COVID-19 vaccine: let’s be honest about serendipity in clinical trials

The views expressed in this letter are those of the author’s. If you would like to submit a letter to The Pharmaceutical Journal, please click here.

After the Pfizer/Moderna COVID-19 vaccine was announced to confer more than 90% effectiveness, the news of the University of Oxford and AstraZeneca’s vaccine seemed a bit flat. This vaccine has 70% efficacy, “on average”. One trial gave half a dose and then, one month later, a full dose. Dig a little deeper, and this regime was owing to a “dosing error”. The efficacy of the vaccine rose to 90%. A head of communications at AstraZeneca called this a “useful mistake” as this dosing regimen was not planned.

What does this say? Well, it particularly highlights the role of serendipity, but it also questions some of the fundamental ethical principles of clinical research, as announcements get made before close scrutiny of the data. It would appear that only a small number of (lower-aged) subjects received the half dose. Without making The Pharmaceutical Journal read like Private Eye, it would appear that key details will be glossed over in order to not stop a press release going out. There needs to be greater transparency and closer scrutiny of the data before we all start patting each other’s backs.

Dave Sharma, company director, Consilia Medica Ltd

Last updated
Citation
The Pharmaceutical Journal, January 2021;Online:DOI:10.1211/PJ.2021.20208662