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Nuance: Touting high effectiveness agains infection, which degrades over time. This has been explained elsewhere in this thread, the original vaccine claims wer

Nuance: Touting high effectiveness agains infection, which degrades over time. This has been explained elsewhere in this thread, the original vaccine claims were similar and later morphed into "but the vaccine was always designed to protect against severe infection". Nuance: Not mentioning that their own full application estimates saving one in a million children, under the best circumstances. See Table 14 on page 34. The difficult ethical question: on one hand there is 1 child you may save given the information available today. On the other hand you don't know which one ahead of time, you need to inoculate 1 million children with a vaccine for which you don't have any longterm data on. https://www.fda.gov/media/153447/download https://www.fda.gov/media/153447/download

fsh 5y ago
Ok, let's have a look what the vaccine manufacturers claimed in their phase 3 study papers about the durability of the protection: BioNTech/Pfizer [1]: "This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remain to be determined." Moderna [2]: "Another limitation is the lack of an identified correlate of protection, a critical tool for future bridging studies. As of the data cutoff, 11 cases of Covid-19 had occurred in the mRNA-1273 group, a finding that limits our ability to detect a correlate of protection. As cases accrue and immunity wanes, it may become possible to determine such a correlate." AstraZeneca [3]: "In this interim analysis, we have not been able to assess duration of protection, since the first trials were initiated in April, 2020, such that all disease episodes have accrued within 6 months of the first dose being administered. Further evidence will be required to determine duration of protection and the need for additional booster doses of vaccine." Johnson & Johnson [4]: "A limitation of the trial is the relatively short follow-up, which was necessitated, as in other Covid-19 vaccine trials, by the urgent need for vaccine. The data do not suggest a waning of protection." [1] https://www.nejm.org/doi/full/10.1056/nejmoa2034577 https://www.nejm.org/doi/full/10.1056/nejmoa2034577 [2] https://www.nejm.org/doi/full/10.1056/nejmoa2035389 https://www.nejm.org/doi/full/10.1056/nejmoa2035389 [3] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [4] https://www.nejm.org/doi/full/10.1056/NEJMoa2101544 https://www.nejm.org/doi/full/10.1056/NEJMoa2101544
- angelzen 5y ago
  Speaking of protection (vaccine effectiveness against infection) durability, I have to admit there is a certain level of disappointment seeing charts like Figure 1 in a US veteran study, which flat out contradicts the J&J claims (VEaI 3%) and partly invalidates the Pfizer claims (VEaI 56%). Or a Qatar study. Or a Sweden study. There is also the official reaction. Aug 18, 2021: "CDC Director Says Coronavirus Vaccines Less Effective For Delta But Still Prevent Severe Infection". Possible all of these studies are flawed. And perhaps I'm accidentally misquoting Rachel Walensky. Given that the original trials were closed by vaccinating the control arm of the studies, not even sure where to look for credible longterm tracking of VE against infection data. On the other hand, possibly the manufacturer original studies were flawed. Or the virus evolved, Delta, duh. These conversations are difficult to carry partly because we are supposed to take the original studies, created with (acceptable) conflict of interest as gold standard, and summarily dismiss any independent verification thereof. https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v1.full-text https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v... https://www.nejm.org/doi/full/10.1056/NEJMoa2114114 https://www.nejm.org/doi/full/10.1056/NEJMoa2114114 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://www.forbes.com/sites/andrewsolender/2021/08/18/cdc-director-says-coronavirus-vaccines-less-effective-for-delta-but-still-prevent-severe-infection https://www.forbes.com/sites/andrewsolender/2021/08/18/cdc-d...
  - angelzen 5y ago
    PS. One more recent VE study picked from the comments, https://www.nature.com/articles/s41591-021-01548-7/tables/3 https://www.nature.com/articles/s41591-021-01548-7/tables/3 UK, VE vs delta over 90 days days VEaPCRI VEaSI after 2nd dose 14 85% 93% 30 83% 92% 60 80% 86% 90 75% 78% The trend makes me fairly intrigued to see the follow up at 180, 270 etc. days after 2nd dose.
    - pbak 5y ago
      Watch this till the end : https://www.youtube.com/watch?v=TSZMtSPX3iE https://www.youtube.com/watch?v=TSZMtSPX3iE

fsh 5y ago

Ok, let's have a look what the vaccine manufacturers claimed in their phase 3 study papers about the durability of the protection: BioNTech/Pfizer [1]: "This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remain to be determined." Moderna [2]: "Another limitation is the lack of an identified correlate of protection, a critical tool for future bridging studies. As of the data cutoff, 11 cases of Covid-19 had occurred in the mRNA-1273 group, a finding that limits our ability to detect a correlate of protection. As cases accrue and immunity wanes, it may become possible to determine such a correlate." AstraZeneca [3]: "In this interim analysis, we have not been able to assess duration of protection, since the first trials were initiated in April, 2020, such that all disease episodes have accrued within 6 months of the first dose being administered. Further evidence will be required to determine duration of protection and the need for additional booster doses of vaccine." Johnson & Johnson [4]: "A limitation of the trial is the relatively short follow-up, which was necessitated, as in other Covid-19 vaccine trials, by the urgent need for vaccine. The data do not suggest a waning of protection." [1] https://www.nejm.org/doi/full/10.1056/nejmoa2034577 https://www.nejm.org/doi/full/10.1056/nejmoa2034577 [2] https://www.nejm.org/doi/full/10.1056/nejmoa2035389 https://www.nejm.org/doi/full/10.1056/nejmoa2035389 [3] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [4] https://www.nejm.org/doi/full/10.1056/NEJMoa2101544 https://www.nejm.org/doi/full/10.1056/NEJMoa2101544

angelzen 5y ago
Speaking of protection (vaccine effectiveness against infection) durability, I have to admit there is a certain level of disappointment seeing charts like Figure 1 in a US veteran study, which flat out contradicts the J&J claims (VEaI 3%) and partly invalidates the Pfizer claims (VEaI 56%). Or a Qatar study. Or a Sweden study. There is also the official reaction. Aug 18, 2021: "CDC Director Says Coronavirus Vaccines Less Effective For Delta But Still Prevent Severe Infection". Possible all of these studies are flawed. And perhaps I'm accidentally misquoting Rachel Walensky. Given that the original trials were closed by vaccinating the control arm of the studies, not even sure where to look for credible longterm tracking of VE against infection data. On the other hand, possibly the manufacturer original studies were flawed. Or the virus evolved, Delta, duh. These conversations are difficult to carry partly because we are supposed to take the original studies, created with (acceptable) conflict of interest as gold standard, and summarily dismiss any independent verification thereof. https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v1.full-text https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v... https://www.nejm.org/doi/full/10.1056/NEJMoa2114114 https://www.nejm.org/doi/full/10.1056/NEJMoa2114114 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://www.forbes.com/sites/andrewsolender/2021/08/18/cdc-director-says-coronavirus-vaccines-less-effective-for-delta-but-still-prevent-severe-infection https://www.forbes.com/sites/andrewsolender/2021/08/18/cdc-d...
- angelzen 5y ago
  PS. One more recent VE study picked from the comments, https://www.nature.com/articles/s41591-021-01548-7/tables/3 https://www.nature.com/articles/s41591-021-01548-7/tables/3 UK, VE vs delta over 90 days days VEaPCRI VEaSI after 2nd dose 14 85% 93% 30 83% 92% 60 80% 86% 90 75% 78% The trend makes me fairly intrigued to see the follow up at 180, 270 etc. days after 2nd dose.
  - pbak 5y ago
    Watch this till the end : https://www.youtube.com/watch?v=TSZMtSPX3iE https://www.youtube.com/watch?v=TSZMtSPX3iE