4 ms·

> Also: this is purely in mice. They have zero data on whether this is true for humans. Out of curiosity, how do you feel about the new bivalent BA4/BA5 booste

by xienze 4y ago

> Also: this is purely in mice. They have zero data on whether this is true for humans. Out of curiosity, how do you feel about the new bivalent BA4/BA5 booster? It's only been tested on... eight mice [0]: > So what data specific to the BA.4/BA.5 boosters, did the FDA use to expand the EUAs to include the BA.4/BA.5 boosters? Well, the answer is at least in part very “mice.” Apparently, both Moderna and Pfizer-BioNTech have provided non-human animal data on the BA.4/BA.5 boosters to the FDA to state their case for the EUA. But they haven’t yet shown this data to the rest of the scientific community or the public. This data have reportedly included some preliminary findings from eight mice. Hey, if that's good enough for emergency use authorization, why aren't the findings in this paper up to snuff? 0: https://www.forbes.com/sites/brucelee/2022/09/12/have-the-new-bivalent-covid-19-vaccine-boosters-been-tested-on-humans/?sh=2b249b573838 https://www.forbes.com/sites/brucelee/2022/09/12/have-the-ne...

ceejayoz 4y ago
A reminder that anyone can be a "Forbes contributor" (https://www.niemanlab.org/2022/02/an-incomplete-history-of-forbes-com-as-a-platform-for-scams-grift-and-bad-journalism/ https://www.niemanlab.org/2022/02/an-incomplete-history-of-f...), and "reportedly" is thrown in there with zero evidence. It's highly unlikely the booster trials were on eight mice. edit: Found the source of the eight mouse thing; it's a misreading of https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-09-01/06-COVID-Miller-508.pdf https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-..., page 21. It's not the safety trial, it's the immunogenicity comparison on a small population of older mice previously given the primary vaccine. (The previous slide, #20, has a heading of "Pre-Clinical Studies"; #21 is describing the early studies before the human trials.) Page six debunks the idea it's only been tested on mice entirely; it cites a trial of 512 human adults for the Moderna BA.4/BA.5 Omicron booster.
- orange_fritter 4y ago
  Page six labels the 512 BA.4/BA.5 test as "Part H" > Part H enrolled Aug 10-23, 2022 These people entered the study less than a month ago? https://www.npr.org/sections/health-shots/2022/08/18/1117778748/whats-behind-the-fdas-controversial-strategy-for-evaluating-new-covid-boosters https://www.npr.org/sections/health-shots/2022/08/18/1117778...
  - ceejayoz 4y ago
    A month is more than enough to demonstrate safety; vaccine reactions to the original shot (and in general) were all rapid. As that article notes, flu shots have a similar regulatory regime: > And some scientists say health officials know enough about how vaccines work to start handling the COVID-19 vaccines like the flu vaccines, which are changed every year to try to match whatever strains are likely to be circulating but aren't routinely tested again every year. and that the new vaccine still expresses the original proteins the already-approved vaccinations were expressing; in the worst-case scenario that mice and humans react similarly to Alpha/Delta but wildly differently to Omicron/BA.4/BA.5, we're still likely generating the at least the original immune response: > The new booster will be identical to the original vaccines except it will contain genetic coding for two versions of the protein the virus uses to infect cells — the protein from the original vaccine and proteins from the BA.4 and BA.5 omicron subvariants. A rapid approval process is going to be important for boosters, for the same reasons it is in flu shots. It's very clear the claim that it was only tested on eight mice is false.
    - TechBro8615 4y ago
      The FDA extended the EUA to include BA.4/BA.5 boosters on August 31, which was 1-2 weeks after those people entered the study.
      - tostonescon 4y ago
        This is because the ba.4/ba.5 vaccine is so incredibly close to the ba.1 bivalent vaccine, which did see more human trials and showed a similar safety profile as the original vaccine. Kinda like how we get a new flu vaccine every year that doesn't go through a years long clinical study (Edit to fix a typo)
        TechBro8615 4y ago
        Sounds like conjecture to me. But that’s fine, I understand the argument for printing new mRNA vaccines. But please don’t force me to take it to keep my job or travel internationally, and don’t call me an anti-vaxxer for refusing to inject myself with an experimental vaccine that’s been tested in eight mice and a small group of humans for two weeks.
importantbrian 4y ago
Well they have tested bivalent COVID-19 vaccines in large human trials. These boosters are functionally the same they just target different strains of COVID. I'm not an expert, but that's how flu vaccines are done. They don't have to seek re-approval for every new strain every season, and that seems fine. Maybe that's a bad practice. I don't know, but I'm comfortable deferring to experts in the field on it.
- dudeDDRrulez 4y ago
  No, they have not tested bivalent COVID-19 vaccines in large human trials. The best we have right now are some antibody titers results from 8 mice.
  - importantbrian 4y ago
    What are you talking about? It's right there in the Forbes article. Did you bother to read it? > "Well, theory is one thing. Concrete scientific evidence is another. The FDA announcement did mention studies that compared the use of bivalent boosters and monovalent boosters that included approximately 600 and 800 individuals 18 years of age and older for the Moderna ones and 600 participants greater than 55 years of age for the Pfizer-BioNTech ones. These studies reportedly found those who gotten the bivalent boosters had “better” immune response than those who had of those who had received the monovalent boosters. The studies also didn’t show any significant safety concerns with the bivalent boosters, mentioning the usual side effect stuff like pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea, vomiting, and fever." Or maybe I wasn't clear in what I said. They have tested bivalent vaccines. Just not for the specific strain of COVID mentioned. I'm saying that seems fine to me since that's what they do for flu, but I'm not an expert. Maybe COVID is different in some fundamental way that means we need to retest for every strain.

by xienze 4y ago

ceejayoz 4y ago

A reminder that anyone can be a "Forbes contributor" (https://www.niemanlab.org/2022/02/an-incomplete-history-of-forbes-com-as-a-platform-for-scams-grift-and-bad-journalism/ https://www.niemanlab.org/2022/02/an-incomplete-history-of-f...), and "reportedly" is thrown in there with zero evidence. It's highly unlikely the booster trials were on eight mice. edit: Found the source of the eight mouse thing; it's a misreading of https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-09-01/06-COVID-Miller-508.pdf https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-..., page 21. It's not the safety trial, it's the immunogenicity comparison on a small population of older mice previously given the primary vaccine. (The previous slide, #20, has a heading of "Pre-Clinical Studies"; #21 is describing the early studies before the human trials.) Page six debunks the idea it's only been tested on mice entirely; it cites a trial of 512 human adults for the Moderna BA.4/BA.5 Omicron booster.

orange_fritter 4y ago
Page six labels the 512 BA.4/BA.5 test as "Part H" > Part H enrolled Aug 10-23, 2022 These people entered the study less than a month ago? https://www.npr.org/sections/health-shots/2022/08/18/1117778748/whats-behind-the-fdas-controversial-strategy-for-evaluating-new-covid-boosters https://www.npr.org/sections/health-shots/2022/08/18/1117778...
- ceejayoz 4y ago
  A month is more than enough to demonstrate safety; vaccine reactions to the original shot (and in general) were all rapid. As that article notes, flu shots have a similar regulatory regime: > And some scientists say health officials know enough about how vaccines work to start handling the COVID-19 vaccines like the flu vaccines, which are changed every year to try to match whatever strains are likely to be circulating but aren't routinely tested again every year. and that the new vaccine still expresses the original proteins the already-approved vaccinations were expressing; in the worst-case scenario that mice and humans react similarly to Alpha/Delta but wildly differently to Omicron/BA.4/BA.5, we're still likely generating the at least the original immune response: > The new booster will be identical to the original vaccines except it will contain genetic coding for two versions of the protein the virus uses to infect cells — the protein from the original vaccine and proteins from the BA.4 and BA.5 omicron subvariants. A rapid approval process is going to be important for boosters, for the same reasons it is in flu shots. It's very clear the claim that it was only tested on eight mice is false.
  - TechBro8615 4y ago
    The FDA extended the EUA to include BA.4/BA.5 boosters on August 31, which was 1-2 weeks after those people entered the study.
    - tostonescon 4y ago
      This is because the ba.4/ba.5 vaccine is so incredibly close to the ba.1 bivalent vaccine, which did see more human trials and showed a similar safety profile as the original vaccine. Kinda like how we get a new flu vaccine every year that doesn't go through a years long clinical study (Edit to fix a typo)
      - TechBro8615 4y ago
        Sounds like conjecture to me. But that’s fine, I understand the argument for printing new mRNA vaccines. But please don’t force me to take it to keep my job or travel internationally, and don’t call me an anti-vaxxer for refusing to inject myself with an experimental vaccine that’s been tested in eight mice and a small group of humans for two weeks.

importantbrian 4y ago

Well they have tested bivalent COVID-19 vaccines in large human trials. These boosters are functionally the same they just target different strains of COVID. I'm not an expert, but that's how flu vaccines are done. They don't have to seek re-approval for every new strain every season, and that seems fine. Maybe that's a bad practice. I don't know, but I'm comfortable deferring to experts in the field on it.

dudeDDRrulez 4y ago
No, they have not tested bivalent COVID-19 vaccines in large human trials. The best we have right now are some antibody titers results from 8 mice.
- importantbrian 4y ago
  What are you talking about? It's right there in the Forbes article. Did you bother to read it? > "Well, theory is one thing. Concrete scientific evidence is another. The FDA announcement did mention studies that compared the use of bivalent boosters and monovalent boosters that included approximately 600 and 800 individuals 18 years of age and older for the Moderna ones and 600 participants greater than 55 years of age for the Pfizer-BioNTech ones. These studies reportedly found those who gotten the bivalent boosters had “better” immune response than those who had of those who had received the monovalent boosters. The studies also didn’t show any significant safety concerns with the bivalent boosters, mentioning the usual side effect stuff like pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea, vomiting, and fever." Or maybe I wasn't clear in what I said. They have tested bivalent vaccines. Just not for the specific strain of COVID mentioned. I'm saying that seems fine to me since that's what they do for flu, but I'm not an expert. Maybe COVID is different in some fundamental way that means we need to retest for every strain.