Trust the Evidence

Trust the Evidence

Share this post

Trust the Evidence
Trust the Evidence
Exploring regulatory data sets of the Comirnaty vaccine - 10c

Exploring regulatory data sets of the Comirnaty vaccine - 10c

The smallest book in the Library

Tom Jefferson's avatar
Carl Heneghan's avatar
Tom Jefferson
and
Carl Heneghan
May 28, 2024
∙ Paid
59

Share this post

Trust the Evidence
Trust the Evidence
Exploring regulatory data sets of the Comirnaty vaccine - 10c
18
3
Share

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:

Exploring regulatory data sets of the Comirnaty vaccine - 1

Exploring regulatory data sets of the Comirnaty vaccine - 1

Tom Jefferson and Carl Heneghan
·
April 15, 2024
Read full story

and here:

Exploring regulatory data sets of the Comirnaty vaccine - 2

Exploring regulatory data sets of the Comirnaty vaccine - 2

Tom Jefferson and Carl Heneghan
·
April 18, 2024
Read full story

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.

Share Trust the Evidence

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…

Keep reading with a 7-day free trial

Subscribe to Trust the Evidence to keep reading this post and get 7 days of free access to the full post archives.

Already a paid subscriber? Sign in
© 2025 Carl Heneghan
Privacy ∙ Terms ∙ Collection notice
Start writingGet the app
Substack is the home for great culture

Share