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  #11  
Old October 24th 20, 10:21 PM posted to rec.aviation.soaring
Papa3[_2_]
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Default An opportunity for people from our demographic to contribute

On Saturday, October 24, 2020 at 1:08:59 PM UTC-4, Gregg Ballou wrote:
On Saturday, October 24, 2020 at 12:44:02 PM UTC-4, wrote:
Gregg Ballou: FYI participants in covid vaccine trials are not eligible to hold a FAA medical.


There is no such FAA medical restriction for vaccine trial participants.. To purposely attempt to derail an effort to save lives is horrific, IMO.

Report participating in vaccine trials on a med application and you will be denied. The FAA is OK with approved vaccines, but not unproven medical trials for any reason.


This comes directly from the FAA "Guide for Aviation Medical Examiners":

Do Not Issue. AMEs should not issue airmen medical certificates to applicants who are using these classes of medications or medications[list abbreviated to include only the relevant passage]:

- FDA (Food and Drug Administration) approved less than 12 months ago. The FAA requires at least one-year of post-marketing experience with a new drug before considering if for aeromedical certification purposes. New antibiotics, lipid-lowering drugs, and antihypertensive medications may be considered earlier than one year. Please contact the RFS or AMCD for guidance on specific applicants.

So, at minimum it looks participation in a Clinical Trial would cause the application to be bumped up for further review.

P3
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  #12  
Old October 24th 20, 11:57 PM posted to rec.aviation.soaring
Ramy[_2_]
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Related question for RAS are clubs that require face diapers going to require a Covid vaccine when one is available? If not why not? And why not require flu shots for all
members now? Flu risk is on par with Covid risk and the soaring crowd has a lot of people in the high risk for the flu category.


I don’t know of any club requiring face diapers. But I know people who should wear face diapers for the purpose diapers are made for.

  #13  
Old October 25th 20, 12:23 AM posted to rec.aviation.soaring
Steve Bralla
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On Saturday, October 24, 2020 at 3:57:57 PM UTC-7, Ramy wrote:
Related question for RAS are clubs that require face diapers going to require a Covid vaccine when one is available? If not why not? And why not require flu shots for all
members now? Flu risk is on par with Covid risk and the soaring crowd has a lot of people in the high risk for the flu category.


I don’t know of any club requiring face diapers. But I know people who should wear face diapers for the purpose diapers are made for.


Just what I was thinking.
  #14  
Old October 25th 20, 04:06 PM posted to rec.aviation.soaring
danlj
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Default An opportunity for people from our demographic to contribute

On Friday, October 23, 2020 at 8:34:32 AM UTC-5, son_of_flubber wrote:
Here is a way to do something about the impact of Covid-19 on Soaring.

COVID-19 Prevention Network (CoVPN) Volunteer Screening Registry is the way to connect volunteers to practical studies related Covid-19.

For example, volunteers, especially older volunteers are sorely needed for Phase III studies of vaccines. Signing up for the registry just lets researchers know that you're open to being asked to participate in a study.

If you're just curious, check out this video narrated by Harrison Ford. https://www.youtube.com/watch?v=lfc2..._source=Eloqua

Or go directly to
https://coronaviruspreventionnetwork.org/ for the facts.

The bottleneck of recruiting participants is delaying the rollout of a vaccine, and you can do something about it.

This is DrDan Johnson, SoaringRx writer, retired general internist, and Sr. AME...
Think carefully about this before participating:
1: Both for and against participating in a vaccine *trial* is that the death risk and severe-illness risk from COVID-19 disease are very high for us elderly. In particular, no elderly person can safely participate in a vaccine trial that inoculates the recipient with the virus (I know of none in the US; have read about 1 in the UK) or that expects recipients to engage in high-risk activities (choirs, weddings, funerals, bars, cocktail parties, etc.; neglecting mask use indoors in public spaces).
(see, for examples, https://www.cdc.gov/coronavirus/2019...th-by-age.html or
https://www.theatlantic.com/health/a...mptoms/615382/ or
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397751/
2: The FAA has not issued regulatory guidance related to this vaccine or vaccine trials. It is not reasonable to interpret the FAA practice of not permitting pilot use of any newly approved medication for 1 year after marketing has begun, as applying to a vaccine: the FAA has not taken this stance with any prior vaccine (e.g., the influenza vaccine is changed nearly every year!), and the prohibition on new meds has been applied to regular use, not one-time administration; this is related chiefly to the possibility of adverse cognitive effects.
FAA guidance is at https://www.faa.gov/coronavirus/regulatory_updates/ and
https://www.faa.gov/licenses_certifi...certification/
3: AMEs are independent designees, and in my experience sometimes interpret FAA guidance and regulations in idiosyncratic ways rather than checking with a Regional Flight Surgeon before making a determination. In any case, AMEs *do not* DENY pilots, they DO NOT ISSUE -- the difference is very important, and non-issuance is much easier to appeal, with a letter arguing that non-issuance seems to have been inappropriate, and including supporting medical evidence to the Regional Flight Surgeon.
4: It is very important, and very useful for every one of us to continue to wear N-95 or 3-layer cloth masks whenever with other people who we don't know to be uninfected (basically, not sick with respiratory symptoms for 2 weeks and no contact with any such person or being unmasked in a crowded public space during that time).
Studies have shown a dramatic reduction in both the risk of getting infected, and the severity of illness if infected, in people who wash hands and wear masks -- about a 75-80% reduction of both infectivity and severity.
Studies have also shown that wearing any cloth in front of our nose and mouth reduce giving and getting the infection. From memory, a single layer of cotton (bandana, etc) reduces infection by 40-50%; a 3-layer cotton mask by about 90%, an N-95 mask by about 97%
succinct, jargon-filled medical article: https://www.acpjournals.org/doi/10..7326/M20-2567
verbose lay article: https://www.nature.com/articles/d41586-020-02801-8
5: Your decision to volunteer or participate should be based, not only on personal altruism or self-protection, but on a careful understanding of what the study vaccine is, exactly, and what are the known and potential risks of receiving it or the placebo.
6: Regardless, now is the time for all of us to get the annual influenza vaccine because getting both viruses together is ... um... unthinkable.
  #15  
Old October 25th 20, 05:02 PM posted to rec.aviation.soaring
Gregg Ballou[_2_]
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From ALPA http://www.alpa.org/news-and-events/...lu-vs-covid-19
'And since no trial COVID-19 vaccine has full FDA approval, the FAA considers participation in COVID-19 vaccine trials medically disqualifying for pilots for an indefinite period. ALPA representatives are working with the FAA to better define a policy as the science evolves. In Canada, the director of Civil Aviation Medicine stated that participation in medical trials isn’t considered compatible with aviation medical certification.'
  #16  
Old October 26th 20, 03:56 PM posted to rec.aviation.soaring
[email protected]
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Default An opportunity for people from our demographic to contribute

On Sunday, October 25, 2020 at 11:07:01 AM UTC-4, danlj wrote:
On Friday, October 23, 2020 at 8:34:32 AM UTC-5, son_of_flubber wrote:
Here is a way to do something about the impact of Covid-19 on Soaring.

COVID-19 Prevention Network (CoVPN) Volunteer Screening Registry is the way to connect volunteers to practical studies related Covid-19.

For example, volunteers, especially older volunteers are sorely needed for Phase III studies of vaccines. Signing up for the registry just lets researchers know that you're open to being asked to participate in a study.

If you're just curious, check out this video narrated by Harrison Ford. https://www.youtube.com/watch?v=lfc2..._source=Eloqua

Or go directly to
https://coronaviruspreventionnetwork.org/ for the facts.

The bottleneck of recruiting participants is delaying the rollout of a vaccine, and you can do something about it.

This is DrDan Johnson, SoaringRx writer, retired general internist, and Sr. AME...
Think carefully about this before participating:
1: Both for and against participating in a vaccine *trial* is that the death risk and severe-illness risk from COVID-19 disease are very high for us elderly. In particular, no elderly person can safely participate in a vaccine trial that inoculates the recipient with the virus (I know of none in the US; have read about 1 in the UK) or that expects recipients to engage in high-risk activities (choirs, weddings, funerals, bars, cocktail parties, etc.; neglecting mask use indoors in public spaces).
(see, for examples, https://www.cdc.gov/coronavirus/2019...th-by-age.html or
https://www.theatlantic.com/health/a...mptoms/615382/ or
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397751/
2: The FAA has not issued regulatory guidance related to this vaccine or vaccine trials. It is not reasonable to interpret the FAA practice of not permitting pilot use of any newly approved medication for 1 year after marketing has begun, as applying to a vaccine: the FAA has not taken this stance with any prior vaccine (e.g., the influenza vaccine is changed nearly every year!), and the prohibition on new meds has been applied to regular use, not one-time administration; this is related chiefly to the possibility of adverse cognitive effects.
FAA guidance is at https://www.faa.gov/coronavirus/regulatory_updates/ and
https://www.faa.gov/licenses_certifi...certification/
3: AMEs are independent designees, and in my experience sometimes interpret FAA guidance and regulations in idiosyncratic ways rather than checking with a Regional Flight Surgeon before making a determination. In any case, AMEs *do not* DENY pilots, they DO NOT ISSUE -- the difference is very important, and non-issuance is much easier to appeal, with a letter arguing that non-issuance seems to have been inappropriate, and including supporting medical evidence to the Regional Flight Surgeon.
4: It is very important, and very useful for every one of us to continue to wear N-95 or 3-layer cloth masks whenever with other people who we don't know to be uninfected (basically, not sick with respiratory symptoms for 2 weeks and no contact with any such person or being unmasked in a crowded public space during that time).
Studies have shown a dramatic reduction in both the risk of getting infected, and the severity of illness if infected, in people who wash hands and wear masks -- about a 75-80% reduction of both infectivity and severity.
Studies have also shown that wearing any cloth in front of our nose and mouth reduce giving and getting the infection. From memory, a single layer of cotton (bandana, etc) reduces infection by 40-50%; a 3-layer cotton mask by about 90%, an N-95 mask by about 97%
succinct, jargon-filled medical article: https://www.acpjournals.org/doi/10.7326/M20-2567
verbose lay article: https://www.nature.com/articles/d41586-020-02801-8
5: Your decision to volunteer or participate should be based, not only on personal altruism or self-protection, but on a careful understanding of what the study vaccine is, exactly, and what are the known and potential risks of receiving it or the placebo.
6: Regardless, now is the time for all of us to get the annual influenza vaccine because getting both viruses together is ... um... unthinkable.


Nice to see someone with some credentials weighing in. As a former medical lab technologist, (CMNT - RT(N) with substantial general and RIA lab experience) I have been in some interesting conversations with Pathologists and Pulmonologists with whom I have worked in the past. Lots of disagreement on their parts. The CDC says A positive test result shows you may have antibodies from an infection with the virus that causes COVID-19. However, there is a chance that a positive result means you have antibodies from an infection with a different virus from the same family of viruses (called coronaviruses). The Coronavirus has been around for quite some time and I wonder how many of the positive cases are really positive for previous Coronavirus infections? Are the numbers skewed?

I am all for wearing a mask and following appropriate procedures for avoiding transmission of the virus to others. I am 70 and don't remember the last time I was sick with any kind of fever, cough or other virus type malady but the last flu shot I took was for Swine Flu and I did not respond well to that.

Walt Connelly CNMT, RT(N) retired
Former Tow Pilot now Happy Helicopter Pilot
  #17  
Old October 27th 20, 04:19 AM posted to rec.aviation.soaring
danlj
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Default An opportunity for people from our demographic to contribute

On Sunday, October 25, 2020 at 11:02:29 AM UTC-5, Gregg Ballou wrote:
From ALPA http://www.alpa.org/news-and-events/...lu-vs-covid-19
'And since no trial COVID-19 vaccine has full FDA approval, the FAA considers participation in COVID-19 vaccine trials medically disqualifying for pilots for an indefinite period. ALPA representatives are working with the FAA to better define a policy as the science evolves. In Canada, the director of Civil Aviation Medicine stated that participation in medical trials isn’t considered compatible with aviation medical certification.'

Thanks, Greg; this is useful.
Dan
 




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