Very grateful to Dr. Jetelina, once again, for the report on this. Have to say, as one in the target group, this is the first time where I find I am hesitant to get a vax, at least until more is known. I thought there were really good cautionary comments coming out of some members of the committee.
>The level of incidence of adverse events gives me pause, for one, and I’m not too keen on the potential duration of side effects—a 20%+ chance of four days of fatigue or myalgia post-vax is not high on my hit parade (though here I may not understand the charts).
>I was also struck by this: “Some advisory committee members felt that because RSV is not currently a public health emergency in this age group, it would be best to conduct trials for additional data before granting licensure.”
>Information on durability also seems suboptimal, per Dr. Jetelina’s comment in that section, “However, what this means for protection against severe disease in humans is not currently known. This is particularly a concern with RSV because we know that infection-induced immunity is incomplete.”
So far, I find myself in the camp of the dissenting votes. Of course there are several more months before the vaccines will be offered, so perhaps we will know enough more by which to make a judgment.
Will be interested in the thoughts of others on these issues.
I really appreciated those comments too. And, honestly, at this point, I don't htink I would recommend my parents and grandparents getting it. Maybe waiting a month to see how the safety data plays out. My HOPE (we'll see if this happens) is that they are collecting data in the interim and will have a more solid picture when the vaccine rolls out. I'll report back if we do.
Dr. Jetelina, given the intervening months, do you now recommend RSV vaccines for people over a certain age? What is your opinion of the safety? thanks!
I have the same question for Dr. Jetelina. Three people in our family have contracted RSV, and my husband and I are well over 60. Should we get the vaccine, or are you still advising your parents to wait?
The durability isn't a huge concern because this vaccine would likely end up being given annually alongside flu and COVID-19 vaccines for older adults (which is a big part of why we need coadministration studies so badly). Truthfully, I think that saying this isn't an emergency is a bit of a copout- the need for an RSV vaccine for older adults is still very urgent. Nearly 200,000 of them are hospitalized by RSV during a typical season and over 14,000 deaths. Additionally, if both vaccines get to market, there will be a choice of which one to get and Pfizer's has a milder side effect profile.
Concur with Susan. Anyone who has read this newsletter for a significant time knows I am a Covid maximalist, fearing (by temperament) the virus and what it can do. Note the use of the present tense. That same fearfulness makes me loath to take a vaccination that has even a 1 in 15,000 chance of getting GBS. I don't think the outcomes of getting RSV for lack of vaccination, are worse than the total catastrophe GBS would be.
From yesterday's New York Times article on RSV vaccines (link below): "Vaccine experts from the Centers for Disease Control and Prevention examined the Pfizer and GSK study data and determined that in one year, more than 21,000 people 65 and older would need to take the GSK vaccine to prevent one R.S.V. death; the number was nearly 25,000 for the Pfizer shot."
So, IMHO, the risk probably isn't worth the benefit. Unfortunately, I have come to view study results from pharma companies on efficacy as "best case scenario," which might not be fair, but at least with the covid vaccines, real world results didn't seem to hold up.
Going to sit this one out, too, and let the experts do their thing. Some pretty concerning red flags with ADEM and GBS, and the absolute numbers needed to vaccinate to prevent one death from the NYT article are sobering. Probably vaccines that should be precisely targeted towards highest risk populations?
Would be nice to see pediatric study, as the past winter strained children’s ERs and hospitals as we recall.
I collect vaccines like passport stamps, but would defer my trip based on this post for now! Will stay tuned...
Perhaps I don’t understand GBS very well, but are you saying only some people are at risk of getting it in general? And if you’re not at risk, the RSV vaccine won’t trigger GBS?
Assuming I were 65+ (I’m not), I still don’t think I’d take the RSV vaccine because:
1) the risk assessment test probably doesn’t account for external factors like one or more vaccines (RSV + flu + Covid co-administered) that could trigger GBS,
2) a vaccine that has one type of adverse reaction probably has others that haven’t been discovered yet,
3) it seems that for every life the vaccine saves, there’s at least one serious adverse outcome, some of which can be life-threatening (according to NYT article),
4) the covid vaccines and boosters have caused me to become skeptical of efficacy and duration promises - the benefits never seem to be as big in the real world
Also, I’m not sure I believe that studies weren’t done while co-administering the covid vaccine. I think these companies run all sorts of studies, and only the most flattering ones get published
How does misinformation show with a vaccine that currently wouldn’t be required? Do we see similar misinformation campaigns for the flu vaccines? Or was COVID uniquely targeted because of the mandates that government put in? I am curious what is the trigger for the misinformation attacks. Science itself or science plus government intervention?
This is such a good question and I have been trying to find patterns. Definitely pediatric vaccines stoke the flame. We saw this hard core with HPV (and covid). That’s why I’m a bit more hopeful for this one, given it’s older adults. Definitely also when benefits and risks are tight (it may be tight with this one). Once pregnant people are eligible (this summer probably) we will see a lot. Will be interesting to follow.
Great question. Nobody seems to want to do a post mortem on the vaccine mandate - were the benefits worth the costs? Under what circumstances should mandates ever be imposed again? What must we first know to be true before imposing any type of future mandate?
I am a big believer in Newton's Third Law: For every action, there's an equal and opposite reaction. Not just in physics, but in life. Some would call this karma. Every force that is applied faces opposition, often in unexpected or unwanted ways.
That's actually not what Newton's Third Law says and you're yanking it out of context in any case.
Interesting that the massive anti-vaccine propaganda campaign is somehow supposed to be caused by vaccine mandates. Seems to me that's ignoring the fact that this campaign originated with and has continually been stoked by the far right perpetual grievance machine. One might almost suspect an attempt to change the subject.
Until the Murdoch media machine decided to adopt it as a badge of autocratic tribal loyalty it was a wacko pseudoscience fringe movement pushed largely by quacks selling snake oil.
Are there resource bottlenecks that make co-administration necessary, or is it simply a matter of convenience for the person getting the vaccine? My inclination is always to space out my vaccines.
Great question. Public health is telling us to get annual flu and Covid (and soon RSV?) shots all at once because they’d rather make sure people check all the boxes because this is what is best at a societal level. My doctor has told me to space out vaccines by at least two weeks because this is what is best at an individual level.
As long as public health recommendations prioritize societal over individual benefits, their recommendations will rightfully be met with skepticism.
Excellent write-up Edward, subscribed to your substack.
Katelyn/Edward - What about the Moderna mRNA RSV vaccine? Why wasn't that under review at this meeting? Too early? Granted it's their own press release, so you take with a grain of salt, but phase 3 trials were promising.
Thanks for the highly informative post. Are you aware that there's yet another RSV vaccine in trials? I'm a 65+ aged male enrolled in a yearlong study led by Bavarian Nordic A/S. I believe part of the trial is in Europe, so perhaps that's where they hope to market it.
There are many RSV vaccine candidates in trials; once we figured out prefusion stabilization of the F protein, a bunch of approaches became viable. There are adenovirus vectored vaccine candidates as well. PATH has a summary:
So with these two possible "side-effects," both of which seem fairly significant, how soon after the vaccine is administered do they manifest themselves? Minutes, hours, or days? And once they appear, what are the remedies? Thank you, Katelyn.
They both took a bit over a week to show up. Treatment is immunosuppression with corticosteroids to stop the inflammation (at least for ADEM- corticosteroids don’t seem to help with GBS), plasma exchange, IVIg, and rehabilitation.
Thank you for unpacking this and for all the work you are doing! I have a question and I think the answer is "we don't know?" However, I am going to ask it anyway . . . Are we getting closer to where this awful virus will actually be more like "other" respiratory viruses?
No, but it's conceivable that many risks turn out to be more deterministically heterogeneous as advances are made in, for instance, genetics and AI. Interesting world we're headed for.
I'd love to see our heroine write something about the public health implications of AI.
Hmmm. It would be helpful to have some sense of the mortality rate of RSV in various age groups, as well as the consequences of the neurological conditions that appeared more often in the vaccinated group. In the absence of these pieces of information, it's difficult for a lay person to make a decision about the RSV vaccine.
Very grateful to Dr. Jetelina, once again, for the report on this. Have to say, as one in the target group, this is the first time where I find I am hesitant to get a vax, at least until more is known. I thought there were really good cautionary comments coming out of some members of the committee.
>The level of incidence of adverse events gives me pause, for one, and I’m not too keen on the potential duration of side effects—a 20%+ chance of four days of fatigue or myalgia post-vax is not high on my hit parade (though here I may not understand the charts).
>I was also struck by this: “Some advisory committee members felt that because RSV is not currently a public health emergency in this age group, it would be best to conduct trials for additional data before granting licensure.”
>Information on durability also seems suboptimal, per Dr. Jetelina’s comment in that section, “However, what this means for protection against severe disease in humans is not currently known. This is particularly a concern with RSV because we know that infection-induced immunity is incomplete.”
So far, I find myself in the camp of the dissenting votes. Of course there are several more months before the vaccines will be offered, so perhaps we will know enough more by which to make a judgment.
Will be interested in the thoughts of others on these issues.
I really appreciated those comments too. And, honestly, at this point, I don't htink I would recommend my parents and grandparents getting it. Maybe waiting a month to see how the safety data plays out. My HOPE (we'll see if this happens) is that they are collecting data in the interim and will have a more solid picture when the vaccine rolls out. I'll report back if we do.
Dr. Jetelina, given the intervening months, do you now recommend RSV vaccines for people over a certain age? What is your opinion of the safety? thanks!
I have the same question for Dr. Jetelina. Three people in our family have contracted RSV, and my husband and I are well over 60. Should we get the vaccine, or are you still advising your parents to wait?
The durability isn't a huge concern because this vaccine would likely end up being given annually alongside flu and COVID-19 vaccines for older adults (which is a big part of why we need coadministration studies so badly). Truthfully, I think that saying this isn't an emergency is a bit of a copout- the need for an RSV vaccine for older adults is still very urgent. Nearly 200,000 of them are hospitalized by RSV during a typical season and over 14,000 deaths. Additionally, if both vaccines get to market, there will be a choice of which one to get and Pfizer's has a milder side effect profile.
Concur with Susan. Anyone who has read this newsletter for a significant time knows I am a Covid maximalist, fearing (by temperament) the virus and what it can do. Note the use of the present tense. That same fearfulness makes me loath to take a vaccination that has even a 1 in 15,000 chance of getting GBS. I don't think the outcomes of getting RSV for lack of vaccination, are worse than the total catastrophe GBS would be.
From yesterday's New York Times article on RSV vaccines (link below): "Vaccine experts from the Centers for Disease Control and Prevention examined the Pfizer and GSK study data and determined that in one year, more than 21,000 people 65 and older would need to take the GSK vaccine to prevent one R.S.V. death; the number was nearly 25,000 for the Pfizer shot."
So, IMHO, the risk probably isn't worth the benefit. Unfortunately, I have come to view study results from pharma companies on efficacy as "best case scenario," which might not be fair, but at least with the covid vaccines, real world results didn't seem to hold up.
https://www.nytimes.com/2023/03/01/health/rsv-vaccine-fda.html?searchResultPosition=1
Going to sit this one out, too, and let the experts do their thing. Some pretty concerning red flags with ADEM and GBS, and the absolute numbers needed to vaccinate to prevent one death from the NYT article are sobering. Probably vaccines that should be precisely targeted towards highest risk populations?
Would be nice to see pediatric study, as the past winter strained children’s ERs and hospitals as we recall.
I collect vaccines like passport stamps, but would defer my trip based on this post for now! Will stay tuned...
If there was some way of assessing your a priori risk of GBS would that change your analysis?
Is there? How accurate?
Sorry, was asking hypothetically. If you had a way of revising your own risk assessment, would you get vaccinated for RSV?
Got it, thanks for clarifying.
Perhaps I don’t understand GBS very well, but are you saying only some people are at risk of getting it in general? And if you’re not at risk, the RSV vaccine won’t trigger GBS?
Assuming I were 65+ (I’m not), I still don’t think I’d take the RSV vaccine because:
1) the risk assessment test probably doesn’t account for external factors like one or more vaccines (RSV + flu + Covid co-administered) that could trigger GBS,
2) a vaccine that has one type of adverse reaction probably has others that haven’t been discovered yet,
3) it seems that for every life the vaccine saves, there’s at least one serious adverse outcome, some of which can be life-threatening (according to NYT article),
4) the covid vaccines and boosters have caused me to become skeptical of efficacy and duration promises - the benefits never seem to be as big in the real world
Also, I’m not sure I believe that studies weren’t done while co-administering the covid vaccine. I think these companies run all sorts of studies, and only the most flattering ones get published
How does misinformation show with a vaccine that currently wouldn’t be required? Do we see similar misinformation campaigns for the flu vaccines? Or was COVID uniquely targeted because of the mandates that government put in? I am curious what is the trigger for the misinformation attacks. Science itself or science plus government intervention?
This is such a good question and I have been trying to find patterns. Definitely pediatric vaccines stoke the flame. We saw this hard core with HPV (and covid). That’s why I’m a bit more hopeful for this one, given it’s older adults. Definitely also when benefits and risks are tight (it may be tight with this one). Once pregnant people are eligible (this summer probably) we will see a lot. Will be interesting to follow.
Great question. Nobody seems to want to do a post mortem on the vaccine mandate - were the benefits worth the costs? Under what circumstances should mandates ever be imposed again? What must we first know to be true before imposing any type of future mandate?
I am a big believer in Newton's Third Law: For every action, there's an equal and opposite reaction. Not just in physics, but in life. Some would call this karma. Every force that is applied faces opposition, often in unexpected or unwanted ways.
That's actually not what Newton's Third Law says and you're yanking it out of context in any case.
Interesting that the massive anti-vaccine propaganda campaign is somehow supposed to be caused by vaccine mandates. Seems to me that's ignoring the fact that this campaign originated with and has continually been stoked by the far right perpetual grievance machine. One might almost suspect an attempt to change the subject.
There has been an anti-vaccine conspiracy machine for as long as there have been vaccines. We're talking centuries here: https://www.vox.com/the-goods/22958419/covid-vaccine-mandate-pandemic-history You can find other historical sources on line here: https://www.oah.org/tah/issues/2015/august/vaccination-resistance/ and here: https://historyofvaccines.org/vaccines-101/misconceptions-about-vaccines/history-anti-vaccination-movements
Until the Murdoch media machine decided to adopt it as a badge of autocratic tribal loyalty it was a wacko pseudoscience fringe movement pushed largely by quacks selling snake oil.
Are there resource bottlenecks that make co-administration necessary, or is it simply a matter of convenience for the person getting the vaccine? My inclination is always to space out my vaccines.
Great question. Public health is telling us to get annual flu and Covid (and soon RSV?) shots all at once because they’d rather make sure people check all the boxes because this is what is best at a societal level. My doctor has told me to space out vaccines by at least two weeks because this is what is best at an individual level.
As long as public health recommendations prioritize societal over individual benefits, their recommendations will rightfully be met with skepticism.
Question: is there data on the risks of having RSV so we can compare that with the risks of the vaccine?
Yes; we didn't focus on it in the post but it is discussed briefly in the FDA briefing documents:
https://www.fda.gov/media/165623/download
https://www.fda.gov/media/165622/download
"RSV disease among adults 65 years of age and older results in an average of 177,000
hospitalizations in the United States (US) each year; during 1999-2018, the highest
mortality was seen in this age group with a mortality rate of 14.7 per 100,000 (CDC,
2022; Hansen et al, 2022). The severity of RSV disease increases with age and
comorbidities (e.g., chronic obstructive pulmonary disease, congestive heart failure,
asthma) (Falsey et al, 2005; Walsh et al, 2004; Korsten et al, 2021; McClure et al, 2014;
Branche et al, 2022)."
"Respiratory syncytial virus (RSV) is a highly contagious human pathogen that causes
respiratory tract infections in individuals of all age groups. The severity of RSV disease
increases with age and comorbidities (e.g., chronic obstructive pulmonary disease, congestive
heart failure, asthma) (Falsey et al, 2005). RSV disease among adults 65 years of age and older
results in an average of 177,000 hospitalizations in the United States (US) each year; during
1999-2018, the highest mortality was seen in this age group with a mortality rate of 14.7 per
100,000 (CDC, 2022; Hansen et al, 2022).
RSV infection does not confer lasting immunity and re-infections occur throughout individual
lifespans. There is currently no immune marker and threshold widely accepted as predictive of
protection against RSV. The durability of naturally acquired immunity after RSV infection is also
not well understood. Studies of immune response after RSV infection indicate an initial rise in
serum antibody levels, with a return to baseline by 16-20 months post-infection (Falsey et al,
2006). Although high rates of re-infection and short durability of protection after infection were
observed in an RSV human challenge study in young adults (Hall et al, 1991), another study
among elderly individuals suggest that natural re-infection with RSV was rarely observed over
two consecutive years (Johnson et al, 1962). "
Excellent write-up Edward, subscribed to your substack.
Katelyn/Edward - What about the Moderna mRNA RSV vaccine? Why wasn't that under review at this meeting? Too early? Granted it's their own press release, so you take with a grain of salt, but phase 3 trials were promising.
https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx
It wasn’t discussed at the meeting; probably isn’t ready yet in terms of the data packet.
Thanks!
Thanks for the highly informative post. Are you aware that there's yet another RSV vaccine in trials? I'm a 65+ aged male enrolled in a yearlong study led by Bavarian Nordic A/S. I believe part of the trial is in Europe, so perhaps that's where they hope to market it.
There are many RSV vaccine candidates in trials; once we figured out prefusion stabilization of the F protein, a bunch of approaches became viable. There are adenovirus vectored vaccine candidates as well. PATH has a summary:
https://media.path.org/documents/RSV-Snapshot_03JAN2023_HighResolution.pdf
Thanks!
So with these two possible "side-effects," both of which seem fairly significant, how soon after the vaccine is administered do they manifest themselves? Minutes, hours, or days? And once they appear, what are the remedies? Thank you, Katelyn.
They both took a bit over a week to show up. Treatment is immunosuppression with corticosteroids to stop the inflammation (at least for ADEM- corticosteroids don’t seem to help with GBS), plasma exchange, IVIg, and rehabilitation.
Thank you, Edward!
Thank you for unpacking this and for all the work you are doing! I have a question and I think the answer is "we don't know?" However, I am going to ask it anyway . . . Are we getting closer to where this awful virus will actually be more like "other" respiratory viruses?
Pediatrician here. Where are the infant studies??
No, but it's conceivable that many risks turn out to be more deterministically heterogeneous as advances are made in, for instance, genetics and AI. Interesting world we're headed for.
I'd love to see our heroine write something about the public health implications of AI.
Hmmm. It would be helpful to have some sense of the mortality rate of RSV in various age groups, as well as the consequences of the neurological conditions that appeared more often in the vaccinated group. In the absence of these pieces of information, it's difficult for a lay person to make a decision about the RSV vaccine.
Thanks, always.
Be sure your daughters are getting adequate Mommy not just the MDR.
Thanks for participating, KB!
When do you get unblinded?