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.

When will a COVID-19 vaccine be ready in the USA?

There are a bunch of vaccines being developed against COVID-19. Focusing on the US-based vaccines, the one leading the race at this time is Moderna. There is also Astrozeneca (AZD1222) but they are not registered on clinicaltrials.gov and are being pretty shady about their US clinical trial, and so I will ignore them for now.

So how soon might the Moderna vaccine be available, if everything goes well?

According to FDA guidelines, for a vaccine to be deemed safe and effective, the vaccine must first be observed to not have "Serious and other medically attended adverse events in all study participants for at least 6 months after completion of all study vaccinations. Longer safety monitoring may be warranted for certain vaccine platforms (e.g., those that include novel adjuvants)."

So basically, the Moderna vaccine will have to wait at least 6 months after the last of the 30,000 shots are administered before the FDA will approve it as "safe and effective." As of July 31, 2020, the vaccine clinical trial was still recruiting participants. According to the CEO of Moderna, it will be challenging to recruit the 30,000 patients necessary. Therefore, optimistically, the Moderna vaccine could be ready for commercialization as early as March 1, 2021 (assuming that all 30,000 patients were recruited as of Aug 1, 2020), but realistically it will be much later than that. I will be keeping an eye on the clinical trial, to see when the status switches from "recruiting" to "active, not recruiting" to know when to start the six month clock.

The FDA is an arm of Human Health Services, which is an arm of the Executive Branch of the US Federal Government. Therefore, I believe there will be immense pressure on Moderna and other companies to "release the vaccine" before the clinical trials have completed the six-month safety study, or perhaps there will be large-scale misinformation about when they will be ready. For example, Dr. Fauci has suggested that "We may be able to at least know whether we are dealing with a safe and effective vaccine by the early winter, late winter, beginning of 2021." That is bullshit, the earliest a Moderna vaccine would be deemed "safe and effective" by the FDA would be March 2021. I think Dr. Fauci is muddying the waters by confusing "FDA approved" with "we may be able to at least know", which is some undefined standard of vaccine goodness. I think this type of imprecision may lead to large-scale repercussions such as the White House trying to over-rule the FDA and get a vaccine released earlier, specifically before the upcoming US Presidential election. If Dr. Fauci thinks a vaccine will be ready in 2020, he should tell us which vaccine he is talking about and when the 30,000 patient recruitment was completed.

Note: other countries may have lower standards for safety than the US and therefore release a vaccine much sooner.