Moderna has “voluntarily” withdrawn its application to the US Food and Drug Administration (FDA) for approval of its Covid-19 and flu combination vaccine amid a recent tightening of regulatory requirements by US Health Secretary Robert F Kennedy (RFK) Jr.
The US drugmaker was brief on details in its 21 May press release, saying only that it had pulled the biologics licence application (BLA) for its combo shot mRNA-1083 “in consultation with the FDA”.
Shares in the Nasdaq-listed company opened 0.4% down at market open on Wednesday (21 May) following the announcement, though they continued to fall by 4% throughout the morning. Moderna has a market cap of $10.4bn.
This month, the company said the FDA wanted to see efficacy data from its flu vaccine before approving the combo shot, which raised questions about a potential delay.
Moderna plans to resubmit later this year after gathering additional efficacy data in an ongoing Phase III trial for its influenza vaccine mRNA-1010 (NCT06602024). Interim data is expected later this year.
The decision also comes a day after the FDA said it would require new clinical trials for approval of annual Covid-19 boosters for healthy people under 65 years.
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By GlobalDataAlthough Moderna’s mRNA-1083 is being developed for adults aged 50 years and older, it is a sign of a widening clampdown on the amount and quality of evidence vaccine makers need to generate during the approval process.
Moderna already has a strong foundation of data for the vaccine. A Phase III trial (NCT06097273) investigating the vaccine in two age group cohorts of around 4,000 each met its primary endpoint of non-inferiority to other licensed vaccines in June 2024.
The combination vaccine comprises mRNA-1010 and mRNA-1283, the latter being Moderna’s next-generation Covid-19 vaccine candidate. Each investigational vaccine has independently demonstrated positive Phase III clinical trial results.
The application shelving is a setback for Moderna, which was banking on sales of a new wave of mRNA vaccines amid falling sales for its Covid-19 vaccine and weak demand for the respiratory syncytial virus (RSV) vaccine mRESVIA.
mRESVIA was approved by the FDA last year, but uptake for the vaccine has been low after a limited recommendation from the US Centers for Disease Control and Prevention (CDC). Grappling market share off GSK and Pfizer, who both already had RSV vaccines on the market, has also proven difficult.
This month, Moderna said it would reduce annual spending by around $1.5bn by 2027 to offset the impact of slowing Covid-related product sales.
Shares in Moderna have consistently fallen since the Covid-19 pandemic and took a further battering when RFK Jr, a vaccine sceptic, was confirmed as the US Health Secretary. Moderna also belongs to a pharmaceutical industry that facing the prospect of sector-specific tariffs by President Donald Trump.
