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Letter to FAA warns that federal law prohibits commercial pilots from flying after taking experimental shots
"[N]ot a single ‘vaccinated’ pilot who has been flying has received an FDA-approved [covid] vaccine and most certainly has not waited the required 12 months post-approval. Just how far has the aviation industry deviated from the law?" (www.theblaze.com) עוד...
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You are correct about the 48-hour guidance (so-called “regulation”). However, that is not the salient question raised in the Horowitz commentary (published by The Blaze) and, more importantly, in the referenced and linked Letter to the FAA & airline CEOs.
Last modified on Feb. 19, 2021, the current Guide For Aviation Medical Examiners (which interprets applicable Federal Aviation Regulation 14 CFR Part 61.53) directs that Do Not Issue shall apply to any medication approved by the FDA less than 12 months ago. Additionally, the AME Guide says, “The FAA generally requires at least one-year of post-marketing experience with a new drug before consideration for aeromedical certification purposes.”
In late 2020, the FAA issued several determinations that the covid vaxxes would be an exception to the established guidance regarding new drugs. The apparent justification for this generous allowance is that the covid situation is “special” and “unusual.”
Does the FAA (via the Regional Flight Surgeon's office, the Aerospace Medicine Certification Division, and/or the AME Guide) have the authority to issue the novel provision, and/or did it follow the proper processes/due diligence in doing so? Are all “vaccines/immunizations” an explicit exception to “any medications”? Arguably, the words “generally requires” may afford the FAA the wiggle room it needs. Of course, there are possible provisions/precedents of which I am unfamiliar that may lawfully apply to this circumstance.
Nonetheless, is the 48-hour wait period operationally-responsible and safe? Is aviator self-reporting sufficient? In detail and with documentation, the Letter asserts that it is neither. And the Letter offers recommendations (particularly medical diagnostics) to ensure safety amid countless knowns and unknowns.
Please see REFERENCES in my reply to self.
Last modified on Feb. 19, 2021, the current Guide For Aviation Medical Examiners (which interprets applicable Federal Aviation Regulation 14 CFR Part 61.53) directs that Do Not Issue shall apply to any medication approved by the FDA less than 12 months ago. Additionally, the AME Guide says, “The FAA generally requires at least one-year of post-marketing experience with a new drug before consideration for aeromedical certification purposes.”
In late 2020, the FAA issued several determinations that the covid vaxxes would be an exception to the established guidance regarding new drugs. The apparent justification for this generous allowance is that the covid situation is “special” and “unusual.”
Does the FAA (via the Regional Flight Surgeon's office, the Aerospace Medicine Certification Division, and/or the AME Guide) have the authority to issue the novel provision, and/or did it follow the proper processes/due diligence in doing so? Are all “vaccines/immunizations” an explicit exception to “any medications”? Arguably, the words “generally requires” may afford the FAA the wiggle room it needs. Of course, there are possible provisions/precedents of which I am unfamiliar that may lawfully apply to this circumstance.
Nonetheless, is the 48-hour wait period operationally-responsible and safe? Is aviator self-reporting sufficient? In detail and with documentation, the Letter asserts that it is neither. And the Letter offers recommendations (particularly medical diagnostics) to ensure safety amid countless knowns and unknowns.
Please see REFERENCES in my reply to self.
REFERENCES:
> https://www.faa.GOV/coronavirus/guidance_resources/vaccine_faq/
> https://www.ecfr.GOV/current/title-14/chapter-I/subchapter-D/part-61/subpart-A/section-61.53
> https://www.govinfo.GOV/app/details/CFR-2012-title14-vol2/CFR-2012-title14-vol2-part67/summary (14 CFR 67 - MEDICAL STANDARDS AND CERTIFICATION Document)
> https://www.faa.GOV/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/pharm/dni_dnf/
> https://www.faa.GOV/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/media/guide.pdf (Published Nov. 23, 2021; See Pg. 384 re vaccines)
> https://www.leftseat.COM/immunizations-faa-medical/
> https://roar-assets-auto.rbl.ms/documents/13286/letter%20to%20FAA.pdf (the “Letter”)
ADDITIONAL REFERENCES:
It would be nice if the FAA had a chart similar to this for post-covid-vax assessment/disposition:
> https://www.faa.GOV/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/media/COVID-19DispositionTable.pdf
Related:
> https://www.faa.GOV/other_visit/aviation_industry/designees_delegations/designee_types/ame/fasmb/media/2021_Volume%2056-3.pdf (See Pg. 10)
> https://www.faa.GOV/coronavirus/guidance_resources/vaccine_faq/
> https://www.ecfr.GOV/current/title-14/chapter-I/subchapter-D/part-61/subpart-A/section-61.53
> https://www.govinfo.GOV/app/details/CFR-2012-title14-vol2/CFR-2012-title14-vol2-part67/summary (14 CFR 67 - MEDICAL STANDARDS AND CERTIFICATION Document)
> https://www.faa.GOV/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/pharm/dni_dnf/
> https://www.faa.GOV/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/media/guide.pdf (Published Nov. 23, 2021; See Pg. 384 re vaccines)
> https://www.leftseat.COM/immunizations-faa-medical/
> https://roar-assets-auto.rbl.ms/documents/13286/letter%20to%20FAA.pdf (the “Letter”)
ADDITIONAL REFERENCES:
It would be nice if the FAA had a chart similar to this for post-covid-vax assessment/disposition:
> https://www.faa.GOV/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/media/COVID-19DispositionTable.pdf
Related:
> https://www.faa.GOV/other_visit/aviation_industry/designees_delegations/designee_types/ame/fasmb/media/2021_Volume%2056-3.pdf (See Pg. 10)
"none of the commercially available versions have even gotten full FDA approval (Comirnaty is not yet available)... A federal judge in Florida recently found the government’s argument that Pfizer is interchangeable with Comirnaty to be “unconvincing.”"
Liar, liar, pants on fire. Comirnaty is the brand name for the Pfizer vaccine. The court ruling in Florida wasn't about the vaccine, it was about the fact that the Pfizer vials don't yet say Comirnaty on the label.
Liar, liar, pants on fire. Comirnaty is the brand name for the Pfizer vaccine. The court ruling in Florida wasn't about the vaccine, it was about the fact that the Pfizer vials don't yet say Comirnaty on the label.
Per the CDC, on a page last updated Dec. 17, 2021:
“COMINARTY products are not orderable at this time. … Pfizer has provided the following statement regarding the COMINARTY branded NDCs and labels:
‘Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.
At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.’”
I repeat the words of the CDC itself: COMIRNATY PRODUCTS ARE NOT ORDERABLE AT THIS TIME.
ACRONYM NOTES: NDC = National Drug Code; BLA = Biologics License Application; AMA = American Medical Association; EUA = Emergency Use Authorization
SOURCE: https://www.cdc.GOV/vaccines/programs/iis/COVID-19-related-codes.html
Interestingly, IF a fully approved and licensed vax were available in the USA, then – by law* – any other covid vaxxes under Emergency Use Authorization would be prohibited from use. Presently, 3 different covid vaxxes are in use in the USA (with Moderna and J&J unequivocally under EUA, and Pfizer/BioNTech/Cormirnaty in dispute). According to the FDA itself:
“Under an EUA, FDA may allow the use of unapproved medical products … when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”
SEE: https://www.fda.GOV/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
* Not to imply any of our Govt agencies’ fidelity to the law, especially in the age of covid.
The primary significance of these matters-in-dispute is, to my mind, whether one can be “forced” to take an experimental (a/k/a EUA) drug/countermeasure. Plenty of existing law (including international treaty/code) says that one can NOT be forced, and that one is guaranteed INFORMED consent without subterfuge; but, in the craze of covid, regular order has been ignored, suspended, and steamrolled.
“COMINARTY products are not orderable at this time. … Pfizer has provided the following statement regarding the COMINARTY branded NDCs and labels:
‘Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.
At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.’”
I repeat the words of the CDC itself: COMIRNATY PRODUCTS ARE NOT ORDERABLE AT THIS TIME.
ACRONYM NOTES: NDC = National Drug Code; BLA = Biologics License Application; AMA = American Medical Association; EUA = Emergency Use Authorization
SOURCE: https://www.cdc.GOV/vaccines/programs/iis/COVID-19-related-codes.html
Interestingly, IF a fully approved and licensed vax were available in the USA, then – by law* – any other covid vaxxes under Emergency Use Authorization would be prohibited from use. Presently, 3 different covid vaxxes are in use in the USA (with Moderna and J&J unequivocally under EUA, and Pfizer/BioNTech/Cormirnaty in dispute). According to the FDA itself:
“Under an EUA, FDA may allow the use of unapproved medical products … when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”
SEE: https://www.fda.GOV/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
* Not to imply any of our Govt agencies’ fidelity to the law, especially in the age of covid.
The primary significance of these matters-in-dispute is, to my mind, whether one can be “forced” to take an experimental (a/k/a EUA) drug/countermeasure. Plenty of existing law (including international treaty/code) says that one can NOT be forced, and that one is guaranteed INFORMED consent without subterfuge; but, in the craze of covid, regular order has been ignored, suspended, and steamrolled.
Repeating the words of the CDC won't somehow make them incompatible with mine. The difference is the label, and implying otherwise is less than honest.
“No person who holds a medical certificate issued under part 67 of this chapter may act as pilot in command, or in any other capacity as a required pilot flight crewmember, while that person ... [is] receiving treatment for a medical condition that results in the person being unable to meet the requirements for the medical certificate necessary for the pilot operation.”
Since we're getting technical, are vaccines a treatment? What is the medical condition? I'll ignore the first of the two requirements that was conveniently omitted and replaced by [is] in the quote above.
"The primary significance of these matters-in-dispute is, to my mind, whether one can be “forced” to take an experimental (a/k/a EUA) drug/countermeasure"
Your premise requires a rather broad and flexible definition of the word forced, don't you think? Are UPS drivers forced to renew their drivers licenses, or are current drivers licenses a condition of employment for drivers at UPS? If you have to force the word force into the conversation, like with a crowbar, maybe it's not the right word.
"Plenty of existing law (including international treaty/code) says that one can NOT be forced, and that one is guaranteed INFORMED consent without subterfuge; but, in the craze of covid, regular order has been ignored, suspended, and steamrolled""
A public health emergency I believe is what they call it, and it addresses plenty of those laws. The craze, by the way, is a lot older than covid... the first was probably the flu but I would assume most current law is courtesy of the anthrax craze 20 years ago. Do you really think while hashing out the Bioshield Act and the multiple acts that followed since they just plum forgot about aviation? "oh, wait, did anyone check to see how this might effect the airline industry, you know, the industry that imploded recently?
In case you didn't notice (but not that you care), some of us find this whole FDA approval thing to be rather irritating since we all know government approval is not the barrier here. Insisting every pilot undergo tens of thousands worth of ct scans and mri's is not out of concern for the general public, it's simply a way to payback and sabotage. Oh, we'd be first in line if the jab had the food and drug administration's seal of approval! Yeah, right, more like we'd just find some other contradiction or inconsistency and apply the same cherry picking & context omitting methods to that instead. And so on and so forth forever.
“No person who holds a medical certificate issued under part 67 of this chapter may act as pilot in command, or in any other capacity as a required pilot flight crewmember, while that person ... [is] receiving treatment for a medical condition that results in the person being unable to meet the requirements for the medical certificate necessary for the pilot operation.”
Since we're getting technical, are vaccines a treatment? What is the medical condition? I'll ignore the first of the two requirements that was conveniently omitted and replaced by [is] in the quote above.
"The primary significance of these matters-in-dispute is, to my mind, whether one can be “forced” to take an experimental (a/k/a EUA) drug/countermeasure"
Your premise requires a rather broad and flexible definition of the word forced, don't you think? Are UPS drivers forced to renew their drivers licenses, or are current drivers licenses a condition of employment for drivers at UPS? If you have to force the word force into the conversation, like with a crowbar, maybe it's not the right word.
"Plenty of existing law (including international treaty/code) says that one can NOT be forced, and that one is guaranteed INFORMED consent without subterfuge; but, in the craze of covid, regular order has been ignored, suspended, and steamrolled""
A public health emergency I believe is what they call it, and it addresses plenty of those laws. The craze, by the way, is a lot older than covid... the first was probably the flu but I would assume most current law is courtesy of the anthrax craze 20 years ago. Do you really think while hashing out the Bioshield Act and the multiple acts that followed since they just plum forgot about aviation? "oh, wait, did anyone check to see how this might effect the airline industry, you know, the industry that imploded recently?
In case you didn't notice (but not that you care), some of us find this whole FDA approval thing to be rather irritating since we all know government approval is not the barrier here. Insisting every pilot undergo tens of thousands worth of ct scans and mri's is not out of concern for the general public, it's simply a way to payback and sabotage. Oh, we'd be first in line if the jab had the food and drug administration's seal of approval! Yeah, right, more like we'd just find some other contradiction or inconsistency and apply the same cherry picking & context omitting methods to that instead. And so on and so forth forever.
It doesn't seem worthwhile on net to continue to hash this out (you certainly have given me a lot I would have to take on), but I appreciate your reply (sorry for my delay). Though I try to be generally well informed, I did not know about the Bioshield Act, so thanks for that. I do not appreciate you impugning my motives and veracity -- I care very much about truth and good governance (both are endangered species, if not unicorns), and no agenda would ever make me intentionally misrepresent anything. I want a better world, including for tyrannized airline pilots.
You're right. I apologize. That last part was directed towards those responsible for the letter and whoever wrote the linked article (calling it an article is probably too generous).
Pay attention to the FAA: https://www.faa.gov/newsroom/novel-coronavirus-covid-19-update-0
A 48-hour “No Fly/No Safety-Related Duty” interval must be observed after each dose.