Increased preterm birth and lack of effect on all-cause lower respiratory tract infections are serious limitations to the evidence base and should warrant larger RCTs
In other words this is a product being given to healthy young people with no definite data supporting its benefit and data that are suspicious for a net harm … is that a fair assessment?
Vinay, please give us your observations on the ADULT RSV vaccines too. I have held off on recommending until there was more safety data regarding new onset a-fib and guillain barre syndrome. I do not trust info from CDC anymore.
Yes please give us your take on the adult RSV vax. My two friends in their 80s received the shot and have been sick with URI symptoms, fatigue, dizziness and weakness for 2 weeks. They also received the “pneumonia” shot a couple days before, and a shingles booster same day as the RSV vax. This is crazy. These poor senior citizens are just blindly following their PCPs advice.
I had some patients come in, I'd ask if they had any questions, and then AFTER I gave the shot ask, "what is RSV anyway?" I learned to ask more specific questions.
No one comes in with any idea that its recommended (if that's even the right word in this case) only for 60+ AND high risk. We even had a complaint to the board when we refused someone.
Update: it’s now 3 weeks and my sweet friends are no better. They are not complainers- we have to pull information out of them. They now describe their arms and legs “not working right”, they’re sleeping excessively. These were 2 very active people prior to this. Both received the RSV vaccine the same day as shingles vax, and 4 days after a “pneumonia” shot.
Sounds like GBS is a distinct possibility. I’m getting very concerned.
Pfizer and Moderna have so many shots in development using the new mRNA platform, who would go near it at this point?
The March 28 investors meeting Moderna held, it’s all about sales, nothing to do with health. Just read the assessment of market opportunities, 1 in 200 babies are born with this or that, they will be able to find 100’s of things they will make a case that we should be stimulating the immune system for.
How about reserve the shots for the 1 in 1000th child that is born and determined to not have a properly functioning immune system. In wildlife management, disease and harsh winters are viewed as a positive to strengthen the herd, remove the weak and leave valuable resources for the healthy and young. Being human, advances in technology have allowed us to escape this harsh reality, but our over zealous approach to one size fits all in public health initiatives has bit us in the ass. We are injecting nearly all perfectly healthy babies with products that have known toxins, unless the parents are willing to be stigmatized as the worst of all possible things, the antivaxxer. But look at the vaxx verse unvaxxd studies, there is a compelling case that not only is vaccinating not beneficial, it’s likely detrimental.
More and more shots and higher and higher rates of chronic sickness have gone hand in hand. There are many things going on from processed foods, toxins in the environment to ever increasing vaccinations. With many of the problems relate to autoimmune issues, how could it be that the one thing on the list that it absolutely can’t be is the item that intentionally stimulates the immune system? One day it will be accepted that we over used vaccines and caused a disaster. But at this point they are still dreaming up as many as they can irrespective of there being a problem needing solving or not. All that matters is that pharma sales / profit go up.
It sure would be a bad time to be just finishing med school and entering the market right when doctors have fallen from the high pedestal of trust and respect that they had previously occupied for so long.
Well said! Thank you, Dag, for this thoughtful post.
Also many thanks to Vinay for educating us on this vaccine. I too, as one commenter wrote, would like to read an article speaking to your assessment of the RSV vaccine for the remainder of the population. As for now, I will advise my family and friends the same thing that I always advise when it comes to a new pharmaceutical agent: wait a few years and see what the data shows at that point before taking it. This advice has proven to be invaluable in the past few years.
Yes, we weren’t even to take an aspirin, nothing. I even’t stopped drinking coffee. I know profit for pharma is their one and only goal never mind about human lives.
I remember my mom telling me how she was offered that for morning sickness and declined (thank-God). But she has taken at least 4 Covid shots....she told me she believes in vaccines because she was raised during a time when she saw the german measles and FDR was in a wheelchair from polio.
I replied to that post with a bunch of the points that vinay was talking about and I had the most likes and comments (mine was in the top of the comments section) and she wouldn’t respond to my post. It was a legit post with good conversation challenging a few things she said-backed by data… and she wouldn’t respond. And responded to all the other posts below mine. I personally don’t like her. She’s too overconfident about things she’s had no context of. She’s not a provider
?? What was E. O. Glorifying? I take every shot that comes along, including cólera and the MMR. Missed that because I’m 87. And went to Mazatlan vía aire. Soon África again. IIRC eight COVID’s!
A new vaccine in pregnant women… she made it sound like it was all good and ready for all pregnant women… there were many researchers who had some concerns.
If it helps, because of what has happened and continues to happen to pregnant moms from the Covid vaccine, most are declining anymore or "other" vaccines. Trust is gone. (nurse)
Vinay -- Excellent post. Besides all the other criticisms that you and the commenters here have listed, let me add something: The researchers choice of words is a linguistic tell that they are really sales reps, not scientists. To keep in line with their pharma paymasters, they pitch the product to appear favorable in any way possible, irrespective of actual data. This is barely distinguishable from the tactics of a car salesman.
Thank you for this post. As I'm 19 weeks pregnant, I may be offered the RSV vaccine soon, so this is good information.
I am curious if you think the risk/benefit might look different depending on your circumstances. The one thing that might make me think of the vaccinating is the fact that I have a toddler at home, so there will be a much higher chance of exposure for my son than there was for my daughter. Would a study that looked only at younger siblings (who are statistically at higher risk of hospitalizations on infancy) show a more impressive result?
That is an excellent question! I wish I had answers.
When are you due?
I was due August 1st and asked the pediatrician if they'd be making sure to have nirvesumab available. He said you can just get the vaccine and not worry. I argued that with a late July birth that wouldn't get my baby through RSV season. A week later, the pharmacy protocols got updated to give it only September to January for pregnant women.
We've still gotten no guidance on whether we should stop it for 60+ high risk patients until September. We've returned remaining flu shots, but have heard nothing regarding RSV.
I also have an an issue with the pediatric trial and subsequent approval. Have you seen the study info on that one? Winter of 2020, odd endpoint, populations in eastern Europe and Africa. Curious to her your thoughts.
I found the Red Pill to be terribly bitter and depressing. Once you truly stare into the dark abyss of Western medicine with open eyes, it does indeed stare right back.
It is amazing watching a sharp intellect like Vinay wake up to this nightmare.
Stop experimenting on pregnant women. How is it possible any human being would run “experiments” on pregnant women, or on any woman of child bearing age.
Only sl. relevant, well w/re big pharma, yes …. Bag lost only clothes I was wearing. So pharmacia w/included Dr. free gave me necessary Rx for Lasix bp and edemia. Enough for two months and cost less than my copay!!!!
Would it be possible for VK Prasad biostatistic lab to review safety and efficacy, FDA approval process, conflict of interest with voting members.... for every vaccine approved in last 30 years?
In other words this is a product being given to healthy young people with no definite data supporting its benefit and data that are suspicious for a net harm … is that a fair assessment?
Vinay, please give us your observations on the ADULT RSV vaccines too. I have held off on recommending until there was more safety data regarding new onset a-fib and guillain barre syndrome. I do not trust info from CDC anymore.
Yes please give us your take on the adult RSV vax. My two friends in their 80s received the shot and have been sick with URI symptoms, fatigue, dizziness and weakness for 2 weeks. They also received the “pneumonia” shot a couple days before, and a shingles booster same day as the RSV vax. This is crazy. These poor senior citizens are just blindly following their PCPs advice.
I had some patients come in, I'd ask if they had any questions, and then AFTER I gave the shot ask, "what is RSV anyway?" I learned to ask more specific questions.
No one comes in with any idea that its recommended (if that's even the right word in this case) only for 60+ AND high risk. We even had a complaint to the board when we refused someone.
Update: it’s now 3 weeks and my sweet friends are no better. They are not complainers- we have to pull information out of them. They now describe their arms and legs “not working right”, they’re sleeping excessively. These were 2 very active people prior to this. Both received the RSV vaccine the same day as shingles vax, and 4 days after a “pneumonia” shot.
Sounds like GBS is a distinct possibility. I’m getting very concerned.
Thank-you
Pfizer and Moderna have so many shots in development using the new mRNA platform, who would go near it at this point?
The March 28 investors meeting Moderna held, it’s all about sales, nothing to do with health. Just read the assessment of market opportunities, 1 in 200 babies are born with this or that, they will be able to find 100’s of things they will make a case that we should be stimulating the immune system for.
How about reserve the shots for the 1 in 1000th child that is born and determined to not have a properly functioning immune system. In wildlife management, disease and harsh winters are viewed as a positive to strengthen the herd, remove the weak and leave valuable resources for the healthy and young. Being human, advances in technology have allowed us to escape this harsh reality, but our over zealous approach to one size fits all in public health initiatives has bit us in the ass. We are injecting nearly all perfectly healthy babies with products that have known toxins, unless the parents are willing to be stigmatized as the worst of all possible things, the antivaxxer. But look at the vaxx verse unvaxxd studies, there is a compelling case that not only is vaccinating not beneficial, it’s likely detrimental.
More and more shots and higher and higher rates of chronic sickness have gone hand in hand. There are many things going on from processed foods, toxins in the environment to ever increasing vaccinations. With many of the problems relate to autoimmune issues, how could it be that the one thing on the list that it absolutely can’t be is the item that intentionally stimulates the immune system? One day it will be accepted that we over used vaccines and caused a disaster. But at this point they are still dreaming up as many as they can irrespective of there being a problem needing solving or not. All that matters is that pharma sales / profit go up.
It sure would be a bad time to be just finishing med school and entering the market right when doctors have fallen from the high pedestal of trust and respect that they had previously occupied for so long.
Well said! Thank you, Dag, for this thoughtful post.
Also many thanks to Vinay for educating us on this vaccine. I too, as one commenter wrote, would like to read an article speaking to your assessment of the RSV vaccine for the remainder of the population. As for now, I will advise my family and friends the same thing that I always advise when it comes to a new pharmaceutical agent: wait a few years and see what the data shows at that point before taking it. This advice has proven to be invaluable in the past few years.
I don't understand why anyone would take ANY PHARMACEUTICAL while pregnant. Thalidomide teach us anything???
On the topic of Thalidomide - I just read an incredible book on this called “Wonder Drug” by Jennifer Vanderbes. Tale as old as time.
Yes, we weren’t even to take an aspirin, nothing. I even’t stopped drinking coffee. I know profit for pharma is their one and only goal never mind about human lives.
I remember my mom telling me how she was offered that for morning sickness and declined (thank-God). But she has taken at least 4 Covid shots....she told me she believes in vaccines because she was raised during a time when she saw the german measles and FDR was in a wheelchair from polio.
Was your mother living in Europe at the time? Thalidomide wasn’t available in the US.
A "normal" reader e.g. the general public or almost every MD on earth would not catch these obfuscations to cover up an ineffective "product" ...
I specifically remember when Emily Oster was glorifying this and I thought this woman is so dangerous….
I replied to that post with a bunch of the points that vinay was talking about and I had the most likes and comments (mine was in the top of the comments section) and she wouldn’t respond to my post. It was a legit post with good conversation challenging a few things she said-backed by data… and she wouldn’t respond. And responded to all the other posts below mine. I personally don’t like her. She’s too overconfident about things she’s had no context of. She’s not a provider
?? What was E. O. Glorifying? I take every shot that comes along, including cólera and the MMR. Missed that because I’m 87. And went to Mazatlan vía aire. Soon África again. IIRC eight COVID’s!
A new vaccine in pregnant women… she made it sound like it was all good and ready for all pregnant women… there were many researchers who had some concerns.
Same!
If it helps, because of what has happened and continues to happen to pregnant moms from the Covid vaccine, most are declining anymore or "other" vaccines. Trust is gone. (nurse)
https://open.substack.com/pub/operationuplift/p/what-my-patients-should-know-about?r=1tk31&utm_medium=ios
We at Operation Uplift posted this months ago; I don’t recommend these shots after studying the Arexvy studies in a deep dive.
Vinay -- Excellent post. Besides all the other criticisms that you and the commenters here have listed, let me add something: The researchers choice of words is a linguistic tell that they are really sales reps, not scientists. To keep in line with their pharma paymasters, they pitch the product to appear favorable in any way possible, irrespective of actual data. This is barely distinguishable from the tactics of a car salesman.
Thank you for this post. As I'm 19 weeks pregnant, I may be offered the RSV vaccine soon, so this is good information.
I am curious if you think the risk/benefit might look different depending on your circumstances. The one thing that might make me think of the vaccinating is the fact that I have a toddler at home, so there will be a much higher chance of exposure for my son than there was for my daughter. Would a study that looked only at younger siblings (who are statistically at higher risk of hospitalizations on infancy) show a more impressive result?
That is an excellent question! I wish I had answers.
When are you due?
I was due August 1st and asked the pediatrician if they'd be making sure to have nirvesumab available. He said you can just get the vaccine and not worry. I argued that with a late July birth that wouldn't get my baby through RSV season. A week later, the pharmacy protocols got updated to give it only September to January for pregnant women.
We've still gotten no guidance on whether we should stop it for 60+ high risk patients until September. We've returned remaining flu shots, but have heard nothing regarding RSV.
I also have an an issue with the pediatric trial and subsequent approval. Have you seen the study info on that one? Winter of 2020, odd endpoint, populations in eastern Europe and Africa. Curious to her your thoughts.
I found the Red Pill to be terribly bitter and depressing. Once you truly stare into the dark abyss of Western medicine with open eyes, it does indeed stare right back.
It is amazing watching a sharp intellect like Vinay wake up to this nightmare.
Article Information-Safety Concerns uses the term "birthing parent"...
Science,language and logic is being destroyed piece by piece....
Stop experimenting on pregnant women. How is it possible any human being would run “experiments” on pregnant women, or on any woman of child bearing age.
Really appreciate your efforts to male the Big Pharm activity available to the public.
Only sl. relevant, well w/re big pharma, yes …. Bag lost only clothes I was wearing. So pharmacia w/included Dr. free gave me necessary Rx for Lasix bp and edemia. Enough for two months and cost less than my copay!!!!
Pics: .Cleyet.org/eclipse
Would it be possible for VK Prasad biostatistic lab to review safety and efficacy, FDA approval process, conflict of interest with voting members.... for every vaccine approved in last 30 years?