Tag: discontinued vaccines

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

 

What Are the Changes in the 2018 Immunization Schedules?

As they do every year, the Advisory Committee on Immunization Practices (ACIP) just released an updated immunization schedule.

The 2018 immunization schedule didn't bring any changes for most kids.
The 2018 immunization schedule doesn’t bring any changes for most kids.

And just like in most other recent years, there were few big changes or announcements.

That means that most kids won’t need any extra shots when they go to their next well check up with their pediatrician or to start school.

What Are the Changes in the 2018 Immunization Schedules?

There are some changes though…

  • A third dose of MMR is now recommended for some people during outbreaks of mumps.
  • MenHibrix was removed from the schedule, which was expected, as this combination meningococcal vaccine for high risk kids was discontinued in 2016 because of low demand. Fortunately, this doesn’t mean that any kids will be left unprotected. They can just get one of the other meningococcal vaccines if they need it, with a separate Hib vaccine, just like other infants.
  • Menomune was removed from the schedule, which was expected, as this older meningococcal vaccine was discontinued in 2017, as it was replaced with the newer meningococcal conjugate vaccines (Menactra and Menveo).
  • Shingrix, the new recombinant shingles vaccine is added to the schedule for adults aged 50 or older. They should get 2 doses 2 to 6 months apart, even if they have had shingles in the past or have had the older Zostavax already. And Shingrix becomes the preferred shingles vaccine for those who are at least 60 years old.

The other changes are to the formatting of the schedule and schedule footnotes.

“The schedule footnotes are presented in a new simplified format. The goal was to remove unnecessary text while preserving all pertinent information and maintaining clarity. This was accomplished by a transition from complete sentences to bullets, removal of unnecessary or redundant language, and formatting changes.”

CDC on Changes to This Year’s Schedule

So, unless your child is in a mumps outbreak, the new immunization schedule shouldn’t mean any extra vaccines.

What to Know About the 2018 Immunization Schedule

The 2018 immunization schedule from the CDC, AAP, ACOG, and AAFP incorporates the latest recommendations from the ACIP, including that folks in a mumps outbreak might need a third dose of MMR.

More on the 2018 Immunization Schedule

Typhus vs Typhoid Fever

Typhus and typhoid have both been in the news recently.

  • Texas officials issue alert about typhus threat
  • Typhoid: Two children die‚ 60 ill after drinking from contaminated stream in South Africa

Should you start panicking?

Of course not.

Even before they knew which bacteria actually caused typhus and typhoid fevers, they knew they were different diseases.
Even before they knew which bacteria actually caused typhus and typhoid fevers, they knew they were different diseases.

While neither is usually a threat to most people in developed countries, instead of panicking, get educated and learn how you can prevent these still common infections.

Typhus Fever

Epidemic typhus fever is spread by human body lice (not head lice!) that are infected with the Rickettsia prowazekii bacteria.

Symptoms of typhus fever can include the sudden onset of:

  • fever
  • muscle aches (myalgias)
  • headache
  • chills
  • not feeling well (malaise)
  • cough

Some patients develop a characteristic rash made up of small red spots (macules) that start on the upper trunk. It then spreads to the rest of the body, but spares the face, palms, and soles. The rash can eventually become petechial.

Untreated, the fever may last up to two weeks, followed by a slow recovery of two to three months for all of the other symptoms. Typhus fever can be fatal.

Fortunately, treatment is available – the antibiotic doxycycline.

How do you prevent epidemic typhus fever? You avoid body lice. And avoid flying squirrels, which can be infected with Rickettsia prowazekii bacteria.

Is typhus fever vaccine-preventable? No, although a typhus vaccine was once available, it was discontinued in 1979.

Keep in mind that in addition to epidemic typhus, which is now very rare, typhus can also be spread by fleas (murine typhus) and chiggers (scrub typhus).

Murine or endemic typhus is common in tropical and subtropical climates, where it is spread by rats and fleas. In the United States, it is mainly found in California, Hawaii, and Texas, where it has also been associated with cat fleas found on cats and opossums.

Scrub typhus is associated with chiggers in rural areas of Southeast Asia, Indonesia, China, Japan, India, and northern Australia.

Typhoid Fever

Although typhus and typhoid some very similar, there are some big differences between these two diseases.

What are they?

Unlike typhus, typhoid fever is:

  • caused by the Salmonella typhi bacteria
  • spread by ingesting contaminated food and water
  • characteristic by symptoms that include a gradual onset of fever, with stomach aches, headache, loss of appetite, and sometimes a rash.
  • still vaccine preventable – in fact, there are two typhoid vaccine, one oral and the other a shot

Fortunately, typhoid fever can be treated with antibiotics, although it is sometimes multi-drug resistant and some people become chronic carriers, even with treatment (Typhoid Mary).

While adventurous and fun, eating street vendor food is probably a good way to get typhoid fever.
While adventurous and fun, eating street vendor food is probably a good way to get typhoid fever. Photo by Sam Sherratt (CC BY-SA 2.0)

That it can still be treated is a good thing, because unlike epidemic typhus, typhoid fever is still very much around.

The CDC estimates that there are about 5,700 cases of typhoid fever in the United States each year, mostly in travelers that leave the country.

Worldwide, there are about 21 million cases of typhoid fever and 222,000 typhoid-related deaths each year!

In addition to getting vaccinated, if traveling to the developing world, to avoid typhoid, you should avoid risky food and be sure to “Boil it, cook it, peel it, or forget it.”

What to Know About Typhus and Typhoid Fever

Typhus and typhoid fevers are two very different diseases that can both be avoided with good hygiene practices.

More on Typhus and Typhoid Fever

Underreporting of Side Effects to VAERS

Vaccine injuries and side effects should be reported to Vaccine Adverse Event Reporting System (VAERS).

Reporting Side Effects to VAERS

The CDC advises that “all significant adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event.”

Are they?

Unfortunately, no.

Vaccine adverse events can be reported to VAERS online or using a downloadable form.
Vaccine adverse events can be reported to VAERS online or using a downloadable form.

 

While both doctors and parents can report these side effects, they don’t always get reported.

Underreporting of Side Effects to VAERS

Still, although reports to VAERS are underreported, they are almost certainly not underreported by as much as some folks believe.

Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS?

That’s not true.

That claim is based on an old study about drug reactions and was not specific to vaccines.

We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. For example, one study found that up to 68% of cases of vaccine-associated poliomyelitis (a table injury) were reported to VAERS, while less than 1% of episodes of rash following the MMR vaccine were reported.

That’s not to say that only severe or serious adverse reactions should be reported.

But since VAERS watches “for unexpected or unusual patterns in adverse event reports,” it still works even if each and every side effect isn’t reported.

VAERS Works

Reports to VAERS are underreported.

VAERS still works well though.

Again, that’s because VAERS doesn’t need each and every adverse event to be reported for the system to work and to help it identify vaccines that might not be safe.

“Despite its limitations, VAERS effectively detected a possible problem soon after introduction of RRV-TV in the United States.”

Lynn R. Zanardi, et al on Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System

We saw that with the RotaShield vaccine. After nearly 20 years of research, the first rotavirus vaccine was approved by the FDA on August 31, 1998. About seven months later, in March 1999, the ACIP published their formal recommendations that all infants get RotaShield on a three dose schedule, when they are two, four, and six months old.

By June 11, 1999, VAERS had received 12 reports of intussusception related to the RotaShield vaccine and by July 13, its use was temporarily suspended, as the CDC continued to investigate.

Once the CDC announced the temporary suspension, even more reports of intussusception after RotaShield were made to VAERS. Those extra reports likely mean that intussusception was being underreported initially, but it still triggered the temporary suspension and extra studies that eventually got the manufacturer to withdraw the vaccine.

“VAERS is used to detect possible safety problems – called “signals” – that may be related to vaccination. If a vaccine safety signal is identified through VAERS, scientists may conduct further studies to find out if the signal represents an actual risk.”

CDC on How VAERS is Used

Early signals in VAERS also helped detect a very small increase in the risk of febrile seizures among toddlers who got the 2010-11 flu vaccine combined with either Prevnar or a DTaP vaccine.

Also keep in mind that VAERS isn’t the only system that helps to monitor vaccine safety. We also have the Vaccine Safety Datalink project, the Clinical Immunization Safety Assessment Network, and the Vaccine Analytic Unit.

What to Know About Underreporting of Side Effects to VAERS

Even though underreporting of side effects to VAERS is an issue, because VAERS works by looking at early signals and trends, it still works well to identify possible safety problems from vaccines.

More About Underreporting of Side Effects to VAERS

Discontinued Vaccines

tripedia
The Tripedia DTaP vaccine was discontinued in 2013.

Most people know that the RotaShield rotavirus vaccine was discontinued in 1999 because it was found to be linked to intussusception.

It took eight years for a new rotavirus vaccine to be licensed.

Lymerix, a Lyme disease vaccine was discontinued in 2002. Unfortunately, we still don’t have a new replacement Lyme disease vaccine.

Vaccines That Have Been Discontinued

More commonly, a vaccine gets discontinued with little notice, as there are other options to keep kids vaccinated and protected.

Other vaccines that are no longer made, include:

  • Menomume – an older meningococcal polysaccharide vaccine was discontinued in 2017 in the US as it was replaced with the newer meningococcal conjugate vaccines Menactra and Menveo.
  • MenHibrix – a meningococcal – Hib combination vaccine that was discontinued in the US in 2016 due to low demand
  • Cervarix – an HPV vaccine that was discontinued in the US in 2016 due to low demand
  • Comvax –  a Hib/Hepatitis B combination – discontinued in 2014
  • Tetanus toxoid – discontinued 2013
  • Tripedia – a DTaP vaccine – discontinued 2011
  • TriHIBit – a DTaP/Hib combination
  • JE-VAX – discontinued 2005
  • Attenuvax – measles vaccine
  • Mumpsvax – mumps vaccine
  • Meruvax II – rubella vaccine
  • M-R-Vax – measles and rubella combo
  • M-M-Vax – measles and mumps combo
  • Biavax II – rubella and mumps combo
  • Heptavax-B – the original hepatitis B vaccine
  • HIB-Vax – the original Hib vaccine
  • Plague vaccine
  • Poliovax
  • Dryvax – smallpox vaccine
  • Measles-Smallpox combination vaccine
  • Diptussis – a diphtheria/pertussis combination (1949-55)
  • Quadrigen – a DTP/Polio combination (1959-68)
  • Streptococcus vaccine (1952-88)
  • Serobacterin – a pertussis vaccine (1945-54)
  • Rocky mountain spotted fever vaccine (1942-78)
  • Typhus vaccine (1941-79)
  • smallpox vaccine (1917-1976)

Most of these vaccines were discontinued because they simply became obsolete.

Orig. Title: SPvac806.8a
A smallpox vaccination kit included the diluent, a vial of Dryvax smallpox vaccine, and a bifurcated needle.

The Hib-Vax and Heptavax-B vaccines, for example, both use older technology, so these vaccines were discontinued when newer Hib and hepatitis B vaccines were introduced.

And some vaccines are discontinued  or are phased out when they get an update:

  • MMR -> MMR-II (1978)
  • Prevnar 7 -> Prevnar 13 (2010)
  • Gardasil -> Gardasil 9 (2014)

Still other vaccines, like Tripedia and TriHIBit, seemed to get discontinued as a business decision. Through mergers, Sanofi Pasteur, Ltd. ended up with two DTaP vaccines. They had their own Daptacel, but also had Tripedia, a vaccine they acquired from Pasteur Merieux. They ended up discontinuing Tripedia.

Merck also stopped making Comvax not because of “any  product safety or manufacturing issues,” but rather “as part of its ongoing effort to focus company resources on opportunities that provide the greatest value for customers, patients, and public health…”

Cervarix was discontinued because of low market demand. The competing HPV vaccine, Gardasil, had the much larger market share.

Vaccine Manufacturers and Discontinued Vaccines

And of course, some vaccine manufacturers simply stopped making vaccines.

The Texas Department of Health Resources once had a license to make vaccines, including DTP, diphtheria, DT, pertussis, tetanus, Td, and typhoid vaccines since 1950. They completely exited the vaccine market in 1979.

In the 1970s and 80s, dozens of vaccines were discontinued as Miles Inc., Eli Lilly, Parke Davis, and other companies stopped making vaccines.

While that is often downplayed these days, it is important to realize that we used to have much more competition among vaccine manufacturers. For example, in the early 1970s, the DTP vaccine was made by at least 11 different companies! We now have just two that make DTaP. And in many other cases, like for Prevnar, MMR-II, polio, and the chicken pox vaccine, there is just one manufacturer.

For More Information on Discontinued Vaccines:

Updated on February 7, 2018

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