‘We are taking the time that we need,’ FDA head says, defending COVID-19 vaccine approval process. Here’s what he told us about what comes next.

‘We are taking the time that we need,’ FDA head says,
defending COVID-19 vaccine approval process. Here’s what he told us
about what comes next. 1

Another thing that I think is important is that the transparency around this, I believe, will provide assurance to the American people that a very rigorous process took place. Finally, we have been very clear in our guidances that we will ask manufacturers, if any vaccine is approved, to put in place a very vigorous surveillance system after the vaccine is authorized, if it is authorized, regarding safety and also to some extent the efficacy, and that system that we’re going to use, that we’re going to ask the manufacturers to use and others, is very rigorous to look for additional safety events should they occur.

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