Up is down — pharmaceutical industry caution versus federal acceleration of COVID-19 vaccine approval

New England Journal of Medicine

15 September 2020 - Nine pharmaceutical company leaders took the unprecedented step on 8 September 2020, of stating that they would refuse to apply for approval of a COVID-19 vaccine until adequate trial data are available.

This announcement reflected an unusual role reversal at a time of unexpected regulatory anomalies. For decades, manufacturers have criticised the FDA for being too slow and demanding too much evidence before approving new products. 

But in the face of growing public concern that the federal government might push forward release of a COVID-19 vaccine despite inadequate evidence, these roles seem to have reversed.

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Michael Wonder

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Michael Wonder