the purpose of the Harvard study which was to see if there was existing effective reporting of adverse vaccine events in approved FDA vaccines - ie could VAERS be improved.
So no placebo group was required as it was a real life study of what was already being done in routine and emergency vaccine health care to see if VAERS reporting was effective.
There were 715,000 normal medical patients from Atrius Health, a medical group with about 700 Doctors in the Boston area with patients from infants to the elderly
About 50% of the patients had their standard or routine vaccines - some vaccines involved multiple shots over time etc.
45 different types of vaccine were given.
Those who did not have vaccines were not due vaccines or did not get them because they forgot etc etc.
This was real life situation and showed what was going on by building a new ESP-VAERS CDC approved system from scratch, with proper adverse vaccine event reporting done by Artius Health. Based on the findings proper reporting was not and is not going on in the rest of the USA.
My concern is to have real data about Adverse Reactions for ADE, transparency about all adverse vaccine events and how long it took/takes to identify a vaccine risk.
This data is not available in a timely or simple way and the Harvard study and other examples below shows the risks are very real and/or badly under reported even for extended time frames
Also please remember the CDC is very clear 85-90% of the 48,000 VAERS reports in 2019 are minor but 10-15% are serious meaning
"permanent disability, hospitalization, life-threatening illness, or death."
See VAERS link and other info in my previous posts showing the same CDC 10-15% risks over time and in 2009
Its the 10-15% serious cases that concern me - it seems very clear that the
Harvard Study highlighted something the CDC still has not reviewed and it looks like it should have as the Harvard study data was presented and discussed by an FDA official and a Harvard researcher at an AIMA Conference in 2009
The Harvard Study Final Report (see PDF link at the end) states on page 6 under the heading
"Results"
The CDC vaccine safety system VAERS reports fewer than 1% adverse vaccine events [of all types both minor and serious] and that these Harvard findings were presented at an AIMA conference in 2009
Most of the info and links I have found are set out below
After the system was developed, coded, rolled out, real short term patient data was used for reporting adverse vaccine events and calculations.
The Artius Health Drs entered patient data into the new system and filled in the adverse vaccine event forms as and when an adverse vaccine event happened. Over time the data was studied
What happened was that 35,000 adverse events were properly recorded and a total of 1.4 million vaccines doses were given
There is even a sample PDF of the form used by the Atrius Health Drs to input the adverse vaccine event data into the system with the VSD/VAERS vaccine codes already inserted so that cross checking could be done to validate the existing VSD and VAERS data against the very detailed and well maintained trial data
digital.ahrq.gov
The Harvard study was HHS/FDA funded for US$ 1Million until to 2009 and appears to have been so successful that Harvard continued unfunded for 2010
After the CDC failed to act on the vaccine findings Harvard developed the
system to cover and search patient records for a very wide range of medical conditions and treatments and this remains in use today
“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.”
All the projects vaccine aims were achieved
(except the CDC allowing a validation of CDC data by cross checking with the high quality trial data. The CDC admits the VAERS data is of poor quality - see my previous posts for CDC studies )
The Harvard study achieved aims included a fully working ESP-VAERS system and a vaccine adverse event reporting system using real patients and real data - which identified 35,000+ adverse vaccine events of all types
Under CDC parameters 10-15% of these vaccine events would result in "permanent disability, hospitalization, life-threatening illness, or death." See VAERS link in my previous post
Some info on the Harvard Study reports on US gov web sites is set out below - also see pdf link for final report and other links later below
"The grant team has a functioning adverse event detection system capable of being expanded and modified to deal with a wide range of conditions. Testing and initial validation are complete. Additional validation was planned as part of dissemination to other sites."
"The team had planned to evaluate the system by comparing their adverse event findings to those in the Vaccine Safety Datalink project a collaborative effort between CDCs Immunization Safety Office and eight large managed care organizations.
Through a randomized trial, the team had also planned to 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 decisionmaking, it was ultimately not possible to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial, or to compare ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data, as was described in the third aim.
However, the infrastructure is available and Dr. Lazarus is hopeful that the project may generate additional interest to complete this study."
After the CDC stopped co-operating with the study, Harvard researchers, developed the system and it sold across the USA to government and private groups - including to the original Artius Health group involved in the Harvard study trial.
Current system sales continue to date but it does not seem to be electionically linked into VAERS though some states appear to use it for vaccine monitoring in some way. See users in link below
The Harvard study details and quotes above are set out in the links below - US Gov website (HHS/FDA related funding etc)
There are several tabs near the top of the page on the links that take you to different reports and on different pages of info - titled
Project Description
Annual Summaries
Final report PDF
Etc etc
The project sought to create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events and found that it is possible to automatically detect adverse events in defined ways, and to electronically report them.
digital.ahrq.gov
The project sought to create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events and found that it is possible to automatically detect adverse events in defined ways, and to electronically report them.
digital.ahrq.gov
Its also clear that there was a population of patients who were vaccinated and unvaccinated that could have been researched in some way to easily provide some initial findings on if there were vaccine derived health events.
As set out at the start my concern is to have real data about Vaccine Adverse Event reactions such as Antibody-dependent enhancement / ADE, transparency about all adverse vaccine events and
how long it takes/took to identify an adverse event risks.
This last point is never really discussed currently or identified anywhere - its all very vague and not very scientific.
There appears to be no system that is publically available or any public reporting of the true figures of ADE or other adverse vaccine events for each vaccine or what if any delays there have been with VAERS identifying a vaccine problem.
More and better data should identify the problems sooner