December 18, 2024 Source: drugdu 39
Another "black swan" event in the field of RSV vaccines.
On December 10, the FDA announced a comprehensive suspension of all RSV vaccine research for infants and young children, including research on Moderna's two vaccines mRNA-1345 and mRNA-1365, and plans to hold an advisory committee meeting on the 12th to discuss the safety of the vaccine.
Among them, mRNA-1345 was approved by the FDA in May for the prevention of RSV in the elderly over 60 years old.
mRNA-1345 was once regarded as a strong competitor to the two RSV vaccines, GSK's Arexvy and Pfizer's Abrysvo. However, on June 26, Moderna released data showing that its efficacy dropped to about 50%. Affected by this news, Moderna's stock price plummeted 11%.
At present, the briefing document released by the FDA reveals a more unfavorable information for Moderna: clinical data show that RSV infection is seriously different between the vaccine group and the control group, and mRNA-1345 and mRNA-1365 may even aggravate RSV virus infection. As soon as the news came out, Moderna's stock price plummeted by 9%.
Obviously, the market is worried about the prospects of Moderna's vaccine, and more worried about whether it will repeat the mistakes of Pfizer's RSV vaccine more than 60 years ago.
After attracting market attention, RSV vaccine can be said to have encountered a countercurrent. First, the US Centers for Disease Control and Prevention narrowed the vaccination population recommendation, and now the indication for children is facing variables. For domestic followers like Clover Biopharmaceuticals that are fully betting on this field, the pressure may be huge.
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