Thanks for this! Your reputation for prudent caution makes this endorsement even more meaningful for primary care docs like me who are reading and filtering, then educating and recommending.
I am troubled slightly by the GBS potential and I’m sure you’ll be watching this closely too. Helen Branswell wrote a good piece recently about these RSV vaccines:
“The background rate of GBS — the rate at which it occurs in the general population — is about 1 case per 100,000 people per year. Three cases in less than half that number — the people vaccinated in the adult RSV trials — gave pause to the members of ACIP’s adult RSV work group…”
I have at least 3 patients who experienced GBS within a suspicious time frame after flu shots, which seems like more than I should see based on the probability. Nonetheless I know experts and advisory committees do the tough and thankless job of weighing risks and benefits, so once again, thanks! I get a flu shot every year of course.
I'm a layperson but know enough to know this is great news and a vaccine I will get not too many years from now. I do have a question for anyone who knows and would be so kind as to answer. With the COVID vaccine, much of the medical establishment repeatedly said that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness." And that was indeed news to me. I knew that they were not 100 percent effective, but I never knew that vaccines in general were not developed and intended to prevent infection with whatever virus they were developed to prevent. And what jumps out at me with this RSV Vax is that it too prevents infection. My question is, do most vaccines actually prevent infection despite what the public was told after discovering that the COVID vaccines did not prevent infection? Pertinent quotation here: "Participants were studied for one year. Those who received the vaccine reduced their risk of RSV acute respiratory infection by 72 percent, of RSV pneumonia by 83 percent, and of severe RSV disease requiring supplemental oxygen or hospitalization by 94 percent." I don't know that Dr. Offit said this and don't mean this to be anything but a sincere question. My feeling is that the medical establishment sort of bent the truth on how vaccines work in order to avoid further public anger in general which was already prevalent with the COVID vax. Thanks.
Long time reader of Dr Offit, haven't seen him reply much in comment section - hope that changes.
My thoughts:
TP: "With the COVID vaccine, much of the medical establishment repeatedly said that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness.""
This was clearly retconning/rewrite of history and you can't blame these people, as they had pushed to get you fired, barred from school, chastised, fined, humiliated if you weren't sold on taking the Covid vaccine as there justification was that the vaccine would stop transmission and end the pandemic - and without everyone taking it Covid would continue to run rampant.
They based this off direct messaging and literal words from public health (Fauci, Wallenksy), the manufacturers of the vaccine (Bourla), our government (Biden), our media (CNN, MSNBC, NYT)
This is what was told to us, repeatedly, which was why there was bipartisan support for the mandates, and firings, and fines.
During the summer of 2021, as the vaccinated stated getting infected, Public Health/Media kept trying to frame this as "Breakthrough cases", but by fall 2021 when it was apparent everyone with the vaccine was getting covid anyway across the globe, that is when this new claim that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness" was peddled.
you can't blame, them, they looked like idiots for just months prior arguing it is just to fire a physician who would rather not take this vaccine, or to bar someone from attending university, so of course they had to lie and make up this false narrative that "we knew all along it wouldn't prevent infection".
Complete bullshit.
To your larger question, what you speak of is sterilizing immunity, which not all vaccines grant.
Respiratory vaccines in particular we have not had good luck with (see the frequent failure of yearly flu vaccines for example). It's very complex why, and we don't have all the answers.
For this particular RSV study, note that it covers only a 6.7 time frame if I am reading the clinical trial data correctly.
40 cases vs 7 cases out of 12,500 per arm (placebo vs intervention). Wonder what happens to the intervention arm on month 12? 15? 24? Could they be more likely to catch RSV than Placebo as we saw happened with Covid vaccine (and this was a known concern of Covid Vaccines as noted by Ralph Baric himself)?
If we vaccinated all 70 million elderly adults with the RSV vaccine, would RSV go the way of Smallpox, or, would it simply mutate a bit to step aside the vaccine like the Flue and Covid?
And as I recall, they thought it did prevent infection until Delta came along. I just feel gaslight by the entire COVID vax debacle and if I do, lots of people do. And that makes me worry about ongoing eroding trust in medical professionals. I was wondering about the respiratory viruses too, and you have validated that the vaccines for them are more difficult or complex as you say. Presumably because of mutations. Anyway, thank you. Appreciate your input.
The larger population certainly feels gaslit, this is why barely anyone bothered to vaccinate their kids, why booster programs collapsed, why countries around the world are throwing out millions of shots no one wants anymore despite demand being incredible early on (remember people lying about age and comorbidities to get in line faster? Feels like a decade ago).
We see that this collapse in trust has now cascaded in other areas - childhood vaccines for example are declining low as noted by the NYT, and this is independent of the drop off in well visits during 2020. The public has rebelled, so some extent. Unclear if this lasts or just a temporary phase.
As I pointed out in an earlier comment to Dr. Offit (primarily directed at Dr. Gorski) [1] - it wasn't a secret we weren't good at ILI vaccines "As recent as 2018 you can find Michael Osterholm saying about flu vaccines "It's much more complicated than we thought," Osterholm says. "I know less about influenza today than I did 10 years ago." in Science Magazine in an article titled "Why Flu Vaccines so Often Fail" [2]
It's puzzling to see PH pretend this wasn't the case temporarily in our hysteria for a Covid vaccine. Well, not puzzling, very fascinating to see the psychology at work when we get unnecessarily scared of something at a population level - the lengths we will go to deceive ourselves.
Gaslighting basically refers to making people feel crazy as a power play, right? The benefits of the mRNA vaccines consistently outweighed the risks. A lack of 100% efficacy, and a lack of 100% safety, are what have driven much of the public away from vaccines, not gaslighting. People are notoriously unable to balance relative and absolute risks in their brains. Gaslighting by the medical community was not the primary driver here, but I’m sure doctor exasperation existed as we worked very hard to persuade patients to get free shots that were MUCH better than taking their chances with COVID.
There’s lots of data to support this, and if you cling to the small but real risks of vaccination exclusively, then you are doing something worse than gaslighting, you are fear mongering and conspiracy driving. That contributes to death and disability and sadness.
Ryan, I am sure you are a wonderful physician, but you are out of touch on why the entire world has turned against the Covid vaccines.
It isn't because they were told they were 95% effective at preventing infection and transmission and it turned out to be 80%, or some lower number.
They turned against them because they were advertised as a vaccine to prevent infection, and it turned out they did not such thing - in fact it's possible they increased your chances of infection [1] which wouldn't be a surprise, because pre-2020, that was a concern of coronavirus vaccines [2].
The public was convinced by Fauci, Wallensky, Bourla, Bancel, Biden, Maddow, Colbert, and the entire PH apparatus that these shots were the key to ending the pandemic, would prevent you from getting infected and become (in the words of Fauci) "a dead end fo the virus".
That turned out to be 100% incorrect.
As 2021 progressed and we started seeing the vaccinated get Covid anyway, the press (via the messaging from Fauci) kept calling these "rare breakthrough cases" and were adamant there was no need to be alarmed. Is it "rare" when literally every single public official got Covid *after* they were vaccinated? Biden getting it, sure, that could be breakthrough. Biden, Jill, Fauci, Bourla, Maddow, Bancel - multiple times too - that's not a "lack of 100% efficacy". It's 100% lack of efficacy.
It was clear to anyone following Israel, which saw the vaccines fail at stopping transmission first, that they didn't do what they were promised.
And here is where the gaslighting comes in.
Rather than own up, and remind everyone "science is a process", and it evolves with new information, and as it turns, they were all wrong about the efficacy, they lied and acted like this was always known, pretended they never said the vaccines wouldn't stop transmission or infection. No, instead they now claimed the vaccine merely lowered chance of bad outcome from Covid, and it was our fault for not understanding the limits of what the vaccine could do.
Unreal.
All of this gaslighting might have been easier if we didn't have them on record saying all this bullshit late 2020 through early 2021. "We have the receipts", so the expression go.
And furthermore, we know it wasn't even a "noble lie", because these people pushed to mandate the vaccine. They pushed to fire medical staff who were uneasy taking the fastest vaccine developed in history, using a platform never rolled out to humans on mass scale [3], against a class of pathogens we had never come close to making an effective vaccine before.
They wanted children barred from school, cancer patient revoked treatment, and firefighters sidelined for any hesitancy because they claimed this was the only way to stop the pandemic.
They can't say "we didn't say the shot would block infection" because that wouldn't make sense on mandate vaccine anymore than mandating statins.
They honestly believed it, were wrong, and when realized they were wrong, rather than admit error, they gaslit.
That's why only 20% bothered to vaccinate their kids, whey few showed up for the booster and even fewer for the biavlent. Why country after country is throwing their unused surplus out. Why Pfizer stock is right back to where it was pre 2020. Why the 3rd world countries we earmarked millions of shots for don't even want them.
Ridiculous to cast my description of reality "fear mongering and conspiracy driving" - that, is gaslighting.
/rant. Sorry a little aggravated tonight, rough week, and I expect to be smarter than this.
__________________
[1] Rather than cite the Cleveland Clinic study showing this, I will show the fact check of that study, because the flimsiness and desperation of the "Fact Check" is even more compelling than the actual CC study
You could of course, simply look at state by state, country by country, cases and all-cause mortality before and after vaccines to see they were no more effective than a placebo and any observational study data drudged up to show the opposite is easily refuted by it's inability to predict anything or replicate.
[2] As recorded by Dan Werb interviewing the Titan of Coronavirology Ralph Baric
"Baric knew that vaccines that didn’t accurately match their targets could weaken human resistance and inadvertently make people who were inoculated sicker.
“Baric was one of the few scientists who saw the stakes clearly. It wasn’t that an eventual SARS vaccine might work or not. It was that a vaccine could be either an antidote or a poison for a future pandemic-ready coronavirus, and there might be no way to tell them apart until it was too late.
p97 The Invisible Siege
[3] Honestly I might be quite wrong on this claim. My understanding is that this was the first time we rolled out mRNA beyond clinical trial phase. I have nothing against the platform. I just wouldn't personally invest much in the stocks of companies pushing it because it's first test was a complete failure and I am a conservative investor.
Hi Michael, while I do appreciate that much of what you’re saying has truth to it, and I’m certainly not going to change your mind commenting, I would point out that there is a lot of absolutism in your thinking. The whole world has not turned against vaccines, and very little in life is 100%.
Blaming people for some real time lane shifts by leaders and experts as this thing played out in real time is not ok. Otherwise you get leaders like Bolsonaro who try to act like they are omnipotent and omniscient, and their strong man approach to uncertainty with certainty leads to hundreds of thousands of people dying unnecessarily in their countries. That unwavering stance pleases a certain mindset of people who cannot handle uncertainty and vagary and flip flopping, but that’s what we need to acknowledge is necessary as something like this mutates and we learn more.
I’ll just conclude that mRNA vaccines have saved millions of lives, prevented hundreds of millions of cases which can lead to permanent damage and disability, and have resulted in a comparatively small number of deaths and disabilities…which we can all agree would never have been an absolute number like 0.
I'm going to read those linked pieces, so thank you. I'm still not positive what I think the truth is. Yes, I recall people lying to get one early, since I was one of those people. And to be clear, I still haven't had COVID yet. But about six or eight months ago i pretty much gave up on the hope that I would never get it and went back to my normal pre pandemic life. But, to be fair, there are therapeutics that we didn't have at the beginning of the pandemic that are partially responsible for my greater comfort that I am not going to get terribly ill or die if I get COVID. Still, as a citizen, I feel gaslit. But as a realist, I am not sure I blame doctors in general as yet. With so much of the population believing crazy conspiracy theories and with the ever evolving virus, I feel for public health professionals. It's been a huge challenge and could become even a greater challenge if this virus mutates or the next virus is worse. As you say, it is fascinating to see the psychology at work. And I assume, for public health officials, it must be terrifying at the same time. I hope the trust issues are temporary but only time will tell. There are amazing advances being made in medicine in part due to the mRNA technology so I try to focus on the big picture. And I try to be comfortable in the knowledge that we are not going to know the outcome of all of this for a very long time. The public most certainly has rebelled. And I guess I don't blame them.
1) If there 3 million cases a year against 77 million people > 60, why were the numbers of RSV cases in the placebo group (40 out of 12,499) so low by ratio? Granted the study period was only 6.7 months, but even that is a nearly a 6-fold decrease in cases in observed study population against the estimate. I would think the estimate would be undercounted as we don't PCR surveil the population for RSV like you would in a trial.
Is this concerning at all? It would suggest either our estimates are wildly off, and we are attacking a problem nearly a magnitude smaller than it is, or, that the GSK trial failed to accurately capture RSV burden and was underpowered.
Now the study does attempt to answer this, making the debatable claim that "Public Health measures to limit Covid-19 transmission reduced the spread of RSV and altered the RSV season" - but if that is the case, wouldn't the prudent approach be to study your vaccine in a regular RSV season before declaring victory? Flu disappeared in 2020 as well (even in countries that didn't mask or distance), would we trust a new Flu vaccine only tested in 2020?
2) I've got 16 years before I would have to consider this shot, but it's a tough sell to take a shot that reduces risk of catching a cold from 40/12,500 down to 7/12,500, when 879/12,500 experienced pain or fatigue.
3) Let's say 10,000 elderly people with diabetes, chronic heart, lung, or kidney disease die each year due to pneumonia following an RSV infection. Do we expect 8,250 of those elderly people not to die that year if vaccinated? Or, would we just whack-a-mole it so another of the hundreds (?) of respiratory viruses takes the place of RSV, and some other virus of opportunity infects the elderly person, causes pneumonia, and the outcome is no different?
I know this is speculative questioning but it seems to me the true measure of efficacy would be if the study also measured overall mortality with a focus on all-cause ILI triggered deaths.
I'm just thinking about when my grandfather passed in 2018, he was very frail already, sitting in a nursing home with late stage Alzheimer's, declining rapidly since his wife passed the year before. Eventually some cold got him, then hospitalized, pneumonia, living will says no vent, they make him comfortable and that's it. 87, lived an amazing life, but didn't know much about the last 4-5 years.
All the way back then we weren't PCR testing to trace every cold source, so who knows what pushed the domino. RSV? Flu? a regular Coronavirus? Any of the other hundreds of ILI?
Even if it was RSV, I just can't imagine had he been vaccinated with RSV that his outcome within a month or two would have been any different, and it seems to me this type of death is what mainly comprises the 10,000 RSV yearly fatalities.
Hope it works though, even if ROI is sketchy (3.5 billion a year to vaccinate yearly everyone 60+)
Looks like 49/12467 (intervention) vs 58/12499 (placebo). Even if difference attributed to the vaccine and all confounders accounted for, it's a .0007 difference. SAE not yet reported beyond this.
Thanks for this! Your reputation for prudent caution makes this endorsement even more meaningful for primary care docs like me who are reading and filtering, then educating and recommending.
I am troubled slightly by the GBS potential and I’m sure you’ll be watching this closely too. Helen Branswell wrote a good piece recently about these RSV vaccines:
“The background rate of GBS — the rate at which it occurs in the general population — is about 1 case per 100,000 people per year. Three cases in less than half that number — the people vaccinated in the adult RSV trials — gave pause to the members of ACIP’s adult RSV work group…”
https://www.statnews.com/2023/05/26/rsv-vaccines-will-older-adults-care/
I have at least 3 patients who experienced GBS within a suspicious time frame after flu shots, which seems like more than I should see based on the probability. Nonetheless I know experts and advisory committees do the tough and thankless job of weighing risks and benefits, so once again, thanks! I get a flu shot every year of course.
I'm a layperson but know enough to know this is great news and a vaccine I will get not too many years from now. I do have a question for anyone who knows and would be so kind as to answer. With the COVID vaccine, much of the medical establishment repeatedly said that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness." And that was indeed news to me. I knew that they were not 100 percent effective, but I never knew that vaccines in general were not developed and intended to prevent infection with whatever virus they were developed to prevent. And what jumps out at me with this RSV Vax is that it too prevents infection. My question is, do most vaccines actually prevent infection despite what the public was told after discovering that the COVID vaccines did not prevent infection? Pertinent quotation here: "Participants were studied for one year. Those who received the vaccine reduced their risk of RSV acute respiratory infection by 72 percent, of RSV pneumonia by 83 percent, and of severe RSV disease requiring supplemental oxygen or hospitalization by 94 percent." I don't know that Dr. Offit said this and don't mean this to be anything but a sincere question. My feeling is that the medical establishment sort of bent the truth on how vaccines work in order to avoid further public anger in general which was already prevalent with the COVID vax. Thanks.
Long time reader of Dr Offit, haven't seen him reply much in comment section - hope that changes.
My thoughts:
TP: "With the COVID vaccine, much of the medical establishment repeatedly said that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness.""
This was clearly retconning/rewrite of history and you can't blame these people, as they had pushed to get you fired, barred from school, chastised, fined, humiliated if you weren't sold on taking the Covid vaccine as there justification was that the vaccine would stop transmission and end the pandemic - and without everyone taking it Covid would continue to run rampant.
They based this off direct messaging and literal words from public health (Fauci, Wallenksy), the manufacturers of the vaccine (Bourla), our government (Biden), our media (CNN, MSNBC, NYT)
This is what was told to us, repeatedly, which was why there was bipartisan support for the mandates, and firings, and fines.
During the summer of 2021, as the vaccinated stated getting infected, Public Health/Media kept trying to frame this as "Breakthrough cases", but by fall 2021 when it was apparent everyone with the vaccine was getting covid anyway across the globe, that is when this new claim that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness" was peddled.
you can't blame, them, they looked like idiots for just months prior arguing it is just to fire a physician who would rather not take this vaccine, or to bar someone from attending university, so of course they had to lie and make up this false narrative that "we knew all along it wouldn't prevent infection".
Complete bullshit.
To your larger question, what you speak of is sterilizing immunity, which not all vaccines grant.
Respiratory vaccines in particular we have not had good luck with (see the frequent failure of yearly flu vaccines for example). It's very complex why, and we don't have all the answers.
For this particular RSV study, note that it covers only a 6.7 time frame if I am reading the clinical trial data correctly.
40 cases vs 7 cases out of 12,500 per arm (placebo vs intervention). Wonder what happens to the intervention arm on month 12? 15? 24? Could they be more likely to catch RSV than Placebo as we saw happened with Covid vaccine (and this was a known concern of Covid Vaccines as noted by Ralph Baric himself)?
If we vaccinated all 70 million elderly adults with the RSV vaccine, would RSV go the way of Smallpox, or, would it simply mutate a bit to step aside the vaccine like the Flue and Covid?
I don' know. Neither does GSK though.
And as I recall, they thought it did prevent infection until Delta came along. I just feel gaslight by the entire COVID vax debacle and if I do, lots of people do. And that makes me worry about ongoing eroding trust in medical professionals. I was wondering about the respiratory viruses too, and you have validated that the vaccines for them are more difficult or complex as you say. Presumably because of mutations. Anyway, thank you. Appreciate your input.
The larger population certainly feels gaslit, this is why barely anyone bothered to vaccinate their kids, why booster programs collapsed, why countries around the world are throwing out millions of shots no one wants anymore despite demand being incredible early on (remember people lying about age and comorbidities to get in line faster? Feels like a decade ago).
We see that this collapse in trust has now cascaded in other areas - childhood vaccines for example are declining low as noted by the NYT, and this is independent of the drop off in well visits during 2020. The public has rebelled, so some extent. Unclear if this lasts or just a temporary phase.
As I pointed out in an earlier comment to Dr. Offit (primarily directed at Dr. Gorski) [1] - it wasn't a secret we weren't good at ILI vaccines "As recent as 2018 you can find Michael Osterholm saying about flu vaccines "It's much more complicated than we thought," Osterholm says. "I know less about influenza today than I did 10 years ago." in Science Magazine in an article titled "Why Flu Vaccines so Often Fail" [2]
It's puzzling to see PH pretend this wasn't the case temporarily in our hysteria for a Covid vaccine. Well, not puzzling, very fascinating to see the psychology at work when we get unnecessarily scared of something at a population level - the lengths we will go to deceive ourselves.
____
[1] https://pauloffit.substack.com/p/do-children-really-need-a-covid-vaccine/comment/14281197
[2] https://www.sciencemag.org/news/2017/09/why-flu-vaccines-so-often-fail
Gaslighting basically refers to making people feel crazy as a power play, right? The benefits of the mRNA vaccines consistently outweighed the risks. A lack of 100% efficacy, and a lack of 100% safety, are what have driven much of the public away from vaccines, not gaslighting. People are notoriously unable to balance relative and absolute risks in their brains. Gaslighting by the medical community was not the primary driver here, but I’m sure doctor exasperation existed as we worked very hard to persuade patients to get free shots that were MUCH better than taking their chances with COVID.
There’s lots of data to support this, and if you cling to the small but real risks of vaccination exclusively, then you are doing something worse than gaslighting, you are fear mongering and conspiracy driving. That contributes to death and disability and sadness.
Ryan, I am sure you are a wonderful physician, but you are out of touch on why the entire world has turned against the Covid vaccines.
It isn't because they were told they were 95% effective at preventing infection and transmission and it turned out to be 80%, or some lower number.
They turned against them because they were advertised as a vaccine to prevent infection, and it turned out they did not such thing - in fact it's possible they increased your chances of infection [1] which wouldn't be a surprise, because pre-2020, that was a concern of coronavirus vaccines [2].
The public was convinced by Fauci, Wallensky, Bourla, Bancel, Biden, Maddow, Colbert, and the entire PH apparatus that these shots were the key to ending the pandemic, would prevent you from getting infected and become (in the words of Fauci) "a dead end fo the virus".
That turned out to be 100% incorrect.
As 2021 progressed and we started seeing the vaccinated get Covid anyway, the press (via the messaging from Fauci) kept calling these "rare breakthrough cases" and were adamant there was no need to be alarmed. Is it "rare" when literally every single public official got Covid *after* they were vaccinated? Biden getting it, sure, that could be breakthrough. Biden, Jill, Fauci, Bourla, Maddow, Bancel - multiple times too - that's not a "lack of 100% efficacy". It's 100% lack of efficacy.
It was clear to anyone following Israel, which saw the vaccines fail at stopping transmission first, that they didn't do what they were promised.
And here is where the gaslighting comes in.
Rather than own up, and remind everyone "science is a process", and it evolves with new information, and as it turns, they were all wrong about the efficacy, they lied and acted like this was always known, pretended they never said the vaccines wouldn't stop transmission or infection. No, instead they now claimed the vaccine merely lowered chance of bad outcome from Covid, and it was our fault for not understanding the limits of what the vaccine could do.
Unreal.
All of this gaslighting might have been easier if we didn't have them on record saying all this bullshit late 2020 through early 2021. "We have the receipts", so the expression go.
And furthermore, we know it wasn't even a "noble lie", because these people pushed to mandate the vaccine. They pushed to fire medical staff who were uneasy taking the fastest vaccine developed in history, using a platform never rolled out to humans on mass scale [3], against a class of pathogens we had never come close to making an effective vaccine before.
They wanted children barred from school, cancer patient revoked treatment, and firefighters sidelined for any hesitancy because they claimed this was the only way to stop the pandemic.
They can't say "we didn't say the shot would block infection" because that wouldn't make sense on mandate vaccine anymore than mandating statins.
They honestly believed it, were wrong, and when realized they were wrong, rather than admit error, they gaslit.
That's why only 20% bothered to vaccinate their kids, whey few showed up for the booster and even fewer for the biavlent. Why country after country is throwing their unused surplus out. Why Pfizer stock is right back to where it was pre 2020. Why the 3rd world countries we earmarked millions of shots for don't even want them.
Ridiculous to cast my description of reality "fear mongering and conspiracy driving" - that, is gaslighting.
/rant. Sorry a little aggravated tonight, rough week, and I expect to be smarter than this.
__________________
[1] Rather than cite the Cleveland Clinic study showing this, I will show the fact check of that study, because the flimsiness and desperation of the "Fact Check" is even more compelling than the actual CC study
https://leadstories.com/hoax-alert/2023/01/fact-check-cleveland-clinic-preprint-study-does-not-prove-risk-of-covid-infection-goes-up-with-each-vaccination.html
You could of course, simply look at state by state, country by country, cases and all-cause mortality before and after vaccines to see they were no more effective than a placebo and any observational study data drudged up to show the opposite is easily refuted by it's inability to predict anything or replicate.
[2] As recorded by Dan Werb interviewing the Titan of Coronavirology Ralph Baric
"Baric knew that vaccines that didn’t accurately match their targets could weaken human resistance and inadvertently make people who were inoculated sicker.
“Baric was one of the few scientists who saw the stakes clearly. It wasn’t that an eventual SARS vaccine might work or not. It was that a vaccine could be either an antidote or a poison for a future pandemic-ready coronavirus, and there might be no way to tell them apart until it was too late.
p97 The Invisible Siege
[3] Honestly I might be quite wrong on this claim. My understanding is that this was the first time we rolled out mRNA beyond clinical trial phase. I have nothing against the platform. I just wouldn't personally invest much in the stocks of companies pushing it because it's first test was a complete failure and I am a conservative investor.
Hi Michael, while I do appreciate that much of what you’re saying has truth to it, and I’m certainly not going to change your mind commenting, I would point out that there is a lot of absolutism in your thinking. The whole world has not turned against vaccines, and very little in life is 100%.
Blaming people for some real time lane shifts by leaders and experts as this thing played out in real time is not ok. Otherwise you get leaders like Bolsonaro who try to act like they are omnipotent and omniscient, and their strong man approach to uncertainty with certainty leads to hundreds of thousands of people dying unnecessarily in their countries. That unwavering stance pleases a certain mindset of people who cannot handle uncertainty and vagary and flip flopping, but that’s what we need to acknowledge is necessary as something like this mutates and we learn more.
I’ll just conclude that mRNA vaccines have saved millions of lives, prevented hundreds of millions of cases which can lead to permanent damage and disability, and have resulted in a comparatively small number of deaths and disabilities…which we can all agree would never have been an absolute number like 0.
https://www.commonwealthfund.org/blog/2022/two-years-covid-vaccines-prevented-millions-deaths-hospitalizations
I won’t reply again, this is Paul Offit’s house so let’s show some good manners and agree to disagree perhaps.
I'm going to read those linked pieces, so thank you. I'm still not positive what I think the truth is. Yes, I recall people lying to get one early, since I was one of those people. And to be clear, I still haven't had COVID yet. But about six or eight months ago i pretty much gave up on the hope that I would never get it and went back to my normal pre pandemic life. But, to be fair, there are therapeutics that we didn't have at the beginning of the pandemic that are partially responsible for my greater comfort that I am not going to get terribly ill or die if I get COVID. Still, as a citizen, I feel gaslit. But as a realist, I am not sure I blame doctors in general as yet. With so much of the population believing crazy conspiracy theories and with the ever evolving virus, I feel for public health professionals. It's been a huge challenge and could become even a greater challenge if this virus mutates or the next virus is worse. As you say, it is fascinating to see the psychology at work. And I assume, for public health officials, it must be terrifying at the same time. I hope the trust issues are temporary but only time will tell. There are amazing advances being made in medicine in part due to the mRNA technology so I try to focus on the big picture. And I try to be comfortable in the knowledge that we are not going to know the outcome of all of this for a very long time. The public most certainly has rebelled. And I guess I don't blame them.
Thoughts from a skeptic:
1) If there 3 million cases a year against 77 million people > 60, why were the numbers of RSV cases in the placebo group (40 out of 12,499) so low by ratio? Granted the study period was only 6.7 months, but even that is a nearly a 6-fold decrease in cases in observed study population against the estimate. I would think the estimate would be undercounted as we don't PCR surveil the population for RSV like you would in a trial.
Is this concerning at all? It would suggest either our estimates are wildly off, and we are attacking a problem nearly a magnitude smaller than it is, or, that the GSK trial failed to accurately capture RSV burden and was underpowered.
Now the study does attempt to answer this, making the debatable claim that "Public Health measures to limit Covid-19 transmission reduced the spread of RSV and altered the RSV season" - but if that is the case, wouldn't the prudent approach be to study your vaccine in a regular RSV season before declaring victory? Flu disappeared in 2020 as well (even in countries that didn't mask or distance), would we trust a new Flu vaccine only tested in 2020?
2) I've got 16 years before I would have to consider this shot, but it's a tough sell to take a shot that reduces risk of catching a cold from 40/12,500 down to 7/12,500, when 879/12,500 experienced pain or fatigue.
3) Let's say 10,000 elderly people with diabetes, chronic heart, lung, or kidney disease die each year due to pneumonia following an RSV infection. Do we expect 8,250 of those elderly people not to die that year if vaccinated? Or, would we just whack-a-mole it so another of the hundreds (?) of respiratory viruses takes the place of RSV, and some other virus of opportunity infects the elderly person, causes pneumonia, and the outcome is no different?
I know this is speculative questioning but it seems to me the true measure of efficacy would be if the study also measured overall mortality with a focus on all-cause ILI triggered deaths.
I'm just thinking about when my grandfather passed in 2018, he was very frail already, sitting in a nursing home with late stage Alzheimer's, declining rapidly since his wife passed the year before. Eventually some cold got him, then hospitalized, pneumonia, living will says no vent, they make him comfortable and that's it. 87, lived an amazing life, but didn't know much about the last 4-5 years.
All the way back then we weren't PCR testing to trace every cold source, so who knows what pushed the domino. RSV? Flu? a regular Coronavirus? Any of the other hundreds of ILI?
Even if it was RSV, I just can't imagine had he been vaccinated with RSV that his outcome within a month or two would have been any different, and it seems to me this type of death is what mainly comprises the 10,000 RSV yearly fatalities.
Hope it works though, even if ROI is sketchy (3.5 billion a year to vaccinate yearly everyone 60+)
Interesting .I'd also like to find what the normal rate of death/hospitalisation due to RSV is by age .and comorbidity In order to make that choice ..
What was the all cause mortality in the two groups? Link to FDA GDK data?
Looks like 49/12467 (intervention) vs 58/12499 (placebo). Even if difference attributed to the vaccine and all confounders accounted for, it's a .0007 difference. SAE not yet reported beyond this.
https://clinicaltrials.gov/ct2/history/NCT04886596?V_7&embedded=true#ROutcomeMeasures
Search for All-Cause Mortality, near the bottom, after section 38
important summary of the long-awaited RSV vaccine
This is great news.
Ops. J
Hoy the wrong button... COVID War” and if so what did you think of it?
Thanks,Dr.Offit. As an 80yo with young grandkids I’ll definitely be getting this vaccine. I was wondering read Lessons from if you’ve had a chance to