Delivering Safe and Effective Vaccines
While 2020 has certainly been one of the most challenging years in modern history and recent memory, there is hope on the horizon that better days are ahead. Although the world is still reeling from the destruction caused by the coronavirus pandemic, glimmers of hope are brightening more each day with the discovery, development and delivery of safe and effective vaccines to save lives and eliminate COVID-19’s stranglehold on society. Indeed, this scientific achievement is coming faster than any other time in human history, and for that, we can and should be exceedingly grateful.
As you might know, vaccines to fight infectious diseases normally take several years to develop and distribute. However, thanks to Operation Warp Speed (OWS), the United States has miraculously been able to race toward discovery of lifesaving vaccines, treatments and therapeutics for COVID-19 in a matter of months. Initiated by the Trump Administration in mid-May, OWS established a public-private partnership between relevant federal agencies – including the Department of Health and Human Services and Department of Defense – and pharmaceutical companies. Since it was created, OWS has not only supported some of the scientific research but it has enabled more rapid development and testing of vaccine candidates, allowing promising candidates to undergo clinical trials at essentially the same time as regulatory approval and preparation for mass production.
Delivering a vaccine in record time has led some to have concerns about safety. However, I want to assure you that the accelerated turnaround is not the result of cutting corners or ignoring the existing safety standards required by statute. Indeed, from research and development to clinical trials to emergency use authorization (EUA), the Food and Drug Administration (FDA) has remained closely involved every step of the way. In fact, clinical trials on promising vaccine candidates cannot even proceed without the FDA’s clearance to do so. Moreover, a Data Safety Monitoring Board advises pharmaceutical companies and oversees results throughout clinical trials. If testing reveals that a vaccine candidate is effective by the end of phase three, a company can then request an EUA from the FDA.
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