18 May 2020
Posted in Coronavirus
Moderna’s and Inovio’s Phase III COVID-19 trials face operational obstacles
Following the announcement of Moderna’s interim data for its Phase I COVID-19 vaccine trial;
Reynald Castañeda, Pharma Writer for the Investigative News team at GlobalData, offers his view:
“Moderna’s registrational trial will face substantial operational challenges, despite having a low success bar for efficacy. Moderna, which stocks shot up almost 30% premarket in reaction to today’s news, is finalizing its Phase III design – with the trial to start in July and a Phase II to start shortly. Assuming a 1.5% incidence rate, the trial will require several thousands of subjects of around 25,000–30,000, who would be followed for a year.
“Inovio Pharmaceuticals is another company with Phase II/III plans for the summer investigating its vaccine INO-4800, leading to a 5% bump on 28 April after the announcement.
“In terms of an efficacy success benchmark, 50%, while low, is acceptable as it would likely be enough to ease the pressure on frontline healthcare resources. Still, it may not be high enough to reach herd immunity. Human challenge trials also hit mainstream media coverage for its promise of rapid results. While these trials can quickly weed out vaccines, which may not be safe or effective, they still face major operational and ethical barriers.
“Caveats to human challenge studies include the need to stage the trial in a specialized location and the difficulty of matching a laboratory-developed version of SARS-CoV-2 to what is present in the community. Also, there is uncertainty about the correct viral dose needed to induce mild COVID-19 symptoms.”