FDA reverses course, refuses to review Moderna’s application for new mRNA flu vaccine
The US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBER) is refusing to review Moderna’s application for approval of a new flu vaccine. The decision comes after the FDA previously indicated support for the company’s phase 3 trial of its mRNA flu vaccine.Moderna’s study included more than 40,000 adults age 50 and
up and was intended to help the company get approval to use the vaccine in that
age-group. In a press release,
Moderna said the FDA determined that the company’s study was not “adequate and
well-controlled” because the comparable vaccine used in the trial did not
represent the “best-available standard of care” in the United States at the
time of the study.
Neither federal rules for how drug studies must be designed,
nor the FDA’s own guidance for flu vaccines, refer to the use of
"best-available standard of care” in selecting comparator vaccines.
Previous correspondence from the FDA to Moderna expressed a preference for the
company to use a higher-dose vaccine for older adults as a comparator but
stated, “We agree it would be acceptable to use a licensed standard dose
influenza vaccine as the comparator in your Phase 3 study.”
The study followed a well-established framework for flu
vaccine trials, according to virologist Angela Rasmussen, PhD, of the
University of Saskatchewan in Canada. “The trial design they used is
essentially the trial design that every single flu vaccine has used,” she tells
CIDRAP news.
Refusal could undermine confidence in FDA
In an interview with The
New York Times, Moderna’s president Stephen Hoge, MD, expressed surprise
and confusion about the decision, noting the FDA’s earlier support for the
company’s study plan. The company’s mRNA vaccine has been accepted for review
in the European Union, Canada, and Australia. Moderna has requested a meeting
with the FDA to understand the basis for their refusal.



















