ARI Vaccine Registration Trials
The Need for a New Approach
By now, most people will be aware of the growing problems with the vaccine registration trials for acute respiratory infection (ARI). We documented several of them in our series on the COVID-19 Comirnaty.
The regulatory trial C4591001 was a large multicenter randomized controlled trial with a single-blind design. It allowed administrators to distinguish the vaccine from a placebo, but it under-reported potential harms, had no completed trials in pregnant women, and used unclear definitions for Covid case effectiveness outcomes.
Exploring regulatory data sets of the Comirnaty vaccine - First part
We have come to an end (for now) of our exploration of the regulatory data available at the time of licensing the vaccine at the end of 2020 and, in a few cases, afterwards. As we covered a lot of ground, we summarise the posts and their content in one-liners in several “posts of posts” to allow readers to get to the bottom line.
Since the 1990s, we have conducted a series of Cochrane reviews both on vaccines and antivirals. Our findings indicate that there is minimal or no data available to guide practice for significant outcomes. Additionally, we found low-certainty evidence regarding influenza and 'influenza-like illness' (ILI), highlighting the weaknesses in the methods employed by those who design and undertake such trials.
The recent overhaul and reorganisation of the US Vaccine Comm…
