Tag: discontinued vaccines

Did the National Childhood Vaccine Injury Act of 1986 Cause the Immunization Schedule to Triple?

Why do some parents think that the National Childhood Vaccine Injury Act of 1986 caused the immunization schedule to triple?

The National Childhood Vaccine Injury Act did not cause the immunization schedule to triple.

The usual suspects…

Did the National Childhood Vaccine Injury Act of 1986 Cause the Immunization Schedule to Triple?

It is not just folks holding anti-vax propaganda signs though.

“In 1986, Congress—awash in Pharma money (the pharmaceutical industry is No. 1 for both political contributions and lobbying spending over the past 20 years)—enacted a law granting vaccine makers blanket immunity from liability for injuries caused by vaccines. If vaccines were as safe as many claim, would we need to give pharmaceutical companies immunity for the injuries they cause? The subsequent gold rush by pharmaceutical companies boosted the number of recommended inoculations from 12 shots of five vaccines in 1986 to 54 shots of 13 vaccines today. A billion-dollar sideline grew into the $50 billion vaccine industry behemoth.”

Robert F Kennedy, Jr on The Harlem vaccine forum

It is a common anti-vax talking point that the immunization schedule ballooned in 1986, with passage of the National Childhood Vaccine Injury Act.

It didn’t.

The National Childhood Vaccine Injury Act did not cause the immunization schedule to triple.

In fact, it is very easy to see that most new vaccines weren’t added to the immunization schedule until the late 1990s and after.

  • hepatitis B – 1981
  • Hib – 1985
  • hepatitis B vaccine (improved) – 1986
  • Hib (improved) – 1988
  • Varivax – 1995
  • DTaP – 1996 (replaces DTP)
  • hepatitis A vaccine – 1996
  • RotaShield – 1998 (quickly withdrawn)
  • LYMErix – 1998 (later withdrawn)
  • Prevnar – 2000
  • FluMist – 2004
  • Menactra – 2005 (replaces the Menomune vaccine approved in 1981)
  • Tdap – 2006
  • RotaTeq – 2006
  • Gardasil – 2006
  • Trumenba – 2014

And the immunization schedule did not change very much at all after passage of the National Childhood Vaccine Injury Act.

What about Bobby Kennedy‘s other point? Why did we need the National Childhood Vaccine Injury Act if vaccines are safe?

Protection from frivolous lawsuits.

What we need now is protection from this kind of misinformation that continues to scare parents away from vaccinating and protecting their kids!

More on the Immunization Schedule

What Ever Happened to the Lyme Disease Vaccine?

A Lyme disease vaccine, LYMErix, was approved by the FDA in 1998.

Unfortunately, the manufacturer stopped making it a few years later.

What Ever Happened to the Lyme Disease Vaccine?

Although Lyme disease is caused by a bacterial infection, the bacteria is transmitted to people through tick bites. Not surprisingly, the original Lyme disease vaccine didn’t attack ticks, it attacked the Borrelia burgdorferi bacteria in those ticks, before they could cause an infection.

A new Lyme disease vaccine would be welcomed in the 14 states where the majority of Lyme disease cases are reported.
A new Lyme disease vaccine would be welcomed in the 14 states where the majority of Lyme disease cases are reported.

After three doses, LYMErix was found to be 78% effective at preventing Lyme disease.

Unfortunately, unverified reports of vaccine side effects, especially arthritis, were hyped by the media and anti-vaccine groups and led folks to avoid the vaccine.

In their article, “Concerns Grow Over Reactions To Lyme Shots,” The New York Times even gave equal time to doctors from the International Lyme and Associated Diseases Society, who push the idea that folks need treatment for chronic Lyme disease.

Another vaccine, ImuLyme, didn’t even bother applying for FDA licensure at the time.

“In 2002, in response to low vaccine uptake, public concern about adverse effects, and class action lawsuits, SmithKline Beecham withdrew the vaccine from the market despite the fact that both pre- and post-licensure safety data showed no difference in the incidence of chronic arthritis between those who received the vaccine and those who had not.”

The History of the Lyme Disease Vaccine

Interestingly, a more current article in The New York Times, “Lyme Disease Is Spreading Fast. Why Isn’t There a Vaccine?,” doesn’t mention the media’s role in bringing down the vaccine.

“But the company took it off the market less than four years later, citing low sales, amid lawsuits from patients who said the vaccine caused severe arthritis and other symptoms… The high cost of the vaccine and confusion over who should get it and how many doses were needed didn’t help its prospects.”

Lyme Disease Is Spreading Fast. Why Isn’t There a Vaccine?

And that’s likely why we continue to see false balance in their reporting, as we see them interview a group who is “skeptical about the new vaccine.”

A new vaccine that hadn’t even made it into phase II trials yet!

“Whatever you think about Andrew Wakefield, the real villains of the MMR scandal are the media.”

Ben Goldacre on The MMR story that wasn’t

The media’s role in scaring folks about vaccines isn’t new.

Lyme Lessons

Unfortunately, the impact of the media on the anti-vaccine movement has been felt far beyond Andrew Wakefield, the MMR vaccine and measles outbreaks.

“As we ask how to weigh public health benefits of interventions against potential risks (notably incurred by identifiable individuals), the LYMErix case illustrates that media focus and swings of public opinion can pre-empt the scientific weighing of risks and benefits in determining success or failure.”

The Lyme vaccine: a cautionary tale

Hopefully, folks have learned their lesson though.

How many people have gotten Lyme disease since LYMErix was withdrawn from the market? After all, Lyme disease should still be a vaccine-preventable disease.

Still Waiting for a New Lyme Disease Vaccine

Instead, we are still waiting for a new Lyme disease vaccine.

How close are we?

One vaccine, VLA15, is on Fast Track for FDA approval, but that doesn’t mean that it will be approved.

In fact, it won’t even complete its first phase II clinical trial until October 2020.

What does that mean? Considering how long it typically takes to develop a new vaccine, it could be another 5 to 8 years before this Lyme disease vaccine gets approval.

More on the Lyme Disease Vaccine

A Shot at the Dark – DPT vs DTaP

Everyone knows that the DPT vaccine caused a lot of vaccine injuries, right?

“I got interested in the topic of vaccines way back in medical school. A friend of mine convinced me to read a book about vaccines, and it ended up being a very anti-vaccine book. It was all about an old vaccine called the DTP vaccine that we don’t use anymore. But the book talked a lot about the risks and the dangers of that vaccine. The author of that book was calling for that vaccine to no longer be used.

A number of years later, it turns out that they did discover that vaccine was causing a lot of very severe, life-threatening, even fatal side effects, so they did end up taking that vaccine off the market.

So it kind of opened my eyes to the fact that there are some very severe, fortunately very rare, side effects to vaccines, and I wanted to learn more about this issue. I started reading a lot more books.”

Bob Sears, MD on The Vaccine War

After all, it was after reports of those vaccine injuries, including seizures and encephalitis, that led to:

  • lawsuits and many pharmaceutical companies to stop making vaccines
  • the DPT: Vaccine Roulette special airing on TV
  • Barbara Loe Fisher, believing that her child was damaged by the DPT vaccine, forming the Dissatisfied Parents Together organization (she later changed the name to the National Vaccine Information Center), and writing the book DPT: A Shot in the Dark (this is the anti-vaccine book that Bob Sears is talking about above)
  • the National Vaccine Injury Compensation Act passing in 1986, creating the National Vaccine Injury Compensation Program and the Vaccine Court
  • the DTaP vaccine replacing the DTP vaccine

But were those reports true?

And did they ever really discover that the DPT “vaccine was causing a lot of very severe, life-threatening, even fatal side effects,” which led to them “taking that vaccine off the market” as Dr. Bob said?

A Shot at the Dark

It is easy to think that they were true, as we don’t use the DTP vaccine anymore.

But was it ever “taken off the market?”

“During the period of transition from use of whole-cell DTP to DTaP, whole-cell DTP is an acceptable alternative to DTaP for any of the five doses. For the first four doses, whole-cell DTP combined with Hib vaccine (DTP-Hib vaccine) is an acceptable alternative to DTaP and Hib vaccine administered at separate sites.”

ACIP on Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children Recommendations of the Advisory Committee on Immunization Practices

No, it was replaced by a newer vaccine – DTaP.

And actually, it is still used in some parts of the world.

The whole-cell DTP vaccine did cause more side effects than the newer DTaP vaccine, but we are talking about relatively mild side effects, like local reactions, pain, and fever. And while that it is good, it comes at a cost, a less effective vaccine.

What about epilepsy and encephalitis?

After all of the scare about the DPT vaccine, studies quickly showed that it didn't cause all of the bad side effects that folks say it did.
After all of the scare about the DPT vaccine, studies quickly showed that it didn’t cause all of the bad side effects that folks say it did.

One clue that the DTP vaccine didn’t cause many of the problems that were blamed on it, is that the same vaccine lawsuits that were succeeding in driving vaccine manufacturers out of business in the United States, were failing in the UK.

“Where given effects, such as serious neurological disease or permanent brain damage, occur with or without pertussis vaccination, it is only possible to assess whether the vaccine is a cause, or more precisely a risk factor, when the background incidence of the disease is taken into account. The question therefore is, does the effect occur more often after pertussis vaccination than could be expected by chance?”

Justice Jeremy Stuart-Smith

There is also the fact that many children who were originally thought to have been vaccine injured after their DPT vaccine are now known to have Dravet syndrome.

Without a diagnosis, Cossolotto said, she would probably still believe — erroneously — that the DPT shot caused Michaela’s illness. “I understand this is a genetic condition,” she said. “Having an answer does make a difference.”

Medical mystery: Seizures strike baby after routine vaccine

And then there are the reports and studies that found:

  • no association with brain injury, epilepsy, SIDS, or infantile spasms
  • no increased risk for serious neurological illness in the week after getting vaccinated with DPT
  • no increased risk for encephalopathy in the 90 days after receiving DTP and MMR vaccines
  • no difference in severe reactions after DPT vs DTaP, including encephalopathy, seizures, and allergic reactions

So no, the DPT vaccine was never really as dangerous as folks said or thought it was, despite what you might read or hear in anti-vaccine books or news reports.

What to Know About the Safety of the DPT Vaccine

Misconceptions about the risks and safety of the DPT vaccine created the modern anti-vaccine movement and unfortunately, continues to influence many people.

More on the Safety of the DPT Vaccine

 

Why Did France Take the Rotavirus Vaccine off Their Schedule?

Have you heard that France took the rotavirus vaccine off their immunization schedule?

Why?

It was supposedly because two babies died of intussusception after being vaccinated.

Rotavirus Vaccines and Intussusception

Intussusception? Wasn’t that just a risk from RotaShield, the original rotavirus vaccine?

While the risk was higher with RotaShield, the current rotavirus vaccines do have a small risk of intussusception.

france-immunization-schedule
The French immunization schedule is published in the Bulletin épidémiologique hebdomadaire and has never included the rotavirus vaccine.

So did France take the rotavirus vaccine off of their schedule?

Technically, France hadn’t yet added the rotavirus vaccine to their schedule, but it had been available since 2006 and they did formally recommend infants get vaccinated beginning in November 2013.

That recommendation was suspended in April 2015, after they recorded 47 cases of intussusception over an 8 year period. This included 14 cases that required surgery and tragically, two deaths, including one child who died at home without getting any medical care. The other developed intussusception after the third dose of vaccine, which is not usually linked to any increased risk.

It is important to note that at least 80 other countries, including the United States, Finland, Germany, Norway, and the UK, haven’t stopped using the rotavirus vaccine.

Why not?

Because the risks of a natural rotavirus infection are much greater than the risk of intussusception. In other words, the benefits of the vaccine exceed its risks.

In France alone, for example, it is estimated that rotavirus vaccines could prevent 30,000 emergency room visits, 14,000 hospitalizations, and 8 to 17 deaths each year, all in children under the age of three years.

And even without the rotavirus vaccine, there are about 200 to 250 spontaneous intussusceptions each year in France. Fortunately, infants with intussusception can almost always be successfully treated, often without surgery.

Why Did France Take the Rotavirus Vaccine off Their Schedule?

It actually makes no sense that France stopped recommending that infants get vaccinated with one of the rotavirus vaccines.

The decision was widely condemned and there are calls to reassess the decision and put the rotavirus vaccine back on the schedule in France.

“After the surprising decision of the CTV-HCSP of April 2015 to suspend its own recommendation for widespread vaccination against Rotavirus (following a false and misleading pharmacovigilance report) against the international recommendations, we advise you to read the meta-analysis on efficacy (in comparative studies) and the effectiveness (field efficacy) of these vaccines.”

InfoVac Bulletin Novembre 11/2016

The benefits of the rotavirus vaccines far outweigh its risks.

“The estimated benefits of vaccination in our study greatly exceed the estimated risks and our results should contribute to provide further evidence for discussions around rotavirus vaccination in France.”

Larmrani et al A benefit–risk analysis of rotavirus vaccination, France, 2015

Why did France take the rotavirus vaccines off their schedule?

News of the Newark kids going to Paris to get Pasteur's rabies vaccine made the front page of the New York Times.
In 1885, four boys from New Jersey went all of the way to France to get Pasteur’s new rabies vaccine, which wasn’t yet available in the US.

That’s a good question.

Another good question? How many infants have died of rotavirus infections since they did? And when will they put the vaccine back on the schedule? Fortunately, the rotavirus vaccines are still available in France, they weren’t banned as some folks say.

Of course, this isn’t the first time that France impulsively suspended a vaccine.

In 1998, France suspended the routine vaccination of teens against hepatitis B because of the possible association of the vaccine with multiple sclerosis. This was done amid “pressure from anti-vaccine groups and reports in the French media have raised concerns about a link between HBV immunisation and new cases or relapses of MS and other demyelinating diseases,” even though “scientific data available do not support a causal association between HBV immunisation and central nervous system diseases, including MS.”

“In 1998, official concerns were first voiced over a possible association between hepatitis B virus (HBV) vaccination and multiple sclerosis (MS). Despite a number of studies that have demonstrated no such association, ten years on the French population’s confidence in the vaccine remains shaken and immunization rates of infants have stagnated beneath 30%. With a chronic carriage of the virus estimated at 0.68%, it seems unlikely that France will be able to control the circulation of the virus. ”

Marta Balinska on Hepatitis B vaccination and French Society ten years after the suspension of the vaccination campaign: how should we raise infant immunization coverage rates?

Do you know where all of this has left France now?

With high rates of vaccine-preventable disease (15,000 cases of measles in 2011, with 16 cases of encephalitis and 6 deaths) and a move towards vaccine mandates. As of January 2018, all infants and toddlers in France must receive DTaP, Hib, HepB, pneumococcal, MMR, and meningococcal C vaccines.

What to Know About France Taking the Rotavirus Vaccine off Their Schedule

In no longer recommending the rotavirus vaccines, officials in France actually put infants at greater risk for sickness and death.

More on France Taking the Rotavirus Vaccine off Their Schedule