Exploring regulatory data sets of the Comirnaty vaccine - 2
The evidence for provisional registration – structuring our review
In the previous post we have described the Common Technical Document and its key component, the clinical study report. Now we look at how we should structure the review of our regulatory data set.
The main problem is the abundance of information on the Comirnaty vaccine. The advantage, however, is that we will only concentrate on data from the period ending with the various provisional registrations granted by multiple countries: EU, UK, US and Canada. All were granted before Christmas 2020. The second advantage is that thanks to the ICH standardised format, we can find our way around pretty quickly and use shortcuts we picked up when learning the trade on antivirals to find what we want.
The best thing to follow what went on is to build an outline timeline. Build the start and the finish, all in 2020 (for now), and then go back and fill in as many spaces as we can by recording as many milestones.
We do not necessarily have to follow regulatory sources to do so, but these are the most trustworthy, as we pointed out in our first post of the series.
