The events of the past week around Covid-19 vaccines have created a whirlwind of confusion—especially for those trying to make the best decisions for themselves and their families.
This is great to keep talking about. To be silent about the persistent Covid threat to pregnant women and young children is to casually endorse the misinformation against vaccination, really. I've been actively writing about this on my site for the past month, whether popular or not!
Vignette: I had the great pleasure of seeing a 32 year old pregnant woman yesterday, due in August, who ASKED ME for a Tdap shot, and how to game out the Covid shot she wants to get soon based upon community rates, anticipated Covid wave in mid-July, maximizing placental transfer of antibodies, etc.
It was like the good old days, and so rewarding, really.
Next patient said "no" to all vaccines recommended.
Great post, as always. I'm a former FDAer and want to provide a little context and advice to help navigate this with vaccine skeptics. You note that the vaccine is "safer than the disease." That is a low bar, and well below what FDA requires for vaccine approval. It's important to remember that vaccine safety has to be considered for use in otherwise healthy people, not the small subset of people who are infected or contract the disease targeted by the vaccine. When they were approved, the safety of COVID vaccines was thoroughly demonstrated, but like any effective vaccine (or drug), they're not completely without risk. FDA makes decisions based on benefit/risk assessment, and the approved vaccines clearly met that standard. There is, however, presumably some residual uncertainty as to whether the modifications made to keep up with variants have the same original efficacy ands safety profile. It's a reasonable assumption but has not been evaluated with the same rigor that these were in the original versions. All that said, I agree that the decision to vaccinate, or boost, should be well-informed (as you have done here) and made by individuals in discussion with their healthcare providers, and not subject to the whims of politics!
"During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died."
That's 20 deaths from the group who took the vaccine and 14 from the group that didn't.
Note deaths recorded are from all causes not COVID or vax related. If the RX and placebo groups are well matched, overall death rates may be comparable. Reporting "adverse events" in the placebo group is expected. They are obviously NOT related to Vax receipt and set a baseline of reported problems (real or subjective, minor or major) against which to compare similar occurrences in vax recipients (which are to be expected to be more numerous). This still does not reveal if the adverse events are actually related to receiving the vax and the cases need to be investigated individually for that.
At best, the Phase 3 Pfizer trial proved nothing. The higher number of deaths in the vax cohort and the higher number of adverse events should give anyone pause, though. It demands a much better and longer trial. The original trial sucked.
But people saying that they have evidence that the vaccine improves a person's overall health outcome? That doesn't exist, sorry.
Ask your friendly neighborhood statistician if these numbers are significant. BTW, your math seems to be off: 17 versus 16. But I haven't reviewed the data. FDA did, and I trust the rigor of FDA review, who actually look at all these data in detail, and I have reservations about other sources of "review" based on high level summaries available to the public
"During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died."
During the blinded period, 15 in the vax group died and 14 in the placebo. After the unblinding, 3 more in the vax group died along with 2 in the original placebo group who decided to take the vaccine. That gives you a total of 20 dead who took the vaccine and 14 in the group that didn't.
as Mark said, how do those numbers compare to the population size and the statistically expected number of deaths in those populations? without that your assertions that safety wasn't thoroughly demonstrated is baseless.
If the vaccine had a positive impact on a person's health, we'd expect to see a statistically significant reduction in hospitalizations and deaths. We don't.
Hi! Great post. Can I ask how you’re making decisions around vaccination and precautions for your kids and yourself at this point? I’m less worried (personally) about severe disease and more worried about long covid and/or the mostly unknown consequences of repeat infections. At the very least they are still disruptive if you’re trying not to pass covid along to anyone else. It feels like without very strict precautions, annual infections are pretty much inevitable — just had my first infection a couple of weeks ago after relaxing on masking, even though my state is in “very low” according to NWSS. I’m feeling well physically, just disappointed. Thanks for anything you’re willing to share about how you’re striking the balance these days.
Thanks! You are truly the "CDC in exile." It is sad and disgusting that the current officials and/or their agencies have not (?cannot) clearly provided this clear risk reduction advice.
BTW I just went to the CDC adult vaccine web site and even though I am a physician, in +/- 3 minutes I could not find any specific guidance for the use of COVID vaccines in pregnancy.
OK, I'm really confused now. Multiple sources have reported that there is now no recommendation for pregnant women since CDC posted its updated vaccine recommendations on May 29. Sure enough, if you can manage to navigate to the new color-coded Table 2 for medical conditions, pregnancy is, "No Guidance/Not Applicable" (https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-medical-condition.html). So how does that make them still eligible?
I am over 75, so this post doesn’t exactly pertain to me. However, I absolutely agree with our YLE. It disturbs me that babies and elders like myself are the ones at greatest risk (including of course those with serious comorbidities) and yet the government is shredding reasonable guidelines and replacing them with confusing and probably misleading and possibly dangerous new rules. As for me, we were told over and over through the past several years that the vaccine immunity wanes in 3 to 4 months for older people. Yet when I went to my local pharmacy (where I’ve had all my Covid shots after the first two), they wouldn’t give me my booster until it had been 6 months since the last (it had been 5 months). Now I’m thinking back to the first 3 years or so of Covid when scientists were hard at work trying to develop vaccines and keep them up to date, while the government dithered about who would get the shots and when and where. It reached a point where it was basically left up to each of us as to whether and when and how to get the shots. I couldn’t get answers from anywhere except YLE! But I accepted (with frustration) that I (me, myself and I) had to take on the responsibility for making this medical/health decision. I have done so ever since 2020. So now today I’m told I must wait 6 months between shots, even if, apparently, there are new Covid variants, and we know that older immune systems are weak and vaccine protection wanes quickly for us. Politicians are waaaay out of their league when they think they are smart enough to make decisions on medical issues and treatments, and ignore science and scientists and epidemiologists and PH experts. How can they be so stupid? I read everything I can find on Covid. Politicians can read the same things (I hope they can read) and recognize the need to bring science back into their decision-making. They have access to a lot more (real) research, and even to the scientists themselves. There is NO EXCUSE for their negligence!!
The interval used to be and remains 6 months with a minimum of 2 months in the updated recommendations of May 29 (https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-age.html), but there's no information on any conditions for using the 2-month interval. Maybe you can refer your pharmacist to this next time.
(If you're using a phone to check the CDC site, all the relevant information might not be visible. Best to download the pdf.)
Thanks very much. I’ve been taking the approach of 4 - 6 months but usually opted for 4 or 5 months until this time. I was in the Texas Cares project and could see the big boost to my immune system after a Covid shot. That was encouraging, though I knew my immunity would wane in a few months. I don’t mind the 6 month wait, as long as the data supports that for people in my age group (over 75). I’ll definitely check out the CDC recommendations. Thanks again.
The emphasis on shared clinical decision-making, or talking to your own OB/pediatrician, is interesting in that everyone from RFK to YLE recommends this, while otherwise offering quite distinct general assessments (on the RFK side: vaccines need to be more extensively studied and may actually cause harm; on the YLE side: vaccines are safe and effective.) I’m guessing that when RFK says it, he means your doctor will say the cons outweigh the pros, and that when YLE says it, she means your doctor will say the pros outweigh the cons. I wonder if most pediatricians would make the same recommendations for the same patients? It would be helpful to know if there is in fact a general consensus among pediatricians, since the AAP and CDC have recommended child boosters in the past, but I’ve encountered many doctors, personally or anecdotally, who thought them unnecessary. Our pediatrician (in northern NJ) does not offer COVID vaccines and could not offer guidance on where to find one when my baby reached 6 months. I finally found a hospital clinic an hour away that vaccinates babies every other Friday, but I wonder if the majority of mothers in my area do not vaccinate their 6-months-olds, in consultation with their pediatricians.
Our providers, in northeastern Ohio at facilities like University hospitals, Akron children’s, and Cleveland clinic, have not recommended Covid vaccines for anyone in our family since 2022. They have offered that they are available, but they have not been recommended. In fact, the UH location where my husband and I go for primary care does not even stock thembecause they don’t routinely recommend them to those under age 50 without comorbidities.
Regarding insurance coverage, I want to highlight that almost half of American children are covered by Medicaid (including mine). I’m not sure if your statement about varying insurance coverage is meant to include Medicaid or not, or if we just don’t know yet since Medicaid is administered at the state level?
Providers are not allowed to bill Medicaid patients for any services, even if they aren’t covered by Medicaid. So if Medicaid doesn’t cover the vaccine for children, it won’t be as simple as self-paying your regular pediatrician.
If not recommended, will it be available by choice? I keep hearing that if it is not recommended, it may be expensive and difficult to find. This elementary teacher married to a high risk spouse would like to protect the two of us as much as possible.
Love your columns. Even when they are not particularly relevant (I'm 77!), they are informative. You are one of the first newsletters I paid a membership for and I will continue. BUT on another topic, why is everyone referring to pregnant women as pregnant "people". As far as I know there haven't been any breakthroughs into research on pregnancy in men.
Hi Deborah — that is a great question. Pregnant people is an inclusive reference to cisgender women (people assigned female at birth who self-identify as female), transgender men (people assigned female at birth but self-identify as male) and nonbinary individuals (people who identify as neither or both genders) who may be or are considering becoming pregnant.
Does the updated guidance about shared decision making refer just to the original series for children or for annual boosters? In other words, if my toddler got the three shot series, will they be able to now get a booster in the fall? That is what I find confusing, especially re: the FDA guy claiming it wouldn't even be *authorized* for under 65
That refers to a 95% relative risk reduction for a very unlikely event (COVID hospitalization) over a very brief period (2 months). It's next to meaningless.
Absolute risk reduction in all-cause hospitalization and all-cause mortality is the only metric that matters.
Highlighting this 95% relative risk reduction for COVID hospitalization over a 2-month period is a way to confuse people and hide the fact that there's no proven benefit from these vaccines to overall health and overall hospitalization risk.
This is excellent and so very helpful! I will share it with pregnant women (and their partners) and new parents. In the midst of the MAHA noise, we desperately need accurate information.
This is great to keep talking about. To be silent about the persistent Covid threat to pregnant women and young children is to casually endorse the misinformation against vaccination, really. I've been actively writing about this on my site for the past month, whether popular or not!
Vignette: I had the great pleasure of seeing a 32 year old pregnant woman yesterday, due in August, who ASKED ME for a Tdap shot, and how to game out the Covid shot she wants to get soon based upon community rates, anticipated Covid wave in mid-July, maximizing placental transfer of antibodies, etc.
It was like the good old days, and so rewarding, really.
Next patient said "no" to all vaccines recommended.
That's the primary care circus.
It's a big tent.
Great post, as always. I'm a former FDAer and want to provide a little context and advice to help navigate this with vaccine skeptics. You note that the vaccine is "safer than the disease." That is a low bar, and well below what FDA requires for vaccine approval. It's important to remember that vaccine safety has to be considered for use in otherwise healthy people, not the small subset of people who are infected or contract the disease targeted by the vaccine. When they were approved, the safety of COVID vaccines was thoroughly demonstrated, but like any effective vaccine (or drug), they're not completely without risk. FDA makes decisions based on benefit/risk assessment, and the approved vaccines clearly met that standard. There is, however, presumably some residual uncertainty as to whether the modifications made to keep up with variants have the same original efficacy ands safety profile. It's a reasonable assumption but has not been evaluated with the same rigor that these were in the original versions. All that said, I agree that the decision to vaccinate, or boost, should be well-informed (as you have done here) and made by individuals in discussion with their healthcare providers, and not subject to the whims of politics!
"When they were approved, the safety of COVID vaccines was thoroughly demonstrated"
How exactly was this "demonstrated?" In the Phase 3 Pfizer trial, there were more adverse events and deaths in the vaccine arm vs. placebo
This is absolutely and categorically NOT TRUE.
Of course it's true. Pfizer told us.
https://www.nejm.org/doi/full/10.1056/NEJMoa2110345
"During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died."
That's 20 deaths from the group who took the vaccine and 14 from the group that didn't.
https://safe.menlosecurity.com/doc/docview/viewer/docN89EC0217315714f85f8aa4393aae18be2caf0aab1ccf85549c2024a2d3dcc7caf3c602ca0c1d
Table S3. 6617 adverse events in the vaccine group. 3048 adverse events in the placebo group.
Note deaths recorded are from all causes not COVID or vax related. If the RX and placebo groups are well matched, overall death rates may be comparable. Reporting "adverse events" in the placebo group is expected. They are obviously NOT related to Vax receipt and set a baseline of reported problems (real or subjective, minor or major) against which to compare similar occurrences in vax recipients (which are to be expected to be more numerous). This still does not reveal if the adverse events are actually related to receiving the vax and the cases need to be investigated individually for that.
At best, the Phase 3 Pfizer trial proved nothing. The higher number of deaths in the vax cohort and the higher number of adverse events should give anyone pause, though. It demands a much better and longer trial. The original trial sucked.
But people saying that they have evidence that the vaccine improves a person's overall health outcome? That doesn't exist, sorry.
Ask your friendly neighborhood statistician if these numbers are significant. BTW, your math seems to be off: 17 versus 16. But I haven't reviewed the data. FDA did, and I trust the rigor of FDA review, who actually look at all these data in detail, and I have reservations about other sources of "review" based on high level summaries available to the public
"During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died."
During the blinded period, 15 in the vax group died and 14 in the placebo. After the unblinding, 3 more in the vax group died along with 2 in the original placebo group who decided to take the vaccine. That gives you a total of 20 dead who took the vaccine and 14 in the group that didn't.
as Mark said, how do those numbers compare to the population size and the statistically expected number of deaths in those populations? without that your assertions that safety wasn't thoroughly demonstrated is baseless.
If the vaccine had a positive impact on a person's health, we'd expect to see a statistically significant reduction in hospitalizations and deaths. We don't.
Hi! Great post. Can I ask how you’re making decisions around vaccination and precautions for your kids and yourself at this point? I’m less worried (personally) about severe disease and more worried about long covid and/or the mostly unknown consequences of repeat infections. At the very least they are still disruptive if you’re trying not to pass covid along to anyone else. It feels like without very strict precautions, annual infections are pretty much inevitable — just had my first infection a couple of weeks ago after relaxing on masking, even though my state is in “very low” according to NWSS. I’m feeling well physically, just disappointed. Thanks for anything you’re willing to share about how you’re striking the balance these days.
Hi KM! Hope this was answered helpfully in the chat earlier today. Good luck!
I worked at a hospital during Covid, had to take care of babies born early from very sick women on ventilators
when the babies were born. They stayed sick for a long time, some died. Unvaccinated, of course…
Thanks! You are truly the "CDC in exile." It is sad and disgusting that the current officials and/or their agencies have not (?cannot) clearly provided this clear risk reduction advice.
BTW I just went to the CDC adult vaccine web site and even though I am a physician, in +/- 3 minutes I could not find any specific guidance for the use of COVID vaccines in pregnancy.
OK, I'm really confused now. Multiple sources have reported that there is now no recommendation for pregnant women since CDC posted its updated vaccine recommendations on May 29. Sure enough, if you can manage to navigate to the new color-coded Table 2 for medical conditions, pregnancy is, "No Guidance/Not Applicable" (https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-medical-condition.html). So how does that make them still eligible?
This is why my reporting leaves the status of pregnant women and the accompanying insurance and provider liability issues still up in the air and awaiting the ACIP meeting in 3 weeks (if allowed by Kennedy) (https://covidandvaccineupdate.substack.com/p/flurry-of-vaccine-policies-with-questions).
I am over 75, so this post doesn’t exactly pertain to me. However, I absolutely agree with our YLE. It disturbs me that babies and elders like myself are the ones at greatest risk (including of course those with serious comorbidities) and yet the government is shredding reasonable guidelines and replacing them with confusing and probably misleading and possibly dangerous new rules. As for me, we were told over and over through the past several years that the vaccine immunity wanes in 3 to 4 months for older people. Yet when I went to my local pharmacy (where I’ve had all my Covid shots after the first two), they wouldn’t give me my booster until it had been 6 months since the last (it had been 5 months). Now I’m thinking back to the first 3 years or so of Covid when scientists were hard at work trying to develop vaccines and keep them up to date, while the government dithered about who would get the shots and when and where. It reached a point where it was basically left up to each of us as to whether and when and how to get the shots. I couldn’t get answers from anywhere except YLE! But I accepted (with frustration) that I (me, myself and I) had to take on the responsibility for making this medical/health decision. I have done so ever since 2020. So now today I’m told I must wait 6 months between shots, even if, apparently, there are new Covid variants, and we know that older immune systems are weak and vaccine protection wanes quickly for us. Politicians are waaaay out of their league when they think they are smart enough to make decisions on medical issues and treatments, and ignore science and scientists and epidemiologists and PH experts. How can they be so stupid? I read everything I can find on Covid. Politicians can read the same things (I hope they can read) and recognize the need to bring science back into their decision-making. They have access to a lot more (real) research, and even to the scientists themselves. There is NO EXCUSE for their negligence!!
The interval used to be and remains 6 months with a minimum of 2 months in the updated recommendations of May 29 (https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-age.html), but there's no information on any conditions for using the 2-month interval. Maybe you can refer your pharmacist to this next time.
(If you're using a phone to check the CDC site, all the relevant information might not be visible. Best to download the pdf.)
Thanks very much. I’ve been taking the approach of 4 - 6 months but usually opted for 4 or 5 months until this time. I was in the Texas Cares project and could see the big boost to my immune system after a Covid shot. That was encouraging, though I knew my immunity would wane in a few months. I don’t mind the 6 month wait, as long as the data supports that for people in my age group (over 75). I’ll definitely check out the CDC recommendations. Thanks again.
Thank you, Katelyn, as always. But don't forget that CHAOS is the entire point :-(
It really is :(
I do not support anyone who uses the phrase "pregnant people".
If you are unaware of what sex is, then I cannot trust any advice that you give.
Ending my paid subscription now.
The emphasis on shared clinical decision-making, or talking to your own OB/pediatrician, is interesting in that everyone from RFK to YLE recommends this, while otherwise offering quite distinct general assessments (on the RFK side: vaccines need to be more extensively studied and may actually cause harm; on the YLE side: vaccines are safe and effective.) I’m guessing that when RFK says it, he means your doctor will say the cons outweigh the pros, and that when YLE says it, she means your doctor will say the pros outweigh the cons. I wonder if most pediatricians would make the same recommendations for the same patients? It would be helpful to know if there is in fact a general consensus among pediatricians, since the AAP and CDC have recommended child boosters in the past, but I’ve encountered many doctors, personally or anecdotally, who thought them unnecessary. Our pediatrician (in northern NJ) does not offer COVID vaccines and could not offer guidance on where to find one when my baby reached 6 months. I finally found a hospital clinic an hour away that vaccinates babies every other Friday, but I wonder if the majority of mothers in my area do not vaccinate their 6-months-olds, in consultation with their pediatricians.
Our providers, in northeastern Ohio at facilities like University hospitals, Akron children’s, and Cleveland clinic, have not recommended Covid vaccines for anyone in our family since 2022. They have offered that they are available, but they have not been recommended. In fact, the UH location where my husband and I go for primary care does not even stock thembecause they don’t routinely recommend them to those under age 50 without comorbidities.
Caught a typo! The hospital I found in Brooklyn actually does vaccines every Friday, not every other (excepting for vacations, understandably.)
Regarding insurance coverage, I want to highlight that almost half of American children are covered by Medicaid (including mine). I’m not sure if your statement about varying insurance coverage is meant to include Medicaid or not, or if we just don’t know yet since Medicaid is administered at the state level?
Providers are not allowed to bill Medicaid patients for any services, even if they aren’t covered by Medicaid. So if Medicaid doesn’t cover the vaccine for children, it won’t be as simple as self-paying your regular pediatrician.
Thank you for this post! What is the current CDC policy for adults under 65 - is the annual shot still recommended?
If not recommended, will it be available by choice? I keep hearing that if it is not recommended, it may be expensive and difficult to find. This elementary teacher married to a high risk spouse would like to protect the two of us as much as possible.
Love your columns. Even when they are not particularly relevant (I'm 77!), they are informative. You are one of the first newsletters I paid a membership for and I will continue. BUT on another topic, why is everyone referring to pregnant women as pregnant "people". As far as I know there haven't been any breakthroughs into research on pregnancy in men.
Hi Deborah — that is a great question. Pregnant people is an inclusive reference to cisgender women (people assigned female at birth who self-identify as female), transgender men (people assigned female at birth but self-identify as male) and nonbinary individuals (people who identify as neither or both genders) who may be or are considering becoming pregnant.
Does the updated guidance about shared decision making refer just to the original series for children or for annual boosters? In other words, if my toddler got the three shot series, will they be able to now get a booster in the fall? That is what I find confusing, especially re: the FDA guy claiming it wouldn't even be *authorized* for under 65
There's no evidence (trial data) that shows any of the covid vaccines are effective at keeping anyone out of the hospital or alive.
Another 'interesting' assertion. In less than 2 minutes I was able to find the following:
"Results of the primary efficacy analysis found that after two doses, that vaccine was 95% effective against COVID-19 hospitalization among adults."
https://cih.jhu.edu/programs/covid-19-pfizer-vaccine-clinical-trial/
are they lying or is your absolutist statement doing so?
That refers to a 95% relative risk reduction for a very unlikely event (COVID hospitalization) over a very brief period (2 months). It's next to meaningless.
Absolute risk reduction in all-cause hospitalization and all-cause mortality is the only metric that matters.
Highlighting this 95% relative risk reduction for COVID hospitalization over a 2-month period is a way to confuse people and hide the fact that there's no proven benefit from these vaccines to overall health and overall hospitalization risk.
then maybe you should focus on making specific assertions in the future instead of easily falsifiable ones.
There's no evidence that taking these vaccines improves a person's overall health outcomes....i.e hospitalization and death from any cause.
This is excellent and so very helpful! I will share it with pregnant women (and their partners) and new parents. In the midst of the MAHA noise, we desperately need accurate information.
Does anyone know how I can find the novavax vaccine in the USA? Preferably near dc?