Trump administration reverses move to block Moderna flu vaccine trial
U-turn comes after backlash from the company and US biotech industry
The US drug regulator has allowed a crucial Moderna flu vaccine trial to proceed, reversing an earlier decision to halt the study that triggered a backlash from the company and wider biotech industry.
In a regulatory filing on Wednesday, Moderna said the Food and Drug Administration would review a late-stage trial for the company’s first-ever flu shot and set an August deadline to approve or deny the drug. Moderna said it held a meeting with FDA staff to revisit the trial application.
Moderna’s announcement ends a brief but intense spat between the Trump administration and the high-profile vaccine maker that was also one of the central companies in developing Covid-19 jabs during the pandemic.
The Department of Health and Human Services (HHS) slammed Moderna last week, claiming its flu shot trial exposed older people “to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists”.
The remarks represented a rare public and pointed critique of a drugmaker by one of the world’s most prominent regulators. HHS, which oversees the FDA, is led by Robert F Kennedy Jr, a vaccine sceptic.
Moderna’s chief executive Stéphane Bancel said in a statement on Wednesday that “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”.
Moderna’s shares rallied 6 per cent on Wednesday. If the shot is approved by the FDA, it will be available during the 2026-27 flu season.
The dispute over the Moderna jab, which unlike current flu vaccines available on the market is based on messenger RNA technology, has shocked the biotech sector and concerned many scientists.
Moderna uses a similar technology for its Covid vaccine, which is also the subject of controversy in President Donald Trump’s administration and Maga movement. Its mRNA technology transmits information to cells to produce immunities against diseases. Most other vaccines use virus parts to trigger an immune response.
HHS said last week that Moderna “refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial”.
“This is exactly why companies discuss trial design before beginning large-scale trials, to avoid a situation like this,” Karen Andersen, director of healthcare research at Morningstar, said last week. “It sounds like [the FDA’s] view of the requirements for filing have changed, which seems consistent with the new, overarching scepticism of vaccines in this administration.”
Other observers said Moderna’s situation with the flu shot underscored the FDA’s continued scepticism towards vaccines.
The agency’s reversal “was a remarkably short turnaround” for a dispute that typically takes up to 60 days to resolve, TD Cowen said in a report on Wednesday morning.
Moderna said the flu shot had already been approved for review in the EU, Canada and Australia. Moderna currently sells Covid and RSV vaccines, but its flu shot would be the first from the company.
Separately on Wednesday, a Trump administration official said Jay Bhattacharya, head of the National Institutes of Health, would become the new acting head of the Centers for Disease Control and Prevention, which makes recommendations for vaccines.
Bhattacharya replaces Jim O’Neill, who stepped down on Friday. Trump is expected to nominate O’Neill to lead the National Science Foundation, according to an administration official.
The CDC has been operating without a Senate-confirmed leader since Susan Monarez was abruptly fired in August.