This stalling technique is dangerous. I'm scared for us all to have delays and denials to vaccines. We have a large measles outbreak, COVID still out there, and H5N1 floating around trying to become a pandemic. And now they want to play games. I don't appreciate that at all.
I'm afraid Makary and Prasad are both basically shills for the administration. Please don't continue to normalize what they're doing - just because they aren't as ridiculously unqualified as RFKjr, and some of what they say makes sense sometimes, doesn't mean they aren't fundamentally undermining the goals of public health, and that should be the main focus, the lede in any article/essay.
What happened at the start of the Covid shots when access was limited was people would lie to get into the pharmacy to ger the vax if they were younger to get ahead. They would say "heart condition" for taking a low dose BP med or "obese" if 10 lbs overweight. This guidance will do the same for younger ones to fudge or lie to get a shot. JUST OFFER IT TO ANYONE BUT STRONGLY ENCOURAGE FOR OLDER, COMPROMISED, ETC. Also, this will likely affect insurance coverage for lower income ones if not covered to not get the shot. They had this tit for tat behind the scenes with the original Covid shots. Dr Fauci, Hotez said just open it to anyone who wants it while others said no just to the most vulnerable. STOP the nuanced messaging.
"They push back on the paper’s implication that low booster uptake reflects public confusion." While politics certainly plays a big role you two may be too deep into your world to recognize how hard it is for us regular people to know what works and what doesn't . . . which then allows political partisanship to have big influence. Medical science leaders did a really lousy job during Covid and that damage needs to be acknowledged before we just move on.
Signed, a big believe in science who is a frequent volunteer for vaccine studies at the Brigham.
Ex. People complained in '20 when Trump took over the WH Covid briefings leaving med people 3 or 4 mins to put out any med info. So, unless they got on tv or a blog they were outnumbered with trying to get out true med info. By '21 the WH med advisors held briefings which were hard on facts from the distribution of vaxes to how the outbreak was doing to the latest info on what the Covid virus was doing & latest research. Daily then 2/3 times weekly, then finally ended. Guess what the networks barely covered them after complaining about the Trump press briefings!! So, the med people couldn't win for losing. What SHOULD have happened was a round table with Walensky, Fauci, Redfield, Slavitt, etc at the HHS building NOT the WH podium and ONLY medical people. Politicians like Pence, Trump, Biden speak at the WH podium. But let the HHS roundtable talk with the latest info, then take questions. Were the medical people at the time perfect NO but they were learning in real time as everyone else who got up that morning with the latest CHANGING information.
You are glossing over the "wrong" part. Many of those you mentioned did not "follow the science". The whole "in real time" thing falls apart when you look at the prior preparation. Don't wear masks. Wear masks. Wear really good masks. Wipe down fruit. Stay indoors. Go outside. Close schools. Herd immunity. And on and on.
#1 Realize that in '20 there was no Covid vax. Mitigations were put out BY THE GOVERNORS/BUSINESSES/SCHOOLS when the CDC put out guidance to try to slow the spread of a novel virus killing 1000s daily. States could do what they wanted.
#2 Within 6 WEEKS the WH med people changed the mask guidance because they saw how much of Covid 19 was spread by those without symptoms. And the data on aerosol spread changed. Again in '20 when there was no vax. And told people to PLEASE mask with whatever you can find and wear is better than nothing. AND a shortage of N95s for med people.
#3 Schools were the privy of each state. Did some stay closed too long sure. Did some open too fast especially exposing adults to Covid 19 before the vaxes came out yes!! When vaxes came out then let the guidance change IF proper protocols are enacted to help especially the adults.
#4 Vaxes were mandated federally for the military & some workers BUT some could opt out IF they tested for ex weekly. And for some interstate travel for a while until contested in the courts. Otherwise states and businesses dealt with vax mandates. Realize that medical facilities, the military already mandate for a number of vaxes. And until recently all states mandated kids entering school had to have for ex MMR, polio, etc.
#5 Final thought. Say that Covid 19 or maybe another virus forbid hits younger people or kids (I'm not saying that it should happen understand) but what if 1000s of young people or kids were dying or hospitalized with no vax yet. Instead of older people who are close to dying anyway the way some feel I think with Covid 19 & any mitigations. Just ethically to consider. Would the same pushback with mitigations happen hum????
You and I aren't going to agree but all I'm looking for is humility from those who were proven wrong regardless if it was a tough call in the moment. The city of Boston public health dept shut down all fall sports in September of 2020 despite the fact they were being played outside with masks. Golf and Cross country too? Yep. You remember the stories (NYT) about low income communities suffering more from Covid due to pollution? That was due to a high death rate in Chelsea . . . which was a result of the Soldiers Home being located there rather than a pollution issue. I could go on and on with wrong stuff (I still can't believe the city of Boston put netting over basketball hoops at all parks. We had plenty of prior data on respiratory viruses. What about the way the lab leak theory was treated in the medical community? All dissent was silenced.
I listened to Dr Fauci a lot because he was the fall guy to try & communicate a lot from the WH. Until he became the #1 boogie man. Anyway, I couldn't count the times he would say "We have to be humble. This is what we know at this time BUT it could change". Others would say the same in different ways. Point is yes mistakes were made BUT most were not intentional. Most were learning as things changed. I think a mistake was not having a Covid 19 Commission set up like the 9/11 Commission. Put out stuff that was learned which a lot was, and mistakes made. WITHOUT pointing fingers & leave the politicians OUT of it. The Covid committees in Congress have been a joke & yes, I have watched them. They are to point out political blame but not to learn for future outbreaks. As far as WIV & lab leaks sorry don't get me started. You think we disagree now you don't want my take on how Drs Fauci, Collins, Dazsak were made the villains. Nope for no scientific reason pure politics against them.
Ben, as Dr Faust has said previously & during his recent chat on MSNBC..."science is messy" & we learn from past experience & yes mistakes. Other than the current administration deliberate & malicious actions, including idiots like JFK Jr, most in the healthcare community act in good faith with the information available.
The recommendations for trials are really poorly thought out. They are likely to be inconclusive, will cost a great deal and may drive manufacturers out of the market. To my knowledge neither Marty Makary or Vinay Prassad has ever designed or conducted a clinical trial.
My biggest concern is that two political appointees with very limited expertise in viral epidemiology or vaccinology seem to making a unilateral decision. This is a complete shift (dare I say paradigm shift) from the highly successful model of having external expert advisors review data carefully and debate recommendations IN PUBLIC with permanent record of the slides and discussion. To my knowledge, unilateral actions by FDA counter to ACIP have almost never been taken, even when true experts like Peter Marks were overseeing CBER.
It is reasonable for ACIP to review data on Covid incidence, waning immunity, and risk of long Covid and debate what the risk benefit ratio is like in 2025 and to look at the wording for recommendations
Katelyn was more eloquent as usual but we were making the same points. The process insures careful review of the data and policy implications, impact on access, public debate among knowledgeable experts and transparency. The unilateral decision by two political appointee, who lack the expertise to be appointed to ACIP accomplishes none of the above.
I remain fully confused about whether, at this point, someone over 65 (in good health no significant co-morbidities) needs to have a covid shot twice a year or simply annually.
Thank you for sharing this discussion! I found it very informative.
I'd love to learn more about the impact of repeated vaccination on both long covid rates and on the elevated risk of things like stroke and heart attack months after a covid infection. In the discussion, you both agreed that vaccination probably does reduce the risk of long covid for the first several doses, but then probably plateaus and we don't know much beyond that. What is the basis for expecting that it plateaus? And would protection against long covid eventually wane, similar to protection against infection, or is there some evidence and/or biological intuition for why it would be permanent?
I complement Dr's Faust & Gounder for presenting this new information. Personally, it became more informative as the chat morphed into the nuances of the immunology & the epidemiology of CoVID.
Most genuinely, the cival comments are refreshing & also informative, thank you fellow contributors. I follow Dr. Offit's posts which are also informative, however the vitriol of far too many on his Substack is saddening. Yes, the solution to not being disappointed in following that forum... don't read the comments. But (not my norm to start a sentence with a conjunction...old school) speaking truth to power, as vailed it may be, is so important. In addition, bullying & rude behavior should be corrected...excuse the digression.
Possibly, we can or do agree mistakes were made during the early & middays or months/yr of the pandemic. To some extent we need to reflect on those events yet the focus of truly keeping Americans healthy is being present & looking forward.
Certainly, your current administration presents a huge challenge to overcome, that being its abysmal actions, inactions & daily behavior 😢
Once again, I have no 'true voice' in America yet I continue to learn from this forum & others that remain positive & collegial. Thank you
this was very helpful. I notice that on the 5calls app today this subject is laid out for me to call my rep and senators which I will do. I am concerned about vaccines not being covered by health insurance as you mentioned as well as the dampening of money for research and tweaking the vaccines as the virus mutates. I wonder if it is possible to devise a vaccine that will not imprint or that will have more lasting antibodies. Thank you both.
Regarding variant updates: Clearly RCTs would take too long. Wouldn’t immunobridging work for this (assuming that this would be acceptable to Prasad and Makary)? Invivyd uses this technique to maintain its EUA for Pemgarda (Covid monoclonal antibodies).
With regard to trials, I think equipoise for those 55-64 is highly debatable, making the ethics of placebo controls questionable. The primary endpoint that matters are severe disease, hospitalization and death, and long Covid, but to have a trial that is adequately powered in the current environment is prohibitive. Doing an underpowered trial allows them to validate their pre-conceptions.
This stalling technique is dangerous. I'm scared for us all to have delays and denials to vaccines. We have a large measles outbreak, COVID still out there, and H5N1 floating around trying to become a pandemic. And now they want to play games. I don't appreciate that at all.
I'm afraid Makary and Prasad are both basically shills for the administration. Please don't continue to normalize what they're doing - just because they aren't as ridiculously unqualified as RFKjr, and some of what they say makes sense sometimes, doesn't mean they aren't fundamentally undermining the goals of public health, and that should be the main focus, the lede in any article/essay.
Update: See Katelyn Jetelina's trenchant analysis at https://yourlocalepidemiologist.substack.com/p/covid-19-vaccines-what-just-happened
What happened at the start of the Covid shots when access was limited was people would lie to get into the pharmacy to ger the vax if they were younger to get ahead. They would say "heart condition" for taking a low dose BP med or "obese" if 10 lbs overweight. This guidance will do the same for younger ones to fudge or lie to get a shot. JUST OFFER IT TO ANYONE BUT STRONGLY ENCOURAGE FOR OLDER, COMPROMISED, ETC. Also, this will likely affect insurance coverage for lower income ones if not covered to not get the shot. They had this tit for tat behind the scenes with the original Covid shots. Dr Fauci, Hotez said just open it to anyone who wants it while others said no just to the most vulnerable. STOP the nuanced messaging.
"They push back on the paper’s implication that low booster uptake reflects public confusion." While politics certainly plays a big role you two may be too deep into your world to recognize how hard it is for us regular people to know what works and what doesn't . . . which then allows political partisanship to have big influence. Medical science leaders did a really lousy job during Covid and that damage needs to be acknowledged before we just move on.
Signed, a big believe in science who is a frequent volunteer for vaccine studies at the Brigham.
I just did a mRNA flu vax study! Haven't heard of I got the new one of the normal one yet but I didn't get sick at all with anything all season.
Ex. People complained in '20 when Trump took over the WH Covid briefings leaving med people 3 or 4 mins to put out any med info. So, unless they got on tv or a blog they were outnumbered with trying to get out true med info. By '21 the WH med advisors held briefings which were hard on facts from the distribution of vaxes to how the outbreak was doing to the latest info on what the Covid virus was doing & latest research. Daily then 2/3 times weekly, then finally ended. Guess what the networks barely covered them after complaining about the Trump press briefings!! So, the med people couldn't win for losing. What SHOULD have happened was a round table with Walensky, Fauci, Redfield, Slavitt, etc at the HHS building NOT the WH podium and ONLY medical people. Politicians like Pence, Trump, Biden speak at the WH podium. But let the HHS roundtable talk with the latest info, then take questions. Were the medical people at the time perfect NO but they were learning in real time as everyone else who got up that morning with the latest CHANGING information.
You are glossing over the "wrong" part. Many of those you mentioned did not "follow the science". The whole "in real time" thing falls apart when you look at the prior preparation. Don't wear masks. Wear masks. Wear really good masks. Wipe down fruit. Stay indoors. Go outside. Close schools. Herd immunity. And on and on.
#1 Realize that in '20 there was no Covid vax. Mitigations were put out BY THE GOVERNORS/BUSINESSES/SCHOOLS when the CDC put out guidance to try to slow the spread of a novel virus killing 1000s daily. States could do what they wanted.
#2 Within 6 WEEKS the WH med people changed the mask guidance because they saw how much of Covid 19 was spread by those without symptoms. And the data on aerosol spread changed. Again in '20 when there was no vax. And told people to PLEASE mask with whatever you can find and wear is better than nothing. AND a shortage of N95s for med people.
#3 Schools were the privy of each state. Did some stay closed too long sure. Did some open too fast especially exposing adults to Covid 19 before the vaxes came out yes!! When vaxes came out then let the guidance change IF proper protocols are enacted to help especially the adults.
#4 Vaxes were mandated federally for the military & some workers BUT some could opt out IF they tested for ex weekly. And for some interstate travel for a while until contested in the courts. Otherwise states and businesses dealt with vax mandates. Realize that medical facilities, the military already mandate for a number of vaxes. And until recently all states mandated kids entering school had to have for ex MMR, polio, etc.
#5 Final thought. Say that Covid 19 or maybe another virus forbid hits younger people or kids (I'm not saying that it should happen understand) but what if 1000s of young people or kids were dying or hospitalized with no vax yet. Instead of older people who are close to dying anyway the way some feel I think with Covid 19 & any mitigations. Just ethically to consider. Would the same pushback with mitigations happen hum????
You and I aren't going to agree but all I'm looking for is humility from those who were proven wrong regardless if it was a tough call in the moment. The city of Boston public health dept shut down all fall sports in September of 2020 despite the fact they were being played outside with masks. Golf and Cross country too? Yep. You remember the stories (NYT) about low income communities suffering more from Covid due to pollution? That was due to a high death rate in Chelsea . . . which was a result of the Soldiers Home being located there rather than a pollution issue. I could go on and on with wrong stuff (I still can't believe the city of Boston put netting over basketball hoops at all parks. We had plenty of prior data on respiratory viruses. What about the way the lab leak theory was treated in the medical community? All dissent was silenced.
I listened to Dr Fauci a lot because he was the fall guy to try & communicate a lot from the WH. Until he became the #1 boogie man. Anyway, I couldn't count the times he would say "We have to be humble. This is what we know at this time BUT it could change". Others would say the same in different ways. Point is yes mistakes were made BUT most were not intentional. Most were learning as things changed. I think a mistake was not having a Covid 19 Commission set up like the 9/11 Commission. Put out stuff that was learned which a lot was, and mistakes made. WITHOUT pointing fingers & leave the politicians OUT of it. The Covid committees in Congress have been a joke & yes, I have watched them. They are to point out political blame but not to learn for future outbreaks. As far as WIV & lab leaks sorry don't get me started. You think we disagree now you don't want my take on how Drs Fauci, Collins, Dazsak were made the villains. Nope for no scientific reason pure politics against them.
Ben, as Dr Faust has said previously & during his recent chat on MSNBC..."science is messy" & we learn from past experience & yes mistakes. Other than the current administration deliberate & malicious actions, including idiots like JFK Jr, most in the healthcare community act in good faith with the information available.
JJF Phm 🇨🇦
The recommendations for trials are really poorly thought out. They are likely to be inconclusive, will cost a great deal and may drive manufacturers out of the market. To my knowledge neither Marty Makary or Vinay Prassad has ever designed or conducted a clinical trial.
My biggest concern is that two political appointees with very limited expertise in viral epidemiology or vaccinology seem to making a unilateral decision. This is a complete shift (dare I say paradigm shift) from the highly successful model of having external expert advisors review data carefully and debate recommendations IN PUBLIC with permanent record of the slides and discussion. To my knowledge, unilateral actions by FDA counter to ACIP have almost never been taken, even when true experts like Peter Marks were overseeing CBER.
It is reasonable for ACIP to review data on Covid incidence, waning immunity, and risk of long Covid and debate what the risk benefit ratio is like in 2025 and to look at the wording for recommendations
See Katelyn Jetelina's trenchant analysis at https://yourlocalepidemiologist.substack.com/p/covid-19-vaccines-what-just-happened
Katelyn was more eloquent as usual but we were making the same points. The process insures careful review of the data and policy implications, impact on access, public debate among knowledgeable experts and transparency. The unilateral decision by two political appointee, who lack the expertise to be appointed to ACIP accomplishes none of the above.
I remain fully confused about whether, at this point, someone over 65 (in good health no significant co-morbidities) needs to have a covid shot twice a year or simply annually.
Thank you for sharing this discussion! I found it very informative.
I'd love to learn more about the impact of repeated vaccination on both long covid rates and on the elevated risk of things like stroke and heart attack months after a covid infection. In the discussion, you both agreed that vaccination probably does reduce the risk of long covid for the first several doses, but then probably plateaus and we don't know much beyond that. What is the basis for expecting that it plateaus? And would protection against long covid eventually wane, similar to protection against infection, or is there some evidence and/or biological intuition for why it would be permanent?
“What’s needed is nuance: boosters for those who need them, optional access for those who want them, and transparency all the way through.”
I agree with all of this.
Thank you, Drs. Gounder and Faust. It helps me understand what the implications are.
And I agree with Nancy's statement below!
Dr. Faust
I was not able to find the research paper you eluted to discussing imprinting & the relationship with subsequent doses for CoVID.
Could you please provide the reference.
Regards, JJF
Great session. Thanks for the irl discussion!
I complement Dr's Faust & Gounder for presenting this new information. Personally, it became more informative as the chat morphed into the nuances of the immunology & the epidemiology of CoVID.
Most genuinely, the cival comments are refreshing & also informative, thank you fellow contributors. I follow Dr. Offit's posts which are also informative, however the vitriol of far too many on his Substack is saddening. Yes, the solution to not being disappointed in following that forum... don't read the comments. But (not my norm to start a sentence with a conjunction...old school) speaking truth to power, as vailed it may be, is so important. In addition, bullying & rude behavior should be corrected...excuse the digression.
Possibly, we can or do agree mistakes were made during the early & middays or months/yr of the pandemic. To some extent we need to reflect on those events yet the focus of truly keeping Americans healthy is being present & looking forward.
Certainly, your current administration presents a huge challenge to overcome, that being its abysmal actions, inactions & daily behavior 😢
Once again, I have no 'true voice' in America yet I continue to learn from this forum & others that remain positive & collegial. Thank you
JJF Phm 🇨🇦
this was very helpful. I notice that on the 5calls app today this subject is laid out for me to call my rep and senators which I will do. I am concerned about vaccines not being covered by health insurance as you mentioned as well as the dampening of money for research and tweaking the vaccines as the virus mutates. I wonder if it is possible to devise a vaccine that will not imprint or that will have more lasting antibodies. Thank you both.
Regarding variant updates: Clearly RCTs would take too long. Wouldn’t immunobridging work for this (assuming that this would be acceptable to Prasad and Makary)? Invivyd uses this technique to maintain its EUA for Pemgarda (Covid monoclonal antibodies).
With regard to trials, I think equipoise for those 55-64 is highly debatable, making the ethics of placebo controls questionable. The primary endpoint that matters are severe disease, hospitalization and death, and long Covid, but to have a trial that is adequately powered in the current environment is prohibitive. Doing an underpowered trial allows them to validate their pre-conceptions.