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Will a fast-tracked COVID-19 vaccine be safe and effective?

As the adage goes, “So, what’s in a name?”, Operation Warp Speed (OWS) was coined in mid-May 2020 to name the concerted US government and private partnership formed to expedite the delivery of a vaccine to combat the COVID-19 pandemic. Like many other descriptive phrases, it encapsulates many complex concepts and numerous activities into a simple term. Despite the emphasis on speed, the partnership does not advocate for shortcuts in the U.S. Food and Drug Administration (FDA)’s vaccine approval process. To expedite vaccine development and distribution, the focus is on robust project management and coordination across all stakeholders in the vaccination supply chain.

Common-sense resource procurement and parallel preparations by OWS are ongoing activities key to the success of the program. Expanding the material supply and manufacturing capacity is required to deliver the millions of dosages needed of an FDA-approved vaccine. The OWS has subsidized early manufacturing of some promising COVID-19 vaccine candidates, even though some may not be shown to be safe and effective and, therefore, never FDA-approved or distributed.

Vaccine development

Undoubtedly, the faster individuals can be immunized against the coronavirus, the more lives will be saved. Proof of safety and efficacy is a critical prerequisite that hinges on strict adherence to ethical clinical trial guidelines and objective regulatory and scientific review of clinical trial results.

Rigorous medical science and its long-standing and vital requirements are the only way for a vaccine to meet the safe and effective standard. Statistically significant and verifiable endpoints achieved in clinical trials are major milestones that require time because of the nature of the biological response of human subjects through the course of the trials.

Understanding that lost time due to unnecessary delays with any aspect of vaccine development (e.g., research, manufacture, distribution) can lead to progressive pandemic growth, OWS emphasizes the importance of evidence-based science and the critical nature of efficiency.

Vaccine approval and acceptance

The commitment of the OWS partnership is well-documented. Equally important are the pledges of doctors, medical researchers and regulators that they will be objective and unwavering in their commitment to follow the recognized medical science of vaccine development.

Key to broad acceptance of any vaccine by the healthcare community will be research that supports the safety and effectiveness of one or more coronavirus vaccines. To this end, Veradigm, an Allscripts company, collaborates with vaccine manufacturers to utilize clinical data from electronic health records (EHR) to more effectively and efficiently advance vaccine development.

While it may appear at first look that rapid vaccine development could jeopardize safety and downstream effectiveness, the use of real-world evidence, randomized clinical trials, innovative project management and real-world evidence can quickly deliver new vaccines that maintain the highest level of safety and effectiveness. By using the numerous talents and tools available within partner organizations, OWS can achieve its goal of expediting the development and distribution of a safe and effective vaccine as fast as possible.

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