OPINION:
Take a breath. There’s much to like about Robert F. Kennedy Jr.’s Make America Healthy Again agenda. Yes, let’s repurpose federal dollars and regulations to combat what Dr. Peter Attia, best-selling author of Outlive: The Science & Art of Longevity, calls the “Four Horsemen” of chronic disease: Heart disease, cancer, neurodegenerative diseases, and metabolic disorders. We agree. Is there anyone who doesn’t?
Health and Human Services Secretary-Designate Kennedy advocates for a comprehensive approach to improving metabolic health, including diet, exercise, weight management, prioritizing protein intake, and balancing carbohydrates and fats. We agree. Is there anyone who doesn’t?
Mr. Kennedy has been tasked with tackling corruption and eliminating kickbacks that account for a significant portion of healthcare spending, often in the form of rebates to insurance companies based on revenue generation rather than health outcomes. We agree. Is there anyone who doesn’t?
Mr. Kennedy’s criticism often stems from his controversial views on vaccine safety. While Mr. Kennedy has questioned the causes of adverse vaccine responses, he asserts that he is not opposed to vaccines per se but is concerned about their safety and efficacy. Although some of his past claims about links between vaccines and autism have been discredited, his calls for better preclinical research to identify factors affecting vaccine safety and effectiveness—and for more comprehensive follow-up studies—are sensible. We agree. Is there anyone who doesn’t?
These reforms are achievable. For example, customizing vaccines to the needs of specific population cohorts could significantly improve safety. Genetic susceptibility plays a major role in adverse vaccine reactions, and advances in genomics and pharmacogenomics could lead to predictive models and safer protocols, ushering in an era of personalized vaccinology.
Traditional vaccines aim to trigger antibodies and immune responses to protect against disease but don’t always align with the body’s natural immune responses. Vaccine strategies could improve by mimicking individual immune responses to natural infections, potentially creating stronger and longer-lasting immunity.
Precision Vaccinology applies the principles of precision medicine to improve how vaccines are developed, administered, and analyzed, and is enabled by large-scale “big data” repositories in vaccinology, the use of advanced technologies such as multi-omics and immune-informatics, and Artificial Intelligence (AI) tools that facilitate smarter vaccine development.
Institutions like Boston University’s Precision Vaccines Program (PVP) are leading efforts to develop next-generation vaccines tailored to vulnerable groups, such as infants, older adults, and the immunocompromised. The PVP’s mission is to enhance vaccine effectiveness and safety by addressing the unique immune needs of these populations, which have historically been overlooked. Precision Vaccinology is the next phase of savvy health care equity.
Recent advancements in genetic engineering and adjuvant technologies enable the creation of vaccines tailored to individual needs based on age, sex, genetics, and health status. By targeting specific components of pathogens and using advanced delivery systems like mRNA, DNA, or nanoparticles, precision vaccines can minimize adverse reactions while maximizing protection. Large language models (LLMs) have already shown promise in identifying and cataloging adverse events (AEs) within clinical data.
Using data from the Vaccine Adverse Event Reporting System (VAERS) from 1990 to 2016, these models have demonstrated their ability to extract and catalog AEs more quickly and accurately than current approaches. Knowledge is Power.
Regulatory agencies have been slow to integrate precision medicine tools due to the iron claws of entrenched interests that hews protectively to an antiquated status quo that favors a one-size-fits-all approach to product development. If Mr. Kennedy wants to truly transform health care in America, he should replace special-interest pleading with cutting-edge regulatory science that transparently identifies individual risks and benefits, starting with preclinical research and continually personalizing outcomes for every American. This isn’t science fiction. It’s science fact.
• Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine. Robert Goldberg, PhD, is Vice President of Research Programs at the Center for Medicine in the Public Interest.
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