Good questions but I do not see any evidence for serious doubt about the major finding of decrease in severe RSV infection in the vaccinated group. We learned from pavilizumab that passive immunity would at best decrease the serious infections. With maternal vaccination, it is not clear what part of the immune response was augmented. Has anyone done T cell studies or will they be done? How about follow-up second year studies? RSV is unique among respiratory viruses in that it is highly contagious and thus very common among infants in the first year of life. Premature infants are at particular risk because passive transfer of maternal antibodies is reduced in linear relationship to the weeks of pregnancy and infections remain common although clinically less severe in the second year. I am encouraged that we might just be making progress in reducing the burden of RSV infection for infants. It is not clear that this vaccine could be formulated for adults in whom RSV infection can also be severe.
"An FDA advisory committee would presumably demand this data during consideration"...really? That seems like pie in the sky thinking. I bet they would approve this without giving anything a thought.
And did they say what the placebo was? After reading Turtles All the Way Down, I have very little faith in placebo studies as it relates to vaccines.
In table S17 of the appendix (Severe or life-threatening adverse events) there were 63 RSVpreF vs. 36 placebo "Pregnancy, puerperium, and perinatal conditions". That sounds like a horrible drug to take during pregnancy (p=0.009).
I agree with the commenters raising issues with lack of transparency especially about things like batch descriptions and no powering for all cause morbidity. In the case of the covid vaccines there's every reason to believe all cause mortality maybe increased. There's also been forensics done on the raw data that were obtained from the FDA on the Pfizer trial that reveal a very peculiar event regarding a cluster of dropouts that looks consistent with a bad batch. They've also found a number of signals in the data that look like serious fraud with imbalanced testing, imbalanced exclusions etc.
The system has learned nothing. It's only got increasingly corrupt. For me it's no more about making a bet on whether or not an intervention has benefits that outweigh the risk. Now it is about making a bet on whether or not it's even worth my time to make such an assessment. Right now with RSV I'm giving 10 to 1 odds that it's a waste of my time to even study and so I'm not going to. Yeah that's the kind of consequence you get when you're a medical system that just keeps pushing the same trash and never learns a single thing and never cleans up a single corruption. At this point it's a more productive use of my time to create a list of bare minimum criteria that need to be met to even deserve my attention. I'm categorically done with vaccines until the system meets that. Thank you Pfizer. Thank you fda. Thank you delusional covid pundits. I'm not anti-vaccine. I'm reasonable.
Let's start with your unproven assertion that "1956, in a time when Jonas Salk’s polio vaccine was in the process of reducing the cases of paralytic polio in the United States from tens of thousands to less than 100 each year". What actually happened was, several different conditions (other diseases plus arsenic and ddt poisoning) were misdiagnosed as polio, and then when the vaccine was introduced diagnosis criteria were made much narrower. In addition, as nutrition and sanitation improved, the need for pesticides declined and people's immunity improved. The polio virus itself was never a major problem, but the various treatments used for polio-like illness were, especially surgeries and immobilization. See "Dissolving Illusions" for details.
Dave, any thoughts on the fact that the placebo group seems to have more congenital abnormalities. This seems a bit suspicious to me - why would *not* getting a vaccine increase your risk of congential abnormality if it's not causing stillbirths or if it doesn't indicate that the groups weren't really random.
Also, where were the neonatal death numbers included in the graphs? I think I missed it.
Longterm testing of detriments benefits required. Immune Training by Natural exposure versus risk of an age-delayed immune challenge and loss of any protection. As we have seen clinical trials involve data &patient manipulations leading to +corporate profits rather than best patient outcomes.
Surely you know that natural immunity is transferred from mother to child through the breast milk, but not artificial immunity? Is that not taught in medical school?
All these vaccine studies are FUNDAMENTALLY FLAWED and must be thrown out IMMEDIATELY.
Due to lack of quality control, contaminants vary 100X among vaccine lots. Impossible to study such vaccines. So this paper is a fraud & must be retracted. Their peer-review was a massive failure.
Science dictates that we know what lots were studied, characteristics of the lots and where they fall vs. all vaccines, before safety conclusions can be drawn. The authors failed to provide ANY such information. I described this in my comment posted in the Annals of Internal Medicine.
There was a contradiction from the start. On the one hand, RSV is so dangerous that we need to vaccinate without showing the thing patients care most about: death. On the other hand, it's not feasible to power a study to show such a benefit. Don Quixote could have been a medical author.
The end result of focusing on hospitalization will be that mild RSV case will be admitted to the hospital in vaccine studies. Bingo, they found a benefit of reduced hospitalization!
AND "the Vaccine Research Development sample management team; and all the Pfizer colleagues not named here who contributed to the success of this trial. "
Brought to you by Pfizer! $$$$$ AND we will need a FOIA to get ALL the clinical trail data they left out.
Good questions but I do not see any evidence for serious doubt about the major finding of decrease in severe RSV infection in the vaccinated group. We learned from pavilizumab that passive immunity would at best decrease the serious infections. With maternal vaccination, it is not clear what part of the immune response was augmented. Has anyone done T cell studies or will they be done? How about follow-up second year studies? RSV is unique among respiratory viruses in that it is highly contagious and thus very common among infants in the first year of life. Premature infants are at particular risk because passive transfer of maternal antibodies is reduced in linear relationship to the weeks of pregnancy and infections remain common although clinically less severe in the second year. I am encouraged that we might just be making progress in reducing the burden of RSV infection for infants. It is not clear that this vaccine could be formulated for adults in whom RSV infection can also be severe.
I'm new to this and I'm trying to figure out how they can have more maternal participants than infants. Anyone?
"An FDA advisory committee would presumably demand this data during consideration"...really? That seems like pie in the sky thinking. I bet they would approve this without giving anything a thought.
And did they say what the placebo was? After reading Turtles All the Way Down, I have very little faith in placebo studies as it relates to vaccines.
Crispy, clear and to the point. Well organized.
In table S17 of the appendix (Severe or life-threatening adverse events) there were 63 RSVpreF vs. 36 placebo "Pregnancy, puerperium, and perinatal conditions". That sounds like a horrible drug to take during pregnancy (p=0.009).
I agree with the commenters raising issues with lack of transparency especially about things like batch descriptions and no powering for all cause morbidity. In the case of the covid vaccines there's every reason to believe all cause mortality maybe increased. There's also been forensics done on the raw data that were obtained from the FDA on the Pfizer trial that reveal a very peculiar event regarding a cluster of dropouts that looks consistent with a bad batch. They've also found a number of signals in the data that look like serious fraud with imbalanced testing, imbalanced exclusions etc.
The system has learned nothing. It's only got increasingly corrupt. For me it's no more about making a bet on whether or not an intervention has benefits that outweigh the risk. Now it is about making a bet on whether or not it's even worth my time to make such an assessment. Right now with RSV I'm giving 10 to 1 odds that it's a waste of my time to even study and so I'm not going to. Yeah that's the kind of consequence you get when you're a medical system that just keeps pushing the same trash and never learns a single thing and never cleans up a single corruption. At this point it's a more productive use of my time to create a list of bare minimum criteria that need to be met to even deserve my attention. I'm categorically done with vaccines until the system meets that. Thank you Pfizer. Thank you fda. Thank you delusional covid pundits. I'm not anti-vaccine. I'm reasonable.
Let's start with your unproven assertion that "1956, in a time when Jonas Salk’s polio vaccine was in the process of reducing the cases of paralytic polio in the United States from tens of thousands to less than 100 each year". What actually happened was, several different conditions (other diseases plus arsenic and ddt poisoning) were misdiagnosed as polio, and then when the vaccine was introduced diagnosis criteria were made much narrower. In addition, as nutrition and sanitation improved, the need for pesticides declined and people's immunity improved. The polio virus itself was never a major problem, but the various treatments used for polio-like illness were, especially surgeries and immobilization. See "Dissolving Illusions" for details.
Dave, any thoughts on the fact that the placebo group seems to have more congenital abnormalities. This seems a bit suspicious to me - why would *not* getting a vaccine increase your risk of congential abnormality if it's not causing stillbirths or if it doesn't indicate that the groups weren't really random.
Also, where were the neonatal death numbers included in the graphs? I think I missed it.
Longterm testing of detriments benefits required. Immune Training by Natural exposure versus risk of an age-delayed immune challenge and loss of any protection. As we have seen clinical trials involve data &patient manipulations leading to +corporate profits rather than best patient outcomes.
Surely you know that natural immunity is transferred from mother to child through the breast milk, but not artificial immunity? Is that not taught in medical school?
All these vaccine studies are FUNDAMENTALLY FLAWED and must be thrown out IMMEDIATELY.
Due to lack of quality control, contaminants vary 100X among vaccine lots. Impossible to study such vaccines. So this paper is a fraud & must be retracted. Their peer-review was a massive failure.
Science dictates that we know what lots were studied, characteristics of the lots and where they fall vs. all vaccines, before safety conclusions can be drawn. The authors failed to provide ANY such information. I described this in my comment posted in the Annals of Internal Medicine.
https://www.acpjournals.org/doi/10.7326/m18-2101
https://twitter.com/SynthIge/status/1607915639343296513
"Rates of breast feeding vary by country but are quite low in the US"
If ANYONE is interested in public health, that would be the problem they would fix first. Injecting garbage into people is not public health.
There was a contradiction from the start. On the one hand, RSV is so dangerous that we need to vaccinate without showing the thing patients care most about: death. On the other hand, it's not feasible to power a study to show such a benefit. Don Quixote could have been a medical author.
The end result of focusing on hospitalization will be that mild RSV case will be admitted to the hospital in vaccine studies. Bingo, they found a benefit of reduced hospitalization!
Was the placebo saline Only?
Disclosures listed at end of paper...
"Supported by Pfizer." And "Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Here is the link on the paper to save you time https://www.nejm.org/doi/suppl/10.1056/NEJMoa2216480/suppl_file/nejmoa2216480_disclosures.pdf
AND "the Vaccine Research Development sample management team; and all the Pfizer colleagues not named here who contributed to the success of this trial. "
Brought to you by Pfizer! $$$$$ AND we will need a FOIA to get ALL the clinical trail data they left out.
Deja vu