For decades, scientists have dreamed about the seemingly endless possibilities of custom-made messenger RNA, or mRNA.
Researchers understood its role as a recipe book for the body’s trillions of cells, but their efforts to expand the menu have come in fits and starts. The concept: By making precise tweaks to synthetic mRNA and injecting people with it, any cell in the body could be transformed into an on-demand drug factory.
But turning scientific promise into medical reality has been more difficult than many assumed. Although relatively easy and quick to produce compared to traditional vaccine-making, no mRNA vaccine or drug has ever won approval.
Even now, as Moderna and Pfizer test their vaccines on roughly 74,000 volunteers in pivotal vaccine studies, many experts question whether the technology is ready for prime time.
“I worry about innovation at the expense of practicality,” Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and an authority on vaccines, said recently. The U.S. government’s Operation Warp Speed program, which has underwritten the development of Moderna’s vaccine and pledged to buy Pfizer’s vaccine if it works, is “weighted toward technology platforms that have never made it to licensure before.”