COVID vaccine trials and medicals

LoLPilot

LoLPilot

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LoLPilot
Any FAA folks in here?

I've been on a discussion thread on Facebook, that was started by a rumor that the FAA will revoke medicals for anybody that participates in a COVID vaccine trial. Nobody could find a published stance on it, so I decided to contact the local FSDO. They got in touch with the medical office in OKC and this was the reply:

"I just spoke to FAA Medical in OKC. Their exact words were if you or anyone do this your Medical will be revoked and it could be several years before you get it back if ever. Please let your friend see this warning."

I intend to call the medical office about this. First, because the FAA's previous stance on this seems to be that vaccines are not medications, therefore it shouldn't factor into the list of "unapproved medications" that cause medical suspension (1). Second, if this is the case, then the FAA should publish an official stance on this, and I intend to find out if they have and what that publication number is.

Has anybody else heard anything about this?
1. https://www.leftseat.com/immunizations-faa-medical/
 
LoLPilot said:
Their exact words were if you or anyone do this your Medical will be revoked and it could be several years before you get it back if ever.
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Wow. Severe. Glad to see the FAA continuing to do everything it can to discourage people from seeing doctors and getting the medical help they need.

Granted, I can also understand why participating in a medical trial could jeopardize your medical. I wonder if they have the same stance on other medical studies.. like if you participate in a trial for a pill you can take that would keep mosquitos from biting you, would that also mean "your Medical will be revoked and it could be several years before you get it back if ever." ?
 
So to clarify I'm not a participant in one of the trials as of now, but I have signed up to be in the pool to be drawn from. I work in research and I think it is important to have people willing to participate in studies like this, and to participate in these studies myself.
 
Tantalum said:
Wow. Severe. Glad to see the FAA continuing to do everything it can to discourage people from seeing doctors and getting the medical help they need.

Granted, I can also understand why participating in a medical trial could jeopardize your medical. I wonder if they have the same stance on other medical studies.. like if you participate in a trial for a pill you can take that would keep mosquitos from biting you, would that also mean "your Medical will be revoked and it could be several years before you get it back if ever." ?
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One of the people on the thread who is an airline pilot, said that in the past people who have participated in medication trials were suspended until after the dosing period was over.

But yeah very much a four letter word move by the FAA if this is the case.
 
LoLPilot said:
I intend to call the medical office about this.
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Please don't. Instead, please read the regs and understand your obligations with respect to medical conditions that may occur in between medical examinations, and leave it at that. No good can come from your proposed course of action. What is the potential upside to making that call?
 
I suspect it has to do with the use of medications that have not been approved by the FAA. They do not know the side effects of new vaccines or medications. I guess if you are part of a study as opposed to a trial, and you are given a placebo, maybe, but how would you know if you were given a placebo?
 
This shouldn't require a new ruling from the FAA. Clinical trials have been underway for decades. Self-grounding while in the study may make sense, but has it ever been their policy to revoke medicals for pilots participating in clinical trials? How about clinical trials of vaccines?

I've no idea what the answers are to the question I just posed, but I see nothing about COVID vaccine trials that should cause them to be treated differently than any other vaccine trial. I'd hope the FAA is at least consistent in how they handle this, because near-simultaneous phase 3 trials of half-a-dozen vaccine candidates will require a LOT of volunteers.
 
Lindberg said:
Please don't. Instead, please read the regs and understand your obligations with respect to medical conditions that may occur in between medical examinations, and leave it at that. No good can come from your proposed course of action. What is the potential upside to making that call?
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Why would I not? I am familiar with the regs. I also know that omitting a relevant fact from a medical application is a criminal offense. I want to have all my t's crossed and i's dotted when I renew.

Here's the other thing. If they are taking this stance, they need to publish something that that effect. I haven't seen it, and apparently others can't find it either. I could see suspending a medical until testing is over, but this whole business of "indefinite suspension without guarantee of reinstatement" is either laziness or a power trip. If that's the case then letters need to go to AOPA, EAA, and Congressional representatives. Why would I not call the medical office? That's their job.
 
I’m still stuck back at why anybody thinks involving oneself in any sort of “trial” would ever be considered “necessary” by any medical bureaucracy tasked with airman perfection.

Was there suddenly something that happened where someone thought OKC was going to magically like such a thing? Ever?

Any indication past or present of behavior that would indicate they would be pleased? LOL.

Do people just forget this stuff because there’s a virus running around, or what? Haha.

What’s Bruce’s advice? Never ask until the answer has to be yes?

It’s as silly as dialing up the IRS “just checking” on your brand new get rich quick without taxes scheme. “Guess what I did! You guys cool with that?” LOL.
 
LoLPilot said:
Any FAA folks in here?

I've been on a discussion thread on Facebook, that was started by a rumor that the FAA will revoke medicals for anybody that participates in a COVID vaccine trial. Nobody could find a published stance on it, so I decided to contact the local FSDO. They got in touch with the medical office in OKC and this was the reply......
Has anybody else heard anything about this?
1. https://www.leftseat.com/immunizations-faa-medical/
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There has never been a problem with vaccines. The potential problem is with as yet unapproved FAA vaccines. "Whassa matta? Doing experimental meds?"
 
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Not the same thing, but related...is there any similar concern with having the blood bank check for antibodies when you donate blood? Just heard they will do that if you want them to. I thought I would the next time I donate, but will have to re-think that if there could be an issue.
 
denverpilot said:
I’m still stuck back at why anybody thinks involving oneself in any sort of “trial” would ever be considered “necessary” by any medical bureaucracy tasked with airman perfection.

Was there suddenly something that happened where someone thought OKC was going to magically like such a thing? Ever?

Any indication past or present of behavior that would indicate they would be pleased? LOL.

Do people just forget this stuff because there’s a virus running around, or what? Haha.

What’s Bruce’s advice? Never ask until the answer has to be yes?

It’s as silly as dialing up the IRS “just checking” on your brand new get rich quick without taxes scheme. “Guess what I did! You guys cool with that?” LOL.
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So that's kind of a false equivalency with the IRS. If you deliberately evade taxes, you know you are breaking the law, views on taxation notwithstanding. But it is also prudent if you are starting a business to meet with an accountant and go over the tax implications, and that is really the issue here. So let's frame this more as starting a side business where you already have an accountant.

You: are required to meet with an accountant every year to go over your taxes (like you're required to have an AME issue a medical). You are required to disclose income. But with your new business you have been increasing the equity of the business' brand, of which you are the sole owner. You wonder if you must report the change in value of the business as income. Now hopefully your accountant knows about that. But what if he doesn't?

Accountant: Says, well gee I'm really not sure. Let me check on that. *Checks on that* Comes back without anything concrete from his literature, maybe because he didn't pay a lot of attention in his tax accounting class. So he says "we really need to check with the IRS on this."

Which makes sense, because they are the source of the regulation. So either way, someone will be calling that office for clarification, because you may get off without a hitch with your get rich quick scheme, but if they find out you're screwed. So it's a better expected value to say "hey you know what I'm planning on raking in piles of cash and I wanna know what this'll do to my taxes.
 
LoLPilot said:
Why would I not?
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The answer to that question is in the OP.

"I just spoke to FAA Medical in OKC. Their exact words were if you or anyone do this your Medical will be revoked and it could be several years before you get it back if ever. Please let your friend see this warning."
Click to expand...

That's not in the regs. And if you hadn't asked, no one would have had the opportunity to say it to you. So now what?

I am familiar with the regs. I also know that omitting a relevant fact from a medical application is a criminal offense. I want to have all my t's crossed and i's dotted when I renew.
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Who said anything about omitting anything? And who said anything about renewal? That has nothing to do with revocation, which was the apparent subject of your post. If you receive medical treatment, you'll need to disclose it at your next medical. No question about that.

Here's the other thing. If they are taking this stance, they need to publish something that that effect. I haven't seen it, and apparently others can't find it either. I could see suspending a medical until testing is over, but this whole business of "indefinite suspension without guarantee of reinstatement" is either laziness or a power trip. If that's the case then letters need to go to AOPA, EAA, and Congressional representatives. Why would I not call the medical office? That's their job.
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They haven't taken an official position on this, but you're going to push them into one. What are the odds anyone will like the position that they take? Talk to your AME. Ask what he will do if you put "COVID vaccine" on your medxpress.
 
LoLPilot said:
So that's kind of a false equivalency with the IRS. If you deliberately evade taxes, you know you are breaking the law, views on taxation notwithstanding. But it is also prudent if you are starting a business to meet with an accountant and go over the tax implications, and that is really the issue here. So let's frame this more as starting a side business where you already have an accountant.
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Exact same with Aeromed. The rules are published. Very few read them. I’m sure this one is in there.

Even less “hire the accountant” as in hire a Doc as a consult prior to applying.

If people don’t pay attention to the rules, like you said, it’s not IRS’ fault. Same with Aeromed. The rules the Docs have to follow are right on the website.

If the flowchart ends in “do not issue, refer to OKC”, better pay attention to that chit.

Like my original response said : Unintended consequences of YOUR medical choices. Better read the rules.
 
Lindberg said:
The answer to that question is in the OP.



That's not in the regs. And if you hadn't asked, no one would have had the opportunity to say it to you. So now what?



Who said anything about omitting anything? And who said anything about renewal? That has nothing to do with revocation, which was the apparent subject of your post. If you receive medical treatment, you'll need to disclose it at your next medical. No question about that.

They haven't taken an official position on this, but you're going to push them into one. What are the odds anyone will like the position that they take? Talk to your AME. Ask what he will do if you put "COVID vaccine" on your medxpress.
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I'm interested in getting confirmation on a rumor that came through a friend who is involved in ALPA. And it sounds like they do have a stance on this, and the issue is sort of in a grey area. The FAA should put out some sort of guidance on this. Again - that is their job. That is one of the things that our taxes go towards, is them managing the regulations for the airman's medical certificates. YMMV, but I'd rather go into my renewal with a statement from the FAA that it was alright for me to have a medical after conclusion of a trial that I was involved in, rather than the AME asking me if I participated in one of the trials and then deciding that without guidance he'd rather not reissue. Again, if you disagree with me on this I really don't care, but (in the spirit of not cursing here) the FAA either needs to do their business or get off the pot on this, because my conversation with the FSDO rep (who although obviously ignorant on what the regs were was extremely polite and was trying to be helpful) indicated to me that there is some sort of internal conversation going on about this and that they DO care one way or another, but they haven't said anything.
 
LoLPilot said:
... The FAA should put out some sort of guidance on this. ....
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playing devil's advocate: perhaps the FAA thinks it already has put out information that would cover this. And if you think they need to be more specific, perhaps they think there would be the "danger" of setting a precedent of providing ever more specific information, leading to a mountain of guidance (which would be impractical to wade through).
 
LoLPilot said:
The FAA should put out some sort of guidance on this.
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They did. 14 CFR.

YMMV, but I'd rather go into my renewal with a statement from the FAA that it was alright for me to have a medical after conclusion of a trial that I was involved in . . . .
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There's ~100% chance they're not going to say that. And how could they? They don't know anything about this hypothetical trial or its effects. At best, you'll get a reference to the rules and the AME general guidance. At worst, they'll tell you is disqualifying.


the AME asking me if I participated in one of the trials and then deciding that without guidance he'd rather not reissue.
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So talk to your AME then. Or don't participate in any trials. The potential side effects of random drug trials are as likely (maybe more) to cost you your medical as the trial itself.
 
Has the FAA had an issue with past vaccine trials?
 
Darn!! This post is certainly timely. I was scheduled to participate in the COVID 19 phase 3 trial next week.


Sent from my iPad using Tapatalk
 
The podcast 21.five had an AME on as a guest and he explicitly said unapproved FDA and FAA vaccines would invalidate airmen medical certificates. I contacted my AME weeks ago for their opinion and they don’t have an answer.
Vince


Sent from my iPad using Tapatalk
 
By the way, the Astra Zeneca vaccine can stay in your system a LONG time. Might not be possible to determine when it's actually gone.
 
Vincent E. Smith III said:
The podcast 21.five had an AME on as a guest and he explicitly said unapproved FDA and FAA vaccines would invalidate airmen medical certificates. I contacted my AME weeks ago for their opinion and they don’t have an answer.
Vince


Sent from my iPad using Tapatalk
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Did he reference a regulation?
 
He doens't need one. It's the authority of the FAS under 67.401, promulgated to all the AMEs electronically.
 
What happens when the vaccine is given FDA EUA? Airmen participating in a trial have to wait until the end of the full two year trial to ASSURE no really bad effects while others have no need to wait? Those flying under Basic Med and in a trial are ok’d by their “Medical Professional” can continue to fly but if they have a Class 1, 2 or 3 are grounded? Who knows what convoluted thinking will ensue?

Cheers
 
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bbchien said:
He doens't need one. It's the authority of the FAS under 67.401, promulgated to all the AMEs electronically.
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Bruce, that’s great that they send it to AME’s, but why not send it to pilots as well.

I recently saw where Europe and other areas will be requiring a vaccine at some point. Well, some of us have to fly those planes there. ???
 
What about getting shot up with a vaccine approved under an EUA? FAA ok with EUAs?
 
Being that cargo pilots are a very important part of the vaccine distribution network, I can see the FAA approving a vaccine quickly so that they can be immunized.
 
As an ame, I have no guidance on the vaccine. We might see it after the formal FDA approval comes through, but I've never had anyone report childhood vaccines or boosters on their forms, nor have I seen guidance. It might be there. One thing I have noticed in the covid era is that they seem to be increasingly, um shall we say scrutinous of everything recently? At my day job, I am likely to be required to get the vaccine, which will then place me in a basic med situation, and as a front line physician, we are first in line. It will be interesting to see what happens in the next week or so.
 
greentips said:
As an ame, I have no guidance on the vaccine. We might see it after the formal FDA approval comes through, but I've never had anyone report childhood vaccines or boosters on their forms, nor have I seen guidance. It might be there. One thing I have noticed in the covid era is that they seem to be increasingly, um shall we say scrutinous of everything recently? At my day job, I am likely to be required to get the vaccine, which will then place me in a basic med situation, and as a front line physician, we are first in line. It will be interesting to see what happens in the next week or so.
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I'm in a similar situation. It's a staged distribution and they want me to sign up now. They won't require me to get vaccinated, and I must admit that I am leery for a variety of reasons including the FAA's position. There's a distinct lack of anything reassuring me that is vaccine is safe and effective. I have about a week to hear from the FAA and be make a decision on vaccine safety.
 
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