Why Vaccines Face a Higher Safety Bar: Paul A. Offit, MD

Before they can be introduced to the general public, vaccines undergo a rigorous regulatory process by both the FDA and the CDC to make sure they are safe and efficacious for public distribution.

Pharmaceutical companies championing a new vaccine must first provide multiple, rigorous clinical trial data supporting the vaccine's safety and efficacy, Paul A. Offit, MD, the director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia and a former member on the CDC's Advisory Committee on Immunization Practices, said in an interview with The American Journal of Managed Care^®.

"You looked at these data and tried to answer the question, ‘Do we know enough?’" he said. "Do we know enough to say that this vaccine is safe? Do we know enough to say that this vaccine is effective? At that point, we did. So, we recommended authorization of that vaccine."

That transparency stands in contrast to actions that public health officials say have undermined the overall safety, efficacy, and necessity of currently approved vaccines.¹ The widespread fear and uncertainty surrounding vaccines can be attributed to many factors, including misinformation, thus underscoring the importance of candid conversations like that of Offit.

The regulatory and recommendation review is scrupulous and held to a higher standard when compared with disease treatments, because more often than not, the recipients are healthy, he said.

"You hold these vaccines to a very high standard of—especially safety because you're giving them to healthy children, and you have to hold [them] to a high standard of safety," Offit explained. "…I think if you have cancer and you're getting a cancer drug, you're willing to accept side effects to a much greater extent than you are for a vaccine because vaccines are given to healthy children."

References

1. McCrear S. Trump childhood vaccine order: what it means for parents and payers. AJMC^®. August 11, 2026. Accessed August 18, 2026. https://www.ajmc.com/view/trump-childhood-vaccine-order-what-it-means-for-parents-and-payers