Sunday, August 9, 2020

Could Trump invoke Emergency Use Authorization for a COVID vaccine?

In my previous post, I discussed the likely timing for a COVID vaccine as being March 2021. However, there is a backdoor to the usual FDA safety studies called "Emergency Use Authorization" (EUA).

So what would be the logistics involved in EUA? Interestingly, it's basically just one person (the Secretary of Human Health Services Alex Azar) that could declare a public health emergency that could justify skipping the usual FDA pathways https://www.law.cornell.edu/uscode/text/21/360bbb-3

Mr. Azar has already used EUA to get some vaccines going into Phase I and II trials. However, some groups are already starting to make noise against EUA for a widely deployed vaccine, such as Public Citizen, a consumer health advocacy group, who feel that EUA could undermine the credibility of the FDA and the trust in vaccines in general, if the usual safety steps are skipped for the full safety study after Phase III. I do not believe that an argument based on long-term credibility will be convincing to President Trump, who is now an underdog to win a second term and is desperate for some easy answers to the COVID19 problem.

So basically, there are a bunch of FDA rules, but they can all be waived if the Secretary of Human Health Services Alex Azar feels like it. Of note is that the Secretary of Human Health Services is nominated by the President, and because Human Health Services is a branch of the Executive, he can actually be fired by President Trump. 

Based on the above, I am changing my prediction: I predict that Emergency Use Authorization will be taken by President Trump on an untested COVID19 vaccine that is part-way through trials, in October 2020. If Alex Azar doesn't go along with the EUA plan, I believe he will be fired.

It's easy to be critical, but if you were Alex Azar, what would you do? You have two options: either you stick with the usual FDA rules and wait until March 2021, and as as results thousands of people will die from COVID19 in the meantime, or you use EUA and you risk deploying a vaccine that has harmful side-effects that could harm millions. It's certainly not an easy decision even in the absence of political elections.

No comments:

Post a Comment