GO-NAD!

GO-NAD!

Audioholic Spartan
Unfortunately, even an impressive formal education is not a guarantee of a high level of capability in actual practice. Some physicians are antivaxers. I have worked with MSEEs who thought there were audible differences in high end audio cables. It happens.
Especially when you allow your political bias to colour your judgement. A couple of MD's in Canada have made themselves known for similar views, as well. They've been "councelled" by the CMA to get with the program as a result.
 
Swerd

Swerd

Audioholic Warlord
Unfortunately, even an impressive formal education is not a guarantee of a high level of capability in actual practice. Some physicians are antivaxers. I have worked with MSEEs who thought there were audible differences in high end audio cables. It happens.
Rand Paul is a lot worse than that.

Excerpted from Wikipedia:
Rand Paul went to good schools, undergrad at Baylor and an MD from Duke. Apparently, he was trained as an ophthalmologist and began practicing in 1993. In 1995 he was certified by the American Board of Ophthalmology (ABO), but the ABO required recertification every 10 years. In 1997, Paul created his own board, the National Board of Ophthalmology (NBO) so he could become self-certified! The NBO offered an alternative certification system, at a cost substantially lower than that of the ABO. Its certification exam was an open book take-home test that Paul helped write. He appointed his own family members to the board of directors and registered the Board to an incorrect address. The NBO was, itself, never accepted as an accrediting entity by organizations such as the American Board of Medical Specialties, and its certification was considered invalid by many hospitals and insurance companies. Paul let his own ABO certification lapse in 2005, which did not affect his practice in Kentucky, as the state does not require board certification. By Paul's estimate, about 50 or 60 doctors were certified by the NBO. The NBO was incorporated in 1999, but Paul allowed it to be dissolved in 2000 when he did not file the required paperwork with the Kentucky Secretary of State's office. He later recreated the board in 2005, but it was again dissolved in 2011. He entered politics in 2010.

Perhaps its good that he no longer practices medicine. Too bad there is no American Board of Politicians. But, I can only imagine just what a 'Board Certified Politician' might be good at.
 
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Mr._Clark

Audioholic Field Marshall
Perhaps its good that he no longer practices medicine.
I'm not sure that is correct. Wiki says "Paul let his own ABO certification lapse in 2005, which did not affect his practice in Kentucky; the state does not require board certification."

There were news reports that he volunteered at a hospital in Kentucky after recovering from COVID but it is not entirely clear exactly what he did while volunteering.

 
S

Speedskater

Audioholic Chief
My wife got her scheduled second jab 8AM Saturday morning at hospital. There were no lines, but many people in the 15 minute observation area. I found the same to be true last month, on a early weekday afternoon.
 
Swerd

Swerd

Audioholic Warlord
I'm not sure that is correct. Wiki says "Paul let his own ABO certification lapse in 2005, which did not affect his practice in Kentucky; the state does not require board certification."

There were news reports that he volunteered at a hospital in Kentucky after recovering from COVID but it is not entirely clear exactly what he did while volunteering.

When I said "Perhaps its good that he no longer practices medicine." I meant that he no longer regularly practices now that he's in the Senate.

If I ran that hospital where he recently volunteered, I wouldn't let an ophthalmologist (board certified or not) treat sick patients. He should know better. This is politics at its worst.

I honestly think he should have his medical license revoked because of his anti-vaxer advocacy.
 
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Mr._Clark

Audioholic Field Marshall
Here's another article discussing the effectiveness of one dose of the Pfizer and Moderna vaccines.

I realize there are arguments both ways, but I tend to agree with the author's statement "The scheduled second dose of these vaccines makes them even more effective, but at a time where vaccine supplies are limited, there’s a lot to be said about prioritizing the first dose for the most people."

At the risk of getting flack from both TLS Guy and Swerd, I still wonder if a hybrid approach (one jab for low risk people, two for high risk) might make sense. From what I have seen, it seems that the effectiveness (expressed as a percentage) is similar across a wide range of ages (I'm not sure this is factually correct). However, given that some people are at very high risk a second dose for these people might save more lives than using the dose as a first dose for a very low risk person. Just to illustrate, if a second jab increases the effectiveness (preventing death) from 85% to 95%, and if a high risk group has a 20% fatality rate, using 100 doses for a 2nd jab in this group would be expected to save 2 lives. Using the same 100 doses as a first jab in lower risk group having a 1% fatality rate would be expected to save 1 life. I realize it's not that simple because there are numerous other factors (e.g. which aproach is most effective with regards to slowing the spread). And of course I picked fairly extreme numbers just to show it might be possible.

>>>A recent study in Israel showed that a single dose of the Pfizer COVID-19 vaccine is highly effective, up to 85%. . . . Using the data from the published study of the Pfizer vaccine, Public Health England determined that vaccine efficacy was 89% for 15-21 days after dose 1 – and before dose 2 on day 21. The range was between 52% and 97%. For days 15-28, or up to the first week after the second dose, protection from the first dose was estimated at 91%. The range for this was between 74% and 97%. A second dose would not be expected to confer immunity within that time.<<<

 
Swerd

Swerd

Audioholic Warlord
My wife got her 2nd Pfizer vaccine dose yesterday morning. Since then, her shoulder is sore, more sore than after the 1st dose. However, she had no fever or other flu-like symptoms.

My 2nd dose comes in 2 weeks, the first Friday in April. Because I got the Moderna vaccine, I had to wait 4 weeks for dose 2. The Pfizer vaccine has a 3 week wait. I doubt if an extra week really matters, but at this point, I'll do whatever I have to get vaccinated.
 
M

Mr._Clark

Audioholic Field Marshall
My wife got her 2nd Pfizer vaccine dose yesterday morning. Since then, her shoulder is sore, more sore than after the 1st dose. However, she had no fever or other flu-like symptoms.

My 2nd dose comes in 2 weeks, the first Friday in April. Because I got the Moderna vaccine, I had to wait 4 weeks for dose 2. The Pfizer vaccine has a 3 week wait. I doubt if an extra week really matters, but at this point, I'll do whatever I have to get vaccinated.
Cool. Every jab is a victory of sorts!
 
Swerd

Swerd

Audioholic Warlord
At the risk of getting flack from both TLS Guy and Swerd, I still wonder if a hybrid approach (one jab for low risk people, two for high risk) might make sense.
I've wondered the same as you. But it would require a unified national definition of low risk and high risk. In essence, a national health program. Now, states and sometimes counties can define such things separately.

I've also wondered if better responses might be seen with two doses of different vaccines. Imagine using the AstraZeneca or Johnson & Johnson vaccine (both are adenovirus vector vaccines) first, followed one of the mRNA vaccines second. Or the other way around, mRNA vaccine first followed by a adenovirus vaccine second. Essentially, that's the approach the Russian Sputnik vaccine takes. It uses the same Spike protein sequence in two different adenovirus vectors (Ad26 and Ad5) for dose 1 and dose 2. It's more expensive and complex to make two different versions of the vaccine, but it minimizes the possibility of immunization against the adenovirs vector instead of the coronovirus Spike protein. Both AZ and J&J have learned how to delete portions of the adenovirus genome that both make them effective vaccine vectors while being less immunogenic.
From what I have seen, it seems that the effectiveness (expressed as a percentage) is similar across a wide range of ages (I'm not sure this is factually correct).
Remember that 'effectiveness expressed as a percentage', is not what clinical trials determine. Here, 'effectiveness' is defined as the number of immunized people who got Covid-19, divided by the number of immunized people on the clincal trial. Clinical trials predict the risk (also expressed as a percentage) of how many immunized people risk coming down with Covid-19. This risk prediction is based on statistics, like insurance companies estimate risks for their insurance policies. Technically, this risk prediction is called efficacy to distinguish it from the simpler percentage-based effectiveness.

If you look at the clinical trial data from one of those large trials, you'll see the difference. If I remember the Pfizer trial data correctly, among the roughly 15,000 people immunized with the vaccine, about 15 people came down with Covid-19. It's effectiveness on that trial = 100 – (15 ÷ 15,000 × 100) = ~99.9%. Yet the vaccine's efficacy was said to be 94%.

The clinical trial tested a very large number of people, some 15,000. But when you go from 15,000 to as much as possible among the entire world's population, it's a small number. There is still a large possibility of sampling error – that those 15,000 people on the trial don't reflect a true randomized sampling of the world's population. As a result, the statistical prediction of efficacy is a better way to express the risk potential instead of a simple arithmetic calculation of effectiveness.
 
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Swerd

Swerd

Audioholic Warlord
I realize there are arguments both ways, but I tend to agree with the author's statement "The scheduled second dose of these vaccines makes them even more effective, but at a time where vaccine supplies are limited, there’s a lot to be said about prioritizing the first dose for the most people."
There is another reason why this isn't (yet) done in the USA. It's a legal reason, not medical or scientific.

When approving the Pfizer, Moderna, and J&J vaccines for use, The FDA granted an Emergency Use Authorization (EUA). An EUA has less hoops to jump through than a full authorization. It's quicker, and the national health emergency certainly justified the EUA. However, the EUA is temporary, until enough long-term safety and efficacy data is collected. For vaccines, I don't know how long that must be, but it might be for another year or two. As a result, the FDA's EUA rules require giving the vaccines exactly as they were tested in the clinical trials. You can't skip a second dose unless the clinical trial never included one. Once enough long-term data is in, there will be some loosening of those rules.

I personally don't believe all those rules should apply so rigidly. However, I know the FDA well enough to be quite certain that it will not violate the very rules that it created. I also know those working in the FDA do take these regulations very seriously. As a front-line intensive care clinican, TLS Guy has a very different view. He takes the well-being of an individual patient very seriously, as opposed to the well-being of the entire public's health. From the FDA's point of view, that would be playing dangerously fast & loose with the public's trust. I can see both point's of view. But in the USA, the FDA's rulings have the power of federal law.
 
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Mr._Clark

Audioholic Field Marshall
There is another reason why this isn't (yet) done in the USA. It's a legal reason, not medical or scientific.

When approving the Pfizer, Moderna, and J&J vaccines for use, The FDA granted an Emergency Use Authorization (EUA). An EUA has less hoops to jump through than a full authorization. It's quicker, and the national health emergency certainly justified the EUA. However, the EUA is temporary, until enough long-term safety and efficacy data is collected. For vaccines, I don't know how long that must be, but it might be for another year or two. As a result, the FDA's EUA rules require giving the vaccines exactly as they were tested in the clinical trials. You can't skip a second dose unless the clinical trial never included one. Once enough long-term data is in, there will be some loosening of those rules.

I personally don't believe all those rules should apply so rigidly. However, I know the FDA well enough to be quite certain that it will not violate the very rules that it created. I also know those working in the FDA do take these regulations very seriously. As a front-line intensive care clinican, TLS Guy has a very different view. He takes the well-being of an individual patient very seriously, as opposed to the well-being of the entire public's health. From the FDA's point of view, that would be playing dangerously fast & loose with the public's trust. I can see both point's of view. But in the USA, the FDA's ruling have the power of federal law.
That makes sense. My self-imposed homework assignment is to figure out what the limits of federal law are in this situation.

The following Federal Register Notice seems to cover the basics. I'm curious what the significance of the "if available" modifier is. At first glance it seems to suggest that clinical trials are not absolutely required in every case (i.e. why is this modifier there if clinical trials are required in every case?).

I'm not sure to what extent existing CFR rules apply as well. Agencies are obviously limited in their ability to change the CFR.

>>>FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA [2] concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) The product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; (4) in the case of a determination described in section 564(b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and (5) that such other criteria as may be prescribed by regulation are satisfied.

No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.<<<(emphasis added)


 
Swerd

Swerd

Audioholic Warlord
That makes sense. My self-imposed homework assignment is to figure out what the limits of federal law are in this situation.

The following Federal Register Notice seems to cover the basics. I'm curious what the significance of the "if available" modifier is. At first glance it seems to suggest that clinical trials are not absolutely required in every case (i.e. why is this modifier there if clinical trials are required in every case?).
If I understand the legal language correctly, this same section of the federal code allows another exception to the standard rule requiring clinical trials, called "Expanded Access".
https://www.fda.gov/news-events/public-health-focus/expanded-access

Expanded Access (previously known as compassionate use) allows using an experimental (investigational) drug or medical device for patient treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

I used to see that occasionally with investigational anti-cancer drugs that were in early clinical trials in adults with various cancers. If a sick child needed such a drug, and the clinical trial excluded children, as they often do, Expanded Access could make it available.
 
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Swerd

Swerd

Audioholic Warlord
How about that! It apparently was the vaccine after all, but there is a targeted treatment.

Good! Now the various EU countries can go ahead with using the AZ vaccine. This was all about due diligence, and not politics.
 
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Irvrobinson

Irvrobinson

Audioholic Spartan
Good! Now the various EU countries can go ahead with using the AZ vaccine. This was all about due diligence, and not politics.
I understand due diligence, but let's think about that for a moment. So as I understand it, from AZ, the clot rate was less than the background rate expected in a population the size of the vaccine recipients. By pausing vaccinations, how many lives would be projected to be lost or require hospitalization? The EU has about 1/3 more people in it than the US, but almost twice the number of COVID-related deaths. The ICUs are filling up again. The EU has vaccinated a much lower percentage of its population the US, or the UK for that matter. If I lived in the EU and was offered the AZ vaccine, even with the uncertainty of the clotting risk, my choice would have unequivocally been to take the vaccine. Looking at the big picture, I suspect if they just asked for volunteers they would have had millions of offers. More than they could probably vaccinate. What's the moral difference between asking for volunteers in trials and asking for volunteers while the due diligence is happening?
 
M

Mr._Clark

Audioholic Field Marshall
How about that! It apparently was the vaccine after all, but there is a targeted treatment.

I hate to say it but this seems like a remarkably convenient result. The clots were caused by the vaccine (and they figured this out almost overnight) so the pause was justified (at least to some extent) but they figured out a treatment in a few days that supposedly works, so people don’t need to be afraid going forward. I realize one could argue that the pause was a mistake regardless, but if you’re in a situation where you’re forced to act according to rigid rules requiring a pause even if you believe it’s a mistake this seems like a way out.

It’s possible of course that my suspicions are incorrect. I don’t have any inside knowledge of what actually happened.
 
Irvrobinson

Irvrobinson

Audioholic Spartan
I hate to say it but this seems like a remarkably convenient result. The clots were caused by the vaccine (and they figured this out almost overnight) so the pause was justified (at least to some extent) but they figured out a treatment in a few days that supposedly works, so people don’t need to be afraid going forward. I realize one could argue that the pause was a mistake regardless, but if you’re in a situation where you’re forced to act according to rigid rules requiring a pause even if you believe it’s a mistake this seems like a way out.

It’s possible of course that my suspicions are incorrect. I don’t have any inside knowledge of what actually happened.
What you’re wondering about would be very risk-taking, career-wise, for the scientists involved. I wouldn’t do it. Would you?
 
M

Mr._Clark

Audioholic Field Marshall
What you’re wondering about would be very risk-taking, career-wise, for the scientists involved. I wouldn’t do it. Would you?
I don’t think the sequence of events supports my initial suspicion.

It appears to me that the Paul Ehrlic Institute initially recommended a pause but then said there was not enough evidence to show causation and said the benefits outweigh the risk.

The research hospital said they found the cause and a treatment, but this appears to be independent and after the fact (i.e. after PEI said to resume).
 
TLS Guy

TLS Guy

Seriously, I have no life.
I hate to say it but this seems like a remarkably convenient result. The clots were caused by the vaccine (and they figured this out almost overnight) so the pause was justified (at least to some extent) but they figured out a treatment in a few days that supposedly works, so people don’t need to be afraid going forward. I realize one could argue that the pause was a mistake regardless, but if you’re in a situation where you’re forced to act according to rigid rules requiring a pause even if you believe it’s a mistake this seems like a way out.

It’s possible of course that my suspicions are incorrect. I don’t have any inside knowledge of what actually happened.
Sir John Bell Regis professor of Medicine at Oxford University agrees with you. He has accused French President Macron of "Demand Management."

Since the clot cases were in younger individuals, Macron has taken it upon himself to stop vaccinating people 55 and under with the AstraZeneca vaccine. This whole episode in Europe was political and not a safety issue. I have to say, SWERD is just plain wrong about this. I understand that he is not well versed in EU thinking and Shenanigans, but I have watched them for years. I knew right away this was not a safety issue, but EU politics.
 
TLS Guy

TLS Guy

Seriously, I have no life.
Good! Now the various EU countries can go ahead with using the AZ vaccine. This was all about due diligence, and not politics.
I do not accept this as due diligence. See my note below where Sir John Bell has accused President Macron of demand management. I'm on Professor Bell's side on this one.
 

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