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**OCTOBER 14, 2020**

Kuttner on TAP

COVID Vaccines: The Deep State Wins One

****

Trump has given the drug companies billions in taxpayer money to develop
a COVID vaccine, ideally by Election Day. A crash program to get a
vaccine is a good idea. What is not good is the way Trump has pressured
both the FDA and the drug industry to approve and distribute vaccines
before they are proven safe and effective.

However, the FDA, despite a great deal of pressure to change the rules
from the White House and from Trump's henchmen at HHS, has stood firm.
There will be no emergency use authorization for a vaccine anytime soon.
If everything breaks just right, we might have vaccine approval by
January at the earliest, and more likely by March or April.

While the FDA does grant emergency use authorizations
for drugs and
medical equipment, it does not do so for vaccines. (A partial one-time
exception was made for the anthrax vaccine after anthrax was weaponized
and sent through the mail in 2001.)

Last month, HHS officials loyal to Trump sought to rebrand emergency use
authorization for a COVID vaccine as a "pre-licensure." But as FDA
officials pointed out, there is no such thing. This ploy was rejected
out of hand
.

Under the FDA's procedures, there must be an official advisory
committee meeting before licensing of a vaccine can even be considered.
The FDA has scheduled such a meeting

for October 22.

But that meeting, which will hear from scientists and other interested
parties, is about criteria for vaccine development and distribution. No
requests for licensing of vaccines, emergency or otherwise, have been
submitted by drug companies. So approval is not on the docket.

That's not surprising, because FDA rules require that a clinical trial
must demonstrate that people in a trial who received the vaccine show a
50 percent improvement in protection
from infection relative to
people who received the placebo. And the trials are far from complete.

In this case, even the drug companies, who are not the republic's most
ethical citizens, resisted Trump's rush to judgment. An unproven
vaccine would make even more vaccine skeptics reluctant to take it, open
companies to lawsuits, and worsen their already dismal image.

You know that Trump is a snake when even Big Pharma, despite billions in
payments from Trump, refuses to do his bidding. So, score one round for
the deep state and big business. Not our favorite combo. But as a
xxxxxx against Trump, we need to take what we can get.

Now let's get on with the urgent matter of developing a vaccine that
is safe and effective.

~ ROBERT KUTTNER

Follow Robert Kuttner on Twitter

Robert Kuttner's latest book is
The Stakes: 2020 and the Survival of American Democracy
.

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