Debunking AntiVax arguments: Vaccine Injuries

The Holy Grail of anti-vaxers is the string of people who say "My child was injured by Vaccines". There's a constant stream of tragic and deeply personal stories of children with often horrific and permanent disabilities. Who couldn't be moved by such tales? Who would be so callous as to question the causation, medical diagnosis or motives of the suffering parents?

Such discussions are the kryptonite of any rational discussion of vaccine safety. If vaccines are so safe, why so many stories of vaccine injured children? Why is there a vaccine court in the United States? Why is there so much opposition to vaccines on the basis of safety?

A discussion on vaccine safety is a complex one that needs to be broken down into constituent parts. It's important because there are only two issues that really matter when it comes to any medical intervention: safety and effectiveness. They can't be dealt with separately because they are interrelated through a process called Risk Management.

Risk Management & Clinical Trials

To start with, there is no such thing as 100% safety in any medical intervention. Paracetamol is not 100% safe, driving your car is not 100% safe, eating your lunch is not 100% safe. This is why medical interventions are not taken unless they exceed the risk for NOT making the intervention. This is where effectiveness comes into play.

All medicines undergo phases of clinical trial with many sub-phases. This applies to vaccines as well. Part of this (where possible) includes what is known as "double blind crossover" trials. This is where half of the recipients receives the vaccine (or medicine) and the other half receives an inert placebo (the control group). In some studies, there may be several medications tested against a single control group. In others, the control group may be smaller.

Neither the patient or those involved in the trial know who has received what. During the trial both effectiveness and adverse events are recorded. Once the trial has completed, the details as to who received what is revealed and the results are compared. If the treatment was no more effective than a placebo, then it was not effective. The adverse events are also checked to see if there is a statistical difference between the control group and the active group.

Typically, a Phase II trial will include around 100 participants. A Phase III trial will be much larger. There may be several such Phase II & III trials with all trials requiring mandatory reporting. In general, the larger the number of trial participants, the more accurate the data is. As an example, here are the results for one of the adverse event Phase II trials for Gardasil:

Yes, you read that right, "Traffic accident" is included as an adverse event.

In some cases a trial may be tainted by other factors and excluded from the overall results as an anomaly. An example of this is found in the manufactroversy in the movie Vaxxed - but I digress.

After a medicine is released, trials do not end. They continue into Phase IV and sometimes Phase V trials (longitudinal studies).

Vaccines are in a special case. This is partly because we are generally dealing with paediatric vaccines, but it's also because we are dealing with no pre-existing conditions. So, for a vaccine to be licenced, not only must it be safe, it must be very, very safe!

VAERS & DAEN

Vaccines are also unique in that there is a mandatory reporting system for ALL adverse events whether caused by the vaccine or not. The reporting system both in Australia and in the United States is open to everyone - not just medical professionals. Both databases are publicly searchable. In Australia it is called the Database of Adverse Event Notifications or DAEN. In the United States it is called the Vaccine Adverse Event Reporting System or VAERS. The DAEN was recently expanded to include all medicines and medical devices. Contrary to what you may have heard, both databases:

 - Are not censored or filtered in any way
 - Are simply reportings of adverse events that happened after the vaccination - whatever the cause

That's right. They may not even be connected. Car accidents and broken bones have been listed as adverse events. One of the more well-known examples of how any unrelated event can make it into VAERS was Dr. James Laidler’s report that the influenza vaccine turned him into the Incredible Hulk.



As an example, here are the results for the M-M-R II vaccine for 2018 in Australia according to DAEN.

So, for the administrations in Australia for this vaccine for the year, there were 170 reports. Of which, 49 could be attributed to the vaccine. Perusing the list, most of these are very minor events. The events of one or two reported cases go for another page and a half. For brevity, they aren't listed, but you can search them yourself.

Both databases are carefully monitored. Any uptick in an adverse event against the background rate OR the rate predicted by the clinical trials is carefully investigated. It's always possible that a side-effect below the rate predictable by clinical trials is possible.

NVICP - The United States Vaccine Court

"So, why is there a Vaccine Court if vaccines are so safe?"

Unlike Australia (and most of the Rest Of The World), The United States has no universal health care. Vaccines are manufactured by drug companies for a profit, however that profit is quite small compared to other medicines. So small, in fact, that the companies manufacturing the vaccines consider it part of their public duty.

Through the 1970s and 1980s, the number of lawsuits brought against vaccine manufacturers increased dramatically, and manufacturers made large payouts to individuals and families claiming vaccine injury, particularly from the combined diphtheria-pertussis-tetanus (DPT) immunization. In this environment of increasing litigation, mounting legal fees, and large jury rewards, many pharmaceutical companies left the vaccine business. In fact, by the end of 1984, only one U.S. company still manufactured the DPT vaccine, and other vaccines were losing manufacturers as well.

In response, In 1988 the US Government setup the National Vaccine Industry Compensation Program (NVICP). It was funded by an 75c per vaccine excise tax. At the time, the number of vaccines administered wasn't as high as today and it was assumed there would be large numbers of successful claimants.

The NVICP didn't stop people from suing drug companies for vaccine injuries, but it was made a far more attractive route to do so for the following reasons:

 - It was essentially free. No out of pocket expenses.
 - The burden of proof is very, very low. In fact, you didn't even have to prove the vaccine caused the injury. All you had to do was show that your child contracted the condition after the vaccine was administered and that is was POSSIBLE for the vaccine to have caused the injury.

With such a low burden of proof, surely there must be huge numbers of payouts. The reality is that the number of payouts is very, very low. In fact:

• of over 3.1 billion doses of vaccines that were distributed in the United States between 2006 and 2016, there were 3,749 compensated claims through the NVICP
• almost 80% of all compensated awards by the NVICP come as a “result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”
• the NVICP cases are published by the U.S. Court of Federal Claims, so all information is disclosed to the public and no safety concerns are hidden.

The NVICP is awash with money. So much so it doesn't know what to do with it. Vaccine manufacturers are keen to settle rather that fight it as it doesn't cost them any money to do so. Plaintiffs lawyers are also keen to settle. Judges are keen to hand over large sums of money to ease the financial burdens on parents with no adequate health care. So, even in the face of this there are fewer than 1 in 1 million claims against this gravy train.

What the vaccine court shows is that vaccine injuries are very, very rare. Source Source

Do Vaccine Injuries occur?

Yes they do, for a very small number of conditions. Most of these are related to specific side effects of individual vaccines that are extremely rare. The standout, however is allergic reaction including anaphalaxis and febrile convulsions. Any child who has such a reaction is contra-indicated and medically exempt from vaccinations. Usually the reaction is due to one of the vaccine components such as the adjuvent, rather than the vaccine itself.

The known vaccine injuries are listed here.

The good thing about the NVICP is that it gives us some concrete data to work with. The percentage of petitions to actual vaccines administered is 0.016%. One one-hundredth of one percent of cases of vaccination have resulted in a petition being filed.

The percentage of compensations to actual vaccines administered is 0.003%. Three one-THOUSANDTHS of one percent of cases of vaccination have resulted in compensation for injury.

I don’t know about you, but a safety rating of 99.997% seems really great to me!
Additionally, the NVICP claims are not limited to children, and the above calculations are by person, not by injection, so the actual safety rate is significantly higher than 99.997%. If you included all adult vaccinations, and counted number of injections rather than number of vaccinated persons, you’d get something that probably looks like 99.99999% of child and adult vaccinations resulting in no serious adverse events.

Let’s put those safety statistics into perspective. Your odds of dying in a car accident are 1 in 572, or .17%, or 58 times greater than experiencing an adverse event from a vaccine. Each year, 80 people die from choking on food, accounting for 11% of deaths in children under eight.

Or, to put in another way: On the day a child is vaccinated, you feed them, drive them to the doctor and the doctor administers the vaccination. Of these three things, the safest is receiving the vaccination.

The Bottom Line – vaccines are safe, and save lives.

But... what about those testimonials!

Many people will claim that any of a dozen injuries are caused by vaccines. They generally do so without any evidence. However vaccine injury stories have become the sacred cow of the anti-vax movement. You are expected to believe parents at face value and questioning them opens you to accusations of being cruel and callous. Regardless, some basic questions must be asked:

1. May I ask why you are so sure it was the vaccine?
2. Has it been medically confirmed?
3. Was anything else going on at the time?
4. Before the vaccine was invented, did this condition exist?
5. What caused these conditions before the vaccine was invented?
6. Could it be possible that these things are causing them now?
7. What is the likelihood that the vaccine caused it versus something else?

Childhood vaccines are administered according to a scientifically designed schedule that maximises protection and immunity and minimises risk. This means vaccines are administered at 2, 4, 6, 12 & 18 months intervals. It is during this time that a child is most susceptible to a variety of child onset diseases that can be congenital, hereditary or have no known causes of onset.

The likelihood of autism, SIDS, SSPE, developmental delay etc occurring or being detected around the time of vaccination is more likely than not. It is not unusual for a parent to look for causes and decide that vaccinations MUST be the cause because it occurred after vaccination. This is the fallacy known as post hoc ergo propter hoc or literally "after the event, therefore because of the event". For example: The sun rose, the shed fell down, therefore the sun knocked the shed down.

One event happening after an event does not necessarily cause the event. Correlation does not equal causation.

YouTube videos are also presented to as “evidence” of vaccine injury, but they are not proof of anything either.  Anecdotal reports – VAERS, DAEN, YouTube, rumours, a friend’s cousin’s hairdresser’s aunt’s version of events – they’re all unreliable. And so is an unqualified and inexperienced parent trying to make medical diagnosis without really understanding the process – no matter how earnest and well-meaning they are.

Real vaccine injuries are recorded. You or your doctor can report the injury and if it’s serious, so begins a public health investigation. They are not overlooked. They are not covered up.  If anything, they are sought after. Vaccine safety is taken extremely seriously by vaccine manufacturers and the medical establishment which includes doctors, nurses, the government, and public health professionals. Even researchers look for vaccine injury reports: sometimes they are written up in the medical literature as a case study.

Only after reports have been medically analysed can they be confirmed as real vaccine injuries, and these cases contribute to official vaccine statistics as legitimate risk of reactions.

As I have shown, when you do the real numbers, the risk of serious vaccine injury is orders of magnitude less than 1%.  

Some of the vaccine injury stories are simply impossible. For example, SIDS and Shaken Baby Syndrome are being blamed on vaccines, when in fact a meta analysis of the medical literature shows that immunizations are actually associated with halving the risk of SIDS. And Shaken Baby syndrome is an abusive head trauma, not a vaccine injury.

Actually, most of the vaccine injuries commonly discussed by vaccine critics have absolutely no connection to immunisations other than coincidental timing with the administration of the vaccine. Some parents who believed that pneumonia, a middle ear infection, a cough or cold, eczema, asthma, autism, epilepsy, and other unrelated conditions were “vaccine injuries” simply because their child had one of these things happen or diagnosed around the same time as their jabs. One woman was convinced that a flu shot gave her endometriosis. Impossible.

  

Then there are genetic conditions, such as epilepsy or autism, which tend to pop up early in a child’s development and may coincide with vaccination. But these things occur in children with or without vaccinations.

True vaccine injuries of a serious nature are exceptionally rare. We know they are real when they’ve been medically confirmed or published in peer-reviewed, credible medical journals. They are so rare we usually hear about them in the media and remember them by name. These kinds of cases should be swiftly and generously compensated.

For example, American David Salamone  and Jacob McCarthy from Australia both developed paralytic polio from the oral polio vaccine, which is no longer administered in the United States or Australia. Saba Button  from Australia developed brain damage after ongoing febrile seizures from CSL’s FluVax. (This vaccine has now been withheld for use in children younger than 5)

Other cases are deemed “causation indeterminable” – but it may be possible the vaccine caused it.  For example: Izzy Olesen suffered from Stevens-Johnson syndrome after the DTaP booster.  It was reported by medical staff as a possible vaccine reaction, but causation cannot be proved.

Some events are so rare, it is impossible to determine whether the vaccine cause it or not.  Other cases are rare, but given other information the possibility of a vaccine injury is not very likely. For example:

The long-held myth of vaccine encephalopathy was debunked upon the discovery of Dravet’s syndrome. But there was no trumpeting fanfare, no viral internet sharing when this news came out.

There is a very sad case of baby Ian Gromowski who allegedly died because of the Hepatitis B shot.  However, Ian’s mother was induced due to toxemia and pre-eclampsia which indicate a high-risk and complicated pregnancy. Moreover, Ian had aspirated meconium prior to birth and was born with a fever indicative of infection.  He was also allergic to an antibiotic he was given.  All of these complex medical factors surrounding his case demonstrate that he did not die simply because of a reaction to the Hepatitis B vaccine. In reality, it was much more complicated than that and the vaccine most likely in fact has nothing to do with his death whatsoever.

Then there are a collection of reports known as the “Gardasil Girls.” Their alleged injuries range from ovarian failure, neurological conditions, meningitis, chronic fatigue, pulmonary embolism, influenza, chronic Lyme’s disease morphing into a vaccine injury and death. But there is no medical evidence that these are caused by the vaccine. However, there is a mountain of scientific evidence demonstrating the safety of the HPV vaccine.  With more than 50 million doses having been given worldwide with very close safety monitoring, we know that this vaccine is safe.

In fact, when you review the evidence, the rates of major events of concern, namely Guillain-Barre syndrome, autoimmune disorders, transverse myelitis, and death, were all exceedingly rare, and not above what one would expect to occur in the normal unvaccinated population.  Gardasil does not cause premature ovarian failure. And deaths from Gardasil are a complete lie.

So why would a parent still cling to a belief when the medical science concludes otherwise?  Perhaps because the emotion surrounding the event cements the conviction firmly in their mind and it’s hard to undo a thought process where emotion overrules logic.

People who don’t have a real vaccine injury and spread myths about them do a great disservice to real vaccine safety advocates; the people who’ve had real vaccine reactions. They undo the good work that people like David Salamone’s father, John, have done.  John was instrumental in lobbying the US government to switch from oral to injectable polio vaccine. He still recommends vaccines and recognizes his son’s reaction is a very rare event.

We cannot be expected to accept vaccine injury stories without a reasonable explanation of the mechanism of harm.  If you think we should accept all stories at face value, I’m afraid you’re missing the mark as vaccine safety advocates.

Source

Debunking AntiVax Arguments: Fetal tissue in vaccines

Most anti vaccine arguments consist of thought-stopping clichés. Basically a half-truth phrased in a way to provoke a visceral, emotional reaction. This one is no different:

Sounds scary!? The photo makes it look like "Human diploid cell" is an ingredient in the vaccine! Are doctors injecting my baby with aborted foetuses!?

When this claim is made it is usually referring to the Rubella component of the childhood MMR vaccine.

Some background on Vaccines

There are many types of vaccine: acellular, inactivated, live attenuated, toxoid, subunit etc. Source They all work in slightly different ways to produce the same result: An immune reaction in the host that will prepare the immune to either prevent the incidence of the disease it is protecting against or reduce the severity of it.

Regardless of type, the cell cultures must be grown in a medium that is favourable to the growth of the culture. For influenza, this is usually done in eggs as most influenza strains reproduce in birds. Note the culture is GROWN in eggs, the egg products are separated from the antigen material during production. No egg products are injected into the human body. Thus, people with egg allergies can have the flu vaccine without a reaction.

The very earliest 'vaccine' was for smallpox. It was found milkmaids that caught cowpox (a very mild disease) didn't catch smallpox. In the 1800s, a physician would make small cuts of the recipients arm and place a drop of blood from a cow infected with cowpox. The recipient would catch cowpox and gain immunity from smallpox. Over the years, the methods, techniques and the sophistication and safety of delivery mechanisms improved.



In the 1970s, the World Health Organisation set on a program to innoculate everyone on the planet at risk for small pox. As a result, smallpox has been eliminated and no one needs to be vaccinated against it any more - because it doesn't exist!



That is the end goal of vaccination programs everywhere. To eliminate the disease, and therefore the need to vaccinate against the disease. source

Cultivation of vaccines in animal products and live animals

Through most of the 20th century, vaccines were cultivated exclusively in animals, either by growing pathogens in live animals or by using animal cells.

Although many vaccines and anti-toxin products were successfully developed this way, using animals in vaccine development – particularly live animals – is not ideal. Research animals are costly and require extensive monitoring, both to maintain their health and to ensure the continued viability of the research. They may be carrying other bacteria or viruses that could contaminate the eventual vaccine, as with polio vaccines from the mid 20^th century that were made with monkey cells and eventually found to contain a monkey virus called SV40, or Simian Virus 40. (Fortunately, the virus was not found to be harmful to humans.) Moreover, some pathogens, such as the chickenpox virus, simply do not grow well in animal cells.

Even when vaccine development is done using animal products and not live animals – such as growing influenza vaccine viruses in chicken eggs – development can be hindered or even halted if the availability of the animal products drops. If an illness were to strike the egg-producing chickens, for example, they might produce too few eggs to be used in the development of seasonal flu vaccine, leading to a serious vaccine shortage. (It’s a common misconception that influenza vaccines could be produced more quickly if grown in cell cultures compared to using embryonated chicken eggs. In fact, growing the vaccine viruses in cell cultures would take about the same amount of time. However, cell cultures do not have the same potential availability issues as chicken eggs.)

For these and other reasons, using cell culture techniques to produce vaccine viruses in human cell strains is a significant advance in vaccine development.

It should be re-iterated here that the culture used to grow the antigen is not an ingredient of the vaccine. That's a bit like saying a frying pan is an ingredient of an omelette. So, vaccines grown in eggs, do not contain eggs; vaccines grown in duck livers, do not contain duck liver and of course, vaccines grown in human cell lines, do not contain human cells.

How do cell cultures work?

Cell cultures involve growing cells in a culture vessel. A primary cell culture consists of cells taken directly from living tissue and never subcultivated, and may contain multiple types of cells.

A cell strain is a cell culture that contains only one type of cell in which the cells are normal and have a finite capacity to replicate. Cell strains can be made by taking subcultures from an original, primary culture until only one type remains.

An immortalized cell line is a cell culture of a single type of cell that can reproduce indefinitely. Normally, cells will reproduce only a finite number of times before they cease to reproduce. However some cells in culture have undergone a mutation, or they have been manipulated in the laboratory, so that they reproduce indefinitely.

Researchers can grow human pathogens like viruses in cell strains to attenuate them – that is, to weaken them. One way viruses are adapted for use in vaccines is to alter them so that they are no longer able to grow well in the human body. This may be done by repeatedly growing the virus in a human cell strain kept at a lower temperature than normal body temperature. In order to keep replicating, the virus adapts to become better at growing at the lower temperature, thus losing its original ability to grow well and cause disease at normal body temperatures. Later, when it’s used in a vaccine and injected into a living human body at normal temperature, it still provokes an immune response but can’t replicate enough to cause illness.

So, what is WI-38?

In 1941, Australian ophthalmologist Norman Gregg first realized that congenital cataracts in babies were the result of their mothers being infected with rubella during pregnancy. Along with cataracts, it was eventually determined that congenital rubella syndrome (CRS) could also cause deafness, heart disease, encephalitis, mental retardation, and pneumonia, among many other conditions.

At the height of a rubella epidemic, it was calculated that 1% of all births at Philadelphia General Hospital were affected by congenital rubella syndrome. In some cases, women who were infected with rubella while pregnant terminated their pregnancies due to the serious risks from CRS.

Following one such abortion, the fetus was sent to Stanley Plotkin MD, at the Wistar Institute in Philadelphia. Testing the kidney of the fetus, Plotkin found and isolated the rubella virus. Separately, Leonard Hayflick (also working at the Wistar Institute at that time) developed a cell strain called WI-38 using lung cells from an aborted fetus. Hayflick found that many viruses, including rubella, grew well in the WI-38, and he showed that it proved to be free of contaminants and safe to use for human vaccines.

Plotkin grew the rubella virus he had isolated in WI-38 cells kept at 30°C, so that it eventually grew very poorly at normal body temperature. After the virus had been grown through the cells 25 times at the lower temperature, it was no longer able to replicate enough to cause illness in a living person, but was still able to provoke a protective immune response. The rubella vaccine developed with WI-38 is still used throughout much of the world today as part of the combined MMR (measles, mumps, and rubella) vaccine.

How safe and effective is the Rubella vaccine

Plotkin’s vaccine was extensivelt tested over a ten year period before being first licensed in Europe in 1970 and Australia in 1971 and was widely used with a strong safety profile and high efficacy. In light of that data, and of larger side effect profiles with the two existing animal-culture rubella vaccines, it was licensed in the United States in 1979 and  replaced the rubella vaccine component that had been previously been used for MMR (measles, mumps, rubella) combination vaccine. In 2005 the CDC declared rubella eliminated from the United States, though the threat from imported cases remains. The World Health Organization declared the Americas free from rubella in 2015. In Australia, in 2017 there were ten reported cases of rubella. In 2018, Australia was declared free from rubella. source

The efficacy of the vaccine rose due to the administration of the second booster.  The first dose of the MMR vaccine is likely to give about 96 percent of those receiving it immunity against measles, mumps and rubella. After the second dose, 99 percent of recipients are likely to be protected against all three illnesses. The third does not only increases this effectiveness, but maintains close to 90% effectiveness in middle and old age.

But what about the ethical issues?

Groups that object to abortion have raised ethical questions about Plotkin’s rubella vaccine (and other vaccines developed with similar human cell strains) over the years.

Because of its position on abortion, some members of the Catholic Church asked for its moral guidance on the use of vaccines developed using cell strains started with human fetal cells. This includes the vaccine against rubella as well as those against chickenpox and hepatitis A, and some other vaccines. The official position according to the National Catholic Bioethics Center is that individuals should, when possible, use vaccines not developed with the use of these human cell strains. However, in the case where the only vaccine available against a particular disease was developed using this approach, the NCBC notes:

One is morally free to use the vaccine regardless of its historical association with abortion. The reason is that the risk to public health, if one chooses not to vaccinate, outweighs the legitimate concern about the origins of the vaccine. This is especially important for parents, who have a moral obligation to protect the life and health of their children and those around them.

source

The Church of Jesus Christ of Latter-day Saints has not specifically addressed the issue of using embryonic cell lines, however the Church has made several statements in support of the entire range of childhood vaccines include an ex cathedra statement from the First Presidency in 1978. The statement read in part:

“Immunization is such a simple, yet vital, matter and such a small price to pay for protection against … destroying diseases.

“Failure to act could subject untold thousands to preventable lifelong physical or mental impairment, including paralysis, blindness, deafness, heart damage, and mental retardation.

“We urge members of the Church … to protect their own children through immunization. Then they may wish to join other public-spirited citizens in efforts to eradicate ignorance and apathy that have caused the disturbingly low levels of childhood immunization.” (Reported in Ensign, July 1978, p. 79.)
source

The statement was re-iterated in 1985. source

The church encourages parents to fully vaccinate their children and also funds an official worldwide initiative for childhood vaccinations.



Thus, for a Latter-day Saint, not only is there no moral excuse for refusing vaccinations, there is a strong moral requirement for parents to fully vaccinate their children given in language that is about as strong as you are ever likely to get from the First Presidency on any issue.