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PSA on the topic of the COVID vaccine and why it isn’t yet mandatory for DoD, unlike other vaccines (and why there’s actually more thought behind that than “lol dumb DoD bosses”). The history of the anthrax vaccine is illustrative here
Before we start I want to be perfectly clear that I think the COVID vaccines approved under an Emergency Use Authorization (EUA) by the FDA are safe and I plan to get mine as soon as it is made available to me
The purpose here isn’t to pooh-pooh the vaccine but rather to hopefully help explain some of the thought process behind why we, as a society, have decided that something being dispensed under a EUA shouldn’t be made mandatory absent extraordinary circumstances
Additionally, I think some of the (younger) folks on here commenting negatively on the low vaccine uptake rate within DoD might be underestimating how much the anthrax debacle impacted the milvet community’s view towards mandatory vaccines
The anthrax vaccine was originally developed several decades ago to protect against the cutaneous form of anthrax. This was the most common form, as it was contracted from handling animals/hides/wool carrying the spores
It was found effective against the cutaneous form, and was approved by the FDA on a limited basis, specifically for individuals who might come into contact with spores occupationally (veterinarians/animal handlers/textile workers) or lab work involving spores
Fast forward to the ‘90s, and all of sudden DoD has an interest in anthrax defense, due in part to a guy named Saddam along with the Kim father-son duo. They ID’d the existing vaccine, and begin efforts to immunize military personnel. There was only one tiny problem
The vaccine had only been approved by the FDA as being effective against the cutaneous form, not the inhalation form, which was what would be encountered if anthrax was used as a weapon. By deploying the vaccine against this form, DoD was effectively using the vaccine “off-label”
Off-label is a term for using a medicine in a fashion that is outside what the FDA has approved it for use as. This is an extremely common occurrence, but it also is intended as an individual discussion between a physician and patient, where the patient can give informed consent
Informed consent in a nutshell is the idea that in order for someone to fully give permission to medical treatment they must fully understand (as best as is known at the time) the known and possible benefits and risks of pursuing the treatment in question
Our understanding and implementation of informed consent has evolved over the years; currently it’s implemented in this country for medicine by the idea that the data contained in studies used to obtain FDA approval provide a full understanding of benefits and risks
If you are using a medicine in a form that isn’t approved for use by the FDA, you may not have all the information to give informed consent. That’s why the individual discussion with your physician is so important. This is impossible to provide in a mass setting
Furthermore, obviously “mandatory” implies that any individual discussion with a physician is a moot point. The challenge here for senior leaders is that without the full data they may not know every possible impact across a large population
I’ll jump back to anthrax for a second, because this is a key point. When the FDA approved the vaccine for limited use, it did so for a specific population based on a limited set of data. To scale that up to hundreds of thousands of servicemembers was a bit of a leap
Additionally, as referenced earlier, the decision to license the vaccine in a limited fashion was made against the cutaneous form. Whatever benefit-cost analysis was done was solely against the cutaneous form. Shifting course towards inhalation potentially shifted that calculus
While you may want the vaccine for yourself based on the data you have seen, if that data isn’t enough for the FDA to issue a license, is that enough for you to give a lawful order for everyone in your command to receive the vaccine?
Before you answer, consider the myriad events in ethics history of individuals from one group thinking they knew what was better for another group. I’m not trying to make some crazy comparison or sound like an anti-vaxxer, because again, I fully intend on getting the shot ASAP
But I think there’s been some hot takes that underestimate the responsibility that comes with ordering someone to put something into their body that the FDA hasn’t licensed. Speaking of which, back to anthrax…
The initial vaccination push for Desert Storm basically amount to DoD saying “there’s a war on” and the FDA saying “sounds good to us, give whatever shots you want”
The larger program in the later ‘90s was a bit more complex. By that time the FDA, DoD, and manufacturer had all recognized that they hadn’t quite dotted all the i’s on the ODS use and it technically wasn’t approved against inhalation
The manufacturer tried to clean that up by submitting a request for an experimental approval against inhalational anthrax, but DoD leaned on the FDA and short-circuited that, resulting in the FDA basically saying “yeah do whatever”
Fast forward a couple years, long suffering federal judge Emmet Sullivan (yes, *that* Sullivan) landed a suit on the subject. His conclusion was that the FDA and DoD had screwed up the paperwork and that absent a Presidential declaration, mandatory vaccination was illegal
Specifically because the vaccine had not been FDA licensed for the exposure route and thus could not fully meet informed consent requirements. This is not to say that the vaccine was unsafe (he didn’t comment there) but that minrunning the paperwork rendered it illegal
Of note, Congress had taken notice of the anthrax debacle and had changed the waiver authority on this subject from the FDA Commissioner to the President. The background here was loads of claims (of which I’ll just say I'm skeptical) of anthrax vaccine injury
However, DoD absolutely shot themselves in the foot here long-term by basically establishing a culture of “we don’t give a fuck about what the FDA says or what your concerns are, we will ram a vaccine down your throat regardless of whether or not it’s legal”
I will just say from personal observation, every single conversation I’ve witnessed re: COVID vaccine and military (which admittedly is skewed old, welcome to FGO/SNCO/retired old fart staff life) has mentioned the anthrax debacle at least once
In the current context, the COVID vaccines being deployed in the US are operating under an EUA. This means the FDA has determined that due to an emergency, based on limited data the FDA has determined that the benefits outweigh the risks
Current US law dictates that the only way a treatment operating under a EUA can be made mandatory to members of the US armed forces is if the President determines that waiving informed consent is not in the interests of national security
Hopefully based on the previous tweets, you can see how making that determination (based on the totality regarding COVID’s effect on actual national security balanced against the concept of informed consent) might be more difficult than the slam dunk some think it is
All that was way longer than I intended (who knew, medical ethics is complicated) but hopefully will help lay out why, even while I fully intend on getting vaccinated as soon as it is offered to me, I understand why DoD isn’t making it mandatory
One last plug: given everything in the thread (especially the history of anthrax as well as other informed consent failures, especially within marginalized communities) I would highly encourage all discussion on the topic to be forward focused w/senior leader engagement
Less “argle-bargle I had to get anthrax/smallpox/JE/whatever and I’m fine and/or I have a VA claim,” more “the vaccines, while under a EUA, have been subject to rigorous initial trials and have passed with flying colors. I plan to be vaccinated as soon as it’s offered to me.”
To their credit, most remotely official DoD accounts have been hammering this message (seems like we’ve finally learned our lesson from the anthrax debacle), but I’m more referring to the thinkfluencer accounts
Less “ugh just make it mandatory,” which inevitably invites tons of “well back in my day we got injected with antifreeze and we liked it” comments which are quite unhelpful in convincing skeptical servicemembers/citizens, and more “I’m getting it and here’s why you should too!”
Also I look forward to the day when the vaccine(s) are fully FDA approved and this whole conversation becomes moot as the official position will be "either take this like you do the annual flu shot or gtfo"
And that position will have an ethical backstop supported by the data and analysis, something that unfortunately does not quite exist today despite the many levels of analysis on the different EUA vaccines
