Moderna’s success was built on regulatory shortcuts

Moderna is scaling back vaccine investment as regulators raise the evidentiary bar, exposing how regulatory shortcuts underpinned approval of its Covid vaccine.

Moderna is pulling back from vaccine development as U.S. vaccine policy shifts toward tougher requirements for clinical trial evidence.

Speaking at the World Economic Forum in Davos last week, chief executive Stéphane Bancel said that without government recommendations, the vaccine market contracts — making large phase III trials financially unattractive.

“You cannot make a return on investment if you don’t have access to the U.S. market,” he told Bloomberg TV.

It was a revealing admission.

Moderna’s growth depended on a regulatory environment in which approval and uptake were effectively assured. And now that those regulations are tightening, the company’s Covid vaccine strategy cannot survive.

This also helps explain how Moderna rose to success so quickly during the pandemic.

Before Covid, Moderna had never brought a single product to market.

Its Covid mRNA shot became Moderna’s first FDA-authorised product, cleared under emergency conditions and rapidly extended across population groups — including children and pregnant women.

Regulatory filings obtained by MD Reports show how that expansion was able to proceed.

Key safety questions went unanswered, evidence gaps persisted, and regulators allowed distribution to continue — even as the public was repeatedly assured the vaccine was “safe and effective.”