Surprise spinosaurid found, Moderna flu shot back on, multidisease vaxx shows promise

"In a sudden turn of events last Wednesday the U.S. Food and Drug Administration agreed to review Moderna's new mRNA flu vaccine, according to the company. The announcement came roughly a week after Moderna revealed that the FDA had rejected its application. The company said the agency originally called the plan for the vaccine's phase 3 trials acceptable, But its position changed after top FDA official Vinay Prasad overruled the agency's reviewers, according to STAT."

"Moderna's press release about the rejection said the FDA had declared the company's study not adequate and well-controlled. Angela Rasmussen, a virologist at the University of Saskatchewan, told CIDRAP news that, quote, The trial design they used is essentially the trial design that every single flu vaccine has used. On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today."

"In the aftermath of the original refusal Bloomberg reported that Moderna's chief executive officer, Stephane Bancel, deemed the agency unpredictable. He said that if the FDA continues to behave this way it, quote, threatens U.S. leadership in innovative medicines. Speaking of innovative medicines, a new study published last Thursday describes a single vaccine that could offer protection against multiple respiratory illnesses at the same time. An extra perk? The vaccine would be inhaledno needles necessary. The work, led by a Stanford University researcher and published in the journal Science, takes a novel approach to vaccines, which since their earliest days have relied on something called antigen specificity. That means t"

The U.S. Food and Drug Administration agreed to review Moderna's mRNA flu vaccine after an earlier rejection. The agency initially called the phase 3 trial plan acceptable but reversed its position after a top official overruled agency reviewers. Moderna reported that the FDA deemed the company's study not adequate and well-controlled. A virologist noted that the trial design mirrors those used for existing flu vaccines. Moderna's CEO characterized the agency as unpredictable and warned that such actions threaten U.S. leadership in innovative medicines. Separately, a Stanford-led study in Science describes an inhaled vaccine aimed at protecting against multiple respiratory illnesses by rethinking antigen specificity.

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