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.

Vaccine research
COVID-19 vaccine developers want to know the goalposts for efficacy and safety early in the development process. • Source: Shutterstock

Regulatory flexibility and early conversations allowed COVID-19 vaccine candidates to move to market quickly and should remain in place as next generation products enter the development process, sponsors said.

Angela Hwang, group president of Pfizer Inc.’s Biopharmaceuticals Group, said “the fit-for-purpose way of looking at what is the issue in hand and what is the kind of approval that we need” was a key advantage that allowed its vaccine to move quickly

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