Alright people, the data you’ve been waiting for: the first real-world effectiveness data on the fall COVID-19 (bivalent) booster. Here are the results. Science until now As a reminder, we hoped the fall booster would accomplish three things: Greater protection
Elderly person here! My wife and I have had 2 MRNA vaccinations + 2 boosters + the Bivalent shots.. But despite all that help, we still think lo-tech behavioral habits: masking, social distancing, and hand washing are our best protection against all known strains, and any and all unknown super-strains that may arise!
I haven't reviewed the recommendations for all European countries, but compared to these countries, the US is taking a very different approach by recommending a 2nd booster for all adults and a 1st booster for children. Can you offer some insight into why our approach is so much more pro-booster than in these other countries?
Thank you for another informative post. We can always count on your posts for the latest data and clear interpretation.
I'm confused by two aspects of the CDC's real world data that was published last Friday:
1) Why wasn't the "left box" (fall booster + 1-4 mRNA shots) compared to a (hypothetical) "1-4 mRNA shots but no fall booster" box? This would answer the question of whether people who have already received 1-4 mRNA shots actually benefit from the fall booster, which is perhaps the more relevant question. It's unlikely that somebody who is still unvaccinated will be motivated by this study's conclusion to go get multiple mRNA shots just to so they can get the fall booster. (My best guess is the CDC did perform the analysis on this hypothetical "1-4 mRNA shots but no fall booster" box, and for whatever reason, they aren't publishing the data).
2) It's possible the data could be skewed if, for some reason, vaccinated people are more likely to have "false negatives" on covid tests. It would be interesting to know whether any studies have been conducted on this.
So, clearly Pfizer and Moderna have efficacy data in their own trials unless they were completely negligent right? Yet why is the CDC the first to release efficacy data? We know Pfizer isn't shy about low sample sizes (their children' booster study had ~10 kids in it and confidence intervals went to 0 but they paraded it around), so it seems to me they just sat on disappointing data.
Also, imo experts would have more credibility if you could just admit that 20-30% (for elderly) efficacy is quite disappointing. Of course it's "better than nothing" but would you say that if efficacy dropped to 10%? 1%?
Always appreciate these updates. Of course it leads to more questions. In my state of Ohio local media reported that 90% of deaths in Ohio between June and October 2022 were age 60 and over. This according to ODH making it the “highest rate for those over 60 since the beginning of the pandemic.” Of course they never provide the percent of those deaths that were unvaccinated/boosted/natural immunity. In my opinion, as a person in this age group, reporting partial information seems counterproductive, if the statistics for covid(due to vs with) covid) aren’t reported at the same time. When are we going to see responsible, professional reporting and less fear mongering type of data?
Thank you for the Fall Booster update, Dr. Jetalina. This is encouraging. When, do you think, we might learn how soon a second bivalent booster might be needed to help shore up protection against severe disease? Every six months? I'd love for the protection to last until next fall, but it seems likely at least we older folks will need another booster sooner.
I realized a strange thing about people. For many the pandemic is becoming normal, but what most are normalizing are the rates of death and handicaps from it, while masking has not been normalized in many locations and groups. WHY is it easier to normalize death and handicaps than a small inconvenience?
Would you please discuss when immunocompromised people who got bivalent booster this fall should get a booster? And is the recommendation the bivalent booster? I'm at 3 months now.
Leana Wen recently published an opinion piece in the Washington Post arguing that the military vaccine mandate no longer makes sense (https://www.washingtonpost.com/opinions/2022/12/09/military-covid-vaccine-mandate-should-end/). If her logic holds, I would think that organizations such as churches, social clubs, etc., would also be OK dropping their vaccination and booster requirements to attend indoor events. I’d love your take on Dr. Wen’s article. Thanks!
Can you expound on the pharmacy COVID test data? So a pharmacy asks a person getting a test for their COVID shot history and writes it all down? Who is collecting and adding up all the data from the pharmacies?
Thanks again, as always, for your timely and thoughtful updates.
Vaccine effectiveness as a function of time in relation to waning effectiveness of most recent vaccination can use more clarification, if possible given the paucity of "real-world" data at this time given this information from this update (12/8):
Among those ages 65 and older, for example, effectiveness was 43% if they got their last mRNA dose more than 8 months ago, compared to 28% if they got their last dose 2 months ago.
• If the last vaccine was 6 months ago, should the >65 year old get vaccinated now or wait 2 months, given that the most recent @ 6 months may have waned to a level of much less than 28% effectiveness?
• If previously infected, should patient follow the CDC “wait 3 months guidance” or should the wait be expanded to 8 months?
Will we need an additional bivalent booster, do you think? We got ours on 9/7, the first day they were available in our area, but are worried that protection will wane during the winter. We are seniors, full-time employed, still masking in crowded indoor setting. We are going to the theater next week - wearing our masks throughout. At the Philharmonic last month, we were among what we calculated to be LESS than 5% of the audience that still masked.
This is about feeling like a lone guinea pig lost in a lab full of other guinea pigs.......
Age 81, fairly good health with stable stage 3 CKD.
Bivalent Sept 27, made me quite sick for two days - a good thing, actually.
Went grocery shopping 3 days ago and visited my Bank yesterday. Double ply mask each time.
Woke this morning at around 4 AM, upper left arm (injection site) very sore, radiating into back of neck. Rest of me fairly OK. I don't have tests at hand, so no certainty either way.
I understand that an N=1 story doesn't do much for science, but for me, telling it is better than kicking the dog.
Thanks for the update. I agree that the real world data is particularly messy. So is it correct to interpret this data as 100vaccinated and boosted(new bivalent) people in a room containing infections individuals, and only 44 of them would avoid being infected?
Such a good result, and the CDC is fortunate to have your voice to help spread the word. I feel justified in my recommendations, and will redouble my efforts with our supply of Pfizer. Maybe I should have waited a bit with the predictable holiday wave, since I got my bivalent one mid September. But then again maybe I’m part of the 44% already!
Elderly person here! My wife and I have had 2 MRNA vaccinations + 2 boosters + the Bivalent shots.. But despite all that help, we still think lo-tech behavioral habits: masking, social distancing, and hand washing are our best protection against all known strains, and any and all unknown super-strains that may arise!
Dr. Jetelina, my family and I have all had their primary series, and my wife and I (both in our 40s) both got the 1st booster. When thinking about getting a 2nd booster, we were struck by the fact that other countries were not recommending that healthy adults under the age of 50 or 60 get boosted. In the UK and Denmark, they only recommend it for 50+ or those with certain serious medical conditions (https://www.gov.uk/government/publications/covid-19-vaccination-autumn-booster-resources/a-guide-to-the-covid-19-autumn-booster) (https://sst.dk/en/English/Corona-eng/Vaccination-against-covid-19). The EU is recommending it only for 60+/serious medical conditions (https://www.france24.com/en/europe/20220711-eu-recommends-second-covid-19-booster-dose-for-people-over-60), and Sweden is recommending it for 65+/serious medical conditions (https://sst.dk/en/English/Corona-eng/Vaccination-against-covid-19). These countries also don't recommend boosters for children, and the UK, Denmark, and Sweden have now completely stopped offering even the primary series to children.
I haven't reviewed the recommendations for all European countries, but compared to these countries, the US is taking a very different approach by recommending a 2nd booster for all adults and a 1st booster for children. Can you offer some insight into why our approach is so much more pro-booster than in these other countries?
Thank you for another informative post. We can always count on your posts for the latest data and clear interpretation.
I'm confused by two aspects of the CDC's real world data that was published last Friday:
1) Why wasn't the "left box" (fall booster + 1-4 mRNA shots) compared to a (hypothetical) "1-4 mRNA shots but no fall booster" box? This would answer the question of whether people who have already received 1-4 mRNA shots actually benefit from the fall booster, which is perhaps the more relevant question. It's unlikely that somebody who is still unvaccinated will be motivated by this study's conclusion to go get multiple mRNA shots just to so they can get the fall booster. (My best guess is the CDC did perform the analysis on this hypothetical "1-4 mRNA shots but no fall booster" box, and for whatever reason, they aren't publishing the data).
2) It's possible the data could be skewed if, for some reason, vaccinated people are more likely to have "false negatives" on covid tests. It would be interesting to know whether any studies have been conducted on this.
So, clearly Pfizer and Moderna have efficacy data in their own trials unless they were completely negligent right? Yet why is the CDC the first to release efficacy data? We know Pfizer isn't shy about low sample sizes (their children' booster study had ~10 kids in it and confidence intervals went to 0 but they paraded it around), so it seems to me they just sat on disappointing data.
Also, imo experts would have more credibility if you could just admit that 20-30% (for elderly) efficacy is quite disappointing. Of course it's "better than nothing" but would you say that if efficacy dropped to 10%? 1%?
Always appreciate these updates. Of course it leads to more questions. In my state of Ohio local media reported that 90% of deaths in Ohio between June and October 2022 were age 60 and over. This according to ODH making it the “highest rate for those over 60 since the beginning of the pandemic.” Of course they never provide the percent of those deaths that were unvaccinated/boosted/natural immunity. In my opinion, as a person in this age group, reporting partial information seems counterproductive, if the statistics for covid(due to vs with) covid) aren’t reported at the same time. When are we going to see responsible, professional reporting and less fear mongering type of data?
Thank you for the Fall Booster update, Dr. Jetalina. This is encouraging. When, do you think, we might learn how soon a second bivalent booster might be needed to help shore up protection against severe disease? Every six months? I'd love for the protection to last until next fall, but it seems likely at least we older folks will need another booster sooner.
I realized a strange thing about people. For many the pandemic is becoming normal, but what most are normalizing are the rates of death and handicaps from it, while masking has not been normalized in many locations and groups. WHY is it easier to normalize death and handicaps than a small inconvenience?
What do you think about adults getting a second bivalent booster in mid-winter if it's been 5+ months since the initial one?
Would you please discuss when immunocompromised people who got bivalent booster this fall should get a booster? And is the recommendation the bivalent booster? I'm at 3 months now.
Leana Wen recently published an opinion piece in the Washington Post arguing that the military vaccine mandate no longer makes sense (https://www.washingtonpost.com/opinions/2022/12/09/military-covid-vaccine-mandate-should-end/). If her logic holds, I would think that organizations such as churches, social clubs, etc., would also be OK dropping their vaccination and booster requirements to attend indoor events. I’d love your take on Dr. Wen’s article. Thanks!
Can you expound on the pharmacy COVID test data? So a pharmacy asks a person getting a test for their COVID shot history and writes it all down? Who is collecting and adding up all the data from the pharmacies?
Thanks again, as always, for your timely and thoughtful updates.
Vaccine effectiveness as a function of time in relation to waning effectiveness of most recent vaccination can use more clarification, if possible given the paucity of "real-world" data at this time given this information from this update (12/8):
Among those ages 65 and older, for example, effectiveness was 43% if they got their last mRNA dose more than 8 months ago, compared to 28% if they got their last dose 2 months ago.
• If the last vaccine was 6 months ago, should the >65 year old get vaccinated now or wait 2 months, given that the most recent @ 6 months may have waned to a level of much less than 28% effectiveness?
• If previously infected, should patient follow the CDC “wait 3 months guidance” or should the wait be expanded to 8 months?
Any thoughts?
Will we need an additional bivalent booster, do you think? We got ours on 9/7, the first day they were available in our area, but are worried that protection will wane during the winter. We are seniors, full-time employed, still masking in crowded indoor setting. We are going to the theater next week - wearing our masks throughout. At the Philharmonic last month, we were among what we calculated to be LESS than 5% of the audience that still masked.
This is about feeling like a lone guinea pig lost in a lab full of other guinea pigs.......
Age 81, fairly good health with stable stage 3 CKD.
Bivalent Sept 27, made me quite sick for two days - a good thing, actually.
Went grocery shopping 3 days ago and visited my Bank yesterday. Double ply mask each time.
Woke this morning at around 4 AM, upper left arm (injection site) very sore, radiating into back of neck. Rest of me fairly OK. I don't have tests at hand, so no certainty either way.
I understand that an N=1 story doesn't do much for science, but for me, telling it is better than kicking the dog.
Best
Heinz
Thanks for the update. I agree that the real world data is particularly messy. So is it correct to interpret this data as 100vaccinated and boosted(new bivalent) people in a room containing infections individuals, and only 44 of them would avoid being infected?
Such a good result, and the CDC is fortunate to have your voice to help spread the word. I feel justified in my recommendations, and will redouble my efforts with our supply of Pfizer. Maybe I should have waited a bit with the predictable holiday wave, since I got my bivalent one mid September. But then again maybe I’m part of the 44% already!