We reported that provisional licensing for Comirnaty was granted by various regulatory bodies in late 2021.

The necessary evidence was based on Study C4951001: A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-COV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals. 

Share

Slowly - bit by bit - we are going through the clinical study report and regulators’ takes on its content. Before we go on, one of TTE’s contacts provided us with a leaflet she got through the letterbox:

Apologies for the poor quality of the reproduction. The leaflet urges people to be vaccinated with Spikewax or Comirnaty. Due to a lack of resources, we have focused on the latter and have a few comments.

The leaflet makes some claims (for example, that the vaccine - in this case, was tested before licensing). This is technically true, thanks to study C4951001. However, as followers of our series know, many unanswered questions exist about its mode of action and harm profile.

Next, the leaflet targets three indications:

1. People aged 75 or over 

2. People with a weakened immune system and are 6 months of age or older 

3. People who live in a care home 

Share Trust the Evidence

Let’s look at the evidence underpinning such recommendations.

People aged 75 or over. In the C4951001 trial, this age group represented 4.4% of the participants: 1,608/18,242 participants were randomised to Comirnaty, and 1,624/18,379 were given the placebo at least seven days after the second immunisation.

According to the Kansas Attorney General Report, Pfizer only tested the booster vaccination on twelve 65 to 85-year-old trial participants. It did not test the booster on any participant older than 85.

“Pfizer should not have represented that the booster was “safe” for 65- to 85-year-olds after only testing 12 trial participants in that age range.”

Then, people with weakened immune systems were excluded from the trial, 

Here’s how EMA summarises the exclusion:

Nursing home residents were never in the picture. A search of the 236 pages of the clinical study report main body, dated 12 December 2021, returns a blank.

The leaflet is produced by Vaccine Knowledge, whose motto is “Reliable information you can trust”. Who is behind this? Well, have a look.

The same group refer to the Summary of Product Characteristics (SPC) and the  Patient Information Leaflet (PIL). It’s a shame they didn’t refer to them as the primary source of knowledge in the leaflet.  But never mind, try clicking on the SPC for the AZ Oxford vaccine, and you’ll get a surprise:

Even more concerning is that the postman never rang, not even twice.

This post was not written by impersonators and is not commercial in confidence. It is not carcinogenic and will not self-destruct or autodelete. We are not on the payroll of any pharmaceutical company, and given the content of our posts, we have been notified that HMG will award us the order of the concrete trousers.