The Licensed Avian Influenza Vaccines: The Informed Consent Forms - Part 1
The MHRA found the forms, including the cover letter.
After nearly seven months and several bouts of wrestling with “enablers” of the MHRA FOI department, we are near completing the picture of what has been going on in the regulatory world of avian influenza vaccines.
Tom requested an internal review of his repeated attempts to examine the informed consent model forms used in the registration trials. To recap our last recap,
The Licensed Avian Influenza Vaccines - from the Horse’s Mouth
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This is what is legally available in the EU:
Now, bear in mind that AFLUNOV and Adjuvanted Zoonotic Influenza Vaccine are the same, says the MHRA.
On 29 April, the “enablers” stated:
The Adjuvanted Zoonotic Influenza Vaccine is essentially a “duplication” of AFLUNOV, albeit with a less catchy name. The adjuvanted zoonotic influenza vaccine is the one that was purchased at great cost and announced triumphantly in December, kicking off our inquiries.
The MHRA’s claim that the product was a ‘duplication of the Aflunov license’ is the reason they give for not requiring bioequivalence studies. However, they are not the same, as Alan Kennedy pointed out:
As the table shows, the Adjuvanted Zoonotic Influenza Vaccine has morphed from H5N1 (+MF59) to H5N8 (+MF59)
We ended our last post with the statement: “We are going through the background documents and will be back with more news”. However, we now have more news from the enablers. A secret squirrel at the MHRA has discovered the relevant forms.