The President And The Coronavirus Vaccine

Trump calls the FDA’s approach to safety a “political hit job”. So let’s be clear on what they’re doing.

You might’ve missed this, since the President’s Tweeting has been so fast and furious — and often changing — over the last couple of days. As if to make up for lost time for the 3 days he was in the hospital. Or squeezing as much possible in before some other shoe drops:

So here’s what’s behind this:

1. President Trump multiple times promises a Coronavirus vaccine by Election Day. Even when people in or close to his own administration say that’s unlikely or impossible, he says they are wrong, and often that the vaccine will come even sooner.
2. The FDA sets up some steps under which it would consider allowing pharmaceutical companies to distribute a vaccine under an Emergency Use Authorization order or EUA. That is, far faster than it’d ever be allowed under the agency’s normal approval process.
3. The White House, realizing this indeed means no vaccine before Election Day — though very likely multiple vaccines before the end of the year — pushes back and threatens to throw out those guidelines.
4. The FDA — for now — prevails. The reason we say “for now” is the guidelines are “nonbinding”. The strongest language the FDA uses is that it “does not expect to be able to make a favorable benefit-risk determination that would support an EUA”, without the data it requests.
5. Trump calls it a “political hit job”.

Now that you’re caught up on the timeline, let’s look at what the FDA proposes for potentially clearing Emergency Use Authorization of a COVID-19 vaccine. And what the President says is horrible and politically motivated:

• The FDA says participants in Phase 3 clinical trials should be followed-up on for at least 2 months after receiving the vaccine. That’s both to ensure the vaccine is safe, and that it actually works.
• In order to demonstrate the vaccine actually works, data must show proof of COVID-19 exposure among participants in trials. This is tricky: because if the vaccine’s really good, no test subjects should be getting sick. But then, how do you know if…