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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Bump!

Also, once FDA approved vaccines are available, will the FAA need to approve for pilot use?

Thank you.

John
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Regarding vaccine clinical trials, I would recommend discussing that with one of AOPA's medical advisors. The devil is usually in the details, but may not be there at all. Call 800-872-2672, option 3.

Regarding approval for pilot use, the details are unknown at this point in time. AOPA has been in touch with the FAA but we were told only that they are closely monitoring the FDA and will not announce anything until FDA acts on the EUA (emergency use authorization). Any rumors about what the FAA may or may not do is VERY speculative at this point, so until the FAA publishes an announcement after the FDA acts, any information coming from anywhere cannot be considered accurate.

The FAA never gets ahead of an FDA decision for new medications, treatments, or medical devices. In fact, in most cases, a new drug that has been FDA-approved must be on the market for at least one year before the FAA will consider the drug’s acceptability for aviation activities. A vaccine, however, is not truly a drug. In this case, an exception is possible, but, again, until the FDA acts, the FAA is keeping appropriately quiet on the discussion.

The FDA could approve the Pfizer vaccine EUA as early as this week, after the FDA advisory panel meets on Thursday. That, too, is speculative so, the operative word right now is patience.
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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

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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.

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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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1407 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.