A consequential meeting took place at the FDA today. Their external scientific committee—called VRBPAC—met to discuss the national plan for COVID-19 boosters going forward. They essentially needed to answer one question: Do we simplify the COVID-19 vaccine approach in the U.S. and, if so, how?
I know doctors don’t think this way (I’m married to one), but unless there’s some significant risk associated with getting a second bivalent booster, why not get one six months after the first one for whatever good it might do? I’m one of the rapidly dwindling « never Covid » contingent, and I’d like to stay that way.
It is so frustrating to hear the glacial pace of vaccine development and the lack of political will to do another round of “Warp Speed” for a virus that is killing 3,000 a week and disabling millions.
It is extremely disheartening to hear this inertia from the scientists and scientific bodies whose entire mission it is to be at the cutting edge of science for public health’s sake. If we cannot depend on them during a global pandemic (and it is crystal clear that we cannot), then why do they exist? To minimize and ignore the severe impact this vascular virus is having on entire generations?
I am entirely frustrated.
- signed, a mom in the US South, whose child is immune-compromised, so we have to continue to sit out on life
What I’d like to know is simple: I got the bivalent Moderna booster in September. Has it likely worn off by now? Is there anything to be gained by getting it again now?
For those asking how likely it is that their bivalent booster has worn off by now: There is a CDC study of waning effectiveness against hospitalization of vaccines over time. Study did not look at bivalent booster, but was done using subjects who'd received original shot plus boosters, during the omicron period but prior to the time when the bivalent vaccine was available. The study's here: https://www.cdc.gov/mmwr/volumes/71/wr/mm7107e2.htm#T1_down
Here's their finding about waning through 4 or 5 months: "During the period of Omicron predominance, vaccine effectivness against COVID-19–associated hospitalizations waned with time since vaccination: vaccine effectiveness after a second dose declined from 71% within 2 months of vaccination to 54% among those vaccinated ≥5 months earlier (p = 0.01). Among recipients of 3 doses, vaccine effectiveness against COVID-19–associated hospitalizations declined from 91% among those vaccinated within the past 2 months to 78% among those vaccinated ≥4 months earlier (p<0.001)."
So clearly effectiveness against hospitalizations wanes. looks like at something like 7% per month, at least over the first few months, which is the period this study looked at. Based on that result, I'm thinking that if people get only one shot per year, they're going to have almost no protection against covid by month 11. For the elderly and other vulnerable people giving shots only yearly seems dumb as hell to me.
Yup, it is definitely overdue for me to upgrade to a paid sub here. Your advice on Covid has been consistently invaluable. Right now, based on what you write here and from others I trust, like Eric Topol, as someone in a high risk group because of age, I am very worried that my cohort is once again going to be left in the dust without sufficient protection to have any semblance of a post-Covid normal life. My worries have been heightened because, despite taking all of your excellent advice and that of others to heart and following it closely, including all your pre-Thanksgiving advice, we were exposed to and contracted Covid from an 85 year old friend who had, as it turned out, a very incomplete understanding of the level of protection vaccines provide, did not realize the importance of same day testing pre-gathering, and on it goes. She turned out to be a superspreader, and everyone in our little new years gathering, all older women at higher risk, contracted Covid. Beyond that, the person next to her got hit really hard, including a whopping Pax rebound. It was very, very scary, only after 25 days has the fatigue lessened enough for her to resume something akin to pre Covid activity. At this point, we really have no idea how we can protect ourselves without locking ourselves in a closet, and what the FDA is contemplating does not appear to be even close to what we need to get past that.
1) Dr. Offit conceding the data over his intuition and original sin (let's take the guilt out of that term somehow!)
2) mRNA technology still a wonder of the world
3) Cute toddler! Some flexibility to convert to remote work (for those fortunate enough to have the option) is such a valuable tool for family life. Disruptions have eased, but life is far from normal for those of us still being careful and conscientious. We should continue to promote that remote option, and employees should fight for it. I am.
4) FDA and CDC and everyone being proactive in January
Not happy about:
1) Over 75 data - I think that slide means that 1.8% of all >75 year olds in the US were admitted to the hospital with Covid between January 2022 to January 2023? Seems like a lot. Would be worse, I know.
2) Stroke data. I still think getting Covid is worse, and certainly a severe case increases stroke risk by 18 fold in a UK study (https://heart.bmj.com/content/109/2/119)
A lot of my savvy elderly patients who were boosted in September are asking about whether they should get another one soon. I reply that there is no recommendation on this yet. But I am troubled by the constant churn of Covid. I don't see waves, and our hospital system's inpatient census has been hovering at around 150 patients hospitalized with Covid for months now. Hoping for a spring reprieve.
I'm no Paul Offit, but if I were at the FDA meeting I might have floated this:
70+ can get booster q6 months until pan-coronavirus vaccines available. Younger generations collectively do little to protect them anymore. A more realistic, once-yearly, fall booster campaign for everyone else - to head off or reduce a holiday wave, and to blunt the back-to-school mess that converts children into efficient vectors.
Thank you Dr. Jetelina. Your reporting is outstanding. You are very much appreciated.
FDA is taking a very high risk with many lives with their strategy. As a former senior government manager I do not think the government can manage their way out of a paper sack. What could go wrong - a lot! I have little confidence that this is going to work out well for the most vulnerable such as myself.
Thanks for all this information which is very helpful! Have you ever considered writing or co-writing a book about your experiences during the pandemic? It would make for riveting reading and I'd certainly buy a copy! As would a while lot of us!
Sounds as if because of waning bivalent booster and lack of further development chances will be very high I could be getting Covid soon after March. September to March. I mask, but almost no one does in my area. Many say, "I had covid and I'm fine, it was like a bad cold".
This is somewhat knowable on an individual level, if you aren't too squeamish about the sight of your own blood. I just got another spike antibody test from Labcorp - I'm almost four months out from the bivalent, which I got in early September right before sitting on a grand jury in Brooklyn for four weeks. I'm fairly optimistic, because my last one, in the middle of December, clocked in at 25000 u/mL.
Basically, different people wane at different rates, and it's OK to know your own biometrics.
If the administration's current Covid strategy is primarily vaccination, rather than NPI--as a high risk person (age and immune issues)--this proposed annual shot which feels like it is premature and not supported by robust data--leaves me feeling even more vulnerable and isolated.
I do understand that the current vaccine strategy is beyond confusing and there is low uptake/buy in at this point.
Recently my county went red, and absolutely no one changed their behavior.
As a high risk person, I'd like the CDC to authorize a 6 month booster--as mine is 6 months out.
Thank you for this very informative and timely post.
Thank you for covering Novavax!! I have had 2 Pfizer’s then a Moderna booster and then had to get a prescription to start Novavax (just had 2nd dose month ago).
Thank you so much for this. Is there anything we can do to help the people in charge to make more progress in funding for studies as well as vaccines? It feels like we are underestimating this virus yet again.
I know doctors don’t think this way (I’m married to one), but unless there’s some significant risk associated with getting a second bivalent booster, why not get one six months after the first one for whatever good it might do? I’m one of the rapidly dwindling « never Covid » contingent, and I’d like to stay that way.
It is so frustrating to hear the glacial pace of vaccine development and the lack of political will to do another round of “Warp Speed” for a virus that is killing 3,000 a week and disabling millions.
It is extremely disheartening to hear this inertia from the scientists and scientific bodies whose entire mission it is to be at the cutting edge of science for public health’s sake. If we cannot depend on them during a global pandemic (and it is crystal clear that we cannot), then why do they exist? To minimize and ignore the severe impact this vascular virus is having on entire generations?
I am entirely frustrated.
- signed, a mom in the US South, whose child is immune-compromised, so we have to continue to sit out on life
What I’d like to know is simple: I got the bivalent Moderna booster in September. Has it likely worn off by now? Is there anything to be gained by getting it again now?
Thanks for this summary. That's a cute photo in your kitchen of the Helper at work too.
For those asking how likely it is that their bivalent booster has worn off by now: There is a CDC study of waning effectiveness against hospitalization of vaccines over time. Study did not look at bivalent booster, but was done using subjects who'd received original shot plus boosters, during the omicron period but prior to the time when the bivalent vaccine was available. The study's here: https://www.cdc.gov/mmwr/volumes/71/wr/mm7107e2.htm#T1_down
Here's their finding about waning through 4 or 5 months: "During the period of Omicron predominance, vaccine effectivness against COVID-19–associated hospitalizations waned with time since vaccination: vaccine effectiveness after a second dose declined from 71% within 2 months of vaccination to 54% among those vaccinated ≥5 months earlier (p = 0.01). Among recipients of 3 doses, vaccine effectiveness against COVID-19–associated hospitalizations declined from 91% among those vaccinated within the past 2 months to 78% among those vaccinated ≥4 months earlier (p<0.001)."
So clearly effectiveness against hospitalizations wanes. looks like at something like 7% per month, at least over the first few months, which is the period this study looked at. Based on that result, I'm thinking that if people get only one shot per year, they're going to have almost no protection against covid by month 11. For the elderly and other vulnerable people giving shots only yearly seems dumb as hell to me.
Yup, it is definitely overdue for me to upgrade to a paid sub here. Your advice on Covid has been consistently invaluable. Right now, based on what you write here and from others I trust, like Eric Topol, as someone in a high risk group because of age, I am very worried that my cohort is once again going to be left in the dust without sufficient protection to have any semblance of a post-Covid normal life. My worries have been heightened because, despite taking all of your excellent advice and that of others to heart and following it closely, including all your pre-Thanksgiving advice, we were exposed to and contracted Covid from an 85 year old friend who had, as it turned out, a very incomplete understanding of the level of protection vaccines provide, did not realize the importance of same day testing pre-gathering, and on it goes. She turned out to be a superspreader, and everyone in our little new years gathering, all older women at higher risk, contracted Covid. Beyond that, the person next to her got hit really hard, including a whopping Pax rebound. It was very, very scary, only after 25 days has the fatigue lessened enough for her to resume something akin to pre Covid activity. At this point, we really have no idea how we can protect ourselves without locking ourselves in a closet, and what the FDA is contemplating does not appear to be even close to what we need to get past that.
Excellent synopsis - thank you.
Happy about:
1) Dr. Offit conceding the data over his intuition and original sin (let's take the guilt out of that term somehow!)
2) mRNA technology still a wonder of the world
3) Cute toddler! Some flexibility to convert to remote work (for those fortunate enough to have the option) is such a valuable tool for family life. Disruptions have eased, but life is far from normal for those of us still being careful and conscientious. We should continue to promote that remote option, and employees should fight for it. I am.
4) FDA and CDC and everyone being proactive in January
Not happy about:
1) Over 75 data - I think that slide means that 1.8% of all >75 year olds in the US were admitted to the hospital with Covid between January 2022 to January 2023? Seems like a lot. Would be worse, I know.
2) Stroke data. I still think getting Covid is worse, and certainly a severe case increases stroke risk by 18 fold in a UK study (https://heart.bmj.com/content/109/2/119)
A lot of my savvy elderly patients who were boosted in September are asking about whether they should get another one soon. I reply that there is no recommendation on this yet. But I am troubled by the constant churn of Covid. I don't see waves, and our hospital system's inpatient census has been hovering at around 150 patients hospitalized with Covid for months now. Hoping for a spring reprieve.
I'm no Paul Offit, but if I were at the FDA meeting I might have floated this:
70+ can get booster q6 months until pan-coronavirus vaccines available. Younger generations collectively do little to protect them anymore. A more realistic, once-yearly, fall booster campaign for everyone else - to head off or reduce a holiday wave, and to blunt the back-to-school mess that converts children into efficient vectors.
Thank you Dr. Jetelina. Your reporting is outstanding. You are very much appreciated.
FDA is taking a very high risk with many lives with their strategy. As a former senior government manager I do not think the government can manage their way out of a paper sack. What could go wrong - a lot! I have little confidence that this is going to work out well for the most vulnerable such as myself.
Thanks for all this information which is very helpful! Have you ever considered writing or co-writing a book about your experiences during the pandemic? It would make for riveting reading and I'd certainly buy a copy! As would a while lot of us!
I've appreciated all of your informational posts, but this was exemplary in the amount of relevant information provided. A sincere thanks.
Sounds as if because of waning bivalent booster and lack of further development chances will be very high I could be getting Covid soon after March. September to March. I mask, but almost no one does in my area. Many say, "I had covid and I'm fine, it was like a bad cold".
This is somewhat knowable on an individual level, if you aren't too squeamish about the sight of your own blood. I just got another spike antibody test from Labcorp - I'm almost four months out from the bivalent, which I got in early September right before sitting on a grand jury in Brooklyn for four weeks. I'm fairly optimistic, because my last one, in the middle of December, clocked in at 25000 u/mL.
Basically, different people wane at different rates, and it's OK to know your own biometrics.
If the administration's current Covid strategy is primarily vaccination, rather than NPI--as a high risk person (age and immune issues)--this proposed annual shot which feels like it is premature and not supported by robust data--leaves me feeling even more vulnerable and isolated.
I do understand that the current vaccine strategy is beyond confusing and there is low uptake/buy in at this point.
Recently my county went red, and absolutely no one changed their behavior.
As a high risk person, I'd like the CDC to authorize a 6 month booster--as mine is 6 months out.
Thank you for this very informative and timely post.
I've appreciated all of your informational posts, but this was exemplary in the amount of relevant information provided. A sincere thanks.
Thank you for covering Novavax!! I have had 2 Pfizer’s then a Moderna booster and then had to get a prescription to start Novavax (just had 2nd dose month ago).
After the third shot of Novavax they have detected sterilizing (mucosal) immunity. Hopefully the new version is out when I’m due for my booster. More info here: https://donford.substack.com/p/the-benefits-of-novavax-explained
Thank you so much for this. Is there anything we can do to help the people in charge to make more progress in funding for studies as well as vaccines? It feels like we are underestimating this virus yet again.