3 ms·

> We have data that shows vaccine effectiveness wanes with time. No, we don't. We have confounded, poorly controlled observational studies, and extrapolation f

by timr 4y ago

> We have data that shows vaccine effectiveness wanes with time. No, we don't. We have confounded, poorly controlled observational studies, and extrapolation from antibody titres. > We know boosters improve immunity. No, we don't. The necessary studies have never been done. Increasing antibodies for a while (in mice) does not equal "improving immunity" in humans. > We've been giving out bivalent booster for over a year and we have data that they're effective. Well, if you say so. But actually...no. Or you'd cite it, instead of just asserting things. > Armchair scientists should leave the medical decisions to the professionals. Such as Paul Offit, FDA VRBPAC member, co-creator of the Rotavirus vaccine, and director of the vaccine education center at the Children's Hospital of Philadelphia? https://time.com/6246525/bivalent-booster-not-very-effective-paul-offit/ https://time.com/6246525/bivalent-booster-not-very-effective... https://www.nejm.org/doi/full/10.1056/NEJMp2215780 https://www.nejm.org/doi/full/10.1056/NEJMp2215780 > In his perspective piece, Offit cites data from two leading virologists—Dr. David Ho, director of the Aaron Diamond AIDS Research Center at Columbia University, and Dr. Dan Barouch at Harvard Medical School—who reported that when serum from people boosted with the bivalent Omicron booster was compared to that from people boosted with a dose of the original vaccine, their levels of neutralizing antibodies against BA.4/5 were comparable. Ho’s work also showed that the bivalent booster did not produce appreciably different antibody responses against newer Omicron variants, such as BQ.1, BQ.1.1, XBB, and now XBB.1.5, which together account for 83% of new infections in the U.S. as of the first week of January. These are for antibodies, mind you...the most reactive short-term signal to a booster vaccination. There's simply no good evidence backing these new vaccines. Anyone who says otherwise doesn't know the data.

chimprich 4y ago
The problem with these kind of debates is that someone can come along and dump a single paper they've found and claim that it backs up their argument. And maybe it does, but the experts at health agencies like the NHS and dozens or hundreds of others (to sidestep your claim about the US one taking the wrong decisions) get to review, full time, with relevant professional experience, all of the evidence. But, let's look at your link. First paragraph: "And the latest data show that the newest booster shot, which targets the Omicron BA.4/5 strain and original virus variants in a bivalent formulation, isn’t that much more effective in generating virus-fighting antibodies than the original vaccine when used as a booster." So this doesn't even back up your claim. It doesn't say boosters aren't effective, just that the bivalent vaccine isn't "that much more effective" than the original vaccine as a booster.
- timr 4y ago
  I didn't "dump a single paper". I posted the opinion of an expert in the field, since you clearly don't trust my own assessment of the data. You don't have to trust me, but you just said we have to trust the experts, right? The "problem" with these kinds of debates is that people who have absolutely no ability to read or evaluate scientific literature confidently assert things that they cannot know, based on what they heard someone else say on social media. > So this doesn't even back up your claim. It doesn't say boosters aren't effective, just that the bivalent vaccine isn't "that much more effective" than the original vaccine as a booster. My "claim" was that there's no evidence supporting the dosing schedule for these boosters (this isn't a claim, it's a fact. The booster doses were approved without a single human efficacy trial [1]). Arguing that antibody titers go up after boosting is not a rebuttal...because that's what antibodies do when you inject things into the body. It's the entire topic of the thread. Antibodies go up, then they go back down. It's a poor proxy for immunity. [1] Here's the announcement from the FDA on the latest dosing recommendations: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines https://www.fda.gov/news-events/press-announcements/coronavi... You'll see fun facts such as: * the single-dose schedule for Moderna bivalent is based on antibody responses in about 1500 people, only 145 of whom had Covid in the past. This doesn't reflect any aspect of the real world, where most of us have had it at least once. * they didn't have enough data to justify their decision, so they just grouped together stuff from prior vaccines because "these vaccines are manufactured using the same process." * for Pfizer, effectiveness of a single dose is supported by OBSERVATIONAL DATA from England on the effectiveness of one dose of monovalent Pfizer-BioNTech COVID-19 Vaccine. * "Among individuals 12 to 17 years of age who had received only one dose of Pfizer-BioNTech COVID-19 Vaccine, those who had evidence of previous infection with alpha, delta or omicron variants had increased protection against symptomatic omicron infection compared with those with no evidence of previous infection" That last one is an absolutely mind-blowing bit of doublespeak, by the way. They're literally saying that they're justifying this as a single-dose vaccine because people who were previously infected show more protection after one dose than those who were never infected. Think about that.
  - chimprich 4y ago
TJSomething 4y ago
I'm not sure what you mean that the necessary studies have not been done. Because they have and broadly agree that a fourth vaccination provides benefits against hospitalization (though not infection) for older people, generally based on epidemiological measures of population-wide severe cases of COVID-19, not immune response. Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Amir O, Freedman L et al. Protection by a Fourth Dose of BNT162b2 against Omicron in Israel. New England Journal of Medicine. 2022. doi: 10.1056/NEJMoa2201570. Magen O, Waxman JG, Makov-Assif M, Vered R, Dicker D, Hernán MA et al. Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2022. doi: 10.1056/NEJMoa2201688. Gazit S, Saciuk Y, Perez G, Peretz A, Pitzer VE, Patalon T. Relative Effectiveness of Four Doses Compared to Three Dose of the BNT162b2 Vaccine in Israel. medRxiv. 2022:2022.03.24.22272835. doi: 10.1101/2022.03.24.22272835. Arbel R, Sergienko R, Friger M, Peretz A, Beckenstein T, Yaron S et al. Effectiveness of a second BNT162b2 booster vaccine against hospitalization and death from COVID-19 in adults aged over 60 years. Nature Medicine. 2022;28:1486–90. doi: 10.1038/s41591-022-01832-0. Regev-Yochay G, Gonen T, Gilboa M, Mandelboim M, Indenbaum V, Amit S et al. Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron. New England Journal of Medicine. 2022;386:1377-80. doi: 10.1056/NEJMc2202542. Muhsen K, Maimon N, Mizrahi AY, Boltyansky B, Bodenheimer O, Diamant ZH et al. Association of Receipt of the Fourth BNT162b2 Dose With Omicron Infection and COVID-19 Hospitalizations Among Residents of Long-term Care Facilities. JAMA Internal Medicine. 2022. doi: 10.1001/jamainternmed.2022.2658. Amir O, Goldberg Y, Mandel M, Bar-On YM, Bodenheimer O, Freedman L et al. Protection against omicron severe disease 0-7 months after BNT162b2 booster. medRxiv. 2022:2022.05.04.22274647. doi: 10.1101/2022.05.04.22274647. Cohen MJ, Oster Y, Moses AE, Spitzer A, Benenson S, Israeli-Hospitals 4th Vaccine Working G. Association of Receiving a Fourth Dose of the BNT162b Vaccine With SARS-CoV-2 Infection Among Health Care Workers in Israel. JAMA Network Open. 2022;5:e2224657-e. doi: 10.1001/jamanetworkopen.2022.24657. Grewal R, Kitchen SA, Nguyen L, Buchan SA, Wilson SE, Costa AP et al. Effectiveness of a Fourth Dose of COVID-19 Vaccine among Long-Term Care Residents in Ontario, Canada. medRxiv. 2022:2022.04.15.22273846. doi: 10.1101/2022.04.15.22273846.
- timr 4y ago
  > Because they have and broadly agree that a fourth vaccination provides benefits against hospitalization (though not infection) for older people That's a pretty conditional statement. We're also not on dose four, we're on dose...seven? And young, healthy people are still being mandated to get these things. I stand by my comment: the studies you are citing are all low-quality, observational data, in older populations. I'll just start working down the list from the top... > Bar-On YM, Goldberg Y, Mandel M... Garbage study. Observational. Confounded (vaccine-seeking behavior). Old people (>60). No control (the "internal control" was not a control). > Magen O, Waxman JG, Makov-Assif M... Obeservational study. Confounded (vaccine-seeking). Effect size was miniscule: "In days 7 to 30 after a fourth vaccine dose, the difference in the absolute risk (three doses vs. four doses) was 180.1 cases per 100,000 persons (95% CI, 142.8 to 211.9) for Covid-19–related hospitalization and 68.8 cases per 100,000 persons (95% CI, 48.5 to 91.9) for severe Covid-19." That's a difference of 0.18% for hospitalization, in a population of people over 60. > Gazit S, Saciuk Y, Perez G Observational study. Older population (60+). Confounded (vaccine-seeking). Found that effectiveness against infection was short-term, and that the fourth dose had very little impact on severe disease or hospitalization. "vaccine effectiveness against infection varied over time, peaking during the third week with a VE of 64% (95% CI: 62.0%-65.9%) and declining to 29.2% (95% CI: 17.7%-39.1%) by the end of the 10-week follow-up period. Unlike VE against infection, the relative effectiveness of a fourth dose against severe COVID-19 was maintained at high level (>73%) throughout the 9-week follow-up period. Importantly, severe disease was a relatively rare event, occurring in <1% of both fourth dose and third dose only recipients." > Arbel R, Sergienko R, Friger M Observational study. Older population (60+). Confounded (vaccine-seeking). Tiny effect size (hospitalization in 4-shot cohort: %0.08; 3-shot cohort: 0.2%) "A total of 563,465 participants met the eligibility criteria. Of those, 328,597 (58%) received a second booster dose during the 40 day study period. Hospitalization due to COVID-19 occurred in 270 of the second-booster recipients and in 550 participants who received one booster dose (adjusted hazard ratio, 0.36; 95% confidence interval (CI): 0.31–0.43). Death due to COVID-19 occurred in 92 second-booster recipients and in 232 participants who received one booster dose (adjusted hazard ratio, 0.22; 95% CI: 0.17–0.28)." > Regev-Yochay G, Gonen T, Gilboa M... Small sample size (N=1050). Not blinded. Not randomized. Lower PCR testing adherence in control group. Short follow-up period. Overall insignificant clinical effect: "25.0% of the participants in the control group were infected with the omicron variant, as compared with 18.3% of the participants in the BNT162b2 group and 20.7% of those in the mRNA-1273 group. Vaccine efficacy against any SARS-CoV-2 infection was 30% (95% confidence interval [CI], −9 to 55) for BNT162b2 and 11% (95% CI, −43 to 44) for mRNA-1273" In other words, the VE confidence interval crossed zero for both vaccines -- it's possible the extra dose made things worse. I've run out of time and this post is getting long, but the remaining studies are no different. Is it possible that there's some tiny effect size for elderly people? Sure. But this data doesn't support shot 7 (or 6, or 5...), and it definitely doesn't support the boosters in people younger than 60.

by timr 4y ago

chimprich 4y ago

The problem with these kind of debates is that someone can come along and dump a single paper they've found and claim that it backs up their argument. And maybe it does, but the experts at health agencies like the NHS and dozens or hundreds of others (to sidestep your claim about the US one taking the wrong decisions) get to review, full time, with relevant professional experience, all of the evidence. But, let's look at your link. First paragraph: "And the latest data show that the newest booster shot, which targets the Omicron BA.4/5 strain and original virus variants in a bivalent formulation, isn’t that much more effective in generating virus-fighting antibodies than the original vaccine when used as a booster." So this doesn't even back up your claim. It doesn't say boosters aren't effective, just that the bivalent vaccine isn't "that much more effective" than the original vaccine as a booster.

timr 4y ago
I didn't "dump a single paper". I posted the opinion of an expert in the field, since you clearly don't trust my own assessment of the data. You don't have to trust me, but you just said we have to trust the experts, right? The "problem" with these kinds of debates is that people who have absolutely no ability to read or evaluate scientific literature confidently assert things that they cannot know, based on what they heard someone else say on social media. > So this doesn't even back up your claim. It doesn't say boosters aren't effective, just that the bivalent vaccine isn't "that much more effective" than the original vaccine as a booster. My "claim" was that there's no evidence supporting the dosing schedule for these boosters (this isn't a claim, it's a fact. The booster doses were approved without a single human efficacy trial [1]). Arguing that antibody titers go up after boosting is not a rebuttal...because that's what antibodies do when you inject things into the body. It's the entire topic of the thread. Antibodies go up, then they go back down. It's a poor proxy for immunity. [1] Here's the announcement from the FDA on the latest dosing recommendations: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines https://www.fda.gov/news-events/press-announcements/coronavi... You'll see fun facts such as: * the single-dose schedule for Moderna bivalent is based on antibody responses in about 1500 people, only 145 of whom had Covid in the past. This doesn't reflect any aspect of the real world, where most of us have had it at least once. * they didn't have enough data to justify their decision, so they just grouped together stuff from prior vaccines because "these vaccines are manufactured using the same process." * for Pfizer, effectiveness of a single dose is supported by OBSERVATIONAL DATA from England on the effectiveness of one dose of monovalent Pfizer-BioNTech COVID-19 Vaccine. * "Among individuals 12 to 17 years of age who had received only one dose of Pfizer-BioNTech COVID-19 Vaccine, those who had evidence of previous infection with alpha, delta or omicron variants had increased protection against symptomatic omicron infection compared with those with no evidence of previous infection" That last one is an absolutely mind-blowing bit of doublespeak, by the way. They're literally saying that they're justifying this as a single-dose vaccine because people who were previously infected show more protection after one dose than those who were never infected. Think about that.
- chimprich 4y ago

TJSomething 4y ago

I'm not sure what you mean that the necessary studies have not been done. Because they have and broadly agree that a fourth vaccination provides benefits against hospitalization (though not infection) for older people, generally based on epidemiological measures of population-wide severe cases of COVID-19, not immune response. Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Amir O, Freedman L et al. Protection by a Fourth Dose of BNT162b2 against Omicron in Israel. New England Journal of Medicine. 2022. doi: 10.1056/NEJMoa2201570. Magen O, Waxman JG, Makov-Assif M, Vered R, Dicker D, Hernán MA et al. Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2022. doi: 10.1056/NEJMoa2201688. Gazit S, Saciuk Y, Perez G, Peretz A, Pitzer VE, Patalon T. Relative Effectiveness of Four Doses Compared to Three Dose of the BNT162b2 Vaccine in Israel. medRxiv. 2022:2022.03.24.22272835. doi: 10.1101/2022.03.24.22272835. Arbel R, Sergienko R, Friger M, Peretz A, Beckenstein T, Yaron S et al. Effectiveness of a second BNT162b2 booster vaccine against hospitalization and death from COVID-19 in adults aged over 60 years. Nature Medicine. 2022;28:1486–90. doi: 10.1038/s41591-022-01832-0. Regev-Yochay G, Gonen T, Gilboa M, Mandelboim M, Indenbaum V, Amit S et al. Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron. New England Journal of Medicine. 2022;386:1377-80. doi: 10.1056/NEJMc2202542. Muhsen K, Maimon N, Mizrahi AY, Boltyansky B, Bodenheimer O, Diamant ZH et al. Association of Receipt of the Fourth BNT162b2 Dose With Omicron Infection and COVID-19 Hospitalizations Among Residents of Long-term Care Facilities. JAMA Internal Medicine. 2022. doi: 10.1001/jamainternmed.2022.2658. Amir O, Goldberg Y, Mandel M, Bar-On YM, Bodenheimer O, Freedman L et al. Protection against omicron severe disease 0-7 months after BNT162b2 booster. medRxiv. 2022:2022.05.04.22274647. doi: 10.1101/2022.05.04.22274647. Cohen MJ, Oster Y, Moses AE, Spitzer A, Benenson S, Israeli-Hospitals 4th Vaccine Working G. Association of Receiving a Fourth Dose of the BNT162b Vaccine With SARS-CoV-2 Infection Among Health Care Workers in Israel. JAMA Network Open. 2022;5:e2224657-e. doi: 10.1001/jamanetworkopen.2022.24657. Grewal R, Kitchen SA, Nguyen L, Buchan SA, Wilson SE, Costa AP et al. Effectiveness of a Fourth Dose of COVID-19 Vaccine among Long-Term Care Residents in Ontario, Canada. medRxiv. 2022:2022.04.15.22273846. doi: 10.1101/2022.04.15.22273846.

timr 4y ago
> Because they have and broadly agree that a fourth vaccination provides benefits against hospitalization (though not infection) for older people That's a pretty conditional statement. We're also not on dose four, we're on dose...seven? And young, healthy people are still being mandated to get these things. I stand by my comment: the studies you are citing are all low-quality, observational data, in older populations. I'll just start working down the list from the top... > Bar-On YM, Goldberg Y, Mandel M... Garbage study. Observational. Confounded (vaccine-seeking behavior). Old people (>60). No control (the "internal control" was not a control). > Magen O, Waxman JG, Makov-Assif M... Obeservational study. Confounded (vaccine-seeking). Effect size was miniscule: "In days 7 to 30 after a fourth vaccine dose, the difference in the absolute risk (three doses vs. four doses) was 180.1 cases per 100,000 persons (95% CI, 142.8 to 211.9) for Covid-19–related hospitalization and 68.8 cases per 100,000 persons (95% CI, 48.5 to 91.9) for severe Covid-19." That's a difference of 0.18% for hospitalization, in a population of people over 60. > Gazit S, Saciuk Y, Perez G Observational study. Older population (60+). Confounded (vaccine-seeking). Found that effectiveness against infection was short-term, and that the fourth dose had very little impact on severe disease or hospitalization. "vaccine effectiveness against infection varied over time, peaking during the third week with a VE of 64% (95% CI: 62.0%-65.9%) and declining to 29.2% (95% CI: 17.7%-39.1%) by the end of the 10-week follow-up period. Unlike VE against infection, the relative effectiveness of a fourth dose against severe COVID-19 was maintained at high level (>73%) throughout the 9-week follow-up period. Importantly, severe disease was a relatively rare event, occurring in <1% of both fourth dose and third dose only recipients." > Arbel R, Sergienko R, Friger M Observational study. Older population (60+). Confounded (vaccine-seeking). Tiny effect size (hospitalization in 4-shot cohort: %0.08; 3-shot cohort: 0.2%) "A total of 563,465 participants met the eligibility criteria. Of those, 328,597 (58%) received a second booster dose during the 40 day study period. Hospitalization due to COVID-19 occurred in 270 of the second-booster recipients and in 550 participants who received one booster dose (adjusted hazard ratio, 0.36; 95% confidence interval (CI): 0.31–0.43). Death due to COVID-19 occurred in 92 second-booster recipients and in 232 participants who received one booster dose (adjusted hazard ratio, 0.22; 95% CI: 0.17–0.28)." > Regev-Yochay G, Gonen T, Gilboa M... Small sample size (N=1050). Not blinded. Not randomized. Lower PCR testing adherence in control group. Short follow-up period. Overall insignificant clinical effect: "25.0% of the participants in the control group were infected with the omicron variant, as compared with 18.3% of the participants in the BNT162b2 group and 20.7% of those in the mRNA-1273 group. Vaccine efficacy against any SARS-CoV-2 infection was 30% (95% confidence interval [CI], −9 to 55) for BNT162b2 and 11% (95% CI, −43 to 44) for mRNA-1273" In other words, the VE confidence interval crossed zero for both vaccines -- it's possible the extra dose made things worse. I've run out of time and this post is getting long, but the remaining studies are no different. Is it possible that there's some tiny effect size for elderly people? Sure. But this data doesn't support shot 7 (or 6, or 5...), and it definitely doesn't support the boosters in people younger than 60.