Exploring regulatory data sets of the Comirnaty vaccine - 10c
The smallest book in the Library
We owe the New Zealand MEDSAFE regulator an apology. We attributed the smallest book in the library to their number of straight answers to public requests. We were wrong, and we recognise this.
As a backup to make 100% and 100% and 100% sure that the registration trials had no evidence that Comirnatry or the AstraZeneca vaccines interrupted transmission, we searched all regulatory correspondence we had access to the Biological Licensing Application (BLA) to both FDA and Health Canada. How and why we did this is explained here:
and here:
We searched under “prophylaxis”, “transmission”, and “interruption”.
We did not have very far to go.
On 21 October 2020, Pfizer applied for registration to the said MEDSAFE.
This is a bog standard covering letter to the CTD that Pfizer submitted to all regulators, as all manufacturers do. Nothing to see here, move along.
Again, as a standard procedure, Pfizer held one or more pre-submission meetings with MEDSAFE (and probably with all other regulators whose c…
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