmaceutical companies making vaccines saw their liability insurance bills soar. Worried not only about multimillion-dollar settlements, but also even the legal costs of defending themselves successfully, several companies simply stopped making vaccine.”

How a Media Scare On Vaccine Started a ‘near-Epidemic’

That’s why the National Vaccine Injury Compensation Act passed in 1986, creating the National Vaccine Injury Compensation Program and the Vaccine Court.

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

But did those DPT vaccine lawsuits prove that vaccines aren’t safe?

Is that why vaccine manufacturers needed help to limit their liability?

“The total amount claimed in 1984 DTP vaccine suits ($1.3 billion) is more than 20 times the total value of 1984 sales of DTP vaccine at the market price of $2.80 per dose.”

Hinman on DTP Vaccine Litigation

Of course not!

While the older DPT vaccine did cause more local reactions, pain, and fever than the newer DTaP vaccine that replaced it, all of the serious reactions that triggered the lawsuits were later found to not be caused by the vaccine.

Most of the DPT lawsuits were thought to be frivolous.

That’s not surprising, as the same vaccine lawsuits that were succeeding in driving vaccine manufacturers out of business in the United States were failing in the UK and Canada!

This included the Loveday judgment in Great Britain’s High Court of Justice, Queen’s Bench Division and the Rothwell judgment in the Supreme Court of Ontario, Canada, both decided in 1988, with justices ruling that there was “insufficient evidence to demonstrate that pertussis vaccine can cause permanent brain damage in children.”

Similar cases were succeeding in the US though..

“The number (and dollar value) of suits increased in 1982, a year when broadcast and print media began to devote considerable attention to the alleged hazards associated with the use of pertussis-containing vaccines. Most of the media coverage has emphasized alleged risks of pertussis vaccines and has given relatively little attention to the benefits of their use.”

Hinman on DTP Vaccine Litigation

Most experts knew that most of the lawsuits were frivolous, but they weren’t able to stop the damage that was to come, as:

  • the DPT: Vaccine Roulette special aired on TV
  • Barbara Loe Fisher, believing that her child was damaged by the DPT vaccine, formed the Dissatisfied Parents Together organization and wrote the book DPT: A Shot in the Dark, which later influenced Bob Sears
  • there were temporary shortages of DTP vaccine in 1984, as “two of the three American manufacturers of the product decided to halt or restrict its sales.”

What else happened? I mean besides all of the studies proving the DPT vaccine was safe?

Parents who had been scared by the DPT controversy were ready and primed when Andy Wakefield showed up and told them that they had something new to worry about – the MMR vaccine and autism.

And of course, pertussis is now returning, as more parents are scared to vaccinate their kids and the newer DTaP vaccine isn’t as effective as DPT.

More on Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

Does Getting the DTaP Vaccine Make You More Susceptible to Pertussis?

Wait, why would anyone think that getting vaccinated would make you more likely to get a vaccine-preventable disease?

Because there is a new pertussis outbreak in California and folks don’t understand how attack rates work…

Does Getting the DTaP Vaccine Make You More Susceptible to Pertussis?

We know that the latest pertussis vaccines aren’t the greatest, having issues with waning immunity.

They don’t actually make you more likely to get pertussis though, at least not relative to being unvaccinated.

“Because of linked-epitope suppression, all children who were primed by DTaP vaccines will be more susceptible to pertussis throughout their lifetimes, and there is no easy way to decrease this increased lifetime susceptibility.”

JD Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future

What the above quote that anti-vaccine folks are misusing is actually saying is that kids who got DTaP vaccines will be more susceptible to pertussis compared to those who got DTwP, the older version of the vaccine. That’s what the whole article is about!

It is not that they will be more suspecptible to pertussis vs someone who was unvaccinated.

Dr. I: Anti-vax folks are misinterpreting that statement, not understanding that it means relative to kids who got DTwP. They think that you are saying that it is the DTaP vaccine itself that makes it more likely that a child will get pertussis, in general. Even relative to someone who is unvaccinated. I know it shouldn’t be necessary, but can you provide a simple quote to clarify this?

JDC: You are of course correct. I was asked to write-up the talk that I have given many times in the US and in many other countries. In the talk, right at the beginning, I mention that today there is 20 fold less pertussis than there was in the pre-vaccine era and that illness in vaccine failures is much less severe that illness in unvaccinated children. I also remember how wrong they were 30 years ago R/E alleged reactions to DTwP.

And if you read his latest article, The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future, especially if you read more than the abstract, you discover that’s what he is saying.

But what about linked-epitope suppression?

In “linked-epitope suppression,” memory B cells out-compete naive B cells for access to the Bordetella epitopes because they are more numerous and their receptors exhibit a higher antigen affinity. Linked-epitope suppression applies as the immune response to novel epitopes is suppressed by the strong response to initial components if they are introduced together.

JD Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future

Basically, the DTwP vaccine included many more epitopes or targets for antibodies to bind to than the newer DTaP vaccine. That’s why it worked better. And you don’t get a good response to non-vaccine epitopes or antigens.

Still, you at least have some memory B cells and antibodies after getting the DTaP vaccine, which is why the idea that getting vaccinated makes you more susceptible to pertussis is silly. You are still protected, even if the protection isn’t perfect.

That’s why Dr. Cherry recommends that folks continue to get vaccinated and protected!

“We should be more vigilant than we have been in the past to recognize and treat pertussis in all age groups so that transmission to young infants is reduced. Most important (although not discussed in this review) is to ensure that all pregnant women receive the Tdap vaccine between 27 and 36 weeks’ gestation with each pregnancy. Also, we should consider routinely administering Tdap vaccine every 3 years to all adolescents and adults who were primed with a DTaP vaccine. This suggestion is contrary to that in the current Advisory Committee on Immunization Practices recommendations. However, from the data available, this approach could be expected to decrease the circulation of B pertussis in adolescents and adults. Also, Tdap should be administered to all adolescent and adults exposed to B pertussis during a school or other group outbreak.”

JD Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future

He does recommend that we work on new pertussis vaccines though.

“Future cohorts would benefit from the development and use of live vaccines and less-reactogenic DTwP vaccines.”

JD Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future

But why are we using a vaccine that doesn’t work as well as the previous vaccine we had?

“Despite the fact that in all but 2 of the efficacy trials the DTwP vaccines had greater efficacy than did the DTaP vaccines being studied, DTaP vaccines were licensed and used in many countries throughout the world; DTaP vaccines had replaced DTwP vaccines. The urgency to adopt DTaP vaccines was driven largely by antivaccine activist groups such as “Dissatisfied Parents Together.” During the rush to adopt DTaP vaccines and tetanus, diphtheria, acellular pertussis vaccines for adults (Tdap), much of the history relating to human pertussis was overlooked.”

JD Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future

But the DTwP vaccines weren’t safe, right?

“The results of a number of controlled studies between 1979 and 2004 indicated that no risk of severe neurologic disease after DTwP vaccinations existed. It was noted by myself and Shields (a pediatric neurologist) that what was being called pertussis vaccine encephalopathy was not an encephalitis-like event but, instead, the first seizure or seizures of infantile epilepsy.”

JD Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future

No, the cases of encephalopathy that were being reported were not caused by the DTwP vaccine. And neither did the DTwP vaccine cause SIDS, as was also reported at the time.

“Since 1997, the DTaP vaccination policy has created a cohort of people (the number of which is expanding yearly) who are more susceptible to repeated clinical illness with B pertussis infection than are DTwP-vaccinated children. There is no feasible way to make this cohort less susceptible.”

JD Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines-Mistakes Made and Implications for the Future

And now, after helping create the current DTaP vaccination policy, anti-vaccine folks want to scare folks away from using the vaccine. Don’t let them. Don’t skip or delay this vaccine and leave your kids susceptible to getting diphtheria, tetanus, and pertussis.

More on Does Getting the DTaP Vaccine Make You More Susceptible to Pertussis?

Diagnosing Vaccine Injuries

Vaccines are often described as one of the greatest public health achievements of the 20th century.

That great benefit also leaves no doubt for most people that getting vaccinated and fully protected far outweighs the very small risks that vaccines might have.

Vaccine Injuries vs Vaccine Side Effects

Vaccines can certainly have side effects.

Fever, pain at the injection site, and redness and swelling where the shot was given are all common, mild problems that can be associated with almost any vaccine.

Some vaccines might also commonly cause fussiness, tiredness or poor appetite, and vomiting within 1 to 3 days of getting the vaccine. Others can cause a rash, headache, or muscle and joint pain for a few days.

Even syncope or fainting can commonly occur within 15 minutes of teens getting a vaccine.

Other vaccine side effects can include persistent crying, nodules at the injection site, limb swelling, and febrile seizures, etc.

These are well known vaccine side effects that are often minor and temporary though.

Is It a Vaccine Injury?

Although the term is typically associated with the anti-vaccine movement, as they tend to think everything is a vaccine injury, it is important to understand that vaccine injuries, although rare, are indeed real.

After all, vaccines are not 100% safe.

In addition to the milder side effects listed above, vaccines can very rarely cause more serious types of adverse events or injuries, including:

  • life threatening allergic reactions
  • brachial neuritis (shoulder pain and then weakness) following a tetanus containing vaccine
  • encephalopathy/encephalitis following a measles, mumps, or rubella, or pertussis containing vaccine
  • chronic arthritis following a rubella containing vaccine
  • thrombocytopenic purpura (ITP) following a measles containing vaccine
  • vaccine-strain measles viral infection in an immunodeficient recipient following a measles containing vaccine
  • intussusception – following a rotavirus vaccine
  • shoulder injury related to vaccine administration – SIRVA

Keep in mind that some of these are just table injuries and are not necessarily proven as being caused by vaccines.

And while vaccines are associated with some serious adverse events, the research is clear that vaccines are not associated with autism, SIDS, and shaken baby syndrome, type 1 diabetes, multiple sclerosis, inflammatory bowel disease, or other so-called vaccine induced diseases.

Or Is It Just a Coincidence?

Dr. Samuel Johnson once said that “It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.”

How does this apply to diagnosing vaccine injuries?

Too often we forget that just because one event is subsequent (happens after) another, it does not mean that it was a consequence (was caused by) the first event. It is another way of saying that correlation does not imply causation.

This is also highlighted by missed vaccine stories, events that would surely be blamed on a vaccine injury, except that a vaccine was never actually given for one reason or another.

Most pediatricians have these types of missed vaccine stories, such as:

  • an infant who begins vomiting on the way home from a well appointment and is diagnosed with intussusception (9 month old visit and didn’t get any vaccines)
  • a 4 year old who developed encephalitis just one week after his well check up (no vaccines – DTP had been deferred to his 5 year old visit)
  • a 2 month old who died of SIDS on the night of his scheduled well child visit (no vaccines as they had forgotten to go to the appointment)
  • a 4 month old who had a seizure at his well child visit (no vaccines were given yet as they were still being drawn up)

Or they have kids who begin to have symptoms or are diagnosed with a condition right around the time of a check up when they would routinely get one or more vaccines, but haven’t yet. From diabetes and POTS to transverse myelitis, some parents would have blamed their child’s vaccines if they had actually been vaccinated at that time and subsequently got diagnosed.

My own son started getting migraines when he was 12 years old and about to start 7th grade. Should I blame his headaches on his middle school booster shots? While it would be convenient, it is more likely that genetics are to blame. I started getting migraines at about the same age, and he began getting them just before he got his booster shots.

Diagnosing Vaccine Injuries

How do you know if your child had a true vaccine injury?

Does the reaction fit into the vaccine injury type AND “time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration” as described in the NVICP vaccine injury tables?

That time period, also known as a risk interval, is when “individuals are considered at risk for the development of a certain adverse event following immunization (AEFI) potentially caused by the vaccine.”

For example, did your child develop an anaphylactic reaction within four hours of getting the DTaP vaccine? While a reaction 14 hours after the vaccine would be much less likely to be caused by the vaccine, if it occurred within 4 hours, that could certainly be a vaccine injury.

How about a child who developed thrombocytopenic purpura 90 days after getting his MMR vaccine? That is unlikely to be a vaccine injury, as the MMR vaccine typically causes TTP within 7 to 30 days.

If you think that your child has had a vaccine injury, be sure to talk to your pediatrician. You should also report any vaccine reaction to Vaccine Adverse Event Reporting System (VAERS) and if you truly believe that your child has been injured by a vaccine, you can file a claim with the National Vaccine Injury Compensation Program (VICP).

“You may file a claim if you received a vaccine covered by the VICP and believe that you have been injured by this vaccine.”

What You Need to Know About the National Vaccine Injury Compensation Program (VICP)

How will your pediatrician figure out if it is a vaccine injury? Among the things that they will consider when evaluating a reaction after a vaccine will be the answers to some key questions, including:

  • Is there any evidence that something else caused the reaction? While getting a vaccine could cause an anaphylactic reaction, so could the fact that your child just eat a peanut butter and jelly sandwich.
  • Is there a known causal association between the reaction and the vaccine?
  • Is there strong evidence against a causal association between the reaction and the vaccine?
  • Is there a laboratory test that implicates the vaccine as a cause of the reaction?
  • If the reaction is an infection, did it have a vaccine or wild type origin?

Your pediatrician will also consider other factors when making a decision, including whether other patients were affected (might implicate a contaminated vaccine), and will make sure that the original diagnosis is correct.

Being able to answer all of these questions often puts pediatricians in the unique position of correctly evaluating potential vaccine injuries. There is even a standardized algorithm that can help your pediatrician collect and interpret all of the data they will get when evaluating a possible vaccine injury.

Another algorithm can help evaluate and manage suspected allergic reactions, including immediate or type 1 hypersensitivity reactions and delayed type 3 hypersensitivity reactions. If the reaction is consistent with an allergic reaction and additional doses of the vaccine are still needed, possible next steps in this algorithm include serologic testing for immunity and skin testing with the vaccine or vaccine components.

For extra help, your pediatrician can consult an allergist or immunologist before considering giving your child another vaccine, if necessary. Experts at the Clinical Immunization Safety Assessment (CISA) are also available for consults about suspected vaccine injuries.

Over-Diagnosing Vaccine Injuries

In addition to vaccine side effects and vaccine injuries, it is much more common for children and adults to develop health problems and symptoms after getting a vaccine that have nothing to do with the vaccine. These are events, sometimes tragic, that would have happened even if they had not been vaccinated.

Anytime we see a post about vaccines and SIDS, we know what happened, an anti-vaccine Facebook group is taking advantage of a grieving family.
Anytime we see a post about vaccines and SIDS, we know what happened, an anti-vaccine Facebook group is taking advantage of a grieving family.

Despite the evidence against it, some parents may still think that their child has been injured or damaged by a vaccine, especially if they:

  • believe all of the vaccine injury stories they hear on the Internet
  • misuse vaccine package inserts
  • believe that VAERS reports have all been confirmed to be true
  • think that vaccine injuries can occur months or years after getting a vaccine
  • find a case report in PubMed and think that is convincing evidence of causality, even though it is really nothing more than a glorified anecdote
  • have found their way into a Facebook group where folks think vaccines always injure kids
  • go to a homeopath, chiropractor, or holistic practitioner who told them the child was injured

For example, studies have repeatedly shown that “vaccination does not increase the overall risk of sudden infant death (SIDS),” and that “the risk of SIDS in vaccinated cases and controls is neither increased nor reduced during the early post-vaccination period.”

What should you do if you really think that your child has a vaccine injury?
Just what a parent needs when their baby dies of SIDS, someone to reach out and tell them it was because they had him vaccinated… 

So a VAERS report of SIDS on the night that an infant received his 4 month vaccines, while tragic, would likely not end up being classified as a true vaccine injury.

Neither should a case report or package insert about SIDS influence your thinking about SIDS being associated with a vaccine injury.

Still, it is easy to understand why many like to blame vaccines.

Vaccines are an easy target, especially as most vaccine-preventable diseases are under fairly good control compared to the pre-vaccine era. And in some cases of SIDS, a new case of diabetes, or the sudden death of an older child, etc., it may happen soon after the child was vaccinated, and that correlation is hard to ignore for some folks.

At least it is hard to ignore and easy to be influenced by anti-vaccine folks if you don’t understand the background rate of these diseases – or the fact that a certain number of children will be affected no matter what, and because many kids get vaccinated, it is only a matter of chance that the two get correlated together. 

Vaccines are safe.

They don’t typically cause serious vaccine injuries.

If you do think that your child has a vaccine injury, talk to your pediatrician. Don’t get diagnosed in a Facebook forum…

More on Diagnosing Vaccine Injuries