Printable PDF of the letter below here.
February 28, 2018
by email and Canada Post
To: Minister of Health Ginette Petitpas Taylor
House of Commons
Ottawa, Ontario
K1A 0A6
Ginette.PetitpasTaylor@parl.gc.ca
Dear Minister of Health Taylor,
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.
Two entities in Canada’s Health Portfolio collect reports on AEFIs—adverse events following immunization — and release public reports on the data. The Public Health Agency of Canada (PHAC) monitors adverse events through the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) and MedEffect™ Canada within Health Canada monitors adverse events through the Canada Vigilance Program. Health Canada oversees both of these programs.(1)
Background
The collection of adverse event reports to biologics (vaccines) marketed in Canada is the basis of Canada’s post-market surveillance system on vaccine safety.
As PHAC explains:
“The Public Health Agency of Canada collects case reports on adverse events following immunization from provincial and territorial health departments, health care professionals and the pharmaceutical industry.
The data is stored in the Canadian Adverse Events Following Immunization (CAEFI) database and is used to signal adverse events that may require more in-depth investigation. The main function of the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) is to ensure the continued safety of vaccines on the Canadian market by monitoring adverse events following immunization with vaccines.“ Source: https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization/form.html
As MedEffect™ further explains:
“All health products carry risks and benefits. Many of these risks are identified in pre-market testing and can be managed as “expected” or “tolerable” side effects that are outweighed by the product’s benefits. However, once a product is made available on the Canadian market, new “unexpected” or undesirable side effects, referred
to as adverse reactions, are sometimes discovered when the product is used in “real world” conditions…Most often, adverse reactions are unexpected and are not necessarily indicated on the product label or on any other information provided with the product.”“Having the ability to track such adverse reactions is therefore critical to assessing and communicating the evolving pattern of risks associated with various health products. The only way to achieve this is if Canadians—health professionals and patients/consumers alike—report adverse reactions to Health Canada.”
Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada.html#a3
Ontario Public Health is even more specific on why adverse event reporting is so important to vaccine safety:
“Provincial reporting of AEFIs is an important component of the overall safety assessment of any vaccine. This type of surveillance, commonly called post-marketing or post-licensure surveillance, allows for monitoring of the vaccines throughout implementation in the context of “scaled up” vaccine production and expansion of the population receiving the vaccine.”
“Individual case reports of AEFIs represent an important source of data as they have the potential to generate signals of adverse reactions not previously recognized in clinical studies which can be further evaluated. This is particularly important for rare adverse events which may not have been evident in clinical trials due to limited sample size.” Source; Page 2, http://www.health.gov.on.ca/en/pro/programs/publichealth/oph_standards/docs/aefi_cd.pdf
We can surmise from these quotes that the reporting and publication of post-market adverse event data, especially serious adverse event data, is information that Canadians should have access to. As you can see by the attached 2-page document, vaccine safety is of particular concern to parents since most serious adverse events are experiences by healthy babies and children.
Report Timelines
The last published quarterly report from PHAC’s CAEFISS was for the third quarter of 2016. The last published quarterly report from MedEffect’s Canada Vigilance (CV) Program was for the fourth quarter of 2016.
In the past, the quarterly reports on adverse events from both agencies were published on a regular and dependable schedule. Although the time period between collection and publication of Canadian data was 2 to 3 times longer than the USA reporting system VAERS—VAERS 3-month time lag, CV 5-month time lag, CAEFISS 9-month time lag—at least the publication schedule was regular. It is now 2 months into the first quarter of 2018 and we have seen no publication of AEFI data for the entire year of 2017 and in the case of CAEFISS for the final quarter of 2016. That particular time lag is now 14 months and counting.
We have inquired by email to both entities regarding this hiatus in published reports. Six months ago we received assurances from PHAC that both the 4th Quarter 2016 CAEFISS report and an annual 3-year summary report (for 2013–2015) would be published “shortly”. When no publications were seen on their website, we inquired again in mid-February and were assured again the 4th Quarter 2016 report would be published “soon” and that the 3-year summary report was scheduled for publication in April of 2018. We have not yet received a reply from MedEffect to our recent email inquiring why no reports have been published for the last 6 months when they normally publish every 3 months.
Most importantly however, our questions regarding policy or other changes that have led to this hiatus of publishing quarterly vaccine adverse event reports from both sources have gone unanswered. Perhaps there is a simple explanation for this hiatus. We would greatly appreciate the Minister of Health looking into this and replying to our concerns in a timely manner.
Sincerely,
Nelle Maxey,
Vaccine Choice Canada Board Member on behalf of the Board of Directors
Footnote (1): See The Public Health Agency of Canada Act which defines PHAC as a Legislated Service Agency (LSA) and
LSAs as follows [Emphasis ours]: “LSAs are:
• headed by a CEO that reports to the Minister;
• supported by a “Board” whose members are Governor-in-Council appointees;
• subject to ministerial discretion;
• separate employers under the Public Service Staff Relations Act
(which increases the staffing authority and flexibility of the agency);
• focused on performance;
• provided with greater financial and administrative authorities than traditional departments; and
• overseen by the Auditor General of Canada.”
Attachment:
2-page Nutshell Summary of 2015 adverse event reports from the Canada Vigilance (CV) database and the CAEFISS database. The PDF of the entire Report (including this Nutshell summary) is available on our website at https://vaccinechoicecanada.com/wp-content/uploads/Vaccine-Safety-Report-2-20B29E.pdf
