The Food and Drug Administration (FDA) reversed course on Wednesday and will now review Moderna’s application for the first mRNA-based flu vaccine after initially declining to consider it.
Moderna announced that the US drug regulator will move forward with reviewing its updated flu vaccine application. The decision comes only a week after the agency turned down the company’s original filing, a move that had prompted criticism across the medical industry about potential changes in how the regulator is making decisions under the Trump administration.
The company is seeking full approval of the vaccine for adults between the ages of 50 and 64, along with accelerated approval for people aged 65 and older.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Stéphane Bancel, CEO of Moderna, in a statement. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
The FDA has set 5 August as the target date for finishing its review, which could allow the vaccine to be available before the next flu season begins.
The agency’s earlier rejection had intensified worries about what many see as a major change in US vaccine policy under the current administration. Those concerns have been tied to declining vaccination rates and broader changes to the regulatory environment for new vaccines.
Andrew Nixon, a spokesperson for the Department of Health and Human Services (HHS), said in a statement: “As authorized under PDUFA (Prescription Drug User Fee Act) and defined in FDA guidance documents, FDA held a Type A meeting with Moderna. Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted. FDA will maintain its high standards during review and potential licensure stages as it does with all products.”
The health secretary, Robert F Kennedy Jr, a longtime vaccine skeptic and a vocal critic of mRNA technology – the platform used in Moderna’s and most other Covid-19 vaccines – recently oversaw the cancellation of a $500m federal contract intended to support development of mRNA vaccines targeting bird flu and other high-risk strains.
The FDA had previously rejected Moderna’s application, saying the company should have administered a higher-strength vaccine to older participants in the control group of its clinical trial.
The FDA commissioner, Dr Marty Makary, said on Tuesday the decision to initially reject Moderna’s application came because the biotech company did not follow the FDA’s earlier guidance, a contention Moderna disputes. A senior FDA official had called Moderna’s clinical trial a “brazen failure” at a press conference last week.
Health experts and advocates were quick to voice concern over the initial refusal by the FDA, which is overseen by Kennedy’s HHS, to consider the mRNA-based flu shot. Many saw it as part of a wider “anti-vaccine agenda” being pushed by the Trump administration and “Make America Healthy Again” (Maha) movement.
