How much data does Moderna need to get a coronavirus vaccine approved?
Moderna Therapeutics’ potential coronavirus vaccine only entered Phase 1 yesterday, but, considering the speed of the program and severity of the pandemic, it’s worth asking: Would the FDA consider approving it before there's proof it protects people?
EvercoreISI analyst Umer Raffat wondered exactly that and went digging through FDA regulations. The agency prefers that vaccines demonstrate protection — preferably in large, placebo-controlled studies — but it reserves the right to approve treatments based on immunological evidence that looks protective. In practice, that has only applied when regulators can be sure that a certain amount of immune activity confers protection. When it comes to coronavirus, no one has any idea.
But the pandemic, which has resulted in more than 180,000 cases around the world, is an unusual case. If the FDA waives its normal requirement, Moderna could file for approval based on the amount of protective antibodies its vaccine produces. And it could win that approval much faster than is currently thought.
EvercoreISI analyst Umer Raffat wondered exactly that and went digging through FDA regulations. The agency prefers that vaccines demonstrate protection — preferably in large, placebo-controlled studies — but it reserves the right to approve treatments based on immunological evidence that looks protective. In practice, that has only applied when regulators can be sure that a certain amount of immune activity confers protection. When it comes to coronavirus, no one has any idea.
But the pandemic, which has resulted in more than 180,000 cases around the world, is an unusual case. If the FDA waives its normal requirement, Moderna could file for approval based on the amount of protective antibodies its vaccine produces. And it could win that approval much faster than is currently thought.
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