On the High-Speed Train to the Future, Exciting Innovation of All Kinds

By Mark Hagland T Mark Hagland

he lightning-fast development of two COVID- 19 vaccines, both based on messenger RNA (mRNA) technology rather than on the injection

of a small amount of the virus itself, has been one of the most exciting and dramatic developments in medical science in recent decades. As Carolyn Y. Johnson wrote in the Washington Post on Dec. 6 of last year, “The world’s hopes have weighed heavily on the quest to develop coronavirus vaccines, with an espe- cially intense focus on two front-runners: one from Moderna, the other from Pfi zer and BioNTech. Both were a speedy but risky — even controversial — bet, based on a promising but still-experimental medical technology.” Fortunately, the bet paid off, and both vaccines received emergency approval from the Food and Drug Administration (FDA) and the go-ahead for distribution from the Centers for Disease Control

and Prevention (CDC) in December. As Johnson noted, “Vaccine development typically takes years, even decades. The progress of the last 11 months shifts the paradigm for what’s possible, creating a new model for vaccine development and a toolset for a world that will have to fi ght more never-before-seen viruses in years to come.” There is great promise in mRNA technology. As the CDC’s website explains, “mRNA

vaccines take advantage of the process that cells use to make proteins in order to trigger an immune response and build immunity to SARS-CoV-2, the virus that causes COVID-19. In contrast, most vaccines use weakened or inactivated versions or components of the disease-causing pathogen to stimulate the body’s immune response to create antibod- ies.” In contrast, “mRNA vaccines have strands of genetic material called mRNA inside a special coating, [which] protects the mRNA from enzymes in the body that would otherwise break it down,” and provides instructions for the cell on how to make a piece of the “spike protein” unique to COVID-19, without doing any harm. What’s interesting is that mRNA vaccine development is not new. The CDC notes that

“Early stage clinical trials using mRNA vaccines have been carried out for infl uenza, Zika, rabies, and cytomegalovirus (CMV). Challenges encountered in these early trials included the instability of free RNA in the body, unintended infl ammatory outcomes, and modest immune responses.” But, the agency notes, the technology has been improv- ing dramatically. Beyond vaccines, numerous preclinical and clinical studies have used mRNA to

encode cancer antigens to stimulate immune responses targeted at clearing or reducing malignant tumors. With regard to that, as Kelly Servick wrote in Science, published by the American

Association for the Advancement of Science (AAAS), online on Dec. 16, “[L]ong before the pandemic, mRNA tantalized pharma, promising a simple and fl exible way to deliver both vaccines and drugs. One mRNA sequence might mend a damaged heart by producing a protein that stimulates blood vessel growth. Another might encode a missing enzyme to reverse a rare genetic disease.” So, even as the United States and the world continue to reel from the deadly impact

of the coronavirus, scientists have rushed to deliver innovations to save the health, and lives, of billions around the world. Moving forward into the future remains challenging, as the leaders of hospitals, medi-

cal groups, and health systems continue forward in the face of the clinical, operational, and fi nancial impacts of the pandemic, and work to move forward into the emerging value-based healthcare system. What concrete steps are they taking? We share the results of our second annual State of the Industry Survey in our cover story (p. 8). What’s clear is that healthcare leaders see the need for innovative change and are moving forward to meet it. A challenging time in healthcare? Absolutely. But also, an exciting one.


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