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.
But does this investigation serve another purpose?
In an interview with Contagion®, Bridget Calhoun, DrPH, MMS, Associate Dean for