COVID-19 vaccines: medical concerns and recommendations

[45dotACP]

My 45 y/o son now has COVID after a J&J/Pfizer combo. He's doing fine and his wife is a Nurse Practitioner. Of course he's on blood thinners after blood clots post J&J but I have no idea how these sorts of medications might interact with COVID.

The first patient I saw die of COVID was a 55yo female who suffered a fatal pulmonary embolism.

COVID patients throw blood clots like crazy. We put our patients on preventative anticoagulation because of how frequently we see blood clots in COVID patients, so if nothing else, your son is probably safer for being on anticoagulation.

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[4RNR]

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Almost two years into the pandemic, it appears more people are going to be sick than ever. What that means for society is a big concern.

What concern? By in large people will get sick, stay home for a few days, get over it and move on. This (Omicron) isn't flying ebola aids they've been scaring everyone with for the past 2 years. As far as I'm aware the one death in Texas was a lie. Or rather a manipulation.

Almost everyone I know has long ago gotten over the sensationalism of this and moved on with their lives. Doing what they did prior to covid.

You know yourself better than anyone. If you need to take whatever precautions then take them and drive on!

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[Paul Blackburn]

Why is Dr. McCullough more compelling then other doctors that are talking about COVID?

Dr McCullough is the most published doctor in the world in his areas of expertise. He began treating his patients at the beginning of this debacle. Listen to any Dr McCullough podcast and they go over hi creds and experience.

[Nephrology]

Dr McCullough is the most published doctor in the world in his areas of expertise. He began treating his patients at the beginning of this debacle. Listen to any Dr McCullough podcast and they go over hi creds and experience.

Being highly published is a game of academic medicine. It reflects your ability to network socially more often than it reflects actual scientific acumen or productivity. I have my name on papers and abstracts that I have barely even read. Those are still "my publications." As a matter of fact, for my COVID review paper where I am list as second author, ostensibly to reflect my significant contributions to the manuscript, I wrote I think about 3 paragraphs.

Still let's accept for the moment that there is no reason that that he cannot walk and chew gum at the same time. Kary Mullis, nobel laureate who invented PCR, went to his grave convinced that HIV does not cause AIDS. This is on the same level as believing the earth is flat. Ironic given that he invented the technology used to confirm HIV infection. Furthermore, in a far less extreme example, the latitude granted by uncertainty is often used by physicians to "go with their gut" despite an uphill gradient of evidence.

What is hard for most people to understand about the academic medical world is that there are Pubmed-indexed, peer-reviewed articles spanning both the benchtop laboratory sciences to clinical research that can support literally any argument you could possibly make. Turmeric extract preventing molecular senescence? Here you go. Endogenous anti microbial peptides as precipitants of acute heart failure? Here's your huckleberry. Alcohol in moderation prevents cancer? Boom. Alcohol in moderation causes cancer? Right here.

What is difficult to appreciate is that this ceaseless back and forth of opinions that seem completely at odds with one another is par for the course in the biomedical research world. I also sympathize with the fact that it is hard to decide "which expert" to believe as you are not wrong to say that McCullough has a strong resumé. However, what separates the wheat from the chaff ends up being the global consensus. The global consensus is quite overwhelming regarding plaquenil and vaccination for COVID-19.

The mRNA COVID vaccines are among the most well studied medical interventions out there. The evidence is pretty overwhelming in their favor, both in terms of their safety profile and their efficacy. Are they bullet proof in the prevention of disease? Of course not. Is there an extremely un-subtle difference in the % of COVID ICU patients who are vaccinated and who are not? Absolutely.

Because of the highly politicized nature of COVID-19 there are strangely potent emotional investments by the public in treatment X or policy Y in the prevention of COVID-19. Because there is evidence to support nearly every possible position, people like McCullough will always have a way to justify their opinions. Without the ability to parse that info yourself and get the 5000 foot view, you're basically beholden to the media to make that choice for you. Frankly they will never have your best interest in mind. They want your clicks. As a result I am generally pretty disgusted by the coverage of COVID-19 by the vast majority of media outlets, left and right, as they are their alarmist or conspiratorial. Neither is to your benefit.

[Totem Polar]

That’s a very lucid post, @Nephrology.

[4RNR]

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The mRNA COVID vaccines are among the most well studied medical interventions out there. The evidence is pretty overwhelming in their favor, both in terms of their safety profile and their efficacy. Are they bullet proof in the prevention of disease? Of course not. Is there an extremely un-subtle difference in the % of COVID ICU patients who are vaccinated and who are not? Absolutely.
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Not trying to be an ass. If it's that well studied why did the CDC say the only way to know what will happen is to give the shots. This should be already known, no?

There is no one Aha moment. More like a lot of these little things that when add up don't amount to a lot of trust in this new vaccine or the push to get them

Also, any thoughts on the new concerns out of Israel?

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[Borderland]

Almost two years into the pandemic, it appears more people are going to be sick than ever. What that means for society is a big concern.

I'm not sure more people will be sick but I'm pretty sure more people will die. 10X more than a normal flu year according to Johns Hopkins. So in response to that the CDC wants people tested, vaccinated and quarantined. Doesn't seem unreasonable to me. If that has an undesirable affect on the economy, which it has and continues to have, I guess that's the price for 36% of the population not being vaccinated.

True, you may be unvaccinated, get Covid, and never be hospitalized. If that were true for everyone who had the virus there would be no cause for alarm. If the mortality rate for Covid were only 2X that of the flu maybe the CDC would back off but as long as 1/3rd of the population isn't vaccinated and the mortality rate stays high, I see some real damage coming to the economy from quarantine mandates. I suppose one could blame the CDC but I don't think that's the problem. It's people being hospitalized with Covid that's the problem.

[Nephrology]

Not trying to be an ass. If it's that well studied why did the CDC say the only way to know what will happen is to give the shots. This should be already known, no?

To my knowledge that is not something that they announced specifically. If you have a link to an official announcement along those lines that I would be curious. However, broadly speaking, this is true of all new drugs/treatments/etc etc.

The development of the vaccines proceeded along an accelerated version of the the standard clinical trials timeline in which 3 trials were conducted back to back - the first, a small study in healthy volunteers to demonstrate safety (phase I), then a 2nd that is larger to demonstrate preliminary evidence of success and confirm safety (phase II), and the final (phase III) to confirm efficacy and safety in a large population statistically powered for this goal.

What is true, however, is that the results of the phase 3 trials suggested the vaccines were far more effective than they ultimately proved to be. There are a few factors that likely contributed :

1. The early trials only included healthy 18-65 year olds and did not include immunocompromised patients. We know now fairly decisively that the immunocompromised do not respond as well to the vaccine the otherwise healthy. If they had included the immunocompromised in early studies they likely would have been shown to be less effective. The reason they did this is in part by including the immunocompromised it would introduce an additional variable in their test population which could have statistically diluted the effect of the vaccine. To compensate for this they would need to have enrolled more people which may have potentially delayed rollout of the vaccine. This is a relatively common practice (edit: really, entirely industry standard) in clinical trials (i.e. developing 'exclusion/inclusion criteria') to focus a question in a way that makes it statistically feasible to get an answer. The pros and cons of this are a nuanced discussion.

2. The early trials of the vaccines only measured effectiveness out to 4 months (120 days). We now know that the immunologic protection from these vaccines in the context of the current prevalence of disease (vaccine effectiveness directly depends on your odds of encountering the disease in the community among other things) wanes at approximately the 6 month mark in healthy people. So this would not have been detected by the initial trials that were the basis of its EUA.

3. By law, physicians cannot prescribe new drugs that have not been proven to be safe/effective. this is a catch-22, of course, because to demonstrate something is safe/effective it has to be used on people. Lab rats do not suffice. For this reason, every drug/device that is trialed in the FDA clinical trials process is evaluated only in a relatively small number of people (on the order of thousands) who sign waivers agreeing to participate in the trial before a given drug approved for use. In the case of the COVID mRNA vaccines, they enrolled 40,000 people between treatment/placebo groups. However, 40,000 is not the same thing as 280 million. There is always the possibility that, as we saw in the COVID vaccines, the results of a clinical trial will not mirror perfectly the rollout to a population much larger than the trial. For this reason open-label post-market studies are becoming increasingly common in order to detect exactly this discrepancy.

Again not familiar with the announcement you're referring to but the spirit of that message is not wrong, for the reasons listed above. The history of medicine is littered with things that we once thought worked that are now relegated to the trashbin of history (eg thalidomide, Xigris...). This does not reflect of a failure of the scientific process but rather a success - if a very messy one. If we did not constantly attempt to re-iterate, re-investigate, challenge dogmatic assumptions, we would be doing a grave disservice to our patients and to society at large.

Let me know I can clarify any of the above.

Also, any thoughts on the new concerns out of Israel?

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Which concerns are you referring to? Waning vaccine efficacy?

edit x2: A final important reason that early estimates of efficacy were more optimistic than they proved to be in practice was the pandemic evolved over time in ways the did not/could not have predicted (eg immune evasion by rapid evolution of multiple viral clades like delta and omicron). No crystal balls in the lab as it were.

[4RNR]

To my knowledge that is not something that they announced specifically. If you have a link to an official announcement along those lines that I would be curious. However, broadly speaking, this is true of all new drugs/treatments/etc etc.

The development of the vaccines proceeded along an accelerated version of the the standard clinical trials timeline in which 3 trials were conducted back to back - the first, a small study in healthy volunteers to demonstrate safety (phase I), then a 2nd that is larger to demonstrate preliminary evidence of success and confirm safety (phase II), and the final (phase III) to confirm efficacy and safety in a large population statistically powered for this goal.

What is true, however, is that the results of the phase 3 trials suggested the vaccines were far more effective than they ultimately proved to be. There are a few factors that likely contributed :

1. The early trials only included healthy 18-65 year olds and did not include immunocompromised patients. We know now fairly decisively that the immunocompromised do not respond as well to the vaccine the otherwise healthy. If they had included the immunocompromised in early studies they likely would have been shown to be less effective. The reason they did this is in part by including the immunocompromised it would introduce an additional variable in their test population which could have statistically diluted the effect of the vaccine. To compensate for this they would need to have enrolled more people which may have potentially delayed rollout of the vaccine. This is a relatively common practice in clinical trials (i.e. developing 'exclusion/inclusion criteria') to focus a question in a way that makes it statistically feasible to get an answer. The pros and cons of this are a nuanced discussion.

2. The early trials of the vaccines only measured effectiveness out to 4 months (120 days). We now know that the immunologic protection from these vaccines in the context of the current prevalence of disease (vaccine effectiveness directly depends on your odds of encountering the disease in the community among other things) wanes at approximately the 6 month mark in healthy people. So the initial 4 month assessment would not have been detected by the initial trials that were the basis of its EUA.

3. By law, physicians cannot prescribe new drugs that have not been proven to be safe/effective. this is a catch-22, of course, because to demonstrate something is safe/effective it has to be used on people. Lab rats do not suffice. For this reason, every drug/device that is trialed in the FDA clinical trials process is evaluated only in a relatively small number of people (on the order of thousands) who sign waivers agreeing to participate in the trial before a given drug approved for use. In the case of the COVID mRNA vaccines, they enrolled 40,000 people between treatment/placebo groups. However, 40,000 is not the same thing as 280 million. There is always the possibility that, as we saw in the COVID vaccines, the results of a clinical trial will not mirror perfectly the rollout to a population much larger than the trial. For this reason open-label post-market studies are becoming increasingly common in order to detect exactly this discrepancy.

Again not familiar with the announcement you're referring to but the spirit of that message is not wrong, for the reasons listed above. The history of medicine is littered with things that we once thought worked that are now relegated to the trashbin of history (eg thalidomide, Xigris...). This does not reflect of a failure of the scientific process but rather a success - if a very messy one. If we did not constantly attempt to re-iterate, re-investigate, challenge dogmatic assumptions, we would be doing a grave disservice to our patients and to society at large.

Let me know I can clarify any of the above.



Which concerns are you referring to? Waning vaccine efficacy?

It was a leaked video of discussing vaccines for kids. I'm paraphrasing but what was said was we don't know whats going to happen to kids and there's only one way to find out and that's to start vaccinating.

New observations out of Israel suggest that MAYBE the mRNA vaccines are destroying immune systems. Enough of a worry that the new round of boosters is only for those who really need it. Their CDC equivalent guy said they cannot stop even though there may be health issues down the road. They have to look into this and give vaccines at the same time.

Again, I'm paraphrasing

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[Kanye Wyoming]

The mRNA COVID vaccines are among the most well studied medical interventions out there. The evidence is pretty overwhelming in their favor, both in terms of their safety profile and their efficacy. Are they bullet proof in the prevention of disease? Of course not. Is there an extremely un-subtle difference in the % of COVID ICU patients who are vaccinated and who are not? Absolutely.

This. Unless/until this is shown not to be true, the rest is mental Toobination.