Since the announcements by federal health authorities earlier this year that federal mRNA vaccine funding will be curtailed, a fierce debate has taken place around the future of mRNA-based vaccines and therapeutics. As San Diego-based innovators of biologic production technologies, we believe abandonment of mRNA technology is a strategic mistake for national health security and undermines U.S. leadership in therapeutic innovation.
Discovered in the 1960s, messenger RNA (mRNA) has stepped out of the shadow of its more famous cousin, DNA. DNA is the master genetic code in our cells — the carrier of inheritance that endures for a lifetime and beyond. mRNA, by contrast, is a short-lived molecule designed to carry DNA’s genetic instructions to the cell’s protein-making machinery. This temporary nature gives mRNA one of its most powerful features: the ability to direct protein production in a controllable way, with potentially far-reaching effects on health.
Importantly, mRNA molecules administered as vaccines have no effect on the genome itself. They serve only as temporary instructions for making proteins that create the desired immune response or therapeutic effect, after which the mRNA is rapidly broken down. These are the same mechanisms our bodies use every day to make essential proteins like insulin, hemoglobin and antibodies.
Built on these realizations, since the early 2000s, scientists have developed and refined mRNA technology to teach the human body how to create new defenses against disease. Development of mRNA-based vaccines and therapeutics was well-advanced by the time COVID-19 emerged, including years of drug design, manufacturing optimization, safety testing, animal studies, and early-stage clinical trials targeting viral diseases and cancers. The decades of groundwork paid off and allowed scientists and clinicians to develop COVID-19 vaccines quickly without compromising regulatory rigor or patient safety. Far from being “rushed” or “untested,” as frequently claimed by mRNA critics, the vaccines received rapid regulatory approval because they were safe and provided strong protection against the virus.
The mRNA vaccines developed during Operation Warp Speed became the main line of defense against COVID-19 and saved tens of millions of lives worldwide. This bipartisan, science-driven collaboration is one of America’s proudest achievements. Large-scale safety data, now covering more than 13 billion doses administered, show that serious side effects are exceedingly rare, comparable to or lower than those from conventional vaccines. By any standard of modern medicine, mRNA vaccines are safe, effective and among the best-studied medical interventions in history.
Building upon the Operation Warp Speed advances, researchers are applying mRNA technology to infectious and genetic diseases once thought intractable. This includes many cancers, genetic disorders such as cystic fibrosis, infectious diseases such as malaria, rare inherited disorders and potential pandemic viruses. Because of the simplicity of designing mRNA instructions and coding these into manufacturing systems, these medicines can adapt quickly to the changing biology of cancer or infectious disease. mRNA is a highly effective tool that can coexist with viral, protein- and cell-based approaches to promote human health and strengthen the broader vaccine ecosystem.
Critics of mRNA technology have cited the erosion of public trust as a reason to cut mRNA funding. Yet much of this skepticism stems from misinformation about the COVID-19 vaccines. While frustration over the pandemic-era shutdowns and vaccine mandates may be understandable, these policies should not be invoked as reasons to abandon mRNA technology.
The United States has long been the world leader in biomedical innovation. mRNA-based medicines represent a tremendous advance in our ability to prevent and treat disease and deserve to be supported with continued development. Excluding mRNA from our medical armamentarium would hand key components of tomorrow’s pharmaceutical industries to other countries working to extend mRNA’s capabilities.
The Human Genome Project mapped the blueprint of human biology and opened the door to understanding the genetic roots of disease. Now mRNA, DNA’s short-lived cousin, has stepped into the spotlight as a uniquely powerful therapeutic tool — one that has already saved tens of millions of lives and holds promise for treating diseases we once thought incurable. We should be nurturing mRNA science, not dismissing it — and ensuring that America remains the place where life-saving technologies are discovered, perfected and shared with the world.
Burch is chief executive officer of Primrose Bio, a San Diego-based biotechnology company. Zieler, Ph.D., is chief technology officer of Primrose Bio.