FDA refuses to review Moderna’s mRNA flu vaccine
Summary
Ars Technica reports that the FDA refused to review Moderna’s mRNA flu vaccine, citing concerns with the trial's comparator and its adequacy as a well-controlled study. Moderna criticized the decision, noting it still plans to engage with the FDA, while the company’s vaccine is already under review in the EU, Canada, and Australia. The piece situates the decision amid broader anti-vaccine discourse and highlights the substantial phase 3 trial involved.