A layperson's guide to a Covid-19 vaccine approval
Given the unprecedented pace of Covid-19 vaccine development, how will the FDA decide whether a vaccine candidate is worthy of approval? STAT’s Matthew Herper lays bare the complex process of regulatory analysis, oversight, and approval.
There could be a lot riding on interim analyses — and for Pfizer and BioNTech, that could one could come as soon as October. Even when these analyses are done, the plan is for the trials to continue even past an approval.
“Generating enough data is also where we take our responsibility, because in the end we will be liable for the product getting into the market,” said Paul Stoffels, Johnson & Johnson’s chief scientific officer.
There could be a lot riding on interim analyses — and for Pfizer and BioNTech, that could one could come as soon as October. Even when these analyses are done, the plan is for the trials to continue even past an approval.
“Generating enough data is also where we take our responsibility, because in the end we will be liable for the product getting into the market,” said Paul Stoffels, Johnson & Johnson’s chief scientific officer.
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