Fantastic summary! And in regard to your statement that someone should help the FDA explain these findings to the public, that someone is definitely YOU! Maybe they would also want a simple 5 word feel-good statement for those in the public that don't have the time or inclination to digest a more complex answer, but for those of us who realize that Covid killed > one million Americans and want to do something about it, you are a lifesaver!
The FDA has plenty of highly seasoned Communications professionals. At issue is them being allowed to communicate. It's no different from the corporate world, though many would argue it should be.
Why will there need to be any discussion about WHO will get the vaccines? We are all at risk from COVID. This shouldn’t even be a conversation at Year 4 of this ongoing pandemic.
As a parent of young kids, I will be LIVID if the so-called public health apparatus decides to leave out our kids AGAIN.
This is just how it’s always done. FDA doesn’t determine it, the CDC does. It’ll be interesting to see what they decide. I could see it going both ways
While that may be true, many of the public health failures of this pandemic can be traced directly to the ossified and glacial processes of the FDA and the CDC.
Additionally, when it comes to children, it is boggling that we have data showing that:
1) COVID mutates far faster than the flu
2) COVID is dangerous even to the vaccinated and boosted
3) Most people will have Long COVID by their 10th infection
4) Approximately 70% of household infections started with a school-age child
At year 4 of this pandemic, I am no longer willing to give much in the way of grace for these systems and structures that prevent agile action, cooperation, and timely prevention. By the time the new formulation is out, it will likely be moot. There are other variants cropping up as we speak (FU1 and FU2). The whole premise of the mRNA vaccines was that it would be easily tweaked to address circulating strains, and it feels like a Herculean effort to get them changed for a third time in 3.5 years.
I really hope next Gen vaccines and treatments hurry up. What is being championed now simply isn’t enough.
Of the roughly 2,000 kids I know through my kids schools and extracurricular activities not a single one has long covid. Is this a statistical anomaly or do you think maybe the prevalence it's overstated because we keep extrapolating estimates from surveys with 5% response rates?
I cannot answer that. What I do know is that kids don’t have the vocabulary to articulate what they’re feeling; parents are not being told what to look for; parents are reluctant to accept that sending their kids back to unsafe schools might have injured them.
Many Long COVID symptoms are neurological, and I am a parent seeing TONS of complaints about children’s awful behavior, reduced attention spans, inability to comprehend or retain information, poor test scores, etc. I wouldn’t be so sure that all of the kids you know have escaped consequences of this virus.
Even in high schools I'm seeing n=1000 and zero long covid. The symptoms of Behavorial, Focus, and poor test scores seem far more likely a result of closing school 6-18 months.
As far as I am aware we aren't seeing this in countries which kept school open.
Wait. Where are you seeing that most people will have long Covid by their tenth infection?? Please give source — if true that would totally change how I’m approaching everything.
Let's be clear - the assertion that long COVID rates are assessed by surveys with abysmal response rates is simply false. The majority of studies assessing long COVID come from large, ongoing registered trials being conducted around the world, and rely on electronic healthcare records collected in clinical settings.
Here's a recent report on a meta-analysis -- the highest level of evidence -- that concludes "[n]early one quarter of pediatric survivors suffered multisystem long COVID, even at 1 year after infection." ("Prevalence and risk factor for long COVID in children and adolescents: A meta-analysis and systematic review" J Infect Public Health. 2023 May; 16(5): 660–672 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9990879/).
Whether the derived rate of 25% is exactly correct is immaterial, as it is clearly not zero at n=1,000 or 2,000. Anecdotally, the story for my family (n=4) all confirmed XBB infected in Dec. 2022 is that each of us are still experiencing some level of symptoms 6 months post-recovery.
Over the entire population, regardless if the actual rate of long COVID is 6% (as some studies have found) or 42% (other studies) there are two novel observations to be made. One -- long COVID is absolutely unlike the persistent sequelae following infections with other circulating viruses like flu or RSV, which occur at much smaller rates and generally resolve more quickly. Two -- the sheer number of people infected in the pandemic means that long COVID presents a public health challenge unprecedented in human history.
Consistently, the best data we have shows that people have between a 10-20% chance of getting COVID with each infection. Some data even seem to conclude that five infections is closer to the tipping point.
Those metrics are based on surveys (lowest tier of evidence) with abysmal response rates (5%) and consist of sprawling questionnaires with leading questions.
For some reason no one is questioning why such poor evidence has been taken as fact despite real world sampling of Long Covid being on par with other post-viral syndromes.
I know so many people whose kids have not been vaccinated at all against COVID, so I just looked up the stat. About 55% of people in the US under 17 have had no COVID vaccines whatsoever, compared to 15% of adults. So maybe they want to focus on a push that will be more successful?
Thanks! It makes sense as I think anyone with young kids is familiar with the illness gauntlet. Was true before Covid and is true now :). Annual Covid vaccines should be available to everyone, just as they are for the flu. I'm trying to wrap my head around this, though: "The researchers said the finding that pediatric COVID-19 transmission was negatively correlated with new community cases during most of the pandemic is consistent with that of a previous study."
The vaccines don't stop transmission though so it's not like this study would be any different if vaccination rates were high. Also it's possible that vaccination increasing susceptibility to future variants as noted:
1) In two Cleveland Clinic studies of medium quality
2) As a concern of Ralph Baric, the "Titan of Coronavirology"
3) Would explain why countries which kept infections controlled in 2020 saw them explode once population was vaccinated (South Korea, Denmark, Portugal, etc)
Probably because after achieving high vaccination rates those countries allowed, or stopped discouraging, casual behavior which led to more infections.
Vaccines aren't nearly as abundant as people seem to assume - for now, they appear to be, because demand is (unfortunately) low. Limiting factors in vaccine production include:
1. Glass
2. Electricity
3. Horseshoe crabs
4. Refrigerant
These aren't just needed for covid vaccines, they're needed for all injectable medicines. So it's not hard to imagine multiple vaccines and medicines competing for the same scarce resources. Maybe not a white swan, but not a black one either.
The bottom line of government is conflict management. That means, in many cases, rationing scarce resources when markets fail to do that efficiently. Public health is an arm of government, and as such it often results in policies that may be sub-optimal to individuals. That sucks, but it's how it needs to be.
Absolutely there were humans who participated in the Covid vaccine clinical trials - I am a proud Phase 3 Pfizer participant! I would do it again in a minute - I met many wonderful fellow trial participants and was glad to contribute to the research. If someone tries to say no one was involved, just tell them your pal Jill sure was.
Did I miss something?? No mention of protection for the immunocompromised, for whom the vaccines don't offer protection. The FDA should be prioritizing this group (est 3% of the pop) which is still the most vulnerable to poor outcomes from Covid.
Query: should those of us who are over 70, currently due for another dose of the bivalent vaccine, and/or traveling abroad between now and early Fall get the old bivalent now—or wait for the new monovalent vaccine? Please advise. Thanks.
Good question. There are 5 months until November. If you were going to get one, I would do it ASAP so there’s enough runway until fall booster (that is assuming you haven’t been infected recently). I would ensure at least 3-4 month runway for maximum protection.
Interesting side note to this, which validates for me how complex this is to sort out for a layperson. Dr. Topol had a Substack note, and I asked him the same Q. He responded “I would wait for the new XBB monovalent booster that should be available by September at the latest.” I would welcome learning more of what is informing expert thinking. On the one hand, getting the bivalent now, so as to have better protection and time for that runway makes a lot of sense. On the other hand, is it possible getting the bivalent now might blunt the effect of the fall vax?
Antibodies drop off fairly steeply by month 6. Those at higher risk or due for the bivalent could manage to seize the opportunity to get one now and still have a good gap to get the updated in late fall before holidays, family gatherings and peak winter viral season.
There could be some concern about blunting effect if vaccinations are too close/often, less than 5-6 months.
Then there is “style” or the “art” of medicine. Given the same facts, there are differing styles, risk aversion, and so much and so little information at the same time.
I got my 94year father another dose, in April, wedged nicely 5.5 months after his first infection and looking to 6 months before his next booster in the fall. I think (cannot recall exactly where I read) the UK is looking at a 12 month gap. But remember, public health doesn’t prioritize individuals.. it takes a global approach to cost, morbidity, mortality and health care cost savings. May be excellent planning, but may not be “the best for you”.
Oof, I just had covid for the first time a couple weeks ago. Picked it up in NYC. Wasn’t terrible after the initial runny nose, sore throat, body aches (my knees really hurt) and fever. Paxlovid to the rescue. Had very mild rebound 2 days after the paxlovid with congestion, low grade fever and oddly leg muscle pain. I had been extra careful because I have diabetes and asthma.
Any news on new antivirals in the works? I know that the fear is that paxlovid may become infective. Paxlovid made me fee, better within hours of taking it.
great that Paxlovid helped you: a year ago in mid May I was sick w/Covid -19 and luckily got an Rx quickly. I could feel it descending into my lungs by the hour, about 24 hours after symptoms started. The rebound is the infection itself, like many viruses one might feel better but then go into a 2nd phase. BUT the Paxlovid slows down and blocks the rapid spread of the virus in the initial days.
I don't understand the claim that the drop in vaccine effectiveness isn't really all that big because of some "immunity wall". What does that even mean? The only immunity I have from COVID is from vaccines.
I think what it's meant to suggest is that even if one individual's immunity might wane in the space of a few months, there are enough people out there whose immunity is high (because there vaccine or infection was more recent, or because their bodies are better at maintaining high levels of immunity) that overall, the effective rate of transmission in the population as a whole is lower.
Firstly, thank you. Additionally, I realize that not having discussed “who” will be eligible does not mean some will he excluded but as someone whose job it is to advocate for Vaccine uptake in children, waiting for late summer to release this is detrimental to acceptance. Success lies with families and this sows doubt in the necessity. This is absolutely what occurred when there was delay approving the bivalent booster. Bu the time it was approved, many willing parents had mentally moved on and it was no longer feeling urgent.
What a pity this will come so late.
I am looking forward to more information about administration data for same day flu and Covid vaccines too.
Thank you for this excellent and timely summary. I am especially hopeful that Novavax will be able to manufacture a booster on time and at scale, and that FDA doesn't restrict access of Novavax for those of us who prefer it over mRNA.
I am unfamiliar with pros and cons of Novovax, and would be interested in more information on that. I gather that there may be fewer side effects than the mRNA vaccines, and that would certainly interest me.
We'll see what happens. One thing I'm concerned about is our dependence on horseshoe crab blood for screening out endotoxins. It's a problem not just for vaccines but for lots of injectable medications. There's a substitute, but in order for pharmaceutical companies to use it "automatically", US Pharmacopeia needs to sign off on it. They haven't done so yet. If they continue to drag their feet, we could see some severe shortages.
Me too. I just hope BARDA (or whoever is responsibler) orders *ENOUGH* Novavax to meet pent up demand. During the FDA meeting there were public comments from people who tried to get Novavax and were denied by pharmacists due to the FDA's restrictive language. It was clear from people's comments that demand for Novavax was much higher than actual doses administered - so hopefully BARDA has an accurate way to project true demand, because basing it on past uptake would be a huge underestimate and result in not ordering enough.
Does the government solicit and consider public input so they can order the right amount from each manufacturer? I hope so, but given all the mismatch of supply and demand, and ultimate waste, it doesn't appear to be the case.
I wish FDA/BARDA had a way of polling people to see which vaccine they preferred so they can order quantity correctly. There was talk at the vaccine meeting that there's value in making the vaccine's as "interchangeable" as possible from a public perception, which includes things like waiting till September to release all boosters even though some manufacturers are ready to ship product in July or August (which would be a huge benefit to school teachers, parents and children). People are more likely to get a booster if they feel like they have choice and access to the one they want. Some will stick with mRNA, some will switch to Novavax, some don't care about brand.
But I just hope BARDA orders enough Novavax so that I can get one, and that FDA doesn't restrict access to it, which puts pharmacists and the public in a terrible spot.
They should just start letting people pre-order way in advance with their doctors. Let the providers, payers, PBM's and pharma manufacturers take it from there. HHS is exempt from HIPPAA when it's for statistical purposes.
A possible barrier is that it's sensitive economic info - these are publicly traded companies. Remember what happened to Martha Stewart....
Did you just edit out a link to Novavax having data that its vaccine helped improve long Covid? I had skimmed all the comments and was just about to follow the link when poof! Gone! By the way, hi, nice to see you! :o)
Yes, I deleted it because the claim came from the public comments portion and not from the actual Novavax presentation. Meaning I’m uncertain of its source or veracity. You can go to Youtube and watch today’s FDA meeting. Youtube has a feature whereby you can display the entire transcript, and search for keywords such as “long Covid.”
It’s my understanding the part about imprinting is true (based on a prepublication I’ve seen), yet I’m unclear what the implications are for people who are already vaccinated. It’s my hope that we don’t all have to start over with a new primary series, and can instead continue with an annual or semi-annual booster.
There was also talk today that the fall ‘22 bivalent boosters are not very helpful with current variants. I think this discussion took place after lunch and before the vote.
Have to say, the booster landscape is getting more and more confusing. I would like to have a better understanding of the risks and benefits than I do so far, particularly on “imprinting” and on the pros and cons of mRNA v. Novovax.
On imprinting, BTW, Faust had this to say: “Second, dropping the Wuhan portion of the vaccine will decrease the immune imprinting that we’ve seen crop up, in which we accepted short-term protection in exchange for longterm higher rates of reinfection. (I discussed this on the PBS News Hour this spring).” This is the first I have heard of that trade off. Is anyone here familiar with what he means?
I’m not high risk (relatively young and healthy) and traveling this summer and was going to get a booster in the next few days to protect my travels, but this article makes it seem like maybe I don’t need to do that?
There are disturbing statistics about an extreme rise in excess deaths among working age people in 2021 and 2022. I would be very grateful if you would discuss. Some are attributing it to the vaccines. The rise is so huge (“blackswan like”) that I will not do another MRNA vaccine until I understand what these excess deaths mean. I have had 4 Modernas but now hear I have no protection against XBB. The risk/benefit calculationis starting to weigh to not getting more vaccines. I hope you can help explain.
I have had the first two Moderna and the first booster. I just established care with a new physician today, and she did not recommend any boosters for me. My previous clinician did not either. I am 43 with no comorbidities, and they both said the risks do not outweigh the benefits. 🤷🏻♀️ I am very disappointed in the messaging.
Virginia, do you have a link on that? I, too, am concerned there is insufficient/unclear risk-benefit information for individuals to make these judgments.
The book “Cause Unknown” by Edward Dowd who is a financial numbers guy. He says statistically this is such an aberation it must be examined. In 2021 the excess deaths switched from old peolple to working age peolple. John Campell (I think that is his name) has discussed the same statistical issue in the UK on his youtube channel. It is quite weird, and disturbing that it happened after the vaccines were required for working people.
Thanks for the Cliff notes from today's FDA meeting on the fall vaccines. Like others, I hope that all can be eligible for the upcoming fall vaccine, just as with the flu vaccine. I'm 62, and feel that I could really benefit, but my layperson's understanding is that everyone could benefit from these vaccines. I look forward to learning more going forward. Thanks again!
For those of us who had the bivalent vaccine last fall, should we get the available next bivalent now, or wait for the fall monovalent vaccine? Over 65 years, in good health.
Query: should those of us who are over 70, currently due for another dose of the bivalent vaccine, and/or traveling abroad between now and early Fall get the old bivalent now—or wait for the new monovalent vaccine? Please advise. Thanks.
Katelyn Jetelina
Good question. There are 5 months until November. If you were going to get one, I would do it ASAP so there’s enough runway until fall booster (that is assuming you haven’t been infected recently). I would ensure at least 3-4 month runway for maximum protection.
Would love to know how long “hybrid immunity” really lasts against infection? I’ve seen experts quote 4-6 months…but that’s quite a gap. Is it closer to 4 or 6?
This is an example of how confusing the booster situation can be for a layperson, even those of us who do our best to educate ourselves. This is an observation from the wonderful Eric Topol on a problem with the effectiveness of the bivalent, relating to a presentation in the FDA meeting: https://twitter.com/EricTopol/status/1669366459678752768
Fantastic summary! And in regard to your statement that someone should help the FDA explain these findings to the public, that someone is definitely YOU! Maybe they would also want a simple 5 word feel-good statement for those in the public that don't have the time or inclination to digest a more complex answer, but for those of us who realize that Covid killed > one million Americans and want to do something about it, you are a lifesaver!
I would love to. My plan is just to be annoying enough where they can’t ignore me anymore ;)
Yes, Katelyn Jetelina, I have seen you in a few interviews, you do a marvelous job!
The FDA has plenty of highly seasoned Communications professionals. At issue is them being allowed to communicate. It's no different from the corporate world, though many would argue it should be.
Why will there need to be any discussion about WHO will get the vaccines? We are all at risk from COVID. This shouldn’t even be a conversation at Year 4 of this ongoing pandemic.
As a parent of young kids, I will be LIVID if the so-called public health apparatus decides to leave out our kids AGAIN.
This is just how it’s always done. FDA doesn’t determine it, the CDC does. It’ll be interesting to see what they decide. I could see it going both ways
While that may be true, many of the public health failures of this pandemic can be traced directly to the ossified and glacial processes of the FDA and the CDC.
Additionally, when it comes to children, it is boggling that we have data showing that:
1) COVID mutates far faster than the flu
2) COVID is dangerous even to the vaccinated and boosted
3) Most people will have Long COVID by their 10th infection
4) Approximately 70% of household infections started with a school-age child
At year 4 of this pandemic, I am no longer willing to give much in the way of grace for these systems and structures that prevent agile action, cooperation, and timely prevention. By the time the new formulation is out, it will likely be moot. There are other variants cropping up as we speak (FU1 and FU2). The whole premise of the mRNA vaccines was that it would be easily tweaked to address circulating strains, and it feels like a Herculean effort to get them changed for a third time in 3.5 years.
I really hope next Gen vaccines and treatments hurry up. What is being championed now simply isn’t enough.
Of the roughly 2,000 kids I know through my kids schools and extracurricular activities not a single one has long covid. Is this a statistical anomaly or do you think maybe the prevalence it's overstated because we keep extrapolating estimates from surveys with 5% response rates?
I cannot answer that. What I do know is that kids don’t have the vocabulary to articulate what they’re feeling; parents are not being told what to look for; parents are reluctant to accept that sending their kids back to unsafe schools might have injured them.
Many Long COVID symptoms are neurological, and I am a parent seeing TONS of complaints about children’s awful behavior, reduced attention spans, inability to comprehend or retain information, poor test scores, etc. I wouldn’t be so sure that all of the kids you know have escaped consequences of this virus.
Even in high schools I'm seeing n=1000 and zero long covid. The symptoms of Behavorial, Focus, and poor test scores seem far more likely a result of closing school 6-18 months.
As far as I am aware we aren't seeing this in countries which kept school open.
Wait. Where are you seeing that most people will have long Covid by their tenth infection?? Please give source — if true that would totally change how I’m approaching everything.
Twitter.com/WHO/status/1651227079684358151?lang=en
The source is Dr. Tedros of the World Health Organization, dated April 26, 2023
Let's be clear - the assertion that long COVID rates are assessed by surveys with abysmal response rates is simply false. The majority of studies assessing long COVID come from large, ongoing registered trials being conducted around the world, and rely on electronic healthcare records collected in clinical settings.
Here's a recent report on a meta-analysis -- the highest level of evidence -- that concludes "[n]early one quarter of pediatric survivors suffered multisystem long COVID, even at 1 year after infection." ("Prevalence and risk factor for long COVID in children and adolescents: A meta-analysis and systematic review" J Infect Public Health. 2023 May; 16(5): 660–672 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9990879/).
Whether the derived rate of 25% is exactly correct is immaterial, as it is clearly not zero at n=1,000 or 2,000. Anecdotally, the story for my family (n=4) all confirmed XBB infected in Dec. 2022 is that each of us are still experiencing some level of symptoms 6 months post-recovery.
Over the entire population, regardless if the actual rate of long COVID is 6% (as some studies have found) or 42% (other studies) there are two novel observations to be made. One -- long COVID is absolutely unlike the persistent sequelae following infections with other circulating viruses like flu or RSV, which occur at much smaller rates and generally resolve more quickly. Two -- the sheer number of people infected in the pandemic means that long COVID presents a public health challenge unprecedented in human history.
Consistently, the best data we have shows that people have between a 10-20% chance of getting COVID with each infection. Some data even seem to conclude that five infections is closer to the tipping point.
Those metrics are based on surveys (lowest tier of evidence) with abysmal response rates (5%) and consist of sprawling questionnaires with leading questions.
For some reason no one is questioning why such poor evidence has been taken as fact despite real world sampling of Long Covid being on par with other post-viral syndromes.
"many of the public health failures of this pandemic can be traced directly to the ossified and glacial processes of the FDA and the CDC." Evidence?
I know so many people whose kids have not been vaccinated at all against COVID, so I just looked up the stat. About 55% of people in the US under 17 have had no COVID vaccines whatsoever, compared to 15% of adults. So maybe they want to focus on a push that will be more successful?
YES!
Can you share your source for point 4? I haven't found much data around where infections are acquired.
https://www.cidrap.umn.edu/covid-19/more-70-us-household-covid-spread-started-child-study-suggests
Thanks! It makes sense as I think anyone with young kids is familiar with the illness gauntlet. Was true before Covid and is true now :). Annual Covid vaccines should be available to everyone, just as they are for the flu. I'm trying to wrap my head around this, though: "The researchers said the finding that pediatric COVID-19 transmission was negatively correlated with new community cases during most of the pandemic is consistent with that of a previous study."
The vaccines don't stop transmission though so it's not like this study would be any different if vaccination rates were high. Also it's possible that vaccination increasing susceptibility to future variants as noted:
1) In two Cleveland Clinic studies of medium quality
2) As a concern of Ralph Baric, the "Titan of Coronavirology"
https://twitter.com/MichaelDAmbro17/status/1669888824095244288
3) Would explain why countries which kept infections controlled in 2020 saw them explode once population was vaccinated (South Korea, Denmark, Portugal, etc)
Probably because after achieving high vaccination rates those countries allowed, or stopped discouraging, casual behavior which led to more infections.
If the updated vaccines are fully approved by FDA then physicians have considerably more discretion on a case-by-case basis, don't they???
Vaccines aren't nearly as abundant as people seem to assume - for now, they appear to be, because demand is (unfortunately) low. Limiting factors in vaccine production include:
1. Glass
2. Electricity
3. Horseshoe crabs
4. Refrigerant
These aren't just needed for covid vaccines, they're needed for all injectable medicines. So it's not hard to imagine multiple vaccines and medicines competing for the same scarce resources. Maybe not a white swan, but not a black one either.
The bottom line of government is conflict management. That means, in many cases, rationing scarce resources when markets fail to do that efficiently. Public health is an arm of government, and as such it often results in policies that may be sub-optimal to individuals. That sucks, but it's how it needs to be.
Absolutely there were humans who participated in the Covid vaccine clinical trials - I am a proud Phase 3 Pfizer participant! I would do it again in a minute - I met many wonderful fellow trial participants and was glad to contribute to the research. If someone tries to say no one was involved, just tell them your pal Jill sure was.
I did the Johnson and Johnson double dose trial. Was happy to be part of it!
Thank you, Mary and Jill!
Did I miss something?? No mention of protection for the immunocompromised, for whom the vaccines don't offer protection. The FDA should be prioritizing this group (est 3% of the pop) which is still the most vulnerable to poor outcomes from Covid.
Query: should those of us who are over 70, currently due for another dose of the bivalent vaccine, and/or traveling abroad between now and early Fall get the old bivalent now—or wait for the new monovalent vaccine? Please advise. Thanks.
Good question. There are 5 months until November. If you were going to get one, I would do it ASAP so there’s enough runway until fall booster (that is assuming you haven’t been infected recently). I would ensure at least 3-4 month runway for maximum protection.
Thanks! Happy that your reply to my query is consistent with my primary-care physician’s similar advice.
Interesting side note to this, which validates for me how complex this is to sort out for a layperson. Dr. Topol had a Substack note, and I asked him the same Q. He responded “I would wait for the new XBB monovalent booster that should be available by September at the latest.” I would welcome learning more of what is informing expert thinking. On the one hand, getting the bivalent now, so as to have better protection and time for that runway makes a lot of sense. On the other hand, is it possible getting the bivalent now might blunt the effect of the fall vax?
Antibodies drop off fairly steeply by month 6. Those at higher risk or due for the bivalent could manage to seize the opportunity to get one now and still have a good gap to get the updated in late fall before holidays, family gatherings and peak winter viral season.
There could be some concern about blunting effect if vaccinations are too close/often, less than 5-6 months.
Then there is “style” or the “art” of medicine. Given the same facts, there are differing styles, risk aversion, and so much and so little information at the same time.
I got my 94year father another dose, in April, wedged nicely 5.5 months after his first infection and looking to 6 months before his next booster in the fall. I think (cannot recall exactly where I read) the UK is looking at a 12 month gap. But remember, public health doesn’t prioritize individuals.. it takes a global approach to cost, morbidity, mortality and health care cost savings. May be excellent planning, but may not be “the best for you”.
Sarah, thank you so much for replying on this. Just chock full of insight and really helpful.
Dr. Topol’s response may have been related to the findings in this study: https://www.cdc.gov/mmwr/volumes/72/wr/mm7224a6.htm
Thank you for taking the time to answer. I've scheduled it for Monday. I am so grateful for your work.
Oof, I just had covid for the first time a couple weeks ago. Picked it up in NYC. Wasn’t terrible after the initial runny nose, sore throat, body aches (my knees really hurt) and fever. Paxlovid to the rescue. Had very mild rebound 2 days after the paxlovid with congestion, low grade fever and oddly leg muscle pain. I had been extra careful because I have diabetes and asthma.
Any news on new antivirals in the works? I know that the fear is that paxlovid may become infective. Paxlovid made me fee, better within hours of taking it.
great that Paxlovid helped you: a year ago in mid May I was sick w/Covid -19 and luckily got an Rx quickly. I could feel it descending into my lungs by the hour, about 24 hours after symptoms started. The rebound is the infection itself, like many viruses one might feel better but then go into a 2nd phase. BUT the Paxlovid slows down and blocks the rapid spread of the virus in the initial days.
I don't understand the claim that the drop in vaccine effectiveness isn't really all that big because of some "immunity wall". What does that even mean? The only immunity I have from COVID is from vaccines.
I think what it's meant to suggest is that even if one individual's immunity might wane in the space of a few months, there are enough people out there whose immunity is high (because there vaccine or infection was more recent, or because their bodies are better at maintaining high levels of immunity) that overall, the effective rate of transmission in the population as a whole is lower.
What is known about how effective a Novovax booster is compared to an mRNA booster (for someone who previously had mRNA boosters)? Thanks.
Firstly, thank you. Additionally, I realize that not having discussed “who” will be eligible does not mean some will he excluded but as someone whose job it is to advocate for Vaccine uptake in children, waiting for late summer to release this is detrimental to acceptance. Success lies with families and this sows doubt in the necessity. This is absolutely what occurred when there was delay approving the bivalent booster. Bu the time it was approved, many willing parents had mentally moved on and it was no longer feeling urgent.
What a pity this will come so late.
I am looking forward to more information about administration data for same day flu and Covid vaccines too.
Thank you!
Agree!
Thank you for this excellent and timely summary. I am especially hopeful that Novavax will be able to manufacture a booster on time and at scale, and that FDA doesn't restrict access of Novavax for those of us who prefer it over mRNA.
I am unfamiliar with pros and cons of Novovax, and would be interested in more information on that. I gather that there may be fewer side effects than the mRNA vaccines, and that would certainly interest me.
One of the biggest pros seems to be that it doesn't knock you out for a whole day....
Thanks for answering on that. I thought that might be the case, and that would certainly be a huge plus.
We'll see what happens. One thing I'm concerned about is our dependence on horseshoe crab blood for screening out endotoxins. It's a problem not just for vaccines but for lots of injectable medications. There's a substitute, but in order for pharmaceutical companies to use it "automatically", US Pharmacopeia needs to sign off on it. They haven't done so yet. If they continue to drag their feet, we could see some severe shortages.
Yes!!! I am very interested in Novavax and hope it will be a viable option!
Me too. I just hope BARDA (or whoever is responsibler) orders *ENOUGH* Novavax to meet pent up demand. During the FDA meeting there were public comments from people who tried to get Novavax and were denied by pharmacists due to the FDA's restrictive language. It was clear from people's comments that demand for Novavax was much higher than actual doses administered - so hopefully BARDA has an accurate way to project true demand, because basing it on past uptake would be a huge underestimate and result in not ordering enough.
Does the government solicit and consider public input so they can order the right amount from each manufacturer? I hope so, but given all the mismatch of supply and demand, and ultimate waste, it doesn't appear to be the case.
I wish FDA/BARDA had a way of polling people to see which vaccine they preferred so they can order quantity correctly. There was talk at the vaccine meeting that there's value in making the vaccine's as "interchangeable" as possible from a public perception, which includes things like waiting till September to release all boosters even though some manufacturers are ready to ship product in July or August (which would be a huge benefit to school teachers, parents and children). People are more likely to get a booster if they feel like they have choice and access to the one they want. Some will stick with mRNA, some will switch to Novavax, some don't care about brand.
But I just hope BARDA orders enough Novavax so that I can get one, and that FDA doesn't restrict access to it, which puts pharmacists and the public in a terrible spot.
They should just start letting people pre-order way in advance with their doctors. Let the providers, payers, PBM's and pharma manufacturers take it from there. HHS is exempt from HIPPAA when it's for statistical purposes.
A possible barrier is that it's sensitive economic info - these are publicly traded companies. Remember what happened to Martha Stewart....
Did you just edit out a link to Novavax having data that its vaccine helped improve long Covid? I had skimmed all the comments and was just about to follow the link when poof! Gone! By the way, hi, nice to see you! :o)
Yes, I deleted it because the claim came from the public comments portion and not from the actual Novavax presentation. Meaning I’m uncertain of its source or veracity. You can go to Youtube and watch today’s FDA meeting. Youtube has a feature whereby you can display the entire transcript, and search for keywords such as “long Covid.”
It’s my understanding the part about imprinting is true (based on a prepublication I’ve seen), yet I’m unclear what the implications are for people who are already vaccinated. It’s my hope that we don’t all have to start over with a new primary series, and can instead continue with an annual or semi-annual booster.
There was also talk today that the fall ‘22 bivalent boosters are not very helpful with current variants. I think this discussion took place after lunch and before the vote.
Thanks so much for clarifying. Thanks also for telling me about that cool YouTube feature! I had no idea you could search transcripts like that.
Interesting article from Jeremy Faust on the meeting: https://open.substack.com/pub/insidemedicine/p/fda-moves-towards-monovalent-covid (For those who asked about benefits in younger populations, he has a good bit to say about that.)
Have to say, the booster landscape is getting more and more confusing. I would like to have a better understanding of the risks and benefits than I do so far, particularly on “imprinting” and on the pros and cons of mRNA v. Novovax.
On imprinting, BTW, Faust had this to say: “Second, dropping the Wuhan portion of the vaccine will decrease the immune imprinting that we’ve seen crop up, in which we accepted short-term protection in exchange for longterm higher rates of reinfection. (I discussed this on the PBS News Hour this spring).” This is the first I have heard of that trade off. Is anyone here familiar with what he means?
I am 43 and have only received the first three shots. I had a physical this morning, and my doctor did not recommend a booster this year.
I’m not high risk (relatively young and healthy) and traveling this summer and was going to get a booster in the next few days to protect my travels, but this article makes it seem like maybe I don’t need to do that?
There are disturbing statistics about an extreme rise in excess deaths among working age people in 2021 and 2022. I would be very grateful if you would discuss. Some are attributing it to the vaccines. The rise is so huge (“blackswan like”) that I will not do another MRNA vaccine until I understand what these excess deaths mean. I have had 4 Modernas but now hear I have no protection against XBB. The risk/benefit calculationis starting to weigh to not getting more vaccines. I hope you can help explain.
It seems quite possible these excess deaths are due to covid itself (its long-term effects perhaps) rather than the vaccine.
Definitely.
I have had the first two Moderna and the first booster. I just established care with a new physician today, and she did not recommend any boosters for me. My previous clinician did not either. I am 43 with no comorbidities, and they both said the risks do not outweigh the benefits. 🤷🏻♀️ I am very disappointed in the messaging.
Virginia, do you have a link on that? I, too, am concerned there is insufficient/unclear risk-benefit information for individuals to make these judgments.
The book “Cause Unknown” by Edward Dowd who is a financial numbers guy. He says statistically this is such an aberation it must be examined. In 2021 the excess deaths switched from old peolple to working age peolple. John Campell (I think that is his name) has discussed the same statistical issue in the UK on his youtube channel. It is quite weird, and disturbing that it happened after the vaccines were required for working people.
Thanks for the Cliff notes from today's FDA meeting on the fall vaccines. Like others, I hope that all can be eligible for the upcoming fall vaccine, just as with the flu vaccine. I'm 62, and feel that I could really benefit, but my layperson's understanding is that everyone could benefit from these vaccines. I look forward to learning more going forward. Thanks again!
For those of us who had the bivalent vaccine last fall, should we get the available next bivalent now, or wait for the fall monovalent vaccine? Over 65 years, in good health.
Get the bivalent now - and then in four to five months get the updated monovalent
I did for extra protection while traveling this summer.
Dr Jetelina answered this above:
Query: should those of us who are over 70, currently due for another dose of the bivalent vaccine, and/or traveling abroad between now and early Fall get the old bivalent now—or wait for the new monovalent vaccine? Please advise. Thanks.
Katelyn Jetelina
Good question. There are 5 months until November. If you were going to get one, I would do it ASAP so there’s enough runway until fall booster (that is assuming you haven’t been infected recently). I would ensure at least 3-4 month runway for maximum protection.
Would love to know how long “hybrid immunity” really lasts against infection? I’ve seen experts quote 4-6 months…but that’s quite a gap. Is it closer to 4 or 6?
This is an example of how confusing the booster situation can be for a layperson, even those of us who do our best to educate ourselves. This is an observation from the wonderful Eric Topol on a problem with the effectiveness of the bivalent, relating to a presentation in the FDA meeting: https://twitter.com/EricTopol/status/1669366459678752768
Always a good read and informative.