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Delivering Safe and Effective Vaccines

December 29, 2020
Weekly Columns

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.

Before an EUA for a vaccine can be granted, an FDA advisory committee must undergo a rigorous and fully transparent review of research and testing data in a public setting before making a recommendation. Moreover, for a vaccine candidate or any other unapproved medical product to receive an EUA from the FDA, it must meet certain conditions required by law under the Federal Food, Drug, and Cosmetic (FD&C) Act. First, a life-threatening illness must exist. Second, it must be reasonable to believe that the illness can be prevented, diagnosed or treated by using the product. Third, the known and potential benefits of using the product must outweigh the known and potential risks. Fourth, there must be no adequate, approved and available alternative to the product.

While there are vaccine candidates for COVID-19 still in development or undergoing clinical trials, two have already received FDA’s authorization for emergency use in the United States. And since the federal government contracted with pharmaceutical companies to pre-purchase hundreds of millions of doses of promising candidates through OWS, vaccines could be manufactured at the same time as clinical trials and made ready to distribute immediately – but only if approved by the FDA. The vaccine developed by Pfizer and BioNTech was the first one approved and deployed nationwide, and Moderna’s followed about a week later. During testing with thousands of volunteers, the results were remarkable, with vaccines proving at least 94 percent effective in preventing sickness from exposure to COVID-19. In fact, this data is even better than the efficacy of annual vaccines to protect against influenza. Neither COVID-19 vaccine has live coronavirus in it. As the Centers for Disease Control and Prevention explains on their website, these messenger RNA vaccines trigger an immune response, which produces antibodies and then protects against infection if the real virus enters the body.

At the recommendation of the Office of the Attending Physician and to demonstrate my total confidence in our nation’s vaccine efforts, I recently received my first dose of the Pfizer and BioNTech vaccine. While vaccinations are a personal decision, defeating this terrible coronavirus is a war we must fight and win together. We can all do our part by taking the free-of-charge vaccine as soon as it becomes available. In the meantime, please continue taking the same practical precautions we have learned this year to slow the spread of COVID-19. Please continue to wear a mask, social distance and frequently wash your hands.

For details and ongoing updates on Oklahoma's four-phase vaccine distribution plan, please visit oklahoma.gov/covid19/vaccine-information.

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