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Having predicted that the PM was about to announce the authorization of one or more Covid vaccines yesterday, I was actually a little relieved when the substance of the announcement focused on the details of the distribution deal with Pfizer. https://www.cbc.ca/news/politics/trudeau-announcement-otoole-vaccine-motion-1.5830938
Importantly, @JustinTrudeau was very careful to say that distribution will only begin once Health Canada had authorized the vaccine.
That signals at least some deference to Health Canada's decision-making, which is critically important.
Deference to the regulator's expertise that has been notably lacking in one neighboring country that I need not name. https://www.npr.org/2020/09/23/916315311/trump-accuses-fda-of-playing-politics-with-covid-19-vaccine-guidelines
Deference to the regulator's expertise that has been notably lacking in one neighboring country that I need not name. https://www.npr.org/2020/09/23/916315311/trump-accuses-fda-of-playing-politics-with-covid-19-vaccine-guidelines
While it's preferable to that -- frankly, anything is -- I'm still struck by how Health Canada authorization is painted as a foregone conclusion not to mention the absolute terms in which authorization -- not if, but when it happens -- is communicated.
Can you imagine what it would take for a reviewer at HC who had genuine concerns about what the data show to actually act upon those concerns and delay authorization?
At this point, that seems unimaginable with the constant talk of when (not if) the vaccine will be authorized.
At this point, that seems unimaginable with the constant talk of when (not if) the vaccine will be authorized.
This is, after all, really complex stuff. In the last week alone, the UK regulator has approved the Pfizer vaccine whereas the Swiss regulator expressed pause.
https://www.cnn.com/2020/12/02/uk/pfizer-coronavirus-vaccine-uk-intl-hnk/index.html
https://www.swissinfo.ch/eng/incomplete-data-stalls-swiss-authorisation-of-covid-19-vaccines/46196598
https://www.cnn.com/2020/12/02/uk/pfizer-coronavirus-vaccine-uk-intl-hnk/index.html
https://www.swissinfo.ch/eng/incomplete-data-stalls-swiss-authorisation-of-covid-19-vaccines/46196598
There are, in short, a lot of unanswered questions about the Pfizer and other Covid vaccines https://www.nature.com/articles/d41586-020-03441-8
And yet many continue to equate vaccine authorization with absolute safety and efficacy.
That is *not* what authorization means.
It means the vaccine is safe and effective *enough* to warrant approval based on the information/evidence then available.
That is *not* what authorization means.
It means the vaccine is safe and effective *enough* to warrant approval based on the information/evidence then available.
When (not if) authorization of Covid vaccines, those given the task of informing people about the vaccine must do a better job of explaining what we do and do not know.
And in raising all of this, I'm not trying to question vaccines in principle, nor the very difficult decisions that HC is in the midst of making.
Rather, I'm trying to preserve space -- as free from political interference as possible -- for that complex decision-making to occur and to encourage more accurate discussion of what an authorization means.
Understanding the safety and effectiveness of Covid vaccines must continue post-authorization.
And the more we talk about HC authorization + safety and efficacy as certainties, the less likely that ongoing evaluation post-authorization will occur.
//end.
And the more we talk about HC authorization + safety and efficacy as certainties, the less likely that ongoing evaluation post-authorization will occur.
//end.
