By Ethical 29 Sep, 2020

A SUSAR in a COVID-19 vaccine development study: a grain of sand in the gears and a case for adjudication

As the world braces for a second wave of the COVID-19 pandemic and scientists around the globe work very hard towards a safe and effective vaccine, a leading pivotal trial suddenly came to a screeching halt. A Suspected Unexpected Serious Adverse Reaction (SUSAR) was reported and the case had to be investigated by an independent committee. 

The announcement in the news was chilling: A SUSAR was reported in the leading Phase III trial for the development of a vaccine against SARS-COV-2. As a result, the study was immediately halted and the Safety and Data Review Committee (DRC) was alerted. As a matter of fact, this is standard procedure and a not-so-rare occurrence in clinical trials. It is also the right thing to do in order to ensure that only safe and effective therapies make it to the market. At the end of the day it is a non-negotiable action.  

Every drug, every vaccine, anything that has a beneficial action in the human body is bound to also have some unwanted effects. As pharmacologists put it “no side effects, no effect”. Remember the sign of pharmacists? Two entangled snakes. The ancient Greeks had gotten the idea: a drug can be a poison; a poison can be a remedy. It is all a question of dose and a question of risk-benefit. A quick look at any package insert reveals that any drug may in rare occasions cause some unwanted side effects – acceptable, though, given the benefit provided. 

Here is where the numbers come into play. A side effect occurring in 1% of the people who take any drug is generally considered rare and acceptable, provided it is not life-threatening. But this does not work in our case. If you intend to vaccinate 2 or 3 billion humans, 20 to 30 million would experience the effect. That is the population of Belgium and Switzerland combined. Totally unacceptable.

One SUSAR among a few thousand subjects in a vaccine trial has to be investigated thoroughly. And fast. The DRC must receive all available data in a predefined format. They may request additional information, clarifications, explanations, confirmations. In this particular case, the stakes were frightenedly high and the burden on the Committee’s shoulders heavy. 

There are many other trials on COVID-19 vaccines going on and all of them are closely monitored for adverse reactions that could simply kill the effort and would, in any case, need quick and decisive resolution. Are there systems in place to funnel all this information quickly, securely and accurately? IT technology must stand to the circumstances and participate in this global effort.

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