Vaccine clinical trial for BasicMed?

W

Wondering

Guest
Hi,

I know that participating in a clinical trial is medically disqualifying for those holding an FAA medical. How does this work for BasicMed? I don't see anything specific in the regulation. I am considering participating in a clinical trial for a covid19 vaccine. I currently hold a 3rd class medical, and I don't want to give up my ability to fly, but if I can participate in the trial and switch to BasicMed, I'd at least like to know if that's an option.

Thanks.
 
Why do you think prior participation in a clinical trial is disqualifying?
Probably because the drug is experimental, not even FDA approved, and with unknown side effects. From the AME Guide:
any airman who is undergoing continuous treatment with anticoagulants, antiviral agents, anxiolytics, barbiturates, chemotherapeutic agents, experimental hypoglycemic, investigational, mood-ameliorating, motion sickness, narcotic, sedating antihistaminic, sedative, steroid drugs, or tranquilizers must be deferred certification unless the treatment has previously been cleared by FAA medical authority. In such an instance, the applicant should provide the Examiner with a copy of any FAA correspondence that supports the clearance.​
 
Probably because the drug is experimental, not even FDA approved, and with unknown side effects. From the AME Guide:
any airman who is undergoing continuous treatment with anticoagulants, antiviral agents, anxiolytics, barbiturates, chemotherapeutic agents, experimental hypoglycemic, investigational, mood-ameliorating, motion sickness, narcotic, sedating antihistaminic, sedative, steroid drugs, or tranquilizers must be deferred certification unless the treatment has previously been cleared by FAA medical authority. In such an instance, the applicant should provide the Examiner with a copy of any FAA correspondence that supports the clearance.​
A vaccine shot isn't continuous treatment.
 
BasicMed is not a fourth class medical certificate...it is a collection of regulatory requirements necessary to bypass the requirement to hold a medical certificate. Provided you've been signed off by a state-licensed physician and don't have a condition identified in 68.9, whether or not you're medical qualified to fly comes down to 61.53(b)...do you have a medical condition that would prevent you from safely operating an aircraft? So unless the treatment causes side effects there is nothing that specifically grounds you. That said, wisdom and logic suggest that you ground yourself following an injection in anticipation of possible side effects.
 
Why do you think prior participation in a clinical trial is disqualifying?
I meant current participation. I anticipate that upon FDA approval the drug would get FAA approval as well, as with Pfizer and Moderna.

I think BasicMed might be a good option. I really want to contribute and I have very high confidence in this vaccine.
 
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