What Should Be Achieved in Phase 3 COVID-19 Vaccine Trials?


Numerous candidates are in late-stage assessment. An expert shares what the diverse agents should show before being considered for regulation.

A quartet of coronavirus 2019 (COVID-19) vaccine candidates are in phase 3 assessment, with another anticipated to reach the late-stage analysis phase later this month.

Clinicians and experts sitting idly by, awaiting more robust, longer, and stratified efficacy and safety data for the would-be first prophylaxes for the pandemic. What will be the first vaccine be, and what are clinicians looking for in data?

Bridget Calhoun, DrPH, MMS, Associate Dean for Academic Affairs and Research, and Chair and Associate Professor at Rangos School of Health Sciences at Duquesne University, joined Contagion® to discuss how past vaccine development plans—both successful and failed—informed the community’s pursuit of diverse COVID-19 vaccine candidates, from varying platforms and dosages, to variable antigen makeup.

“A lot of science goes into this, a lot of brilliant people are working on it—and all from different approaches,” Calhoun said.

Calhoun discussed the emphasis on short-term detectable antibodies, and the long-term hope for immunity longevity that may come from phase 3 results in the near future. Accomplishing the former has already been observed in early phases; the latter is an uncertainty relative to a still mostly unknown viral infection.

“One of the biggest challenges is that viruses are dynamic,” Calhoun said. “Once we have the structure and sequencing of a virus, it can change.”

Calhoun also discussed matters of vaccine distribution and prioritization in the US, and her hopes for a post-pandemic mindset that reflects lessons learned from the ordeal.

“Hopefully we’ll all resume back to some level of normalcy, but I hope people have a greater respect for infectious diseases,” she said. “In the war between viruses and man, we don’t always win.”

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