So a young, but mathematically very adept med student is merely ‘disappointed’ in FDA ... 3+ years into a ‘pandemic’ with an IFR lower than the Asian Flu of 1957-58, which served as a pretext for the complete suspension of basic civil liberties guaranteed by the US constitution.
We’re 2+ years into a hastily enacted ‘vaccine’ regimen that prompted a 15-40% excess death increase in working-age people throughout the industrialized west.
We’re 2+ years into SCOTUS’ ignominious abdication of its responsibility to quash administrative overreach.
Even though we are both health care providers, we are not the same.
You want a stronger FDA. I just want to find someone who will sell me a rocket launcher.
Are you okay with the Hepatitis B vaccines being licensed in newborn babies using "In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy
One thing for sure now days...if the FDA approved something LOOK OUT....your life maybe at risk or others you love....need to get all the data available and secret documents the FDA used to make that decision...read it entirely ...and make up your own opinion. Remember this same FDA said the COVID vaccine was safe and effective...it was NOT.... and safe for pregnant folks....NEVER TESTED....and the myriad of female issues were known but never communicated to women. You truly risk a great deal if you do not look into this approval yourself....I personally do not trust any of their work!
Based on the table shown, this vaccination has no measurable efficacy. But the committee voted unanimously on the vaccine’s efficacy. What am I missing?
I disagree on one point: the FDA should not just require more disclosure and data from the manufacturer (e.g. Pfizer). The FDA should replicate the trial itself and make all such data available!
I had never watched an FDA meeting before, and so this one was quite enlightening. Your point questioning the wisdom of giving Pfizer the last word is well taken. Thanks.
I'm not sure that "We need a stronger FDA" follows from your article. An approval does not mean that everyone has to jump on the bandwagon. We need to have an understanding that the FDA is approving drugs based on safety and non-inferiority (not superiority). Is the RSV vaccine better than nothing for some people? Probably. Is the safety profile acceptable to those people? Probably. We do need doctors (and medical students) to analyze data in this way so that we can make informed decisions about who to give this RSV vaccine to. Just because the FDA approves it, doesn't mean everyone needs it.
Uh, I think you need to question some basic assumptions about RSV that have really weak empirical evidence, for example the "surge" in RSV. There are so many problems with monitoring this, and you accept a lot of propaganda points about how RSV works peddled by the people you criticize.
I get your overall gist and agree with your skepticism, but I think you seriously need to step back and review the empirical basis for the reasoning to have an RSV vaccine in the first place.
Pretty sure if you did, this entire narrative would fall apart. The RSV vaccine is rampant capitalism at work: if there's no market for your product, you have to create that market by forcing the product on people.
So, your critiques are taken, but the basic logic in the first place fails to identify a much greater issue. I promise you, if we had anything like basic measures that actually regulate people, we would have no discussion on an RSV vaccine and there would be efforts put into actual medical problems rather than creating artificial markets.
Unfortunately, the VRBPAC has become just a tool of Big Pharma. Medicine, at least academic medicine, has squandered their integrity for a few bucks. It will take decades to regain trust.
Some VRBPAC members are new but many are the same placeholders present for years. Dr Rubin, the editor for NEJM where clinical trials are published with data omissions or not, continues to sit as do members of the CDC and DHHS. There are not enough sitting members who do the RCT data analysis, research and understand the implications of the data results. The committee is selected by the FDA. It is not representative of the real world. As an aside how did Offit vote?
Excellent evaluation. Please everyone, let’s get the word out. I’ve sent to all my doctor and nurse friends. If doctors and nurses stop blindly following the FDA & other alphabet groups, we will have far fewer harmed infants, dead infants, autistic children, etc. Is the risk of RSV in infants worth all the repercussions / ramifications of premature birth?
Has everyone read TURTLES ALL the WAY DOWN, Vaxxine Myths, by now?
So a young, but mathematically very adept med student is merely ‘disappointed’ in FDA ... 3+ years into a ‘pandemic’ with an IFR lower than the Asian Flu of 1957-58, which served as a pretext for the complete suspension of basic civil liberties guaranteed by the US constitution.
We’re 2+ years into a hastily enacted ‘vaccine’ regimen that prompted a 15-40% excess death increase in working-age people throughout the industrialized west.
We’re 2+ years into SCOTUS’ ignominious abdication of its responsibility to quash administrative overreach.
Even though we are both health care providers, we are not the same.
You want a stronger FDA. I just want to find someone who will sell me a rocket launcher.
Are you okay with the Hepatitis B vaccines being licensed in newborn babies using "In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy
infants and children (up to 10 years of age) who were monitored for 5 days after each dose." ? Section 6.1 ( https://www.fda.gov/media/74274/download ). See summary for basis of approval for more details...Unfortunanly they don't give ages, control group, or any additional follow up beyond the 5 days ( https://wayback.archive-it.org/7993/20170723025131/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM244544.pdf )
What about the other Hepatitis B vaccine licensed for use in newborns that " In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration."? Section 6.1 ( https://www.fda.gov/media/119403/download ). In the summary for basis of approval Table 1. does show 11 studies with a total of 998 newborns in HBsAg negative mothers were studies (https://wayback.archive-it.org/7993/20170404184231/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110155.pdf ). The FDA has been captured for a long time
One thing for sure now days...if the FDA approved something LOOK OUT....your life maybe at risk or others you love....need to get all the data available and secret documents the FDA used to make that decision...read it entirely ...and make up your own opinion. Remember this same FDA said the COVID vaccine was safe and effective...it was NOT.... and safe for pregnant folks....NEVER TESTED....and the myriad of female issues were known but never communicated to women. You truly risk a great deal if you do not look into this approval yourself....I personally do not trust any of their work!
Based on the table shown, this vaccination has no measurable efficacy. But the committee voted unanimously on the vaccine’s efficacy. What am I missing?
Thanks for this thoughtful and thorough analysis.
I disagree on one point: the FDA should not just require more disclosure and data from the manufacturer (e.g. Pfizer). The FDA should replicate the trial itself and make all such data available!
I had never watched an FDA meeting before, and so this one was quite enlightening. Your point questioning the wisdom of giving Pfizer the last word is well taken. Thanks.
I'm not sure that "We need a stronger FDA" follows from your article. An approval does not mean that everyone has to jump on the bandwagon. We need to have an understanding that the FDA is approving drugs based on safety and non-inferiority (not superiority). Is the RSV vaccine better than nothing for some people? Probably. Is the safety profile acceptable to those people? Probably. We do need doctors (and medical students) to analyze data in this way so that we can make informed decisions about who to give this RSV vaccine to. Just because the FDA approves it, doesn't mean everyone needs it.
If other medical students are like Dave, there is hope.
The disgust I feel for the sycophants (aka FDA) is somewhat balanced by knowing that a future doctor has his head on straight
.
Laughter Is The Best Medicine:
If You Are Vaccinated ...
You’re The Reason We’re Not Sick.
- We’ve Been Laughing Our Asses Off At You.
That You Are Too Stupid To Realize It
Makes It Even Funnier
For All Of Us.
We Owe You One.
You Beautiful Morons You.
.
Uh, I think you need to question some basic assumptions about RSV that have really weak empirical evidence, for example the "surge" in RSV. There are so many problems with monitoring this, and you accept a lot of propaganda points about how RSV works peddled by the people you criticize.
I get your overall gist and agree with your skepticism, but I think you seriously need to step back and review the empirical basis for the reasoning to have an RSV vaccine in the first place.
Pretty sure if you did, this entire narrative would fall apart. The RSV vaccine is rampant capitalism at work: if there's no market for your product, you have to create that market by forcing the product on people.
So, your critiques are taken, but the basic logic in the first place fails to identify a much greater issue. I promise you, if we had anything like basic measures that actually regulate people, we would have no discussion on an RSV vaccine and there would be efforts put into actual medical problems rather than creating artificial markets.
Unfortunately, the VRBPAC has become just a tool of Big Pharma. Medicine, at least academic medicine, has squandered their integrity for a few bucks. It will take decades to regain trust.
Some VRBPAC members are new but many are the same placeholders present for years. Dr Rubin, the editor for NEJM where clinical trials are published with data omissions or not, continues to sit as do members of the CDC and DHHS. There are not enough sitting members who do the RCT data analysis, research and understand the implications of the data results. The committee is selected by the FDA. It is not representative of the real world. As an aside how did Offit vote?
Excellent evaluation. Please everyone, let’s get the word out. I’ve sent to all my doctor and nurse friends. If doctors and nurses stop blindly following the FDA & other alphabet groups, we will have far fewer harmed infants, dead infants, autistic children, etc. Is the risk of RSV in infants worth all the repercussions / ramifications of premature birth?
Has everyone read TURTLES ALL the WAY DOWN, Vaxxine Myths, by now?
And people wonder why vaccine hesitancy is increasing. We should eliminate all vaccine mandates for children immediately.
This is very helpful, thank you. I hope you'll do a similar analysis for RSV monoclonal antibodies for infants (nirsevimab).