Full Press Release Details
The Department of Health and Human Services has come out in support of Center for Biologics Evaluation and Research head Vinay Prasad after the health official shot down Moderna’s mRNA flu vaccine mRNA-1010, refusing to accept the application for review.
“The FDA rejected Moderna’s application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy,” Andrew Nixon, spokesperson for the department, said in a statement, according to a Wednesday report fromFierce Biotech.
Nixon also asserted that Moderna “exposed participants aged 65 and over to increased risk of severe illness” by using “substandard of care against the recommendations of FDA career scientists.” The company, he continued, should have used certain high-dose flu shots as controls for this age group, in keeping with CDC guidelines. The CDCrecommendsthat people 65 and older receive a high-dose shot, but says when such a shot is not available, they may be given a standard dose instead.
In itsrefusal-to-file letter, which Moderna made public on its website, the FDA similarlysaidthat the company failed to present an “adequate and well-controlled” study to support mRNA-1010. In particular, Moderna used a control group that “does not reflect the best-available standard of care.”
Moderna hit back in anews release on Wednesday, pointing out that the FDA’s guidance for vaccine development does not “contain any reference to the use of a comparator reflecting the ‘best-available standard of care.’” The company also said that the refusal-to-file letter is “inconsistent” with previous communications with the FDA, which had agreed that using a standard-dose flu control was “acceptable.”
The letter itself does not make mention of the 2024 FDA guidance that Nixon brought up, only noting that the need to use the “best-available standard of care” vaccine as a comparator was “consistent with the FDA’s advice given to you prior your study.”
A senior FDA official, speaking to reporters on Wednesday off-the-record, suggested that Moderna used the “substandard” comparator to inflate the efficacy of its product, according toNBC News. “You can either do what’s right, and give seniors the standard of care that best protects them the best, or you can kind of rig the study so it makes your product look better.”
The official added that the doors haven’t closed yet for a resubmission—though it would be good for Moderna to “show some humility and that, yes, we didn’t follow your recommendation.”
A refiling, the unnamed FDA official continued, would likely also fare better if it were focused on a narrower age group, proposing mRNA-1010 for patients aged 50 to 64 years. If proven effective and safe, “doctors can use it off-label if it ends up getting approved,” the official added, according to reporting fromEndpoints News.