Thank you for this post. A question: You say, "The risk/benefit calculus among 60-74-year-olds without a comorbidity was tight, as shown in the slide below." Could please elaborate on that? Exactly what the slide is showing --- the various numbers in the horizontal axis, the "lower bound" reference --- is not clear to me. Thank you.
Great question! I could have definitely been clearer with that.
Epidemiologists use bounds to estimate "worse case" and "best case" scenario since our mathematical models assume a lot of factors. So the lower bound here is the "best case" scenario in deaths from RSV for those aged 60-74. If we look at that left panel, that is 14 deaths from RSV over the past year. The reason they called this out is because it overlaps with the number of GBS cases (in other words 14 is between the bounds of GBS which is 3-29), which means that the number of deaths isn't different than the number of GBS cases.
The slide in question compares the number of bad RSV outcomes (hospitalization, ICU admission, and death) averted through vaccination of the indicated group (60-74 year-olds) in the form of a confidence interval and notes the expected number of cases of Guillain-Barre syndrome that would occur from vaccinating these people. The risk of bad outcomes in otherwise healthy 60-74-year-olds is relatively low to start with, so the balance of risks and benefits is narrower and depends a lot on the specific number of cases of GBS. In particular, given the current estimated rate of GBS from the Pfizer RSV vaccine, we might see more cases of GBS than RSV deaths averted in this age group, if we use the lower bound of the estimate for deaths averted. Nonetheless, GBS is not uniformly fatal, which complicates interpretation. It may therefore be reasonable in this age group to, for the time being, defer vaccination until either additional risk factors emerge or one ages into a group at higher risk of poor outcomes (although this is a bit fraught because the risk is likely continuous and does not simply jump up once you reach 75). Hope that helps.
Sad to say, about consulting with your doctor, when I indicated to my PCP that I and my spouse planned to get the RSV vax this year (I am 75, my spouse is 76), my doctor offered no information pro or con, so, unbeknownst to me, I was flying blind. I wasn’t advised 1) about the GSB possibility at all, let alone receiving information of level of risk; 2) that there was more than one choice of vaccine, let alone anything about possible differences among them; 3) the current status of when or whether to get a booster. If I had known what I read in Ryan McCormick’s post on RSV at the time, I would have chosen against getting the vaccine because of the GSB possibility, until and unless I was able to get clear information from my PCP. I don’t place blame on the PCP for this: Ryan has written how difficult it is to fit all the things expected of a primary care doctor into a single visit—particularly with older people who may have multiple things going on. I’d be interested in anyone’s thoughts about how PCPs could be better supported to make such consults possible. One that occurs to me is for the health care site to prepare a flyer that can be handed to each patient, with a brief explanation of key points about which to be aware. I’d be very interested in thoughts and suggestions from Team YLE and PCPs.
PCPs have a bit of an insuperable task at the bedside for sure. CDC is generally very helpful about providing educational materials on vaccines- they would be one of my first choices to look for additional information.
Agree with you 💯💯💯 about the insuperable task facing PCPs. I don’t, though, think having individual patients try and search the CDC site is the right answer. Most won’t do it, and older folks are often even less able to do so. Also, while I have searched the CDC for information many times, and while there is a lot of good information there, it is a swamp. It is also necessary to realize there is something you don’t know and need to find out. My thought is that something simple like a flyer PCPs and MD offices could pass out would be helpful, and, generally, PCPs need much better support so they have time and sufficient information to help patients assess what is best for them to do. I think these big hospital systems (like the one where I obtain my care) are falling down woefully in providing the support both PCPs and their patients need, on many levels, of which this is just one.
I appreciate very much that you pointed this out (as well as the other links), and I didn't mean to be crabby with YOU about it, but was rather expressing my general frustration about the lack of communication "on the ground." The VIS statement is indeed excellent, and you are right to point it out specifically. The question I have is, what is actually happening where the rubber hits the road? My personal experience is of course only anecdotal, but neither my PCP nor the pharmacist provided this statement, and it leads me to wonder how widespread a problem that is. I think this is a good example of a communications failure, and, in this case, one that could be resolved even more easily than I'd first thought. For example, could it not be distributed by targeted broadcast communications to relevant patients through the hospital or health care system as part of their many prompts for folks to get their vaccinations? I'd be interested in any thoughts you have on that.
I have a covid vaccine injury do to the MRNA vaccine. I have been thrilled to have a non MRNA Novovax covid shot this year thanks to you informing me. I am most concerned about getting RSV. I am a 69 year-old-woman and since my Vacc Injury I have been told by my Drs. to never receive another MRNA vaccine. Is there any work being done on a non MRNA vaccine?
I’d be interested in researchers including autoimmune disease as a comorbidity in these analyses. Because, it’s known that people with autoimmune disease are more likely to develop other autoimmune diseases. So if they are seeing the possibility of GBS from this vaccine it’s logical that autoimmune folks could be at higher risk for GBS after vaccination. The potential statistical difficulty is that there’s a range of immunosuppression and ability to manage the disease in the “autoimmune” category.
Can you share information about the side effects for older adults from the RSV vaccine. Our internist told us to not get it yet (69 years old) because of the extreme side effects. She did not say what those side effects were…
You are correct. It has not been observed to have this risk beyond the natural rate of the condition, nor have mRNA vaccines in general, despite looking closely. In particular, though it may actually be better from a safety perspective, it appears to wane in protection more quickly than either protein vaccine, although the comparisons merit caution. We have less data on how well it works than for either of the other options, and, being an mRNA vaccine, it is tougher from a reactogenicity perspective.
Reactogenicity refers to the common, expected side effects you get from vaccination that are a natural consequence of activating the immune system. These include things like local reactions (pain at the injection site, redness, swelling, sometimes a rash, swelling of the lymph nodes, etc.) and systemic reactions (fever, joint aches, muscle aches, etc.). These symptoms should generally resolve within a few days, usually sooner. It is commonly (but not universally) the case that vaccines that are more effective in inducing the immune response are more reactogenic (i.e. that they cause more of these symptoms), but the presence or absence of such symptoms in an individual does not necessarily tell you anything about the quality of the immune response (with the exception of fever, which does seem to associate with a better immune response to mRNA vaccines- but this does not mean that those who do not develop fevers will not make good immune responses). In general, reactogenicity is unpleasant, but not dangerous.
Reactogenicity is a part of safety, but not quite the same thing. Safety is a more global consideration, taking into account things like the rare but serious adverse events- for example, anaphylaxis or myocarditis. Vaccines can be very reactogenic and also very safe- which is a reasonable way to describe current mRNA vaccines.
In terms of which vaccine to get for RSV: they all have pros and cons and it depends on multiple factors and what matters most to you:
- As of the current data, we see that Pfizer and GSK's vaccines seem to be more durable in their protection than Moderna's.
- Pfizer's is also less reactogenic than either Moderna's or GSK's, but has the highest risk of Guillain-Barre syndrome (GBS) in the available data.
- As of this moment, there is no clear increased risk of GBS from Moderna's vaccine, but there are also fewer people to base this data on, and GBS is very rare- it is likely that if there is an increased risk of GBS with Moderna's RSV vaccine, it won't be apparent until after it's been given to many more people. At the same time, mRNA vaccines for COVID-19 have not been associated with an increased risk of GBS.
- It is likely that regardless of which vaccine you opt for, you will need a booster at some point (though clearly not every year).
All of the choices are reasonable, and the best one for you depends on which factors are most important to you.
Any info on why the RSV vaccine isn’t offered to people of any age with lung conditions like asthma and COPD? I’m well under the minimum age but guaranteed complications from any respiratory infection, so it’s frustrating I can’t get this vaccination.
The vaccines are still relatively new; it may take time for recommendations to trickle down to other groups as data accrue on the balance of risks and benefits. Classically, RSV is dangerous principally at the extremes of age, so this approach (vaccinating in pregnancy and vaccinating older adults) targets those individuals. Your best bet may be to ask your PCP about off-label vaccination, but be aware that none of the vaccines are cheap. In addition, if you are not in these age groups, you should be aware that there is a lack of data to inform risks that may disproportionately affect your age group (e.g., GBS is more common as you get older, but myocarditis with the COVID-19 vaccines tends to be an issue of younger males).
The vaccines in general are safe with only very rare risks of serious adverse events. The question is less about safety and more about how the risks compare to the benefits. In those aged 74 and older, the risks of bad outcomes from RSV are much greater, and as a result, the very small risk of things like Guillain-Barre syndrome is a much less important consideration. For example, for every 1 million people aged 75 and older vaccinated with the GSK vaccine, we would be able to prevent 254 to 605 deaths, 311 to 604 ICU stays, and about 4000 hospitalizations, but we would expect 3 cases of Guillain-Barre syndrome. Clearly, the benefits are much larger than the risks.
Can you comment on whether expectant grandparents should get vaxxed. Expectant parents asked their parents to consider getting vaxxed to protect new baby when it comes. Is there data on the vax preventing transmissible infection?
I am 73 years old and had CABGx4 six years ago. Am I considered at increased risk of of severe RSV and would it be advisable to get the vaccine? Thank you for your ongoing help!
What about getting RSV at the same time with Covid & Senior flu vaccines? I've read a few things saying it's safe, but am wondering about increased side effects (?). I've gotten Covid & flu together (am 81), & didn't think there were any more side effects than usual (I've never really had side effects with flu shots, but do with Covid, for a day or so). It sure would help me to have just one appointment, but then I'd not know, because RSV is new, what the side effects might be from that vaccine. Any input from the experts? Thanks!!
What is the data source(s) for the figure in this post, please, so I can access the raw data? Please reply either here or directly to me at bblack@northwestern.edu. Bernie Black (Prof of Law and Finance, Northwestern)?
"Preterm births were followed extra carefully after licensure because of some weird data during the clinical trial: a numerically (but not statistically) higher (1%) risk of preterm births driven almost entirely by the data from one specific site that participated in the clinical trial: South Africa. There’s a lot of speculation about why, but experts think it is an interaction between the vaccine, the immune system, and an environmental factor (like previous infection). "
Gentle reminder to be cautious about statements like this (as you know, of course) - I'm not familiar with this study, but if that (rather small!) change in risk was not statistically significant, it's best to assume that this difference was due to chance, yes? But maybe there is more to the story?
It could be random chance for sure, but it could be that the effect is real but the number of events was too small to give clear signal. That's why we had the enhanced monitoring and now the preponderance of data suggests that this is not a true risk of RSV vaccination in pregnancy.
Thank you for this post. A question: You say, "The risk/benefit calculus among 60-74-year-olds without a comorbidity was tight, as shown in the slide below." Could please elaborate on that? Exactly what the slide is showing --- the various numbers in the horizontal axis, the "lower bound" reference --- is not clear to me. Thank you.
Great question! I could have definitely been clearer with that.
Epidemiologists use bounds to estimate "worse case" and "best case" scenario since our mathematical models assume a lot of factors. So the lower bound here is the "best case" scenario in deaths from RSV for those aged 60-74. If we look at that left panel, that is 14 deaths from RSV over the past year. The reason they called this out is because it overlaps with the number of GBS cases (in other words 14 is between the bounds of GBS which is 3-29), which means that the number of deaths isn't different than the number of GBS cases.
The slide in question compares the number of bad RSV outcomes (hospitalization, ICU admission, and death) averted through vaccination of the indicated group (60-74 year-olds) in the form of a confidence interval and notes the expected number of cases of Guillain-Barre syndrome that would occur from vaccinating these people. The risk of bad outcomes in otherwise healthy 60-74-year-olds is relatively low to start with, so the balance of risks and benefits is narrower and depends a lot on the specific number of cases of GBS. In particular, given the current estimated rate of GBS from the Pfizer RSV vaccine, we might see more cases of GBS than RSV deaths averted in this age group, if we use the lower bound of the estimate for deaths averted. Nonetheless, GBS is not uniformly fatal, which complicates interpretation. It may therefore be reasonable in this age group to, for the time being, defer vaccination until either additional risk factors emerge or one ages into a group at higher risk of poor outcomes (although this is a bit fraught because the risk is likely continuous and does not simply jump up once you reach 75). Hope that helps.
Same question, thanks.
Sad to say, about consulting with your doctor, when I indicated to my PCP that I and my spouse planned to get the RSV vax this year (I am 75, my spouse is 76), my doctor offered no information pro or con, so, unbeknownst to me, I was flying blind. I wasn’t advised 1) about the GSB possibility at all, let alone receiving information of level of risk; 2) that there was more than one choice of vaccine, let alone anything about possible differences among them; 3) the current status of when or whether to get a booster. If I had known what I read in Ryan McCormick’s post on RSV at the time, I would have chosen against getting the vaccine because of the GSB possibility, until and unless I was able to get clear information from my PCP. I don’t place blame on the PCP for this: Ryan has written how difficult it is to fit all the things expected of a primary care doctor into a single visit—particularly with older people who may have multiple things going on. I’d be interested in anyone’s thoughts about how PCPs could be better supported to make such consults possible. One that occurs to me is for the health care site to prepare a flyer that can be handed to each patient, with a brief explanation of key points about which to be aware. I’d be very interested in thoughts and suggestions from Team YLE and PCPs.
PCPs have a bit of an insuperable task at the bedside for sure. CDC is generally very helpful about providing educational materials on vaccines- they would be one of my first choices to look for additional information.
The following are aimed at the general public:
https://www.cdc.gov/vaccines/hcp/vis/vis-statements/rsv.pdf
https://www.cdc.gov/rsv/vaccines/older-adults.html
This is a guidance for clinicians:
https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html
If you seek even more detail, the ACIP recommendations have a lot of data:
https://www.cdc.gov/acip-recs/hcp/vaccine-specific/rsv.html
In addition to the CDC, I really like the materials from the Immunization Action Coalition, especially their Ask the Experts pages:
https://www.immunize.org/ask-experts/topic/rsv/
They also have a site targeted at the general public to help direct them to sources of information:
https://www.vaccineinformation.org/
Hope this is helpful.
Agree with you 💯💯💯 about the insuperable task facing PCPs. I don’t, though, think having individual patients try and search the CDC site is the right answer. Most won’t do it, and older folks are often even less able to do so. Also, while I have searched the CDC for information many times, and while there is a lot of good information there, it is a swamp. It is also necessary to realize there is something you don’t know and need to find out. My thought is that something simple like a flyer PCPs and MD offices could pass out would be helpful, and, generally, PCPs need much better support so they have time and sufficient information to help patients assess what is best for them to do. I think these big hospital systems (like the one where I obtain my care) are falling down woefully in providing the support both PCPs and their patients need, on many levels, of which this is just one.
The CDC's VIS statements are there for that reason (first link). It is a requirement that they be provided before vaccination.
I appreciate very much that you pointed this out (as well as the other links), and I didn't mean to be crabby with YOU about it, but was rather expressing my general frustration about the lack of communication "on the ground." The VIS statement is indeed excellent, and you are right to point it out specifically. The question I have is, what is actually happening where the rubber hits the road? My personal experience is of course only anecdotal, but neither my PCP nor the pharmacist provided this statement, and it leads me to wonder how widespread a problem that is. I think this is a good example of a communications failure, and, in this case, one that could be resolved even more easily than I'd first thought. For example, could it not be distributed by targeted broadcast communications to relevant patients through the hospital or health care system as part of their many prompts for folks to get their vaccinations? I'd be interested in any thoughts you have on that.
I think that there could be more of an outreach effort to get to targeted groups for sure.
Is RSV a relatively stable virus or does it continually mutate like influenza, requiring repeated vaccinations with new strains?
I have a covid vaccine injury do to the MRNA vaccine. I have been thrilled to have a non MRNA Novovax covid shot this year thanks to you informing me. I am most concerned about getting RSV. I am a 69 year-old-woman and since my Vacc Injury I have been told by my Drs. to never receive another MRNA vaccine. Is there any work being done on a non MRNA vaccine?
Neither Pfizer nor GSK's vaccines are mRNA.
I’d be interested in researchers including autoimmune disease as a comorbidity in these analyses. Because, it’s known that people with autoimmune disease are more likely to develop other autoimmune diseases. So if they are seeing the possibility of GBS from this vaccine it’s logical that autoimmune folks could be at higher risk for GBS after vaccination. The potential statistical difficulty is that there’s a range of immunosuppression and ability to manage the disease in the “autoimmune” category.
Can you share information about the side effects for older adults from the RSV vaccine. Our internist told us to not get it yet (69 years old) because of the extreme side effects. She did not say what those side effects were…
Am I correctly reading the CDC website as indicating that the Moderna RSV vaccine has not shown a risk for causing GBS?
You are correct. It has not been observed to have this risk beyond the natural rate of the condition, nor have mRNA vaccines in general, despite looking closely. In particular, though it may actually be better from a safety perspective, it appears to wane in protection more quickly than either protein vaccine, although the comparisons merit caution. We have less data on how well it works than for either of the other options, and, being an mRNA vaccine, it is tougher from a reactogenicity perspective.
Can you explain what "tougher from a reactogenicity perspective" means?
If one is over 75, but otherwise in good health, which vaccine would you recommend?
Reactogenicity refers to the common, expected side effects you get from vaccination that are a natural consequence of activating the immune system. These include things like local reactions (pain at the injection site, redness, swelling, sometimes a rash, swelling of the lymph nodes, etc.) and systemic reactions (fever, joint aches, muscle aches, etc.). These symptoms should generally resolve within a few days, usually sooner. It is commonly (but not universally) the case that vaccines that are more effective in inducing the immune response are more reactogenic (i.e. that they cause more of these symptoms), but the presence or absence of such symptoms in an individual does not necessarily tell you anything about the quality of the immune response (with the exception of fever, which does seem to associate with a better immune response to mRNA vaccines- but this does not mean that those who do not develop fevers will not make good immune responses). In general, reactogenicity is unpleasant, but not dangerous.
Reactogenicity is a part of safety, but not quite the same thing. Safety is a more global consideration, taking into account things like the rare but serious adverse events- for example, anaphylaxis or myocarditis. Vaccines can be very reactogenic and also very safe- which is a reasonable way to describe current mRNA vaccines.
In terms of which vaccine to get for RSV: they all have pros and cons and it depends on multiple factors and what matters most to you:
- As of the current data, we see that Pfizer and GSK's vaccines seem to be more durable in their protection than Moderna's.
- Pfizer's is also less reactogenic than either Moderna's or GSK's, but has the highest risk of Guillain-Barre syndrome (GBS) in the available data.
- As of this moment, there is no clear increased risk of GBS from Moderna's vaccine, but there are also fewer people to base this data on, and GBS is very rare- it is likely that if there is an increased risk of GBS with Moderna's RSV vaccine, it won't be apparent until after it's been given to many more people. At the same time, mRNA vaccines for COVID-19 have not been associated with an increased risk of GBS.
- It is likely that regardless of which vaccine you opt for, you will need a booster at some point (though clearly not every year).
All of the choices are reasonable, and the best one for you depends on which factors are most important to you.
Can you provide any advice regarding which RSV vaccine to choose? Thanks.
Any info on why the RSV vaccine isn’t offered to people of any age with lung conditions like asthma and COPD? I’m well under the minimum age but guaranteed complications from any respiratory infection, so it’s frustrating I can’t get this vaccination.
The vaccines are still relatively new; it may take time for recommendations to trickle down to other groups as data accrue on the balance of risks and benefits. Classically, RSV is dangerous principally at the extremes of age, so this approach (vaccinating in pregnancy and vaccinating older adults) targets those individuals. Your best bet may be to ask your PCP about off-label vaccination, but be aware that none of the vaccines are cheap. In addition, if you are not in these age groups, you should be aware that there is a lack of data to inform risks that may disproportionately affect your age group (e.g., GBS is more common as you get older, but myocarditis with the COVID-19 vaccines tends to be an issue of younger males).
Thank you for this data! How about those above as 74? Safe?
The vaccines in general are safe with only very rare risks of serious adverse events. The question is less about safety and more about how the risks compare to the benefits. In those aged 74 and older, the risks of bad outcomes from RSV are much greater, and as a result, the very small risk of things like Guillain-Barre syndrome is a much less important consideration. For example, for every 1 million people aged 75 and older vaccinated with the GSK vaccine, we would be able to prevent 254 to 605 deaths, 311 to 604 ICU stays, and about 4000 hospitalizations, but we would expect 3 cases of Guillain-Barre syndrome. Clearly, the benefits are much larger than the risks.
Yes! No questions for those over 75
I have the same question.
Can you comment on whether expectant grandparents should get vaxxed. Expectant parents asked their parents to consider getting vaxxed to protect new baby when it comes. Is there data on the vax preventing transmissible infection?
We don’t have the data on this :( It may help a little but we simply don’t know
I am 73 years old and had CABGx4 six years ago. Am I considered at increased risk of of severe RSV and would it be advisable to get the vaccine? Thank you for your ongoing help!
What about getting RSV at the same time with Covid & Senior flu vaccines? I've read a few things saying it's safe, but am wondering about increased side effects (?). I've gotten Covid & flu together (am 81), & didn't think there were any more side effects than usual (I've never really had side effects with flu shots, but do with Covid, for a day or so). It sure would help me to have just one appointment, but then I'd not know, because RSV is new, what the side effects might be from that vaccine. Any input from the experts? Thanks!!
What is the data source(s) for the figure in this post, please, so I can access the raw data? Please reply either here or directly to me at bblack@northwestern.edu. Bernie Black (Prof of Law and Finance, Northwestern)?
Could you please clarify: “ protection is low, and uptake is suboptimal.” Thanks.
"Preterm births were followed extra carefully after licensure because of some weird data during the clinical trial: a numerically (but not statistically) higher (1%) risk of preterm births driven almost entirely by the data from one specific site that participated in the clinical trial: South Africa. There’s a lot of speculation about why, but experts think it is an interaction between the vaccine, the immune system, and an environmental factor (like previous infection). "
Gentle reminder to be cautious about statements like this (as you know, of course) - I'm not familiar with this study, but if that (rather small!) change in risk was not statistically significant, it's best to assume that this difference was due to chance, yes? But maybe there is more to the story?
It could be random chance for sure, but it could be that the effect is real but the number of events was too small to give clear signal. That's why we had the enhanced monitoring and now the preponderance of data suggests that this is not a true risk of RSV vaccination in pregnancy.