By Scott Gottlieb and Mark McClellan (original source The Wall Street Journal)
“One of the most effective aspects of the Trump administration’s response to Covid-19 has been Operation Warp Speed, the effort to move a vaccine to market. It’s all the more puzzling, then, that the administration would interrupt this good work with a statement that it may try to weaken the long-established criteria for judging the safety and effectiveness of a vaccine.
“We’re trying to make sure that the guidance we give” is not “a inhibitor to getting things out fast,” White House chief of staff Mark Meadows said on CBS’s “Face the Nation” Sunday. But the criteria the administration is criticizing aren’t some unexpectedly higher bar for approval. The Food and Drug Administration has been sharing its guidance with drug makers, who have been using it to inform their development work.
The insinuation is that these standards would delay a vaccine past the election. It’s beside the point. A vaccine authorization was always most likely to occur after the election. The goal must be a process that delivers a safe and effective vaccine that people trust. That could happen sometime this year if trials are successful, but political interference could slow development and is already eroding the public’s confidence.”
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