Trying to get informed consent

The recent “Why do you overeat?” note shared something that happened 20 years ago. This week’s note shares something that happened three years ago. I hesitated before sharing this, as I know that the topic is emotive; but the exchange is interesting and important and so I decided to share it with you.

Introduction

I first started researching vaccines for coronaviruses in spring/summer 2020 when it became obvious that lockdowns were not going to be “three weeks to flatten the curve.” It became clear that it was intended that we should remain in lockdown until a vaccine was developed. I cannot convey how much that alarmed me. Everything that was happening at that time was in conflict with my core values and my response was visceral.

My first post on Covid-19, on March 20th, 2020, reported that coronaviruses were first identified in the mid-1960s (Ref 1). We had thus had coronaviruses for over 50 years. My research quickly revealed that we had developed no vaccines during that time. This appeared to be because of something called “Antibody dependent enhancement”, which showed up in animal testing. In brief, this meant that the animals developed antibodies following vaccination (which was good), but they then had a worse response than unvaccinated controls when exposed to the virus (which was bad).

Lockdown was announced in the UK on Monday March 23rd, 2020. The UK Astra Zeneca Covid-19 vaccine trial was registered three days earlier on 20th March 2020 (Ref 2). I didn’t know that at the time; it would have shocked me. The trial registration submitted full plans for 19 different arms/interventions. These included the product to be injected (ChAdOx1 nCoV-19), the dose(s), the placebo (a meningitis vaccine), the timetable, the locations, the number of participants, inclusion and exclusion criteria etc. The speed at which products were moving from laboratories to arms was impressive to many and concerning to some (one could be both impressed and concerned). I was aware that the Astra Zeneca (AZ) trial was already underway as early as spring 2020, as I knew one participant. When the first trial papers were published (December 2020), it was confirmed that recruitment for the AZ trial had started from April 23rd, 2020 (Ref 3).

In October 2020, Dr Peter Doshi’s important paper was published in the BMJ (Ref 4). This paper analysed seven vaccines in development and what they were designed to test. Doshi reported that none of the vaccine trials were designed to test for either transmission or severity of outcome. The two things that we most wanted to know – will vaccines stop spread and will they provide protection against bad outcomes – were not even being tested. The only outcome of interest was – did the trial participant test positive on a PCR test, which was a highly unreliable measure.