HEDLEY'S INTERVIEW WITH MEGAN REDSHAW FOR TRIALSITE NEWS

Novel gene-based mRNA vaccines were rushed

Yesterday, I was interviewed by Megan Redshaw on behalf of TrialSite News.

The hypothesis was:

Developing novel gene-based vaccines such as the COVID-19 mRNA vaccines requires more than 9 months of effort. For example, the development of safe and effective new molecular entities, typically less complicated to develop than biologics, on average takes 10 to 12 years. The premise behind the acceleration of the COVID-19 vaccines must be questioned and challenged.

In short, they were rushed through with no thought of patient safety.

What is your reasoning?

The injections are biologics—very complex to develop. For example, they are difficult to produce consistently and safe, as they are based on living matter. They are sensitive to temperature, process, and the like.

They are also gene-based therapies—the regulations and industry practices are still unfolding and not yet mature. In many cases the best practices and guidance are not there to support such …