You are making dangerous and inaccurate claims for someone who is still in training. I hope the magnitude of your responsibility humbles you once you are actually responsible for patient care. It’s easy to throw stones when others (your attendings) have to sign off on your plans.
“Effectiveness at preventing PCC (post Covid condition) of at least one dose of vaccine was 58% and rose with the number of doses:
21% [1 dose],
59% [2 doses],
73% [≥3 doses].”
And we should stop with the false equivalencies that run like this:
Report (admittedly incremental) benefits of additional shots only in terms of hospitalization and death, ignoring that even a 3-4 month 30-50% reduction in Covid infections during peak holiday transmission times would result in millions of cases prevented, and that each case is a roll of the dice in terms of long covid conditions, potential cumulative damage to the immune system that we are just learning about ( https://libguides.mskcc.org/CovidImpacts/Immune via Memorial Sloan Kettering) , or that spread of Covid is a long, punishing chain of transmission that goes well beyond the individual, and often hurts the most vulnerable in our society like older people who rarely enter the group dialogue as factors to consider.
Report ALL adverse effects of vaccines/boosts, which are real and significant but rare, yet ONLY compare them to deaths and hospitalizations from Covid. Like it's a dichotomous choice between preventing hospitalization/death or being unlucky enough to get an adverse reaction.
Why not report deaths/hospitalizations definitively attributed to vaccines, instead of this inequivalent umbrella: "Serious adverse reactions are defined as 'death; life-threatening at the time of the event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgment.”
"Medically important event based on medical judgement" under the same umbrella as death?? That's not a fair comparison.
The myocarditis signal with Covid vaccines falls off with subsequent boosts. Young males receiving their first doses of mRNA were at highest risk, but still better than with Covid illness myocarditis:
And finally sowing fear about the unknown long term effects of vaccination/boosts only, while never mentioning the growing body of evidence that repeat Covid infections take a cumulative toll on every organ system in the body - gut, cardiac, neurologic, pulmonary, psychiatric, endothelial, etc. In kids, too.
Calling for absolutely settled science on Covid boosters while tolerating unsettled science on not getting boosters and instead dealing with variant infections unprimed, repeatedly, is another false equivalance.
The thesis here may please a certain audience, but a much more nuanced and balanced approach would be truly helpful, if not "liked" by as many with preformed conclusions. CDC, ACIP, FDA are not perfect, but in the end their conclusions are the result of some heavy intellectual lifting and analysis, the kind most of us are not equipped to do. I am not a biostatistician, and I would never presume that I've figured it all out in contrast to a team of experts and leaders in their fields.
And so I would urge you to stay humble and fair about what we know and don't know. I would avoid casting the experts in with the Pharma companies and thereby fueling distrust of the institution of medicine. Direct to consumer ads are bad enough! And if you don't want to get another boost/Covid vaccine, OK. But bring the fair comparisons, keep the standards undoubled, and leave the political rabble rousing quotes out of a piece in which you then go on to impugn the rabble rousing and hyper-partisanship around this.
And P.S. - By calling this site "sensible medicine," are the authors laying claim to a being the only grown ups among the thousands of researchers, clinicians, and experts out there sifting through data, clinical trials, and tough questions, aiming to balance risk/reward/harm/benefit?
Lost my previously healthy 60yo uncle to his Pf booster in Aug 2022, the likely connection acknowledged by his doc and the family. Trust in mainstream medicine and all the agencies irreparably broken for me. I see a health freedom ND now and will only go to a hospital in case of a car or similar accident.
didnt more patients die in pfizer's dose group in its ph3 trial than the placebo arm?
if you account for the elimination of the control group, didnt more patients die from the eliminated & dosed placebo group following vaccination?
given those facts - forgive the lack of citation here, but the non statistically significant increase in deaths in the dose vs placebo group of the ph3 trials has been reported widely...
how can you make this statement: "We know with a high degree of certainty that the first few vaccines saved lives among vulnerable populations."
notably in the face of high rates of excess mortality that are still being see in countries which heavily used mrna products from pfizer & moderna?
mRNA vaccines have demonstrated ZERO efficacy at saving lives OVERALL in the gold-standard randomized clinical trials, even at the height of the pandemic in Winter 2020-2021. The mortality results in the Pfizer and Moderna clinical trials (the ONLY truly unbiased mortality data) were:
COVID deaths: 2 vaccine vs. 5 placebo
non-COVID deaths: 29 vaccine vs. 25 placebo
Overall: 4 excess non-COVID deaths for every 3 less COVID deaths (i.e. 4 KILLED FOR EVERY 3 SAVED)
The study you cite was not designed to detect mortality. The number of events was too low to make any firm conclusions about mortality. The studies of different vaccines were in very different settings with very different risks. The authors are known Covid deniers, and have worked with the dangerous Florida governor. That study has never been published in peer review, and for good reasons. It's a poorly done study that shows nothing.
The mortality results in the clinical trials totaling >70,000 adults are what they are, and these unfavorable results cannot be circumvented by claiming the trials were "not designed to detect mortality". The "Covid denier" authors you speak of cannot change the mortality results in the clinical trials (and neither can any of us), and actually, their study/analysis was published in a peer-reviewed journal. Regardless, nobody can claim their numbers are incorrect, as the numbers match those in the NEJM publications.
The numbers are correct. Your interpretation of their significance is not. If you don't understand statistical power, and the chance of a Type I and II errors, that might explain why you don't understand why your interpretation is incorrect. The mortality results are not clinically important based on this study, and sorry, that's the way it is. And that's likely why it's never been published.
In this context, obsessing over traditional "statistical significance" is just a cop-out to dismiss the obviously unfavorable mortality results. People in their right mind will not take a vaccine for which the net mortality impact in the clinical trials was "4 killed for every 3 saved" even at the height of the pandemic and at peak effectiveness (these are the exact same trials that showed >90% effectiveness against infection). People in their right mind will not give their INFORMED consent to take such a vaccine. A 16% increase in non-COVID mortality and a 45% increase in cardiovascular-related mortality absolutely do have PRACTICAL significance in this particular context; hiding behind "statistical significance" is not going to erase these terrible results. And finally, it IS published despite your claiming that it's not: https://www.cell.com/iscience/fulltext/S2589-0042(23)00810-6?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS2589004223008106%3Fshowall%3Dtrue
Yes, after major alterations. You will note that the conclusions have absolutely no mention of deaths due to vaccines, so the "obvious mortality results" is laughable. If it was "obvious", don't you think the authors would have mentioned it? The article does, however, include the following statement: "In a real-life situation in which the COVID-19 vaccines are administered to highly vulnerable populations with high COVID-19-related mortality, significant reductions in overall mortality are expected, also for mRNA vaccines." Their data show a decrease in Covid mortality with mRNA vaccines, and the difference in overall mortality is due to some theoretical protection against cardiovascular disease in adenovirus vaccines...which is fine. You want to prevent cardiovascular disease, then suggest all patients get adenovirus vaccines. And finally, as I already said: "The number of deaths in these RCTs was limited, and chance could therefore have played a role in these findings." I find it interesting that you are making claims that the authors didn't make, couldn't make on the basis of their own analysis, and therefore why do you think your "analysis" is of value?
I got Novavax instead of an mRNA booster this fall. NO side effects. I hope to never get another mRNA vaccine. And Novavax might be more durable in protection.
“At the beginning of the pandemic, randomized data showed that two vaccines in short succession reduced the incidence of COVID infection (Pfizer, Moderna).”
How did you overcome the statistical challenge of Pfizer only characterizing as “vaccinated” those who survived 14 days post second jab in their trials?
Have you done so little work reviewing the RCT data that you aren’t even aware of these anomalies? If so, it reveals a real deficiency in your curiosity/skepticism/understanding of the corrupt nature of Big Pharma.
That means that all adverse events of any kind (and there will be many with 10s of thousands of trials participants) were attributed to the placebo/unvaxxed group for the period from first jab to 14 days post second jab, inclusive. This statistical “trick” was also used for many of the studies I reviewed which suggested MRNA protection from disease, hospitalization, and death. Unfortunately, until you address this statistical sleight of hand it is hard to take your views as credible.
And we have not even addressed the outright exclusion (fraud) which occurred with trials participants who suffered serious adverse events, like Maddie de Garay.
I don't understand the repeated "healthy vaccine effect" argument. The unvaccinated people I know are the healthiest. Ideal weight, eat healthy food, little to no regular medications etc. I am not sure this repeated assumption holds.
Folks who volunteer to be vaccinated tend to be worried well. Those with chronic underlying conditions tend to not volunteer for medical intervention, except via the ER in acute exacerbations of their conditions.
Manufatured Consent is not something new. Noam Chomsky even wrote a book warning of this. Follow themoeny is not limited to working only in the criminal world.
Why would anyone in their right mind trust companies that are basically criminal enterprises with more criminal fines than any business sector in history.
You are making dangerous and inaccurate claims for someone who is still in training. I hope the magnitude of your responsibility humbles you once you are actually responsible for patient care. It’s easy to throw stones when others (your attendings) have to sign off on your plans.
Hi Wil. I have some bones to pick. The hyper-cynical and misapplied quote that starts this piece is a red flag of the thesis to come.
Extrapolate the benefits of boosters from here:
https://www.jwatch.org/na56865/2023/12/15/how-well-do-covid-19-vaccines-work-prevent-post-covid-19
“Effectiveness at preventing PCC (post Covid condition) of at least one dose of vaccine was 58% and rose with the number of doses:
21% [1 dose],
59% [2 doses],
73% [≥3 doses].”
And we should stop with the false equivalencies that run like this:
Report (admittedly incremental) benefits of additional shots only in terms of hospitalization and death, ignoring that even a 3-4 month 30-50% reduction in Covid infections during peak holiday transmission times would result in millions of cases prevented, and that each case is a roll of the dice in terms of long covid conditions, potential cumulative damage to the immune system that we are just learning about ( https://libguides.mskcc.org/CovidImpacts/Immune via Memorial Sloan Kettering) , or that spread of Covid is a long, punishing chain of transmission that goes well beyond the individual, and often hurts the most vulnerable in our society like older people who rarely enter the group dialogue as factors to consider.
Report ALL adverse effects of vaccines/boosts, which are real and significant but rare, yet ONLY compare them to deaths and hospitalizations from Covid. Like it's a dichotomous choice between preventing hospitalization/death or being unlucky enough to get an adverse reaction.
Why not report deaths/hospitalizations definitively attributed to vaccines, instead of this inequivalent umbrella: "Serious adverse reactions are defined as 'death; life-threatening at the time of the event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgment.”
"Medically important event based on medical judgement" under the same umbrella as death?? That's not a fair comparison.
The myocarditis signal with Covid vaccines falls off with subsequent boosts. Young males receiving their first doses of mRNA were at highest risk, but still better than with Covid illness myocarditis:
https://yourlocalepidemiologist.substack.com/p/fall-boosters-myocarditis-and-benefitsrisks
And finally sowing fear about the unknown long term effects of vaccination/boosts only, while never mentioning the growing body of evidence that repeat Covid infections take a cumulative toll on every organ system in the body - gut, cardiac, neurologic, pulmonary, psychiatric, endothelial, etc. In kids, too.
Calling for absolutely settled science on Covid boosters while tolerating unsettled science on not getting boosters and instead dealing with variant infections unprimed, repeatedly, is another false equivalance.
The thesis here may please a certain audience, but a much more nuanced and balanced approach would be truly helpful, if not "liked" by as many with preformed conclusions. CDC, ACIP, FDA are not perfect, but in the end their conclusions are the result of some heavy intellectual lifting and analysis, the kind most of us are not equipped to do. I am not a biostatistician, and I would never presume that I've figured it all out in contrast to a team of experts and leaders in their fields.
And so I would urge you to stay humble and fair about what we know and don't know. I would avoid casting the experts in with the Pharma companies and thereby fueling distrust of the institution of medicine. Direct to consumer ads are bad enough! And if you don't want to get another boost/Covid vaccine, OK. But bring the fair comparisons, keep the standards undoubled, and leave the political rabble rousing quotes out of a piece in which you then go on to impugn the rabble rousing and hyper-partisanship around this.
And P.S. - By calling this site "sensible medicine," are the authors laying claim to a being the only grown ups among the thousands of researchers, clinicians, and experts out there sifting through data, clinical trials, and tough questions, aiming to balance risk/reward/harm/benefit?
Lost my previously healthy 60yo uncle to his Pf booster in Aug 2022, the likely connection acknowledged by his doc and the family. Trust in mainstream medicine and all the agencies irreparably broken for me. I see a health freedom ND now and will only go to a hospital in case of a car or similar accident.
didnt more patients die in pfizer's dose group in its ph3 trial than the placebo arm?
if you account for the elimination of the control group, didnt more patients die from the eliminated & dosed placebo group following vaccination?
given those facts - forgive the lack of citation here, but the non statistically significant increase in deaths in the dose vs placebo group of the ph3 trials has been reported widely...
how can you make this statement: "We know with a high degree of certainty that the first few vaccines saved lives among vulnerable populations."
notably in the face of high rates of excess mortality that are still being see in countries which heavily used mrna products from pfizer & moderna?
Fact and citation free
Let's be honest, no fact will change your mind from your dogmatic belief.
https://alexberenson.substack.com/p/more-people-died-in-the-key-clinical
mRNA vaccines have demonstrated ZERO efficacy at saving lives OVERALL in the gold-standard randomized clinical trials, even at the height of the pandemic in Winter 2020-2021. The mortality results in the Pfizer and Moderna clinical trials (the ONLY truly unbiased mortality data) were:
COVID deaths: 2 vaccine vs. 5 placebo
non-COVID deaths: 29 vaccine vs. 25 placebo
Overall: 4 excess non-COVID deaths for every 3 less COVID deaths (i.e. 4 KILLED FOR EVERY 3 SAVED)
Pfizer: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf – Table S4
Moderna: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113017/suppl_file/nejmoa2113017_appendix.pdf – Table S26
Layman's summary here: https://dailysceptic.org/2022/04/09/covid-vaccines-increase-risk-of-heart-related-deaths-by-up-to-50-lancet-analysis-of-trial-data-finds/ (their facts are correct, though some may not care for their slightly sensationalist writing style)
The study you cite was not designed to detect mortality. The number of events was too low to make any firm conclusions about mortality. The studies of different vaccines were in very different settings with very different risks. The authors are known Covid deniers, and have worked with the dangerous Florida governor. That study has never been published in peer review, and for good reasons. It's a poorly done study that shows nothing.
The mortality results in the clinical trials totaling >70,000 adults are what they are, and these unfavorable results cannot be circumvented by claiming the trials were "not designed to detect mortality". The "Covid denier" authors you speak of cannot change the mortality results in the clinical trials (and neither can any of us), and actually, their study/analysis was published in a peer-reviewed journal. Regardless, nobody can claim their numbers are incorrect, as the numbers match those in the NEJM publications.
The numbers are correct. Your interpretation of their significance is not. If you don't understand statistical power, and the chance of a Type I and II errors, that might explain why you don't understand why your interpretation is incorrect. The mortality results are not clinically important based on this study, and sorry, that's the way it is. And that's likely why it's never been published.
In this context, obsessing over traditional "statistical significance" is just a cop-out to dismiss the obviously unfavorable mortality results. People in their right mind will not take a vaccine for which the net mortality impact in the clinical trials was "4 killed for every 3 saved" even at the height of the pandemic and at peak effectiveness (these are the exact same trials that showed >90% effectiveness against infection). People in their right mind will not give their INFORMED consent to take such a vaccine. A 16% increase in non-COVID mortality and a 45% increase in cardiovascular-related mortality absolutely do have PRACTICAL significance in this particular context; hiding behind "statistical significance" is not going to erase these terrible results. And finally, it IS published despite your claiming that it's not: https://www.cell.com/iscience/fulltext/S2589-0042(23)00810-6?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS2589004223008106%3Fshowall%3Dtrue
Yes, after major alterations. You will note that the conclusions have absolutely no mention of deaths due to vaccines, so the "obvious mortality results" is laughable. If it was "obvious", don't you think the authors would have mentioned it? The article does, however, include the following statement: "In a real-life situation in which the COVID-19 vaccines are administered to highly vulnerable populations with high COVID-19-related mortality, significant reductions in overall mortality are expected, also for mRNA vaccines." Their data show a decrease in Covid mortality with mRNA vaccines, and the difference in overall mortality is due to some theoretical protection against cardiovascular disease in adenovirus vaccines...which is fine. You want to prevent cardiovascular disease, then suggest all patients get adenovirus vaccines. And finally, as I already said: "The number of deaths in these RCTs was limited, and chance could therefore have played a role in these findings." I find it interesting that you are making claims that the authors didn't make, couldn't make on the basis of their own analysis, and therefore why do you think your "analysis" is of value?
Money truly is the root of so much evil.
How many COVID vaccines are enough?
No more than you currently have...
The Emperor has no cloths.
I got Novavax instead of an mRNA booster this fall. NO side effects. I hope to never get another mRNA vaccine. And Novavax might be more durable in protection.
“At the beginning of the pandemic, randomized data showed that two vaccines in short succession reduced the incidence of COVID infection (Pfizer, Moderna).”
How did you overcome the statistical challenge of Pfizer only characterizing as “vaccinated” those who survived 14 days post second jab in their trials?
Have you done so little work reviewing the RCT data that you aren’t even aware of these anomalies? If so, it reveals a real deficiency in your curiosity/skepticism/understanding of the corrupt nature of Big Pharma.
That means that all adverse events of any kind (and there will be many with 10s of thousands of trials participants) were attributed to the placebo/unvaxxed group for the period from first jab to 14 days post second jab, inclusive. This statistical “trick” was also used for many of the studies I reviewed which suggested MRNA protection from disease, hospitalization, and death. Unfortunately, until you address this statistical sleight of hand it is hard to take your views as credible.
And we have not even addressed the outright exclusion (fraud) which occurred with trials participants who suffered serious adverse events, like Maddie de Garay.
I’ve read all the replies by my comment and I completely stand by my note.
There’s nothing wrong with being devout in your faith. But please, don’t try and pass it off as “science.”
Thanks, excellent write-up.
I don't understand the repeated "healthy vaccine effect" argument. The unvaccinated people I know are the healthiest. Ideal weight, eat healthy food, little to no regular medications etc. I am not sure this repeated assumption holds.
Folks who volunteer to be vaccinated tend to be worried well. Those with chronic underlying conditions tend to not volunteer for medical intervention, except via the ER in acute exacerbations of their conditions.
"The CDC and FDA are whittling away at public trust by forgoing their duty to protect and inform."
Au contraire...there's nothing there to whittle away. It's GONE. Been GONE. You can't whittle on something that's not there.
Manufatured Consent is not something new. Noam Chomsky even wrote a book warning of this. Follow themoeny is not limited to working only in the criminal world.
Why would anyone in their right mind trust companies that are basically criminal enterprises with more criminal fines than any business sector in history.
https://en.m.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements
I’ve been a critical care nurse for 30 years and I’m utterly ashamed of what health care and healthcare research has become.