MHRA changes their rules to fit Pfizer's frozen vaccines

You couldn't make this up :(

Orange Guide Updated

MHRA has just updated its Rules and Guidance for Pharmaceutical Manufacturers and Distributors to a 2022 version.

As I leafed through it, to see if there were any substantive changes from the 2017 version, I was shocked to the core.

The picture below of page 563 showed that the definition of ‘reconstitution’ had been changed as it applied to advanced therapy medicinal products (ATMPs), otherwise known as somatic cell therapy, gene therapy and tissue engineered products.

Take a look at what it says:

What do you say about that? To me, it’s written to replicate what Pfizer did with their frozen injections in the vaccination centres.

Take a look now at the only reference to ‘reconstitution’ in the previous version: