“I know the FDA, CDC and the White House have enthusiastically endorsed the Moderna Covid-19 vaccine for all infants. I think a system that is capable of such an endorsement is broken, and in dire need of fixing.”
Really well put.
As a lay reader I don’t know what to conclude -- other than these trials are tiny and should’ve been bigger -- but it’s easy enough to see that the confident pronouncements from folks like Walensky and Jha bear little resemblance to the actual clinical trial submissions...
Where I live (California) there’s a proposed bill to punish doctors for spreading Covid vaccine misinformation. Presumably, adopting the position you’ve sketched in this article could be enough to get California doctors delicensed! Scary stuff.
Here’s to hoping cooler heads will prevail, doctors can advise as they see fit, and we stop rewarding cheerleading and re-focus on evidence as the basis of pharmaceutical regulation.
I hate to be alarmist, but cooler heads will not prevail. This wasn't an accident. This is regulatory capture, complete and absolute. It was willful, and those who willed it will not let it go easily. It will take accurate data and studies to undo the damage, and also the sunlight of legitimate studies and conclusions being spread far and wide. However, the captured organizations control all the mechanisms and funding for such studies, and, increasingly, control almost all of the media that would spread accurate conclusions to the masses. It's not going to get better.
Yep, now investigate your statement that the adult version has "been truly life-saving". It has not. It has been statistical games, nothing more. You've been duped. Hard. Hopefully your identity doesn't experience a crisis upon this realization.
I'm a social scientist extensively trained in research methodology and spent much of my career teaching research methodology. I found it difficult to believe what I was reading here. Has anyone bothered to compute the probability that an effect like this could occurr by change? Well let me tell you that with the group sizes here it must be infintisimally small. How can trained (one assumes) medical researchers or practistioners read findings like this and not seem to notice effects of this magnitude. I can no longer believe that this could occur due to simple incompetence or inadequate training. Something is beginning to smell seriously rotten here.
So what about the fact that the study began with 4500+ infants, of which 3000 dropped out. Of the 1500 (not 1800) that were left, 3X the number of the vaccinated developed COVID-19. After removing al but those that received both doses, the vaccinated were 3 and the placebo were 7. Not much of an effect.
Is there a motive for approval for children other than “the science”? Why yes, I believe there is. Consider the following: The drug companies need this last remaining age group to be included under the EUA, because once the emergency is finally declared “over,” the next phase of liability shielding requires that the shots receive approval by the CDC’s Advisory Committee on Immunization Practices. Once the vaccine is on the childhood vaccination schedule, the vaccine makers are permanently shielded from liability for injuries and deaths that occur in any age group, including adults
Thank you for this. I have a 7 week old grandson whose parents are hell bent on having him immunized as soon as they can. My husband and I are very leery of the vaccine for reasons not important here but my daughter and her husband (respectfully) think we're anti-vaxers and they won't listen to us. I want to share this article with them. Obviously the final decision is theirs and I'll pray with all of my heart that all goes well if they choose to vaccinate him, but I would love for them to review this well-reasoned discussion of how/why the benefit may not outweigh the risk
I am a practicing pediatrician and have seen 100's of covid cases in our newborn to 5 year patients. We have had 2 patients hospitalized with MSID . Neither of these kids have had a positive COVID test and received the diagnosis because "what else could have caused it?". As a physician that is unacceptable. Before the pandemic the dx would have been Kawasaki's syndrome and the cause would be post viral (treatment and follow up was identical )
No vaccine (and this is not a vaccine per sec) would be rolled out on this schedule to a cohort that is at low risk. The push for this shot has tainted the water for all of our other vaccinations
Why would we be surprised by a wider diversity of unprecedented adverse events? The LNP-borne mRNA modality is completely new - and though the dose of "instructions" for making the toxic S protein is thought to be known, the quantity of antigen actually made by the body (and sites of production) is not known.
When a genetically diverse population is fed the same toxin, the outcomes can be very different. Some will seem to be unaffected, while others will have a rash, and others may have malaise, and others could exhibit a higher propensity to fall ill to viral and microbial diseases, and so on. Moldy wallpaper in Victorian England released toxic, volatile arsenic compounds, creating general ill health which worked itself out through a large variety of symptoms and secondary illnesses. (And nobody blamed the wallpaper.)
How can any doctor or committee make the "safe" call without long-term followup studies? Biodistribution studies? Aggressive monitoring and screening for sub-clinical effects such as subtle heart damage? No, this isn't just another vaccine, another dot of light in the constellation of injections on the childhood schedule.
In the end, Moderna did not calculate the number of children that must be injected in order to save one life. The study was not set up to answer this question. They did not demonstrate that the product saves lives at all. They only met "success criteria" via the immunobridging scheme, which showed seroresponse among injected children, without studying increased serpositivity (due to infection) in the control group. Who knows, the control group might have met immunobridging criteria as well!
I think you have presented this information the most objectively I've seen yet, and your conclusion is so well articulated.
As sad as this newest development is for infants, it is quite the litmus test in exposure for those who are just peddling bullshit (i.e. walensky).
I've been striving to see the best of intentions in these policy makers throughout all this, but we are hitting horrifying new territory. I hope this absurdity triggers a wake up call and reevaluation in those who still retain their humanity, before it goes too far.
I'm a medically-knowledgeable non-physician who has followed the mRNA vaccine discussion with great interest. The age cohort studies should probably have been acknowledged, in so far as the infinitesimal risk of death in those twenty and younger amplifies the significance of any adverse vaccine events. Simply put, why administer a vaccine to someone with a de facto zero risk of death from the disease?
I think this might just be your "red pill" moment. I really enjoyed reading your process of re-evaluating the data and updating your opinion
“I know the FDA, CDC and the White House have enthusiastically endorsed the Moderna Covid-19 vaccine for all infants. I think a system that is capable of such an endorsement is broken, and in dire need of fixing.”
Really well put.
As a lay reader I don’t know what to conclude -- other than these trials are tiny and should’ve been bigger -- but it’s easy enough to see that the confident pronouncements from folks like Walensky and Jha bear little resemblance to the actual clinical trial submissions...
Where I live (California) there’s a proposed bill to punish doctors for spreading Covid vaccine misinformation. Presumably, adopting the position you’ve sketched in this article could be enough to get California doctors delicensed! Scary stuff.
Here’s to hoping cooler heads will prevail, doctors can advise as they see fit, and we stop rewarding cheerleading and re-focus on evidence as the basis of pharmaceutical regulation.
I hate to be alarmist, but cooler heads will not prevail. This wasn't an accident. This is regulatory capture, complete and absolute. It was willful, and those who willed it will not let it go easily. It will take accurate data and studies to undo the damage, and also the sunlight of legitimate studies and conclusions being spread far and wide. However, the captured organizations control all the mechanisms and funding for such studies, and, increasingly, control almost all of the media that would spread accurate conclusions to the masses. It's not going to get better.
Apropos of "regulatory capture", see this recent piece in BMJ:
"From FDA to MHRA: are drug regulators for hire?" (Published 29 June 2022)
https://doi.org/10.1136/bmj.o1538
Look at that. Published yesterday. Timely.
Yep, now investigate your statement that the adult version has "been truly life-saving". It has not. It has been statistical games, nothing more. You've been duped. Hard. Hopefully your identity doesn't experience a crisis upon this realization.
I'm a social scientist extensively trained in research methodology and spent much of my career teaching research methodology. I found it difficult to believe what I was reading here. Has anyone bothered to compute the probability that an effect like this could occurr by change? Well let me tell you that with the group sizes here it must be infintisimally small. How can trained (one assumes) medical researchers or practistioners read findings like this and not seem to notice effects of this magnitude. I can no longer believe that this could occur due to simple incompetence or inadequate training. Something is beginning to smell seriously rotten here.
So what about the fact that the study began with 4500+ infants, of which 3000 dropped out. Of the 1500 (not 1800) that were left, 3X the number of the vaccinated developed COVID-19. After removing al but those that received both doses, the vaccinated were 3 and the placebo were 7. Not much of an effect.
Is there a motive for approval for children other than “the science”? Why yes, I believe there is. Consider the following: The drug companies need this last remaining age group to be included under the EUA, because once the emergency is finally declared “over,” the next phase of liability shielding requires that the shots receive approval by the CDC’s Advisory Committee on Immunization Practices. Once the vaccine is on the childhood vaccination schedule, the vaccine makers are permanently shielded from liability for injuries and deaths that occur in any age group, including adults
Thank you for this. I have a 7 week old grandson whose parents are hell bent on having him immunized as soon as they can. My husband and I are very leery of the vaccine for reasons not important here but my daughter and her husband (respectfully) think we're anti-vaxers and they won't listen to us. I want to share this article with them. Obviously the final decision is theirs and I'll pray with all of my heart that all goes well if they choose to vaccinate him, but I would love for them to review this well-reasoned discussion of how/why the benefit may not outweigh the risk
I am a practicing pediatrician and have seen 100's of covid cases in our newborn to 5 year patients. We have had 2 patients hospitalized with MSID . Neither of these kids have had a positive COVID test and received the diagnosis because "what else could have caused it?". As a physician that is unacceptable. Before the pandemic the dx would have been Kawasaki's syndrome and the cause would be post viral (treatment and follow up was identical )
No vaccine (and this is not a vaccine per sec) would be rolled out on this schedule to a cohort that is at low risk. The push for this shot has tainted the water for all of our other vaccinations
Why would we be surprised by a wider diversity of unprecedented adverse events? The LNP-borne mRNA modality is completely new - and though the dose of "instructions" for making the toxic S protein is thought to be known, the quantity of antigen actually made by the body (and sites of production) is not known.
When a genetically diverse population is fed the same toxin, the outcomes can be very different. Some will seem to be unaffected, while others will have a rash, and others may have malaise, and others could exhibit a higher propensity to fall ill to viral and microbial diseases, and so on. Moldy wallpaper in Victorian England released toxic, volatile arsenic compounds, creating general ill health which worked itself out through a large variety of symptoms and secondary illnesses. (And nobody blamed the wallpaper.)
How can any doctor or committee make the "safe" call without long-term followup studies? Biodistribution studies? Aggressive monitoring and screening for sub-clinical effects such as subtle heart damage? No, this isn't just another vaccine, another dot of light in the constellation of injections on the childhood schedule.
In the end, Moderna did not calculate the number of children that must be injected in order to save one life. The study was not set up to answer this question. They did not demonstrate that the product saves lives at all. They only met "success criteria" via the immunobridging scheme, which showed seroresponse among injected children, without studying increased serpositivity (due to infection) in the control group. Who knows, the control group might have met immunobridging criteria as well!
I think you have presented this information the most objectively I've seen yet, and your conclusion is so well articulated.
As sad as this newest development is for infants, it is quite the litmus test in exposure for those who are just peddling bullshit (i.e. walensky).
I've been striving to see the best of intentions in these policy makers throughout all this, but we are hitting horrifying new territory. I hope this absurdity triggers a wake up call and reevaluation in those who still retain their humanity, before it goes too far.
https://wellnessandequality.com/2016/06/20/how-much-money-do-pediatricians-really-make-from-vaccines/
I'm a medically-knowledgeable non-physician who has followed the mRNA vaccine discussion with great interest. The age cohort studies should probably have been acknowledged, in so far as the infinitesimal risk of death in those twenty and younger amplifies the significance of any adverse vaccine events. Simply put, why administer a vaccine to someone with a de facto zero risk of death from the disease?
Sorry, in previous post "change" should of course be "chance".