Adverse-event reporting in Ontario is broken
Public health policies and procedures to track COVID-19 vaccine safety are inconsistent with existing physician guidelines and nobody cares.
The safety of the COVID-19 vaccines was established in the manufacturers’ trials and maintained by health authorities through the 2021-2022 vaccination campaigns. At least so goes the dominant feel-good story. Along with many other critical observers, I have sincere doubts about that narrative and one concern centers on Canada’s process for reporting Adverse Events Following Immunization (AEFIs). The resulting under-estimation of the magnitude of vaccine injury is apparent in their data as compared to the American and European reporting systems, as I have written on March 31.
Over the weekend, I got some new insights into how the College of Physicians and Surgeons of Ontario (CPSO) exculpates its member doctors’ failure to report serious AEFIs. The College’s Inquiries, Complaints and Reports Committee had to consider a complaint about a physician who declined a vaccine-injured patient’s request to report a neurological adverse event. The injury was later officially recorded as an AEFI by the local health unit upon the patient’s own reporting. But the Committee dismissed the complaint on the basis of CPSO’s Mandatory and Permissive Reporting policy, which was last updated in October 2017. That policy requires a physician to report only a short list of serious events, and only if they believe that the event occurred as a result of immunization or may be related to it.
It must be noted that the CPSO policy is nearly identical to Sections 38(1) and 38(3) of Ontario’s Health Protection and Promotion Act (HPPA). They are quite apparently written for childhood vaccines (“persistent crying or screaming”) and to monitor for immediate, serious reactions. The time window is between three and 42 days after vaccine administration, and the events range from arthritis and anaphylactic shock to seizures, collapse, and death.
However, public health authorities, at least on paper, have a very different view of the need to track AEFIs in the context of the novel, genetic-based COVID-19 injections. For example, the Ontario Ministry of Health provides detailed case definitions for AEFIs in its May 2022 health standards report. They are clear in that “passive vaccine safety surveillance relies on reporting of AEFIs by health care providers, vaccine recipients or their caregivers to their local public health unit”. The corresponding footnote points to a report by Ahmadipour et al. on the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) published in 2018, well before this pandemic. Since the CPSO policy starts with the principle that “Physicians must be aware of and comply with the legal, professional and ethical reporting obligations relevant to their practice” (emphasis in original), one should expect CPSO members to know and care about the AEFI reporting expectation after COVID-19 vaccination.
Importantly, the reporting expectation is comprehensive: doctor or nurse are supposed to report any new, unexplained patient concern, as long as it “cannot be clearly attributed” to a known cause. A “confirmed case” is thus defined very broadly:
Any untoward medical occurrence in a vaccine recipient which follows immunization that cannot be clearly attributed to other causes. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.
A causal relationship with the administration of the vaccine does not need to be established in order to be reported as a confirmed case.
The idea behind passive vaccine safety surveillance is that causal events will emerge as a “signal” among a large number of reports, many of which may be coincidental. As an example, growing reports of myocarditis beyond the level expected among the vaccinated population have generated such a safety signal, albeit late and with limited consequences. The entire system relies on the reporting of all potential vaccine side effects, so that relevant information can be mined from a dataset that is as large and comprehensive as possible. If the geographer who writes these lines can understand this approach, we should hope that our medical doctors do too and that they care enough about public health to participate in this process.
For better clarity, Public Health Ontario has also published a short overview on “How vaccine safety is monitored in Canada” in December 2020, which includes the same explanation of post-marketing surveillance of vaccine safety and the same broad AEFI case definition highlighted right on its first page. Based on the Ministry of Health report, anything from “Pain or redness or swelling at the injection site” within 2-7 days after immunization to “Any death of a vaccine recipient temporally linked (within one month) to immunization, where no other clear cause of death can be established” constitutes an adverse event. My point here is that even minor indisposition is to be reported.
It is not credible that health-care practitioners would have missed the need to report any and all side effects of the COVID-19 vaccines. At a minimum, they would have looked it up when a patient asked them to report their injury. When it comes to the College and the public health authorities, it is extremely disappointing to see the lack of interest in collaborating on this massive issue. It would be easy enough for either side to communicate and reiterate the critical importance of AEFI reporting to doctors, nurse practitioners, and also to the general public.