COVID-19 Vaccine Clinical Trials
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Would participation in a COVID-19 vaccine clinical trial be reportable to your AME or the FAA and if so would it cause you to lose your FAA medical?
9 Replies
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Many thanks for the answers and the specific references, Ron, I do appreciate it. I think this is useful information for a lot of people.
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1154 Posts
Michael Ryan:
Hi Ron,

Thanks for your reply. I should have been more clear - I wasn't suggesting not reporting the visit on a pilot's next medical, but rather would it be immediately reportable, a la a DUI or something similar. Or just at your next medical.
The only thing immediately reportable is a motor vehicle action as defined in 61.15. But as I read the FAA's guidance, once you enter a clinical trial for an unapproved medication, you'd have to ground yourself IAW 61.53.
Michael Ryan:
And does anyone know how it would work with BasicMed? Could you self-ground, or is it the same, where it's just a no-no?
As I read the FAA's guidance, 61.53(b) would apply to those on Basic Med, and you'd have to self-ground while taking an unapproved medication.

For the fastest official answers to these questions, I suggest contacting your local Regional Flight Surgeon.
Regional Flight Surgeon Contact Information (faa.gov)

Note that the FAA has approved both the Pfizer and Moderna vaccines, although my natural caution suggests self-grounding for 48 hours after the injection.  Supporting that caution is the experience of some folks I know who said their arm felt like it had been hit by a sledge hammer for a day or two after, and I can't imagine flying like that.
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Hi Ron,

Thanks for your reply. I should have been more clear - I wasn't suggesting not reporting the visit on a pilot's next medical, but rather would it be immediately reportable, a la a DUI or something similar. Or just at your next medical.

And does anyone know how it would work with BasicMed? Could you self-ground, or is it the same, where it's just a no-no?

Just curious about these issues.

Many thanks again!
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1154 Posts
Michael Ryan:
Does anyone know the answer to the original question: is participating in a clinical trial reportable to either the FAA or a respective pilot's AME?

All visits to a health professional are reportable on your FAA medical application for the next three years. I don't imagine that you can participate in a clinical trial without visiting a health professional.
Michael Ryan:
Is it immediately grounding?
If the clinical trial involves taking a medication which is not FDA-approved, I believe it would be banned for flight under the provisions of 61.53(a)(2), since the side effects are unknown until the clinical trial is completed and the medication is approved by the FDC. Only when the side effects are known can a determination be made that the medication is safe to have in your system while flying. Beyond that, you'd have to ask FAA Medical or the Chief Counsel.
 
Michael Ryan:
The other question which I'm guessing is very difficult to answer, if you were to participate in a trial and a month later the vaccine candidate gets FDA (and presumably shortly thereafter FAA) approval, are you good if you participated in the trial, or only good to get the vaccine after it was approved?


I would assume that if the medication you received in the clinical trial was then FDA-approved, and the FAA accepted it, you'd be good to go, but you'd have to confirm that with FAA Medical/Legal.
Michael Ryan:
I'm sure a lot of pilots would like to do their small bit for humanity, but without these answers it's prohibitive. 

 

I do understand your feelings, but sometimes what you do isn't compatible with participation in medical research. When I was flying in the military, there were many things I might like to have done but were explicitly prohibited by the service. Life is full of choices -- choose wisely.
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Does anyone know the answer to the original question: is participating in a clinical trial reportable to either the FAA or a respective pilot's AME? Is it immediately grounding? The other question which I'm guessing is very difficult to answer, if you were to participate in a trial and a month later the vaccine candidate gets FDA (and presumably shortly thereafter FAA) approval, are you good if you participated in the trial, or only good to get the vaccine after it was approved?

I'm sure a lot of pilots would like to do their small bit for humanity, but without these answers it's prohibitive. 
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1154 Posts
Daddis At AOPA:

It is now OFFICIAL - only a 48-hour wait period after each dose is received. See the December 12th AOPA article for more details - https://www.aopa.org/news-and-media/all-news/2020/december/12/faa-permits-pfizer-biontech-covid-19-vaccine-requires-48-hour-no-fly-period

That's true for the FDA-approved vaccines (Pfizer last week, and Moderna just today), but not for participation in a clinical trial for a still-experimental, not-yet-approved vaccine.  The FAA is deeply suspicious of any "experimental" medications or procedures, mainly for lack of information on potential side effects or unexpected ill effects.  Participation in a clinical trial (as opposed to receiving an approved vaccine) could compromise your medical certification status.  Strongly suggest avoiding clinical trials of anything lest you risk your medical certification.