Expert questions proposal for placebo-controlled trials in new vaccine safety testing

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Stacey Kostell Vice President and Dean of Enrollment | Northwestern University

Expert questions proposal for placebo-controlled trials in new vaccine safety testing

The proposal by Health and Human Services Secretary RFK Jr. to mandate that all new vaccines undergo safety testing through placebo-controlled trials has sparked debate within the scientific community. Seema Shah, a professor of pediatrics at Northwestern University Feinberg School of Medicine and director of research ethics at Ann & Robert H. Lurie Children's Hospital of Chicago, has expressed concerns about this approach.

"Requiring placebos for all vaccine trials is a little like making basketball players do tryouts before every game — a waste of everyone’s time and money," Shah stated, indicating her belief that such trials are unnecessary under certain conditions.

Shah's research concentrates on when it is ethically and legally permissible to expose people to risk for the benefit of others, particularly in pediatric, infectious disease, and global health research contexts.

She elaborated on the ethical considerations, stating, "If we have vaccines or treatments that work, it’s wrong to give some research participants nothing. There are some exceptions, such as if there is an important scientific reason." Shah cited examples like trials of pain medication where placebos might be used due to the placebo response or in low-risk situations, such as testing for seasonal allergy treatments.

However, Shah argues against a blanket requirement, pointing out that "for many diseases, scientists already know how to measure if the vaccine is giving the immune system the information it needs to fight the disease, and there is no need to use a placebo injection."

She warns that enforcing such a rule could lead to unethical treatment of participants and hinder progress against infectious diseases. "A blanket rule to use placebos will force scientists to treat people unethically. It seems like another way to gum up the works so fewer people will be protected against infectious diseases in the future," Shah emphasized.

Shah is open to media interviews to further discuss her stance. Interested parties can contact Kristin Samuelson to arrange an interview.

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