Since December 2019, the emergence of the Covid-19 pandemic has caused both industry and non-industry sponsors to hunt for suitable therapeutics and vaccines for the disease. A global effort in tackling this disease has meant both sponsors and regulatory agencies have had to shift priority from standard practice to focusing on delivering effective vaccines and drugs. Sponsors have used pivotal trials for Covid-19 to gain marketing approval from regulatory authorities such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA).
A pivotal or registration clinical trial is a trial seeking to prove the efficacy of new therapeutics and vaccines. According to GlobalData’s Clinical Trials Database, there were 53 trials for Covid-19 categorised as pivotal or registration studies last year, whereas this year, this decreased to 41 trials. The value for the coming year is still ongoing. These values may seem small; this is due to sponsors focusing on expedited approval programmes, especially for Covid-19. Under accelerated approval and fast-track programmes by regulatory agencies, therapeutics and vaccines that prove to be effective for serious or life-threatening diseases can receive conditional approval. With the emergence of the new Omicron variant, the focus has been placed on the efficacy of booster vaccinations.