Why the AstraZeneca & Oxford University trial's pause due to an adverse event was a sign to Fauci the vaccine monitoring systems are working.
Coronavirus 2019 (COVID-19) vaccine candidates are nearing the stage in which real-world phase 3 data will become available for public consumption and regulatory consideration.
Speculation as to when the first designed prophylaxes will become available have varied from anytime soon to mid-2021—but in just 7 months of research and development, COVID-19 vaccines have become a likelihood.
Of course, understanding surrounding vaccine effectiveness and safety is still under development with the agents themselves.
This week, Anthony Fauci, MD, director of the National Institutes of Allergy and Infectious Diseases (NIAID), joined Lungcast, a respiratory health podcast series from sister publication HCPLive® and the American Lung Association (ALA).
Fauci discussed his belief on how prioritization of differing vaccines may look once multiple options are available. He also discussed the recent news surrounding a serious adverse event in the phase 3 international trial for AZD-1222, the adenovirus-based candidate from AstraZeneca and Oxford University which is currently under independent safety review.
Such a situation, which is common in nearly every vaccine development trial, Fauci said, is looked at with great scrutiny for a vaccine that would be potentially administered to millions after just months of assessment.
He argued against the notion that the trial pause is indicative of an unsafe agent; rather, he said, it’s proof of a careful assessment system that is not compromised by the expediency of the trial itself.
“This shows the system actually works, because when you do have a serious adverse event, the system allows you to immediately pick it up, put on a pause, examine what went on before you make a decision to proceed,” Fauci told HCPLive. “It actually gives you comfort that the system is working, as opposed to you’re doing something that is inherently unsafe.”
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