Vaccination mortality risk – there’s nothing there

Vaccination mortality risk is often trumpeted (no evidence, of course) by the vaccine deniers as being very high, and one of the major reasons to avoid vaccines. The news reports about deaths after HPV vaccines (bogus, of course) often focus on deaths, without even considering general background mortality of teens and young adults, even for relatively rare conditions.

Moreover, deaths attributed to vaccines are often not causally related. It may feel like one event that follows another event is related – but there may not be any correlation, let alone causality between the first event and the second.

Those of us who accept the fact that vaccines are very safe, and indeed, not really a risk for causing death, have found no evidence that there has been a single death attributed to vaccines over the past couple of decades. But that’s just examining the high quality scientific and medical literature, which may or may not be 100% inclusive of all post-vaccination mortality.

But, that has changed with a new study that was published on 1 February 2015.

Vaccination mortality risk study

 

Natalie McCarthy et al. published an article in Pediatrics that examined the deaths of individuals, between the ages of 9 and 26, between 1 January 2005, and 31 December 2011, a period of seven years.

During that seven-year period, there were 1100 deaths identified within the 12 months following any vaccination among nearly 2.2 million patients (receiving nearly 8.5 million vaccines) enrolled in the Vaccine Safety Datalink (VSD), a collaborative project between the Centers for Disease Control and Prevention (CDC) and several managed health care systems, which monitors the safety of vaccines in the United States.

The VSD is a powerful tool to examine the safety and effectiveness of vaccines. It captures comprehensive medical histories for over 9 million individuals who are are vaccinated annually. The VSD has access to electronic medical records and other data at each site which allows researchers to exhaustively analyze correlation and causation between vaccinations and medical outcomes – including mortality.

Just to clarify, these 1100 deaths were all deaths after vaccination, which would form the cohort to analyze whether or not these individual’s deaths are correlated to vaccines, and whether there is any indication of causality.

Of the 1100 deaths identified, the following data was uncovered:

  • the mean number of days between delivery of the vaccine and death was approximately 179;
  • only 76 deaths (7%) occurred 0 to 30 days post vaccination;
  • 60 of those 0-30 day deaths followers receipt of 1 vaccine, 11 had received 2 vaccines, 2 had received 3 vaccines, and 3 had received ≥ 4 vaccines.
  • The researchers performed a cluster analysis, a statistical methodology to determine if there are patterns of data over time. As a result, they saw no clusters of data, so chose a 0-30 day window of risk of death post-vaccination to ascertain biological plausibility and potential causality.

The next step of the research was to examine the 76 deaths that occurred within 30 days post vaccination. Here’s how those broke down:

  • 17 lacked a medical record of death and had to be excluded from the study. These deaths were reported to state authorities, but lacked any information that might have allowed researchers to ascertain a causal relationship with vaccines.
  • This left 59 with detailed medical records of the death.
  • Of the 59 deaths, 33 were directly attributed to external causes, including murder, suicides and accidents. These are definitely not related to vaccines.
  • Further, 25 were related to non-external causes: these included 5 neoplasms, 6 diseases of the circulatory system, 3 diseases of the respiratory system, and one each of Addison disease, Rett syndrome, cerebral palsy, Takayasu disease, aplastic anemia, grand mal seizure, diabetes, obstetric cause, congenital malformation of heart, septic shock, and morbid obesity.
  • The cause of one death was unknown.
 
 

Examining causality

 

The next step of the research was to examine the potential causality between vaccines and the death of the patient. A team of CDC physicians individually reviewed the complete medical record review forms and additional documents to confirm the stated cause of death – they then assessed the possibility of a causal relationship between death and vaccination.

To be thorough, if the documents on the cause of death was incomplete, the CDC ordered coroner’s reports. And if the review at that point could not clarify the cause of death or association with vaccines, investigators from the CDC and each VSD site further studied the case.

Each death was classified according to established criteria for causality assessment. Mortality events were thenclassified into 3 categories:

  • consistent with a causal relationship between the death and vaccine,
  • inconsistent with a causal association, or
  • indeterminate (if the evidence was insufficient to confirm or rule out a causal relationship).

Out of the 59 cases, 56 showed no relationship to vaccines. External causes, like homicide, suicide and accidents, were obviously eliminated from having a relationship with vaccines. Only 3 required deeper assessment to determine whether there was evidence for a causal relationship between the vaccine and the death.

The results of the examination of the 3 deaths that showed potential causality from the vaccination was critical to this study. The working group looked at each case carefully:

  • The first case included a patient who had received tetanus and the quadrivalent HPV vaccine 14 days before death –the cause of death given by the coroner was thoracic aortic dissection, a tear in the lining of the aorta which causes blood to flow within the arterial wall. There are no known relationships between vaccines and aortic dissection, a deadly condition. It is generally caused by hypertension, connective tissue disease, chest trauma, and some genetic diseases. Based on the cause of death, and all of the evidence provided, “the working group determined the cause of death to be inconsistent with a causal association between the vaccines received and death.”
  • The second case included a patient who received Tdap vaccine (for tetanus, pertussis and diphtheria) and the quadrivalent HPV vaccine 11 days before death. The cause of death was given by the coroner as “unknown.” Lacking a cause of death, the working group was unable to determine a relationship between the vaccine and the death, and could not confirm or rule out a causal association. (And please don’t rely on the argument from ignorance, that is, that because we don’t have data, it could mean the vaccine is involved – no, since the risk of death is so small, it probably means that there is no relationship.)
  • The third case was a patient that received the quadrivalent HPV vaccine 18 days before death. The cause of death, listed in the patient’s medical report and the coroner’s reports, was sepsis of unknown origin. “The working group categorized the cause of death in this case as indeterminate because of a lack of a confirmed etiology of sepsis and, therefore, lack of evidence to confirm or rule out a causal association.”

Thus, after 8.5 million vaccinations, only three deaths might have been related to the vaccinations. However, further evaluation show us that one case was definitely not related to the vaccine, and in the two others there was no evidence that supported a conclusion that the deaths were related to the vaccine. None.

The risk of death after vaccination

 

One of the most surprising pieces of data is that the of the non-external causes of death (those that might be related to vaccines) after vaccination was 43% lower than the general population, a statistical significant number. In other words, getting a vaccine reduces your death rate from all non-external causes.

Why? Reduction of disease is the obvious one.  But also, we can assume someone who is vaccinated is generally healthier, seeks better health care practices, and simply doesn’t die early.

To be honest, I doubt that these results can be useful to a solid conclusion until such time that we gather more data.

 

TL;DR version

 

  1. Study looked at deaths after 8.5 million vaccinations in the VSD.
  2. Only 76 deaths were found with 30 days of the vaccination, the biologically plausible cutoff date for a temporal causal relationship.
  3. Of those 76 deaths, 17 lacked medical records (so cause of death was indeterminate), 33 were attributed to external causes (homicide, suicide, and accidents), 26 were attributed to non-external causes. Only three warranted further examination as to causality – of those one was found to not be related, and the other two lacked evidence to establish causality.
  4. The overall risk of death post-vaccination is lower than the general population.

To quote the authors, “Risk of death was not increased during the 30 days after vaccination, and no deaths were found to be causally associated with vaccination.”

This was a thorough examination of a population of vaccinated individuals with detailed medical records that allowed neutral observers to deduce whether the vaccine(s) were related to mortality. And what they found was that there was no relationship.

Key citations

 

The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!