Review Summary
The 2018 CAEFISS (Canadian Adverse Events Following Immunization Surveillance System) Summary Report on four years of post-market surveillance of adverse event following immunization is beyond disappointing. It appears to be a well-calculated attempt to comply with reporting requirements without actually providing meaningful information. The report is sloppily written, poorly designed and not transparent. It reports different numbers for the same data, makes statements that are nonsensical and makes declarations that are non-verifiable from the data presented.
Obscuring critical information
The data is reconfigured in five figures and five tables that obscure the limited information on Serious Adverse Events (SAE). This is particularly concerning as 80% of serious events are suffered by children. As always, the youngest children who receive the most vaccinations in the shortest time period suffered the greatest number of serious adverse events.
In comparison, an Australian surveillance report shows how data can be reported transparently in well-designed charts and tables, and, more importantly, it shows an emphasis on adverse event data for children. This is completely at odds with the CAEFISS report where our public health officials obscure this data.
Contradictory data reporting
While the report has severely condensed content compared to previous summary reports, a major concern that calls in question its accuracy, is the contradiction of its own previously published data on numbers of AEFI (adverse event following immunization) and SAE reports received. No one reading the report would be aware of this since previously published data and trends are completely excluded from the report. Our graph below highlights the discrepancies between the latest report and the previous reports.
Low AEFI reporting rates does not equal low AEFI
The self-congratulatory nature of the report is particularly disturbing. A lower AEFI reporting rate of adverse events compared to other countries is not something to be proud of. Quite the opposite in fact, since low reporting rates do not mean that fewer adverse events are actually occurring. Diminished reporting likely reflects an ideology on the part of medical professionals that vaccines are safe, rather than reflecting a genuine attempt to collect and analyze empirical data that could prove otherwise.
While the CAEFISS Summary Report goes to great lengths to distance vaccines from adverse events reports, it then turns around and claims that low reporting rates by inference are a proxy for actual adverse events occurring and therefore somehow prove that vaccines are safe.
Canada is not alone in this disinformation campaign. All internationally established pharmacovigilance schemes use the low reported AEFI numbers against the actual number of vaccine doses to calculate reporting rates and assure us that these low reporting rates mean vaccines are safe. This is illogical, deceptive and dangerous.
One simply cannot use the low reported number of adverse events—a number that represents at most a tiny portion (less than 1%) of actual events—to calculate a reporting rate that is based on all vaccine doses and then conclude that vaccines “have an excellent safety profile”.
The actual conclusion
The only conclusion the currently contrived reporting rates are concretely telling the public is that fewer and fewer adverse events are being reported over time in Canada.
We estimate that in the four years covered by the CAEFISS report, at a bare minimum, over one million adverse events actually occurred. Of these, almost 50 thousand were serious adverse events, the majority experienced by children.
As a final comment, if CAEFISS continues on this downward spiral of barely useful summary reports, trust in the Public Health Agency of Canada and their surveillance system will correspondingly continue to erode. It is becoming increasingly difficult for public interest groups like VCC to monitor vaccine safety in Canada since CAEFISS is not fulfilling its mandate. Canadians deserve reports on adverse event data that are meaningful, timely, and entirely transparent.
Review outline
Parts 1 and 2 in the review are concerned with the disparity to previously published CAEFISS data for the 4 years covered in the report. Part 3 reviews the tables and figures in the report. Part 4 of this review is concerned with comparisons—first, to previous CAEFISS Summary Reports in order to examine the multi-year Canadian trends and second, to the 2015 Surveillance Report from Australia. Part 5 concerns itself with the meaning of very low reporting rates and how these rates must be interpreted if they are to continue to be used as a proxy for actual adverse events occurring in a vaccinated population.
To read the full review by researcher Nelle Maxey see the following PDFs:
Two-page spreads edition for reading online
or
Single page edition for printing
Previous vaccine safety reports:
Report on the Canada Vigilance Database- What the Public Sees – by Nelle Maxey – April 2015
Update Report on the Canadian Adverse Events Databases by Nelle Maxey – Summer 2015
Vaccine Safety Report – An analysis of data & databases available to the Canadian Public by Nelle Maxey – March 2016
Vaccine Safety Report 2 – An analysis of 2015 Adverse Events Data & Databases by Nelle Maxey – November 2016
Vaccine Safety Report 3 – An analysis of 2016 Adverse Events Data & Databases by Nelle Maxey – June 2018
Further reading:
Nelle writes to the Canadian Health Minister:
Unexplained Delays in Canadian Vaccine Adverse Events Reporting – From February 2018
“Vaccine Choice Canada is deeply concerned that the public reporting of adverse events by both PHAC and MedEffect™ Canada are for unexplained reasons in hiatus. We appeal to you to look into this matter and explain why this hiatus has occurred as it directly affects the ability of the Canadian public to make informed decisions regarding vaccines.”
