Next-Gen Vaccine Makers Want Up-Front Discussions With US FDA To Expedite Development
Early conversations on clinical trial endpoints were particularly helpful in developing Comirnaty, a Pfizer executive said. Whether sponsors can continue to get such discussions may go a long way in determining whether a new generation of products is developed.
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COVID Vaccines: What FDA Isn’t Talking About Ahead Of Upcoming Advisory Panel
From next-generation vaccine technology to safety data and global harmonization, what isn’t in the Vaccines and Related Biological Products Advisory Committee preview documents and on the 26 January meeting agenda may be just as important as what is.
Next-Gen COVID Vaccines Could Be Awesome – If They Ever Get Made
Mucosal and other new vaccines in development should target infection and transmission prevention, as White House’s Ashish Jha calls for them to be ‘better than terrific.’ But with the market transitioning to a flu-like status, incentives for big investments seem limited.
Califf Previews US FDA’s Authorization Rationale For COVID Bivalent Boosters
FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’