Despite media headlines, a narrow approval was granted, which will make Moderna's vaccines far less available to children than they have been until now.
One of my main current "beefs" with all this as Dr Faust mentioned is that the pharma comps won't do the big trials, etc because why waste the time and money when the FDA is already laying out its criteria. This is just the start too. The same will happen with flu vaxes & others. It will be slowly whittled to fewer & fewer eligible for the shots because the mantra of "the healthy don't need all these shots" or "too many shots for kids" before 5, etc. They will appear to still care by not taking away all the vaxes although who knows a year or two from now what it looks like. But it's starting down the path of less & less reliance on vaxes/therapeutics & just do wholesome living with a wrist monitor.
Exactly...drip drip drip....of opinions wanting to distract critical thinking. Nancy...read the clinical trial yourself. And ask yourself what yiou would recommend: vaccinate all healthy children up to age 6 without any real efficacy data because ~0.2% of them might have underlying conditions that their docs haven't noticed.• Forget the pain of injection, fatigue, headache, nausea, crying, chills, loss of appetite the babies (and their mothers/families go through). Forget the 0.1% that get febrile seizes from the vaccine (per the trial which is not even designed to measure efficacy).
Nancy \the essay could be seen as deceitful and uses hard-core persuasion tactics to bypass critical scrutiny. On one hand, the essay implies the FDA is hiding the information used to form the decision but in another place acknowledges the "information" which is described as the "the Gold standard".
I’m confused about the wording of the limited approval. When a drug is fully FDA-approved for one indication, physicians can prescribe it “off-label” for other indications (? other patient populations). Does this apply to the pediatric Covid vaccine?
Yes we can prescribe off label. But insurance may not cover and public programs may not offer. And docs won't feel like they are protected, especially since a broader indication (EUA) got narrowed ("full approval"). This move specifically sets docs up to have exposure to risk if they off label prescribe, in my view.
Well the problem is going through more hoops to get the vax if you want your kids or even teens vaxed. They want to make it harder to just go to a pharmacy or wherever & get the shot. And keep in mind especially many lower ones on the economic scale will they fool around to get a clinic or doc to approve off label? Many won't. Add in the future Medicaid mess will make it worse. And many docs will say the guidance is just for the compromised, etc so I don't feel at ease okaying for your kids, whatever. Lots of potential hurdles ones who maybe don't have the time or money (which they may have to pay for if off label) won't bother with.
Yes, of course doctors can prescribed "off-label". Dr. F's post is deceitful. The vaccine will not be "DENIED" for use by physicians as language by Dr. F suggests over and over.
The only reason I can see for the use of these deceptive tactics (at a cost of integrity) by Dr. F...is around reimbursement. Can you imagine the $$ for ALL children under 6 years of age?
Title: No, the FDA did not actually fully approve Moderna's pediatric Covid-19 vaccine yesterday.
Sub-title: Despite media headlines, a narrow approval was granted, which will make Moderna's vaccines far less available to children than they have been until now.
Tactic used: Loaded negation
Effect on audience: “No” sets up a confrontation; implies author authority as the final and corrected opinion on the matter (as it incorporate all other older sources and corrects earlier errors); implies audience operating from misinformation.
But then....confrontation is the way of the day!!!!
see how you react to this paragraph:
"Vaccinations are not the problem, the problem is the way antivaxxers think and behave. They approach any discussions from a viewpoint of confrontation. It is ingrained in their behaviour! Anti-vaxxers are stubborn, unable to be open to alternative ideas, don't listen, react too emotionally, can't reason. And they use aggressive, bad-faith tactics like name calling."
Do you get my point? The description above could be applied to how we are in discussions about vaccine and trump. I have been called "crazy" right here in this post. we have started to mimic our "opponents". [[[did anyone flinch at the use of the word here--"opponents".]
Other notes on the original post's introduction:
--The word “actually” adds a rhetorical jab, implying others are wr or dishonest.
---The phrase “did not fully approve” uses technical hedging to suggest deception occurred—even if a form of approval was indeed granted.
----It negates a presumed belief or narrative (e.g., “The FDA approved it”), but it does so in a rhetorically loaded way, not neutrally.
the title and first lines could have been instead, for example:
What Did the FDA Actually Approve for Moderna's Pediatric COVID-19 Vaccine?
The headlines say one thing—but the fine print tells a different story.
On the surface, recent news coverage suggests the FDA has granted full approval for Moderna’s COVID-19 vaccine in children. Yet a closer examination reveals that the authorization applies only to a limited group of pediatric patients—those with pre-existing high-risk conditions. This shift marks a significant departure from the broader access previously available under emergency use authorization and raises questions about how regulatory decisions are communicated, interpreted, and implemented—especially in a new era of health policy leadership.
it promotes: analytical, thought-provoking attitudes that maintains factual integrity and prompts critical engagement from the reader: And hopefully, a want to get to the primary source and form independent opinions.
Yet another reason why I may feel forced to move out of the U.S., i.e. it's becoming increasingly impossible to trust what were once reliable agencies on basic health issues.
Title: No, the FDA did not actually fully approve Moderna's pediatric Covid-19 vaccine yesterday.
Sub-title: Despite media headlines, a narrow approval was granted, which will make Moderna's vaccines far less available to children than they have been until now.
Tactic used: Loaded negation
Effect on audience: “No” sets up a confrontation; implies author authority as the final and corrected opinion on the matter (as it incorporate all other older sources and corrects earlier errors); implies audience operating from misinformation.
But then....confrontation is the way of the day!!!!
see how you react to this paragraph:
"Vaccinations are not the problem, the problem is the way antivaxxers think and behave. They approach any discussions from a viewpoint of confrontation. It is ingrained in their behaviour! Anti-vaxxers are stubborn, unable to be open to alternative ideas, don't listen, react too emotionally, can't reason. And they use aggressive, bad-faith tactics like name calling."
Do you get my point? The description above could be applied to how we are in discussions about vaccine and trump. I have been called "crazy" right here in this post. we have started to mimic our "opponents". [[[did anyone flinch at the use of the word here--"opponents".]
Other notes on the original post's introduction:
--The word “actually” adds a rhetorical jab, implying others are wr or dishonest.
Well...my comment did deserve that. :) Just make up your own mind. Read the clinical trial that is used for the FDA decision and the commentary here. Don't take anyone's word on this topic. https://www.nejm.org/doi/full/10.1056/NEJMoa2211031
I will post later how I came to this point of view about only this article's thesis and why I say the post is deceptive. (I shouldn't have said Dr. F. is; just this post).
If there is a need for tribal confrontation...think more about the respect the continual erosion of respect for doctor's ability for independent decision-making (almost to AI think)...and what that means. Not application of vaccination per ACIP recommendations.
I have been reading your work and (I guess) I disagree with some items/opinions. (It is difficult to hold an opinion--and try communicate it--when almost all peers disagree with me and do so strongly.)
Your last article here there are these lines: “Come on boys, walk that walk! Let’s hash it out. I’m actually willing to change my mind on the merits of this decision, if the data are there.]”
I would like to take you up on that challenge as maybe a Letter to the Editor kind of thing. Will you read it (fairly) if I assemble the argument for you? [The guardrails: The argument will only focus on the topic of the last article and will maintain emotional control (hehe; it just a hot topic)]. karen
"So, my message to FDA leadership is this: Show your work."
It's doubtful that the FDA will respond to this substack post. You should submit a FOIA request.
For better or worse, FDA and HHS are aware of this newsletter. But I agree, that a FOIA would be ideal.
I will make sure everyone is aware of this post...and I will show all my work used to form the decision that post could be seen as deceitful.
One of my main current "beefs" with all this as Dr Faust mentioned is that the pharma comps won't do the big trials, etc because why waste the time and money when the FDA is already laying out its criteria. This is just the start too. The same will happen with flu vaxes & others. It will be slowly whittled to fewer & fewer eligible for the shots because the mantra of "the healthy don't need all these shots" or "too many shots for kids" before 5, etc. They will appear to still care by not taking away all the vaxes although who knows a year or two from now what it looks like. But it's starting down the path of less & less reliance on vaxes/therapeutics & just do wholesome living with a wrist monitor.
drip drip drip. exactly, Nancy
Exactly...drip drip drip....of opinions wanting to distract critical thinking. Nancy...read the clinical trial yourself. And ask yourself what yiou would recommend: vaccinate all healthy children up to age 6 without any real efficacy data because ~0.2% of them might have underlying conditions that their docs haven't noticed.• Forget the pain of injection, fatigue, headache, nausea, crying, chills, loss of appetite the babies (and their mothers/families go through). Forget the 0.1% that get febrile seizes from the vaccine (per the trial which is not even designed to measure efficacy).
Nancy \the essay could be seen as deceitful and uses hard-core persuasion tactics to bypass critical scrutiny. On one hand, the essay implies the FDA is hiding the information used to form the decision but in another place acknowledges the "information" which is described as the "the Gold standard".
I’m confused about the wording of the limited approval. When a drug is fully FDA-approved for one indication, physicians can prescribe it “off-label” for other indications (? other patient populations). Does this apply to the pediatric Covid vaccine?
Yes we can prescribe off label. But insurance may not cover and public programs may not offer. And docs won't feel like they are protected, especially since a broader indication (EUA) got narrowed ("full approval"). This move specifically sets docs up to have exposure to risk if they off label prescribe, in my view.
Well the problem is going through more hoops to get the vax if you want your kids or even teens vaxed. They want to make it harder to just go to a pharmacy or wherever & get the shot. And keep in mind especially many lower ones on the economic scale will they fool around to get a clinic or doc to approve off label? Many won't. Add in the future Medicaid mess will make it worse. And many docs will say the guidance is just for the compromised, etc so I don't feel at ease okaying for your kids, whatever. Lots of potential hurdles ones who maybe don't have the time or money (which they may have to pay for if off label) won't bother with.
YUP!!!!
Yes, of course doctors can prescribed "off-label". Dr. F's post is deceitful. The vaccine will not be "DENIED" for use by physicians as language by Dr. F suggests over and over.
The only reason I can see for the use of these deceptive tactics (at a cost of integrity) by Dr. F...is around reimbursement. Can you imagine the $$ for ALL children under 6 years of age?
Don’t understand what you think is deceitful or deceptive.
just the title:
Title: No, the FDA did not actually fully approve Moderna's pediatric Covid-19 vaccine yesterday.
Sub-title: Despite media headlines, a narrow approval was granted, which will make Moderna's vaccines far less available to children than they have been until now.
Tactic used: Loaded negation
Effect on audience: “No” sets up a confrontation; implies author authority as the final and corrected opinion on the matter (as it incorporate all other older sources and corrects earlier errors); implies audience operating from misinformation.
But then....confrontation is the way of the day!!!!
see how you react to this paragraph:
"Vaccinations are not the problem, the problem is the way antivaxxers think and behave. They approach any discussions from a viewpoint of confrontation. It is ingrained in their behaviour! Anti-vaxxers are stubborn, unable to be open to alternative ideas, don't listen, react too emotionally, can't reason. And they use aggressive, bad-faith tactics like name calling."
Do you get my point? The description above could be applied to how we are in discussions about vaccine and trump. I have been called "crazy" right here in this post. we have started to mimic our "opponents". [[[did anyone flinch at the use of the word here--"opponents".]
Other notes on the original post's introduction:
--The word “actually” adds a rhetorical jab, implying others are wr or dishonest.
---The phrase “did not fully approve” uses technical hedging to suggest deception occurred—even if a form of approval was indeed granted.
----It negates a presumed belief or narrative (e.g., “The FDA approved it”), but it does so in a rhetorically loaded way, not neutrally.
the title and first lines could have been instead, for example:
What Did the FDA Actually Approve for Moderna's Pediatric COVID-19 Vaccine?
The headlines say one thing—but the fine print tells a different story.
On the surface, recent news coverage suggests the FDA has granted full approval for Moderna’s COVID-19 vaccine in children. Yet a closer examination reveals that the authorization applies only to a limited group of pediatric patients—those with pre-existing high-risk conditions. This shift marks a significant departure from the broader access previously available under emergency use authorization and raises questions about how regulatory decisions are communicated, interpreted, and implemented—especially in a new era of health policy leadership.
it promotes: analytical, thought-provoking attitudes that maintains factual integrity and prompts critical engagement from the reader: And hopefully, a want to get to the primary source and form independent opinions.
I will show you.
Yet another reason why I may feel forced to move out of the U.S., i.e. it's becoming increasingly impossible to trust what were once reliable agencies on basic health issues.
If we can't do preventive medicine right, we will be hosed for sure.
ust the title:
Title: No, the FDA did not actually fully approve Moderna's pediatric Covid-19 vaccine yesterday.
Sub-title: Despite media headlines, a narrow approval was granted, which will make Moderna's vaccines far less available to children than they have been until now.
Tactic used: Loaded negation
Effect on audience: “No” sets up a confrontation; implies author authority as the final and corrected opinion on the matter (as it incorporate all other older sources and corrects earlier errors); implies audience operating from misinformation.
But then....confrontation is the way of the day!!!!
see how you react to this paragraph:
"Vaccinations are not the problem, the problem is the way antivaxxers think and behave. They approach any discussions from a viewpoint of confrontation. It is ingrained in their behaviour! Anti-vaxxers are stubborn, unable to be open to alternative ideas, don't listen, react too emotionally, can't reason. And they use aggressive, bad-faith tactics like name calling."
Do you get my point? The description above could be applied to how we are in discussions about vaccine and trump. I have been called "crazy" right here in this post. we have started to mimic our "opponents". [[[did anyone flinch at the use of the word here--"opponents".]
Other notes on the original post's introduction:
--The word “actually” adds a rhetorical jab, implying others are wr or dishonest.
The "once reliable" and "impossible to trust" secret agent here is Dr. F himself.
If you're talking about Dr. Faust or maybe Dr. Fauci, go sell crazy somewhere else.
Well...my comment did deserve that. :) Just make up your own mind. Read the clinical trial that is used for the FDA decision and the commentary here. Don't take anyone's word on this topic. https://www.nejm.org/doi/full/10.1056/NEJMoa2211031
I will post later how I came to this point of view about only this article's thesis and why I say the post is deceptive. (I shouldn't have said Dr. F. is; just this post).
If there is a need for tribal confrontation...think more about the respect the continual erosion of respect for doctor's ability for independent decision-making (almost to AI think)...and what that means. Not application of vaccination per ACIP recommendations.
Hi Dr. Faust,
I have been reading your work and (I guess) I disagree with some items/opinions. (It is difficult to hold an opinion--and try communicate it--when almost all peers disagree with me and do so strongly.)
Your last article here there are these lines: “Come on boys, walk that walk! Let’s hash it out. I’m actually willing to change my mind on the merits of this decision, if the data are there.]”
I would like to take you up on that challenge as maybe a Letter to the Editor kind of thing. Will you read it (fairly) if I assemble the argument for you? [The guardrails: The argument will only focus on the topic of the last article and will maintain emotional control (hehe; it just a hot topic)]. karen