With each passing day, there is more reason to think that US President Donald Trump’s Food and Drug Administration may issue an emergency use authorisation for two or more Covid-19 vaccines in late October.
In an ideal world, this would be terrific news. We are, after all, in the grip of a major global emergency. Roughly 1,000 Americans die from the virus every day, or roughly one every 80 seconds. A vaccine would save lives.
Yet an emergency use authorisation, or EUA, is likely to be met with pervasive scepticism by many. The reason isn’t hard to see. Trump has tried over the last four years to politicise nearly every aspect of independent judgement by government officials.
The “known and potential benefits” of the vaccine must “outweigh the known and potential risks taking into consideration the material threat posed” by Covid-19. That burden could also be met, provided that early results don’t show the vaccines harming people who take them
He has delegitimized agencies like the Department of Justice and the FBI, which he sees as threats, and attacked institutions from the judiciary to the post office when it has suited his political purposes.
Now, Trump (and the rest of us) are about to inherit the whirlwind. At precisely the moment when we could benefit massively from public trust in independent agency judgement, our trust is shot.
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Trump critics have become accustomed to distrusting Trump’s agencies, much as Trump himself has somewhat successfully convinced his own supporters that there is no such thing as governmental objectivity or independence, but only politics all the way down.
Even if there is good reason for the EUA to be issued and for people who have the opportunity to receive the vaccines to do so, some — perhaps many — rational people aren’t going to trust the FDA enough to make that choice.
Preliminary phases of vaccine trials
Of course, we do not yet have all the data from the preliminary phases of the vaccine trials. But the federal law that authorises EUAs sets a standard that these trials could well meet.
It says that an EUA may be issued when, “based on the totality of scientific evidence available including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing” the disease in question.
That’s an extremely low bar: that it is “reasonable” to believe that the vaccine “may” work.
The law also imposes a caveat. The “known and potential benefits” of the vaccine must “outweigh the known and potential risks taking into consideration the material threat posed” by Covid-19. That burden could also be met, provided that early results don’t show the vaccines harming people who take them.
If the vaccines do qualify for an EUA, based on non-partisan scientific and public health judgement, they should be made available. That should be true no matter who is president, and regardless of whether Trump will use the EUA announcement as an October surprise for partisan electoral advantage.
Unfortunately, even if the FDA were justified in issuing an EUA, it would be very difficult for much of the public to accept that doing so was based on sound judgement rather than partisanship. That is more or less what happened when an EUA was issued for convalescent plasma therapy in late August.
The therapy almost certainly met the low bar needed for the EUA. Yet not only Trump but the Secretary of Health and Human Services and the Commissioner of the FDA made mistaken claims about the efficacy of the treatment at the press conference announcing it. The result was, you guessed it, scepticism and further loss of legitimacy.
Vaccines are bizarrely controversial even when there is no pandemic. Anti-vaxxers on the left and the right already express and encourage scepticism about their efficacy and potential dangers.
We need more clear thinking about vaccines, not less. And after four years of undercutting his own government agencies, Donald Trump has made that clarity much, much harder to achieve.
Noah Feldman is a columnist and host of the podcast “Deep Background.” He is a professor of law at Harvard University
Bloomberg
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