. @GovCanHealth has authorized the $PFE / BioNTech Covid19 vaccine.

https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00730

Here are a few first impressions:

1. The authorization is pursuant to section 5 of the Interim Order, which was put into place in mid-September.

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs.html

2. The mechanism matters. Unlike the anti-viral drug remdesivir, which HC *approved* over the summer, this is an authorization under an IO.

The legal authority is different. For one thing, the IO has an expiry date of 1 year...

So today's authorization will need to be continued beyond that date somehow. HC is already working on that, which is important because rollout is expected to consume most/all of 2021.

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization.html

Also, an authorization under the IO does not carry the power to *compel* post-market studies

In contrast, the Notice of Compliance w/ conditions (NOC/c) that was used to approve remdesivir, does give HC the power to compel such postmarket studies

https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00669

Without the power to compel further, active studies of the vaccine, HC did the most it could do which was to put into place a "Risk Management Plan" (RMP)

Again, see the regulatory decision for details of the RMP

https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00669

3. The timing of this. It is hard to imagine that FDA's likely approval date of tomorrow (Dec. 10th) did not, somehow/some way, factor into @GovCanHealth 's authorization today.

There is intense competition among regulators (other than the FDA) to *not* be the last to authorize

...Some of that is attributable to politics.

But some of it is internal to the regulator.

Let's call it...wait for it...

"Regulatory FOMO"

(oped coming!)

4. Even tho @US_FDA hasn't authorized this vaccine yet (that will change tomorrow), it has put out a great deal of data about the vaccine.

https://www.fda.gov/media/144246/download

HC hasn't. But when it does, it will be here:

https://clinical-information.canada.ca/search/ci-rc 

And the data available will be different than what the FDA has disclosed (the two bodies disclose different info).

So bookmark that HC page.

As we've argued for months, HC (and other regulators) should have been putting up info for quite some time.

https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsaa083/5991911?searchresult=1

So, I hope it makes it onto the portal asap.

Update: As Peter Doshi just pointed out to me, HC has said that the clinical info behind the authorization will be made available by March 31, 2021.

https://covid-vaccine.canada.ca/pfizer-biontech-covid-19-vaccine/product-details

That is simply NOT acceptable. The data should be online way faster than that.

But -- and this is important -- HC has posted its authorization letter and there is a lot "terms and conditions" that were attached to the authorization.

Unclear to me how enforceable these are. But important to see the details.

https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-authorisation.pdf

Condition #2 is especially important re preserving blinding of the trial (albeit within the team) as there have been many signals that $PFE may unblind the trial.