The Licensed Avian Influenza Vaccines: The Informed Consent Forms - Part 2

An introduction to the significance of our review of consent forms

We asked the MHRA “enablers” for the model consent forms used in the trials of Adjuvanted Zoonotic Influenza Vaccine and its lookalikes.

 

The Licensed Avian Influenza Vaccines: The Informed Consent Forms - Part 1

We have been quiet while we went through the forms and performed some cross-checking. With 20 trials, that is quite a lot of work. As it turns out, the forms and their provenance tell two interesting stories.

The MHRA provided us with a regulatory trail going back 25 years. In 1999, the reference vaccine was called FLUAD and was produced by Chiron. Chiron merged with Novartis in 2005. In 2015, Novartis sold its human vaccines business, excluding the influenza vaccines, to GSK. 

Novartis influenza vaccines were sold to CSL for $275 million, which became Seqirus in 2015. Seqirus is a subsidiary of CSL Limited, an Australian biotechnology company. 

This may sound unusual, but in the pharmaceutical industry, it is challenging to keep track of who owns what and what they do - only the insiders know, not two old geezers.

Anyway, enough of that. The point is th…