Here's the problem - A year ago the CDC, Twitter Med, and a variety of news outlets promoted the vaccine to pregnant people specifically because a study found mRNA did *not* pass through the breast milk. This was the metric used to prove it was safe to breastfeed.
"No traces of mRNA COVID-19 vaccines found in breast milk: Research"
“We didn’t detect the vaccine associated mRNA in any of the milk samples tested,” said lead author Yarden Golan, PhD, a postdoctoral fellow at UCSF. “These finding provide an experimental evidence regarding the safety of the use of mRNA-based vaccines during lactation.”
"We show here that the mRNA from anti-COVID BNT162b2 (Pfizer) and mRNA-1273 (Moderna) vaccines is not detected in human breast milk samples collected 4-48 hours post-vaccine. These results strengthen the recommendation of ABM and WHO that lactating individuals who receive the anti-COVID-19 mRNA-based vaccine should continue to breastfeed their infants uninterrupted."
I always had the same question Krista O asked in earlier comment - "Why is mRNA in breastmilk (even if a small amount) a bad thing?
I propose that lay people would assume it must be a bad thing considering the studies set out to prove this did not happen, and argued it was safe specifically *because* "...mRNA from anti-COVID BNT162b2 (Pfizer) and mRNA-1273 (Moderna) vaccines is not detected in human breast milk samples collected 4-48 hours post-vaccine."
Now that this has turned out to be incorrect, rather than digging into to how this was missed on the study which promoted this apparently false claim, concern is essentially dismissed as "well that's not a big deal anyway". Can you see how they may feel "gaslit"?
If this wasn't a concern in the first place, why was it pursued at all? Why didn't the original claim say "we don't find it so far, but even if it was present it doesn't matter because of x, y, z"?
Why isn't there more focus on how the original study could have missed this in the first place? Why do I have to read conspiracists to get a good understanding of the flaws of the original study and how they were avoided in an attempt to replicate? [1]
Covid vaccine enthusiasm has clearly plummeted among the general public. We saw this when the <12 kids never passed 30%. We saw this again when the <2 got stuck at 5%. Few countries even authorized for this cohort. The latest booster has far lower demand than expected. Switzerland is discarding unused doses, Denmark stopped offering to anyone under 50.
I don't think this reluctance can be blamed on "antivaxx" sentiment. I argue it is due to the erosion of trust in our scientific institutions, and this is just the latest example of why there is a breakdown in trust. It should have been communicated much better, with more humility.
Very well said. I have totally lost trust in the CDC. They answer to no one. They cherry pick the science. The suppress data that doesn't fit their narrative. They don’t acknowledge their inconsistencies.
It is reasonable for citizens to ask questions about vaccine safety and effectiveness. Curiosity and diligence shouldn't automatically mark someone as an anti-vaxer and misinformed.
I’m a vaccinator and demand for the bivalent booster in my area is hearty. We have been extremely busy giving it. We are even seeing a fair number of people getting their very first COVID vaccine which I never expected to see an increase in uptake for that again. For kids, especially the youngest group, I do agree the uptake has been very poor.
"with more humility." Perfectly chosen phrase. Anti-vaxxing sentiment has a lot of political posturing to blame for people distrusing "expert" reports, BUT this problem of official information being delivered from "on high" and as absolute truth is, as you say, a major reason why people distrust so much that the CDC, FDA and other medical authorities proclaim to be the truth. If they would stop patronizing their listeners, they would find communicating much easier. (As a side note, this is a problem which has wracked our political system as well.)
I wish we could find some *authentic* discussions ("Let's pretend our only goals are truth and people's wellbeing") moderated by people who know how to moderate discussions on contentious topics. Until then, yeah, it's a good idea to read alternate points of view that are well-reasoned (and to have the luxury of time to do that and an understanding of how nuances of methodology and implementation of the statistical analysis plan can sometimes have outsize effects on the 'results'). Especially important until the evidence is "settled," though the Newtonian concept of gravity as a force exerted by one object on another was considered based on settled evidence until Einstein published a very different perspective which must have upset a lot of people at the time... 100% on 'communication with humility!'
Katelyn Jetelina advocates giving what the FDA in 2020 considered experimental gene therapy to the most vulnerable members of our population.
In her article on the mRNA trials in babies aged from 6 months, she cites reasons other than protection from severe disease, even, bizarrely, the reduced requirement to socially distance.
Any product that doesn’t reduce transmission and requires repeated dosing is a therapy. The gold standard primary endpoint for any trial in any therapy is ALL CAUSE mortality and morbidity.
The MRNA drugs' original trials in adults didn’t show benefit in all cause mortality. The primary endpoint wasn’t even reduced risk of severe disease caused by Covid.
Any parent or prospective parent has a duty to discuss the data RCTs with an immunologist who knows their own or their child’s personal history. Parents should ask for clear evidence of efficacy in reduced risk of severe disease shown by blood work (T cell response) and how long the protection lasts.
Blood Work should be available for each participant and, in cases where the second dose wasn’t given, the reasons should be clear. That's why raw data is so important.
As for the evidence that the shots are safe for reproductive health, in pregnancy, for nursing infants…
the above article cites a meta analysis “pooling many of these studies'. Prasad et al. exclude many, whittling them down to just 23. One notable exclusion is the Shimabukkuro et al. study, which was touted early in the roll out as evidence the mRNA shots were safe in pregnancy. The authors' own data, however, didn’t support their conclusions and a correction was issued, although the paper hasn’t been retracted.
Prasad et al. say one of the strengths of their study is that they use “grey” literature such as government reports (Are we to trust government reports coming from bodies that pushed the covid shots so hard?)
The authors include one large Canadian study where the number of doses is unspecified (In Canada and the US, vaccination status is unreliable because many hospitals record patients as “unvaccinated” until two weeks after the second dose.)
Immunologist Dr. Male cites the study by Gat et al that DID find a negative effect on sperm. The authors’ conclusion is that it was temporary and therefore of no concern but the data do not support that:
How long was the follow-up? We were told vaccine-induced myocarditis was “mild” and “temporary” before we even had evidence from MRIs and subsequent studies have found fibrosis and fatal heart attacks from the shots.
Another major limitation of the meta analysis by Prasad et al. and the Swiss study by Favre et al. ( a poor quality study being “observational”) that the authors say themselves is that they don’t focus on health outcomes for infants.
What about the sexual health of the infants, comparing size of testes, incidence of myocarditis, respiratory and neurological conditions?
What about the long-term effects (such as cancer) for anyone? If a product is marketed as a vaccine then certain safety studies don't need to be done:
You can find reports in VAERS of severe adverse effects (including death) of nursing infants whose mothers had been jabbed. Kateyln Jetelina says these are not greater than normal. Does she know that VAERS is severely under-reported?
In the clip below, you can watch nurses giving evidence at a Health and Welfare meeting of the Louisiana House of Reps on the "terrifying" vaccine injuries they're seeing. The nurses (cardiac and general) speak at the one hour mark. They both say (and their testimony is consistent with other nurses and doctors from other countries) the injuries are not being reported to VAERS:
Katelyn Jetelina is keen to counter "misinformation". There are over 1000 peer-reviewed papers on AEs from the shots. I'd be interested to know what she thinks of the testimony of three participants (and the mother of another) in the original trials who say severe AEs such as paralysis, cancer, pericarditis, neurological were covered up?
"(Are we to trust government reports coming from bodies that pushed the covid shots so hard?)"
The answer is a resounding YES. And you have totally exposed yourself, just by this question, as a spreader of disinformation and creator of confusion about reasonable scientific research conclusions. You have apparently deliberately come on to this website with the intention of "discrediting" an honest and intelligent commentator, in the person of Katelyn. It won't work, but nonetheless, go away and stop clogging up the comments section.
Yes, agreed. There is clearly a lot of nonsense there. Just wanted to hightlight the most unmistakable of it - he "pushed covid shots so hard" was a dead giveaway. And, as I've noted before, even if you modestly don't admit to it, you are obviously a very well-informed and astute readerl.
I prefer to make health decisions based on raw data from RCTs which have substantial and equal numbers in both groups, use biomarkers and have transparency re. exclusions, rather than trusting observational studies with small numbers or government reports.
This is a dead giveaway. True. It's a dead giveaway I don't blindly trust "the experts".
I don't know if you recall thalidomide and how long the warnings were being sounded before the harms were "officially" acknowledged? Same thing with Vioxx (I was prescribed this drug but never took it) The sugar industry paid three Harvard professors to demonise saturated fat, which has left the population deficient in fat soluble vitamins A and D, which are partners and should be high normal.
Look how many doctors bought into a myth and how much damage has to have been done. Still is. You can find "heart smart" low fat options on children's menus in hospitals even now.
It's a resounding "yes" from you that we should trust government reports?
The Israeli government turned the population into Pfizer's unwilling lab rats, coercing them with the Green Pass. Investigative reporter Yaffa Shir-Raz leaked evidence the MOH didn't track safety data and when it found evidence of harm, covered it up. This is plausible because damages to infants are the most costly of all.
One of the sources referred to by Katelyn is an Israeli registry study comparing outcomes of vaccinated versus unvaccinated pregnant women:
Look at the study yourself. It has vastly different numbers in each group, doesn't stipulate the number of doses received, excludes the first trimester and 12% of all the cases:
There's no long-term follow-up and nothing at all re. incidence of cancer, which is of particular concern as a case of T cell lymphoma (Olivia Tessinar) occurred on the Moderna trial in adults.
So the world of trial participants reporting (or not) symptoms on trials where protocol stipulated investigators could use clinical judgement as to whether or not to test is adequate to claim efficacy and force onto the population?
What about the word and medical evidence of harm from participants on those same trials?
Are Augusto Roux (Pfizer), Maddie de Garay (Pfizer) Olivia Tessinar (Moderna), Brianne Dressen (Astrazenecca) talking nonsense?
The FDA document calls the Covid vaccine ‘investigational” and Moderna’s SEC filing states (as does Pfizer’s) that the FDA consider the mRNA products to be “gene therapy”:
The FDA Q&A sheet for the general public also made it clear it wasn't known if the Covid shots could function as traditional vaccines and reduce the transmission of Covid (Bourla himself said he thought mRNA was "counterintuitive')
So referring to documents produced by the FDA and the drug makers themselves is parroting and pseudoscience?
I'd be interested to know then what source you trust the most, what you consider the most robust scientific evidence that the mRNA drugs are safe and effective, particularly for young children.
I'd also like to know what you think of the analysis by researcher Toby Rogers. He says the trial on babies 6 months to four years is "an embarrassment". He says Pfizer found ways to 'whittle down" participants to fit the data.
I noticed whittling down going on in real-world studies I've read (Yousaf et al.) and in some of those I referred to that Katelyn Jetelina mentioned in her article. If you select, exclude and hide, you can pretty much claim anything (No wonder John Ionnidis and Dr Marcia Angell said you can't trust most of what's published!) I don't know how anyone can be so certain about efficacy and safety without seeing the raw data from the RCTs.
I’m increasingly conflicted about exposing my own body to mRNA. I would find it excruciating to make this decision for my newborn or child who was too young to have input.
The younger the child, the higher the bar should be set on “safe and effective.”
Part of the reason people are encouraged to get vaccinated/boosted is to reduce transmission and protect the vulnerable. When it comes to small children, the ONLY morally permissible justification for recommending vaccine/booster is to protect that particular child from severe illness, hospitalization and death - all of which are small risks for kids.
It is therefore unconscionable to recommend the jab for small kids on the basis of protecting the rest of society - the older and unhealthy - when so much is unknown, and when the child has absolutely no say in whether they get jabbed.
This is a little off topic, but I'm surprised given the volume of discussion about intranasal vaccines that no one has discussed Ocugen getting the license for the Indian nasal vaccine. I know there's a ways to go (and the Indian vaccine is emergency authorized, hard data coming in the next few months) but this feels like a major step forward for mucosol vaccination: https://finance.yahoo.com/news/ocugen-announces-agreement-washington-university-103000226.html
Exciting progress. The giant drug companies seem to be doing nothing, but, if this venture produces results that are successful, - and somebody will pay the probably high demanded price for the new vaccine - than maybe Ocugen will get bought by the "whales" who can lobby effectively for its promotion in the medical field and with the FDA and Medicare.
Am guessing that for the mRNA to offer protection it would have to (a) not be degraded in stomach or small intestine, (b) be absorbed into circulation, (c) get into cells to (d) get them to produce spike protein, ultimately (e) engage the baby's immune system to produce antibodies.
As Katelyn's post says, it happens from the antibodies the mother's body develops in response to the vaccine (which do pass through milk) - not mRNA from the vaccine.
Great and timely article. Shared it with my lactation consultant and childbirth working friends. I appreciate the time and care you put into this endeavor!
Thank you for this! I help breastfeeding moms, and also help direct the nonprofit organization through which I volunteer. We value evidence-based information, and it is so handy to have the risks and benefits laid out all in one place.
Has any data been reviewed that addresses ideal timing of receiving a vaccine or booster, during pregnancy, in order to best protect mother during pregnancy and baby afterward? If I'm reading this correctly, anytime seems to be helpful for baby's protection after birth?
I wonder which is better: vaccine while pregnant (I wouldn't be due for the new booster until about 36 weeks) or vaccine while breastfeeding. I'm struggling with that decision. Since there is no guarantee I will be successful with breastfeeding, I'm leaning towards while pregnant. Though I do like the possibility of 6 months of antibodies in breastmilk.
I think it's better to get when pregnant, as COVID is worse for pregnant people than breastfeeding people, I believe. But, for what it's worth, I got my first booster when pregnant and just got the bivalent booster while breastfeeding (well, pumping). Which is to say, there will probably be another booster when you are feeding your baby, so I wouldn't wait. :)
Since there is no guarantee I will be successful with breastfeeding… you can be very successful with the correct information about breastfeeding and with help. You’ve got this mama!! I suggest watching videos on how to latch a baby and learn what to expect the first 2 weeks of breastfeeding. Look for an IBCLC now. Almost all insurances pay for 4-6 visits. Good luck and congratulations!!
I was not successful with my last child despite seeing a IBCLC and SLP (no further need for SLP, suck and swallow was normal). But this isn't the place to discuss it. Thank you for the support.
I understand as I am an IBCLC. My comment was made bc I find that a lot of moms do not know that their insurance covers lactation visits. It was not posted to be debated here.
Is this strictly about initial vaccination series or does this also include booster (3rd or 4th) shot during pregnancy? Do I create the same levels of antibodies with a booster to pass through the placenta as a person who completes their initial series during pregnancy?
Here's the problem - A year ago the CDC, Twitter Med, and a variety of news outlets promoted the vaccine to pregnant people specifically because a study found mRNA did *not* pass through the breast milk. This was the metric used to prove it was safe to breastfeed.
"No traces of mRNA COVID-19 vaccines found in breast milk: Research"
https://www.dailysabah.com/life/health/no-traces-of-mrna-covid-19-vaccines-found-in-breast-milk-research
“We didn’t detect the vaccine associated mRNA in any of the milk samples tested,” said lead author Yarden Golan, PhD, a postdoctoral fellow at UCSF. “These finding provide an experimental evidence regarding the safety of the use of mRNA-based vaccines during lactation.”
https://www.ucsf.edu/news/2021/07/421041/no-sign-covid-19-vaccine-breast-milk
"We show here that the mRNA from anti-COVID BNT162b2 (Pfizer) and mRNA-1273 (Moderna) vaccines is not detected in human breast milk samples collected 4-48 hours post-vaccine. These results strengthen the recommendation of ABM and WHO that lactating individuals who receive the anti-COVID-19 mRNA-based vaccine should continue to breastfeed their infants uninterrupted."
https://www.medrxiv.org/content/10.1101/2021.03.05.21252998v1
I always had the same question Krista O asked in earlier comment - "Why is mRNA in breastmilk (even if a small amount) a bad thing?
I propose that lay people would assume it must be a bad thing considering the studies set out to prove this did not happen, and argued it was safe specifically *because* "...mRNA from anti-COVID BNT162b2 (Pfizer) and mRNA-1273 (Moderna) vaccines is not detected in human breast milk samples collected 4-48 hours post-vaccine."
Now that this has turned out to be incorrect, rather than digging into to how this was missed on the study which promoted this apparently false claim, concern is essentially dismissed as "well that's not a big deal anyway". Can you see how they may feel "gaslit"?
If this wasn't a concern in the first place, why was it pursued at all? Why didn't the original claim say "we don't find it so far, but even if it was present it doesn't matter because of x, y, z"?
Why isn't there more focus on how the original study could have missed this in the first place? Why do I have to read conspiracists to get a good understanding of the flaws of the original study and how they were avoided in an attempt to replicate? [1]
Covid vaccine enthusiasm has clearly plummeted among the general public. We saw this when the <12 kids never passed 30%. We saw this again when the <2 got stuck at 5%. Few countries even authorized for this cohort. The latest booster has far lower demand than expected. Switzerland is discarding unused doses, Denmark stopped offering to anyone under 50.
I don't think this reluctance can be blamed on "antivaxx" sentiment. I argue it is due to the erosion of trust in our scientific institutions, and this is just the latest example of why there is a breakdown in trust. It should have been communicated much better, with more humility.
[1] Example of the type of research and examination I would hope to see elsewhere: https://igorchudov.substack.com/p/bill-gates-funded-scientists-found
Very well said. I have totally lost trust in the CDC. They answer to no one. They cherry pick the science. The suppress data that doesn't fit their narrative. They don’t acknowledge their inconsistencies.
It is reasonable for citizens to ask questions about vaccine safety and effectiveness. Curiosity and diligence shouldn't automatically mark someone as an anti-vaxer and misinformed.
I’m a vaccinator and demand for the bivalent booster in my area is hearty. We have been extremely busy giving it. We are even seeing a fair number of people getting their very first COVID vaccine which I never expected to see an increase in uptake for that again. For kids, especially the youngest group, I do agree the uptake has been very poor.
"with more humility." Perfectly chosen phrase. Anti-vaxxing sentiment has a lot of political posturing to blame for people distrusing "expert" reports, BUT this problem of official information being delivered from "on high" and as absolute truth is, as you say, a major reason why people distrust so much that the CDC, FDA and other medical authorities proclaim to be the truth. If they would stop patronizing their listeners, they would find communicating much easier. (As a side note, this is a problem which has wracked our political system as well.)
I wish we could find some *authentic* discussions ("Let's pretend our only goals are truth and people's wellbeing") moderated by people who know how to moderate discussions on contentious topics. Until then, yeah, it's a good idea to read alternate points of view that are well-reasoned (and to have the luxury of time to do that and an understanding of how nuances of methodology and implementation of the statistical analysis plan can sometimes have outsize effects on the 'results'). Especially important until the evidence is "settled," though the Newtonian concept of gravity as a force exerted by one object on another was considered based on settled evidence until Einstein published a very different perspective which must have upset a lot of people at the time... 100% on 'communication with humility!'
Katelyn Jetelina advocates giving what the FDA in 2020 considered experimental gene therapy to the most vulnerable members of our population.
In her article on the mRNA trials in babies aged from 6 months, she cites reasons other than protection from severe disease, even, bizarrely, the reduced requirement to socially distance.
Any product that doesn’t reduce transmission and requires repeated dosing is a therapy. The gold standard primary endpoint for any trial in any therapy is ALL CAUSE mortality and morbidity.
The MRNA drugs' original trials in adults didn’t show benefit in all cause mortality. The primary endpoint wasn’t even reduced risk of severe disease caused by Covid.
Any parent or prospective parent has a duty to discuss the data RCTs with an immunologist who knows their own or their child’s personal history. Parents should ask for clear evidence of efficacy in reduced risk of severe disease shown by blood work (T cell response) and how long the protection lasts.
Blood Work should be available for each participant and, in cases where the second dose wasn’t given, the reasons should be clear. That's why raw data is so important.
As for the evidence that the shots are safe for reproductive health, in pregnancy, for nursing infants…
the above article cites a meta analysis “pooling many of these studies'. Prasad et al. exclude many, whittling them down to just 23. One notable exclusion is the Shimabukkuro et al. study, which was touted early in the roll out as evidence the mRNA shots were safe in pregnancy. The authors' own data, however, didn’t support their conclusions and a correction was issued, although the paper hasn’t been retracted.
Prasad et al. say one of the strengths of their study is that they use “grey” literature such as government reports (Are we to trust government reports coming from bodies that pushed the covid shots so hard?)
The authors include one large Canadian study where the number of doses is unspecified (In Canada and the US, vaccination status is unreliable because many hospitals record patients as “unvaccinated” until two weeks after the second dose.)
Immunologist Dr. Male cites the study by Gat et al that DID find a negative effect on sperm. The authors’ conclusion is that it was temporary and therefore of no concern but the data do not support that:
https://boriquagato.substack.com/p/pfizer-vaccine-effects-on-total-motile
How long was the follow-up? We were told vaccine-induced myocarditis was “mild” and “temporary” before we even had evidence from MRIs and subsequent studies have found fibrosis and fatal heart attacks from the shots.
Another major limitation of the meta analysis by Prasad et al. and the Swiss study by Favre et al. ( a poor quality study being “observational”) that the authors say themselves is that they don’t focus on health outcomes for infants.
What about the sexual health of the infants, comparing size of testes, incidence of myocarditis, respiratory and neurological conditions?
What about the long-term effects (such as cancer) for anyone? If a product is marketed as a vaccine then certain safety studies don't need to be done:
https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf
You can find reports in VAERS of severe adverse effects (including death) of nursing infants whose mothers had been jabbed. Kateyln Jetelina says these are not greater than normal. Does she know that VAERS is severely under-reported?
In the clip below, you can watch nurses giving evidence at a Health and Welfare meeting of the Louisiana House of Reps on the "terrifying" vaccine injuries they're seeing. The nurses (cardiac and general) speak at the one hour mark. They both say (and their testimony is consistent with other nurses and doctors from other countries) the injuries are not being reported to VAERS:
https://house.louisiana.gov/H_Video/VideoArchivePlayer?v=house%2F2021%2Fnov%2F1108_21_HW
Katelyn Jetelina is keen to counter "misinformation". There are over 1000 peer-reviewed papers on AEs from the shots. I'd be interested to know what she thinks of the testimony of three participants (and the mother of another) in the original trials who say severe AEs such as paralysis, cancer, pericarditis, neurological were covered up?
"(Are we to trust government reports coming from bodies that pushed the covid shots so hard?)"
The answer is a resounding YES. And you have totally exposed yourself, just by this question, as a spreader of disinformation and creator of confusion about reasonable scientific research conclusions. You have apparently deliberately come on to this website with the intention of "discrediting" an honest and intelligent commentator, in the person of Katelyn. It won't work, but nonetheless, go away and stop clogging up the comments section.
Yes, agreed. There is clearly a lot of nonsense there. Just wanted to hightlight the most unmistakable of it - he "pushed covid shots so hard" was a dead giveaway. And, as I've noted before, even if you modestly don't admit to it, you are obviously a very well-informed and astute readerl.
David McNiff,
I prefer to make health decisions based on raw data from RCTs which have substantial and equal numbers in both groups, use biomarkers and have transparency re. exclusions, rather than trusting observational studies with small numbers or government reports.
This is a dead giveaway. True. It's a dead giveaway I don't blindly trust "the experts".
I don't know if you recall thalidomide and how long the warnings were being sounded before the harms were "officially" acknowledged? Same thing with Vioxx (I was prescribed this drug but never took it) The sugar industry paid three Harvard professors to demonise saturated fat, which has left the population deficient in fat soluble vitamins A and D, which are partners and should be high normal.
Look how many doctors bought into a myth and how much damage has to have been done. Still is. You can find "heart smart" low fat options on children's menus in hospitals even now.
It's a resounding "yes" from you that we should trust government reports?
The Israeli government turned the population into Pfizer's unwilling lab rats, coercing them with the Green Pass. Investigative reporter Yaffa Shir-Raz leaked evidence the MOH didn't track safety data and when it found evidence of harm, covered it up. This is plausible because damages to infants are the most costly of all.
One of the sources referred to by Katelyn is an Israeli registry study comparing outcomes of vaccinated versus unvaccinated pregnant women:
https://jamanetwork.com/journals/jamapediatrics/fullarticle/2788938
Look at the study yourself. It has vastly different numbers in each group, doesn't stipulate the number of doses received, excludes the first trimester and 12% of all the cases:
https://jamanetwork.com/journals/jamapediatrics/fullarticle/2788938
There's no long-term follow-up and nothing at all re. incidence of cancer, which is of particular concern as a case of T cell lymphoma (Olivia Tessinar) occurred on the Moderna trial in adults.
So the world of trial participants reporting (or not) symptoms on trials where protocol stipulated investigators could use clinical judgement as to whether or not to test is adequate to claim efficacy and force onto the population?
What about the word and medical evidence of harm from participants on those same trials?
Are Augusto Roux (Pfizer), Maddie de Garay (Pfizer) Olivia Tessinar (Moderna), Brianne Dressen (Astrazenecca) talking nonsense?
Goodby plrase
The FDA document calls the Covid vaccine ‘investigational” and Moderna’s SEC filing states (as does Pfizer’s) that the FDA consider the mRNA products to be “gene therapy”:
https://www.fda.gov/media/142749/download
https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm
The FDA Q&A sheet for the general public also made it clear it wasn't known if the Covid shots could function as traditional vaccines and reduce the transmission of Covid (Bourla himself said he thought mRNA was "counterintuitive')
So referring to documents produced by the FDA and the drug makers themselves is parroting and pseudoscience?
I'd be interested to know then what source you trust the most, what you consider the most robust scientific evidence that the mRNA drugs are safe and effective, particularly for young children.
Perhaps you'd like to refute the argument of the researchers of this study in pre-print? https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4206070
I'd also like to know what you think of the analysis by researcher Toby Rogers. He says the trial on babies 6 months to four years is "an embarrassment". He says Pfizer found ways to 'whittle down" participants to fit the data.
I noticed whittling down going on in real-world studies I've read (Yousaf et al.) and in some of those I referred to that Katelyn Jetelina mentioned in her article. If you select, exclude and hide, you can pretty much claim anything (No wonder John Ionnidis and Dr Marcia Angell said you can't trust most of what's published!) I don't know how anyone can be so certain about efficacy and safety without seeing the raw data from the RCTs.
https://tobyrogers.substack.com/p/the-pfizer-clinical-trial-in-kids?utm_source=profile&utm_medium=reader2
I’m increasingly conflicted about exposing my own body to mRNA. I would find it excruciating to make this decision for my newborn or child who was too young to have input.
The younger the child, the higher the bar should be set on “safe and effective.”
Part of the reason people are encouraged to get vaccinated/boosted is to reduce transmission and protect the vulnerable. When it comes to small children, the ONLY morally permissible justification for recommending vaccine/booster is to protect that particular child from severe illness, hospitalization and death - all of which are small risks for kids.
It is therefore unconscionable to recommend the jab for small kids on the basis of protecting the rest of society - the older and unhealthy - when so much is unknown, and when the child has absolutely no say in whether they get jabbed.
You can igore your own health with your stupidity, but I hope you don't have a child who has to suffer from it too.
This is a little off topic, but I'm surprised given the volume of discussion about intranasal vaccines that no one has discussed Ocugen getting the license for the Indian nasal vaccine. I know there's a ways to go (and the Indian vaccine is emergency authorized, hard data coming in the next few months) but this feels like a major step forward for mucosol vaccination: https://finance.yahoo.com/news/ocugen-announces-agreement-washington-university-103000226.html
Exciting progress. The giant drug companies seem to be doing nothing, but, if this venture produces results that are successful, - and somebody will pay the probably high demanded price for the new vaccine - than maybe Ocugen will get bought by the "whales" who can lobby effectively for its promotion in the medical field and with the FDA and Medicare.
Why is mRNA in breastmilk (even if a small amount) a bad thing? Wouldn't that offer the baby some protection? I'm confused.
Am guessing that for the mRNA to offer protection it would have to (a) not be degraded in stomach or small intestine, (b) be absorbed into circulation, (c) get into cells to (d) get them to produce spike protein, ultimately (e) engage the baby's immune system to produce antibodies.
Thanks. So it sounds like any passing on of immunity from breastmilk to baby is happening through some other mechanism?
As Katelyn's post says, it happens from the antibodies the mother's body develops in response to the vaccine (which do pass through milk) - not mRNA from the vaccine.
Great and timely article. Shared it with my lactation consultant and childbirth working friends. I appreciate the time and care you put into this endeavor!
Thank you for this! I help breastfeeding moms, and also help direct the nonprofit organization through which I volunteer. We value evidence-based information, and it is so handy to have the risks and benefits laid out all in one place.
Has any data been reviewed that addresses ideal timing of receiving a vaccine or booster, during pregnancy, in order to best protect mother during pregnancy and baby afterward? If I'm reading this correctly, anytime seems to be helpful for baby's protection after birth?
I wonder which is better: vaccine while pregnant (I wouldn't be due for the new booster until about 36 weeks) or vaccine while breastfeeding. I'm struggling with that decision. Since there is no guarantee I will be successful with breastfeeding, I'm leaning towards while pregnant. Though I do like the possibility of 6 months of antibodies in breastmilk.
I think it's better to get when pregnant, as COVID is worse for pregnant people than breastfeeding people, I believe. But, for what it's worth, I got my first booster when pregnant and just got the bivalent booster while breastfeeding (well, pumping). Which is to say, there will probably be another booster when you are feeding your baby, so I wouldn't wait. :)
Since there is no guarantee I will be successful with breastfeeding… you can be very successful with the correct information about breastfeeding and with help. You’ve got this mama!! I suggest watching videos on how to latch a baby and learn what to expect the first 2 weeks of breastfeeding. Look for an IBCLC now. Almost all insurances pay for 4-6 visits. Good luck and congratulations!!
I was not successful with my last child despite seeing a IBCLC and SLP (no further need for SLP, suck and swallow was normal). But this isn't the place to discuss it. Thank you for the support.
No. There is no guarantee even with all those things.
I understand as I am an IBCLC. My comment was made bc I find that a lot of moms do not know that their insurance covers lactation visits. It was not posted to be debated here.
Yeah for vaccine information! Thank you!
Is this strictly about initial vaccination series or does this also include booster (3rd or 4th) shot during pregnancy? Do I create the same levels of antibodies with a booster to pass through the placenta as a person who completes their initial series during pregnancy?