Chapter 11: Article 1
One of the most critical components to ensuring ongoing improvement in vaccine safety is the Vaccine Adverse Event Reporting System (VAERS). Unfortunately, VAERS is a complete and utter failure.
Doctors are REQUIRED to report to VAERS any medical events that occur temporally after vaccination, because those events might be symptoms of a vaccine injury. However the majority of doctors have never been informed of VAERS existence. Why?
The USA government acknowledges that the current VAERS system is woefully inadequate, because it is a passive voluntary system. As a result of VAERS inadequacy, in 2006 the government looked into having an automated system developed.
So, how would an automated VAERS system work?
Medical visits and medical records are managed in electronic online databases. Because of this, it becomes possible to use those electronic health records to identify medical events which occurred temporally after receipt of a vaccine.
To create an automated program, HHS used $1 million of tax payer money, and contracted Harvard Pilgrim Health Care Institute (Harvard) to develop the necessary software system, and to test the programming performance between 2006 and 2009.
Ross Lazarus, the Principle Investigator for the project, prepared his final report for HHS in 2010 (Here). Within that report, he explains exactly what I stated above, that very few adverse vaccine events are reported, because of doctors' lack of awareness. He says:
Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative.
When describing the performance of the software programming that his team created, he had the following to say (emphasis mine):
Public and professional confidence in vaccination depends on reliable postmarketing surveillance systems to ensure that rare and unexpected adverse effects are rapidly identified. The goal of this project is to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS).
...Every patient receiving a vaccine was automatically identified, and for the next 30 days, their health care diagnostic codes, laboratory tests, and medication prescriptions are evaluated for values suggestive of an adverse vaccine event. When a possible adverse event was detected, it was recorded, and the appropriate clinician was to be notified electronically.
...Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average of 890 possible events, an average of 1.3 events per clinician, per month. These data were presented at the 2009 AMIA conference.
When discussing the status and success of each of the goals identified for the project, (these goals were called "Aims" 1 through 4), Lazarus had the following to say about Aim 2 and 3:
...The goal of Aim 2 was the Development of [health data exchange] for [VAERS] to ensure secure transmission to CDC...Synthetic and real test data ... was generated and transmitted between Harvard and Constella. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the CDC had yet to respond to multiple requests to partner for this activity.
...[Regarding Aim 3] We had initially planned to evaluate the system by comparing adverse event findings to those in the Vaccine Safety Datalink project—a collaborative effort between CDC’s Immunization Safety Office and eight large managed care organizations. Through a randomized trial, we would also test the hypothesis that the combination of secure, computer-assisted, clinician-approved, adverse event detection, and automated electronic reporting will substantially increase the number, completeness, validity, and timeliness of physician-approved case reports to VAERS compared to the existing spontaneous reporting system; however, due to restructuring at CDC and consequent delays in terms of decision making, it became impossible to move forward with discussions regarding the evaluation of VAERS performance in a randomized trial, and compare VAERS performance to existing VAERS and Vaccine Safety Datalink data. Therefore, the components under this particular Aim were not achieved.
Regarding the final status of the project, Lazarus had the following to say:
Proactive, spontaneous, automated adverse event reporting imbedded within [electronic health records] and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs.
Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.
Of course identifying any potential increase in medical events following immunization would help improve vaccine safety by:
ensuring unsafe and harmful vaccines are promptly removed from market, and
identifying vaccines brands that cause fewer reactions, which could allow for promotion of those less reactive vaccines
Using the study data, let's broaden our discussion of adverse vaccine reactions beyond the Harvard study group. In Lazaurs' final report summary, specific details were not provided about the study patients' ages, nor was information provided for the number of doses administered of each vaccine brand. Because of that, one can only use the general numbers provided, to calculate a rough average, concluding that each vaccinated person within the study received an average of 3.72 doses of vaccine, over the course of three years of testing. In the Results section of the study, the patient profile described that only 25% of the patients studied were under the age of 18. So the pediatric population was not the main source for data in this trial.
To compare, according to the HHS there are 4 million babies born in the US each year. The pediatric population is the most heavily vaccinated. If vaccinated according to the CDC schedule, that child will receive up to 37 doses of vaccine by age 2.
In the software testing, the data showed that 2.6% of vaccine recipients experienced an event that was potentially a vaccine related event (or a combination of events) during the following 30 days after vaccination (events described below). The software programming looked for:
an Emergency Room visit
an allergic reaction
an "unwell" doctor's office appointment
an abnormal vital sign assessment
abnormal lab results
a need for prescription drug(s)
Recognizing that there are 4 million infants born annually, and using the study's 2.6% adverse event rate, that means it's possible that at least 104,000 infants, age 0-12 months, will require medical support annually, following the receipt of the 29+ doses of vaccines they received in their first year. The same can be said for the toddlers in the 1-2 years age bracket, as they are vaccinated with 10 doses in their second year. That adds 104,000 more children who will require medical care for their vaccine adverse events, annually. In the the childhood population, age 4-6 years, that group receives 9 doses before school, so they too will account for at least 104,000 medical events requiring doctor support. The 11-12 year old population receives 8 doses of vaccines, so they will also likely account for at least 104,000 medical events requiring doctor support.
So, it's likely the USA is seeing a minimum of 416,000 adverse vaccine events in the childhood population that require medical support. That estimation does not included any other age groups, and every age is recommended to receive an annual flu vaccination.
At present, according to the CDC, a merger 30,000 reports are filed annually to VAERS. That means that currently VAERS is capturing less than 7% of the medical events that doctors are required, by law, to report.
Please note, it is reasonable to assume that a person's risk of reaction increases when the number of drugs received within a period of time is increased. The pediatric population receives 37 doses of vaccine against 14 illnesses, within their first two years of life. In comparison, the study group received an average of 3.7 doses of vaccine over three years time. Based on the significantly increased vaccine exposure rate experienced in the pediatric population, one can reasonably assume that more than 2.6% of the pediatric population are requiring medical support after vaccination, annually.
The final report prepared by HHS (Here) explains that Harvard successfully achieved 3 of the 4 goals required of them to automate the VAERS database, but the project failed and was not completed. HHS noted that the project's failure was due to restructuring within the CDC, as this restructuring prevented the necessary testing from occurring, testing which could have satisfied the final outstanding goal. The final reports prepared by HHS and Harvard were completed in 2010, which means that the CDC has since had ten years to complete their restructuring and resume communications with the Harvard team. It appears that to date, neither HHS nor CDC have made any efforts to resume this project.
Harvard created an automated system that could quickly identify more reactive and unsafe vaccines. With such information, the Health Authority could properly manage the vaccine supply, allowing only the safest vaccines to remain on the market. Such action might have restored faith in the vaccine program, recognizing that hesitancy crept in and continues to grow.
As a result of HHS and CDC's apathy, the public has been left to continue relying on a passive voluntary system which the Government admits is woefully inadequate and ineffective. That means that for the time being, $1 million tax payer dollars was wasted and our infants and children remain at serious risk .
CONTINUE to the next article in: Ch11: Part 2
Article Sources
The National Childhood Vaccine Injury Act of 1986 Here
Reporting medical events to VAERS is the law Here
Medical events that need to be reported to VAERS Here
Merck MMR-II package insert states that parents should be instructed about reactions that need to be reported to VAERS, and doctors are required to file these reports Here US National Vaccine Injury Table Here)
Dr. David Davis explains that in his first 35 years practicing as an ER physican, he never knew of the VAERS database and his responsibility to report medical events to it Here
The VAERS Link Here
The link to the Canadian version of VAERS (also a passive system) Here
Health Canada explains the responsibility to report temporally related events Here
Details from the Health and Human Services website, about the contract with Harvard Pilgrim Health Care Institute and the "conclusion" of the study Here and Here
Collaboration between Harvard Pilgrim Health Care Institute and Harvard Medical School Here and Here
Harvard's Principle Investigator, Ross Lazurus, provides his final report on the "failed" automation of the VAERS database Here
HHS website - American Birth Rate Here
Current US Childhood Vaccination Schedule Here
Current Canadian Vaccination Schedule (Province of Alberta) Here
CDC explains that approximately 30,000 reports are filed in VAERS annually Here
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