04 May Should COVID-19 clinical trial plans still center around EUAs?

In the event the FDA limits or shutters its EUA pathway, it would throw COVID-19 vaccine and drug development pipelines into the deep end.

By Urtė Fultinavičiūtė, Clinical Trials Arena

The FDA’s Emergency Use Authorization (EUA) allows Covid-19 vaccines and therapeutics to enter the market quicker than the usual pathway of full licensure. But as the government and the public look to shift into an endemic state, questions arise as to the future of this regulatory trail.
The most clear-cut signal as to when EUA doors may shut is when the pandemic is officially declared over. Yet health leaders are having to tread carefully as how or when this might happen. Last week, Dr. Anthony Fauci, the US president’s chief medical advisor, stated that the US is stepping out of the “full-blown explosive” Covid-19 pandemic phase, but one day later clarifying his statement by saying that the country is still in the pandemic.

Timelines as to when EUAs will no longer be available or given out to a limited number of assets is critical for clinical trial sponsors, as it is a key element on how they design their trials and shuffle their pipeline plans. There are 1,455 industry-sponsored clinical trials that are investigating Covid-19 vaccines and therapeutics, and nearly half of them still in the planning stage, according to the GlobalData Clinical Trials Database. GlobalData is the parent company of Clinical Trials Arena. Read more …