Moderna claims its mRNA vaccine is rapidly cleared from the body. What does its data show?
The company’s biodistribution study was meant to reassure vaccine advisors — but it raises more questions than it answers.
Last September, advisers on the CDC’s Advisory Committee on Immunization Practices (ACIP) discovered that a foundational safety study for Moderna’s Covid-19 vaccine had never been conducted.
There were no biodistribution studies using the actual product administered to millions of people — studies designed to show where an injected vaccine travels in the body, which organs are exposed, and how long vaccine material persists.
Despite that absence of evidence, Moderna’s Covid-19 vaccine was authorised — and later fully approved.
How the gap came to light
The absence of biodistribution data surfaced publicly during an ACIP meeting last September.
Members of the Covid-19 vaccine workgroup, including Tufts University cancer biologist Charlotte Kuperwasser and Brown University oncologist Wafik El-Deiry, examined FDA documents submitted during Moderna’s approval process.
They found that biodistribution studies had not been performed using Moderna’s commercial Covid-19 vaccine, mRNA-1273.