How Are Vaccines Deemed Safe?


A discussion on the process by which the FDA regulates vaccine candidates at a time when COVID-19 candidates are progressing.

New findings from an Israel-based study shows the policies and procedures mandated by the US Food and Drug Administration (FDA) for vaccine development and distributed result in robustly safe outcomes.

Investigators from the Sheba Medical Center, led by Noam Tau, MD, of the Department of Diagnostic Imaging, noted the great scrutiny applied by the FDA on vaccine manufacturer practice has made the last quarter century of new vaccine development a largely safe practice in the US.

The team conducted a retrospective cohort analysis of all vaccines approved by the FDA between 1996-2015—a total of 57 vaccines with a median cohort size of 4161 participants.

They then compared the vaccines’ original safety data at the time of their approval with subsequent new safety data following their widespread use. The FDA’s vaccine safety monitoring system observed 58 post-approval safety issues across all 25 vaccines, with most instances being of limited clinical impact.

Just one vaccine, RotaShield, was observed to have an unacceptable safety profile once reaching the market, and resulted in its rapid market withdrawal.

This research—which began prior to even the first reported SARS-CoV-2 infection—could now have a huge impact on interpreting the FDA’s role in managing the rapidly developing vaccine candidates for the coronavirus 2019 (COVID-19) pandemic.

In an interview with Contagion® regarding the findings, Tau discussed his own surprise at the observed efficiency of the FDA in regulating vaccine development, and what he thinks such data means for the progression of COVID-19 candidates.

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