Vaccine safety, can we make our monitoring system better?

Public Health Ontario has released its first report on vaccine safety PHO AEFI 2012 report .  Great news for those objectively trying to ensure we utilize quality and safe vaccines.  It is not a first, Health Canada used to release  such reports decades ago and then stopped in the pre-PHAC days.  There are vestiges of a vaccine safety system in Canada, actually a very good one, but lacking in national or even provincial reporting, until now.

Canada has a solid adverse events following immunization (AEFI) reporting system CAEFIS .  Standardized reporting forms, electronic data collection and transmission, formalized causality assessment processes -  all of which seems headed into a black hole.  The data are available for those who want to mine the data sets and know who to ask.  The problem is a lack of dedicated resource focused on vaccine safety surveillance.  Hence we collect the data and it sits.  Occasionally at an immunization conference one may find a poster on a provincial sub-analysis of the data, but rarely has anyone been so bold as to put the data out in the public eye.

So congratulations to PHO despite the shortcomings in the data.  We know that AEFI reporting by physician delivered systems is substantively less frequent and qualitatively different than where public health nurses diligently collect and submit the data.  Physicians are less likely to report, and much less likely to report what public health calls ‘mild’ AEFIs even though they are very disconcerting to parents.

Underestimation of actual rates because of relatively poor data quality is likely the main reason most jurisdictions are uncomfortable in data release (it is not that the findings suggest that there are significant harms of vaccines that there is a reluctance).  To this end, releasing the Ontario data does everyone a service.  It demonstrates the safety of vaccines, it demonstrates that public health does seriously care about AEFIs, and it demonstrates to the immunizing community that all those forms and time spent collecting AEFI information is being put to use.  Where generators of the data see the data being put to use, data quality and quantity will improve. Can the other provinces follow suit?  Or perhaps agree to let PHAC release the Canadian data. 

Canada has for over 17 years poured money into the major pediatric hospitals to have nurses intensively investigate cases admitted with events after immunization.  Probably the most biased method of data collection, and given the sparse funding for the universal data collection system,  clearly something that needs questioning.  The IMPACT program does produce a plethora of scientific publications carefully listed at the IMPACT   website.   The impact of IMPACT deserves greater scrutiny but appears to have become a sacred institution in Canada and a diversion of the scarce vaccine safety resources nationally.

Why in Canada have we perpetuated an elitist and biased surveillance system while allowing a standardized national system crumble should raise questions.  Worse, the IMPACT system skews what we can say about vaccines as it biases towards supporting vaccines as safe rather than stating vaccine safety in an objective and clear manner so that consumers can make an informed choice.  PHO’s report also contains biases towards communicating vaccines as safe.  

And then we wonder why parents remain skeptical about public health claims of the safety of vaccines.  Until we objectively and consistently report on the actual risks, that skepticism will continue to grow, fueled by what amounts to bad science.

Internationally those interested in vaccine safety should follow the   Brighton Collaboration as a body that is applying scientific rigor to the questions of vaccine safety.  The US approach of allowing anyone to submit a report on adverse events following a vaccine likely biases to overreporting of the effects of vaccines, but does present the worst case scenario VAERS  and is transparent.    

A closing note, the routinely available vaccines remain the best and safest way to protect ourselves and our families. It is almost unconscionable and unethical to withhold immunization from our children and ourselves.   While we should be critical of the current AEFI reporting system and accountability which has room to improve, there is nothing hiding in the data or reports that would do anything but provide further assurance about the safety of the vaccines we use.  In this respect, PHO should again be congratulated for challenging the Canadian public health system to be transparent and accountable on one of its foundational pillars.