Perspective on the ongoing independent safety reviews for one of the more promising vaccine candidates.
Just last week, the US Food and Drug Administration (FDA) launched an independent investigation into the safety data currently available for coronavirus 2019 (COVID-19) vaccine candidate AZD1222, from AstraZeneca.
The adenovirus-based vaccine, being investigated by the company and the University of Oxford in phase 2/3 international trials, is among the leading candidates for potential FDA regulation and marketing for the prevention of the virus, pending late-stage efficacy and safety findings.
However, this new independent safety investigation is a continued stop from reports of a serious adverse event in a UK-based participant last month, and could greatly influence the FDA’s decision on marketing approval once an application is submitted.
Or, does this investigation serve another purpose?
In an interview with Contagion®, 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, discussed the appropriateness of the FDA’s decision to hit pause on the US-based trial arm for AZD1222—especially at a time of heightened scrutiny surrounding rapidly-progressing COVID-19 vaccine trials.
“Particularly in our democracy, we put a lot of faith in our national organizations,” Calhoun said. “So they have to be spot-on. They have to have reputable, responsible folks who are going to look at the data and make data-driven decisions based on the safety and efficacy of these vaccines.”
Calhoun added that public willingness and interest in a COVID-19 vaccine—a major factor in adopting a safe level of COVID-19 immunity—may be influenced by assuredness in vaccine research.
“And the way that we convince the general public to do that, and show them that it is in fact beneficial, is to know that it was scrutinized at every level,” she said.