Beyond the curve: Dr. Peter Lurie's COVID-19 blog
The winds of change are in the air. Just yesterday, General Services Administration head Emily Murphy actually acknowledged the looming reality by designating Joe Biden as the President-elect. And three vaccine companies have announced promising results in vaccine trials, though all appear only in press releases so far.
Time to get to work. Some companies have already submitted their applications for Emergency Use Authorizations, initiating a process whereby career officials at FDA pore over raw company data on safety, effectiveness, pharmacology, manufacturing, labeling and much more. No other drug approval agency in the world has access to the raw data the way FDA does. The agency will convene a meeting of its Vaccine and Related Biological Products Advisory Committee, after which a CDC committee will consider for which populations the product, if approved, should be recommended.
In other words, business as usual, except conducted at breakneck pace.
But the Trump Administration’s predilection for disparaging its own regulatory agencies, including FDA and CDC, has undermined public confidence to the point that in some surveys up to a half of respondents profess to being unsure whether they’d roll up their sleeves and accept a vaccine. In an attempt to reassure a skeptical public, seven states and DC have undertaken to conduct their own vaccine reviews or to piggyback on California’s review.
But ad hoc state committees simply cannot hope to replicate the review conducted by FDA staff. And the implicit message is that FDA review might somehow be suspect. In this op-ed in Barron’s, submitted at the suggestion of my colleague Jim O’Hara, I argue that the states should leave vaccine review to the people at FDA who do this unsung work day in and day out.
Drop me a note or comment below and tell me what you think.
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