5 ms·

AZ tested every patient weekly for covid, regardless of self reported symptoms. No other trial did this. Which means the 95% efficacy for phizer/moderna is not

AZ tested every patient weekly for covid, regardless of self reported symptoms. No other trial did this. Which means the 95% efficacy for phizer/moderna is not actually correct. we have no way of knowing how many were asymptomatic.

_Microft 6y ago
Data from Israel suggests that the Pfizer/Biontech vaccine prevents 97% of symptomatic and 94% of asymptomatic cases. (After the intial trial phases had concluded Pfizer only reported how many symptomatic cases were prevented which might be the "95%" number you have in mind)
- mutagen 6y ago
  Is this the Israel study you're referring to? https://www.nejm.org/doi/full/10.1056/NEJMoa2101765 https://www.nejm.org/doi/full/10.1056/NEJMoa2101765 Just curious, as I've received the Pfizer/Biontech vaccine.
  - _Microft 6y ago
    I think it was more recent than that but I only saw reports about the numbers, not the thing itself.
orblivion 6y ago
I assumed every vaccine trial would be testing people regularly. I'm a little shocked if what you're saying is true. Is there not a lot on the line here? Maybe because it was in their interest to hide bad news?
- linuxftw 6y ago
  These are for-profit companies shielded from liability. They're going to do only the bare minimum to get the product to market. For other classes of drugs, these same companies have been sued and fined for billions of dollars for covering up problems with their drugs. The regulators are beyond incompetent, they're typically industry shills.
  - leesalminen 6y ago
    The fact that the regulators have only issued Emergency Use Authorization for the vaccines shows that less than the bare minimum has been done to bring these products to market. The bare minimum used to be FDA Approval.
    - maxerickson 6y ago
      If "used to be" counts, then the bare minimum is whatever it takes to get someone to pay for it, like in the literal snake oil days. It is such a weird stance, implying that it can never make sense for the FDA to change how they do things.
      - leesalminen 6y ago
        > If "used to be" counts, then the bare minimum is whatever it takes to get someone to pay for it, like in the literal snake oil days. I’m advocating for higher standards, not lower. With regards to the COVID vaccine, we’ve decreased the quality and quantity of research performed over what we’ve done for previous vaccines. It sounds like you’re saying that the research on these vaccines is better than before. Which is confusing because they have not obtained FDA Approval. If they had been tested to the same rigor as other vaccines, they would have received this Approval. > implying that it can never make sense for the FDA to change how they do things. Again, that’s not what I’m implying. I’m implying that we should change how they do things in only one direction- more safe. Long term research and vigorous testing. Not rushed testing who’s new rules are dictated by industry-captured regulators.
  - CyberDildonics 6y ago
    What evidence are you basing this on?
    - linuxftw 6y ago
      Below are some top results for the google search "FDA revolving door". I mean, is this a serious question? https://www.citizen.org/article/outrage-of-the-month-revolving-door-to-fda-commissioners-office-sows-distrust-in-agency/ https://www.citizen.org/article/outrage-of-the-month-revolvi... https://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry https://www.npr.org/sections/health-shots/2016/09/28/4956945... https://www.sciencemag.org/news/2018/07/fda-s-revolving-door-companies-often-hire-agency-staffers-who-managed-their-successful https://www.sciencemag.org/news/2018/07/fda-s-revolving-door...
- maxerickson 6y ago
  Prevention of severe disease is a perfectly reasonable standard to use to evaluate a vaccine. Just look at the hospitalization and death rates for old people in the countries with high vaccination rates.
  - orblivion 6y ago
    Fair enough, I don't mean to discount the value of the metrics they did use. However I can think of two things that could be gained from testing people weekly. 1) If it actually prevents detectable infection altogether, it's some evidence of preventing spread, sooner. (as I understand we have some of that evidence now that it's in wide use) 2) If there are long term effects of even asymptomatic cases, we'd have some reason to believe that those are mitigated as well.
datenhorst 6y ago
That's a bold claim. Any sources to back it up?
- joeaca04 6y ago
  I am in a different Astrazeneca vaccine trial in the USA. (Got jabbed in December) I get my blood drawn monthly, and have weekly symptom check ins via smart phone. I do not get tested weekly
  - raducu 6y ago
    Is there a way to detecy COVID-19 infection post vaccination from blood? I presume you already have a lot of antibodies after vaccination.
- MrAlex94 6y ago
  From the Oxford study[1]: "To test for asymptomatic infections, participants in COV002 in the UK were asked to provide a weekly self-administered nose and throat swab for NAAT testing from 1 week after first vaccination using kits provided by the UK Department of Health and Social Care (DHSC)." With notes: "In Brazil, there was no testing plan for asymptomatic infections. In South Africa, asymptomatic infections were detected from swabs obtained at study visits attended, but are not summarised here as there were only a small number of timepoints for detection of these cases." And you can see results here [2], which includes both symptomatic and asymptomatic cases (if someone could confirm)? From Pfizer study [3]: "Confirmed Covid-19 was defined according to the Food and Drug Administration (FDA) criteria as the presence of at least one of the following symptoms: fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea, or vomiting, combined with a respiratory specimen obtained during the symptomatic period or within 4 days before or after it that was positive for SARS-CoV-2 by nucleic acid amplification–based testing, either at the central laboratory or at a local testing facility (using a protocol-defined acceptable test)." And per their news release [4]: "Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 15 years of age will be gathered in the months ahead." [1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext#cesec100 [2] https://www.evaluate.com/vantage/articles/news/snippets/astrazeneca-looks-us-data-and-next-gen-vaccine [3] https://www.nejm.org/doi/full/10.1056/NEJMoa2034577 [4] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-publication-results-landmark
kylecordes 6y ago
Imagine a world where competent regulators require a reasonable commonality of what data is gather across all the different vaccine trials. (Plus whatever extra stuff data they want to gather - a common baseline, not a takeover) Maybe someday.
zajio1am 6y ago
> Which means the 95% efficacy for phizer/moderna is not actually correct. It is correct, it just efficacy against covid-19 disease, not against SARS-CoV-2 infection. Infection and disease are two distinct concepts.
- KaiserPro 6y ago
  > efficacy against covid-19 disease, not against SARS-CoV-2 infection. There is no distinction between "disease" and "infection" in medicine. There is asymptomatic infection, mild, serious and fatal. Even then its not as clear cut as that. We don't yet have clear data on asymptomatic infection for J&J, moderna, phizer or novavax. I'm not suggesting that we stop jabbing people, quite the opposite. Even if AZ is less effective, roll it the fuck out. The quicker we get 60-70% of people immune, or partially immune, the quicker this shitshow will be over.
  - margalabargala 6y ago
    > There is no distinction between "disease" and "infection" in medicine. That's completely false. An infection is an invasion by a foreign pathogen, a disease is a set of observed symptoms[0]. For other examples of infection/disease distinctions, see HIV and AIDS. [0]: https://www.ncbi.nlm.nih.gov/books/NBK235412/ https://www.ncbi.nlm.nih.gov/books/NBK235412/
    - KaiserPro 6y ago
      I have made an in incorrect assertion. Obviously there is a distinction, auto immune diseases/cancer/congenintal are the overwhelming example. What I should have said is: that in this instance we are measuring infection. disease is marketing speak.
      - gwerbret 6y ago
        This is also incorrect. "Prevention of disease" and "prevention of infection" are two related but clinically-distinct objectives for these vaccines. So far, early clinical trials were generally testing the first objective, and less so the second. It is thus not "marketing speak", but precise language about what was actually tested.
maxerickson 6y ago
It's against a defined endpoint. It's a reasonable one, as a vaccine that prevents severe disease is a lot better than no vaccine. That people don't bother to understand what they read is a problem of course.

_Microft 6y ago

Data from Israel suggests that the Pfizer/Biontech vaccine prevents 97% of symptomatic and 94% of asymptomatic cases. (After the intial trial phases had concluded Pfizer only reported how many symptomatic cases were prevented which might be the "95%" number you have in mind)

mutagen 6y ago
Is this the Israel study you're referring to? https://www.nejm.org/doi/full/10.1056/NEJMoa2101765 https://www.nejm.org/doi/full/10.1056/NEJMoa2101765 Just curious, as I've received the Pfizer/Biontech vaccine.
- _Microft 6y ago
  I think it was more recent than that but I only saw reports about the numbers, not the thing itself.

orblivion 6y ago

I assumed every vaccine trial would be testing people regularly. I'm a little shocked if what you're saying is true. Is there not a lot on the line here? Maybe because it was in their interest to hide bad news?

linuxftw 6y ago
These are for-profit companies shielded from liability. They're going to do only the bare minimum to get the product to market. For other classes of drugs, these same companies have been sued and fined for billions of dollars for covering up problems with their drugs. The regulators are beyond incompetent, they're typically industry shills.
- leesalminen 6y ago
  The fact that the regulators have only issued Emergency Use Authorization for the vaccines shows that less than the bare minimum has been done to bring these products to market. The bare minimum used to be FDA Approval.
  - maxerickson 6y ago
    If "used to be" counts, then the bare minimum is whatever it takes to get someone to pay for it, like in the literal snake oil days. It is such a weird stance, implying that it can never make sense for the FDA to change how they do things.
    - leesalminen 6y ago
      > If "used to be" counts, then the bare minimum is whatever it takes to get someone to pay for it, like in the literal snake oil days. I’m advocating for higher standards, not lower. With regards to the COVID vaccine, we’ve decreased the quality and quantity of research performed over what we’ve done for previous vaccines. It sounds like you’re saying that the research on these vaccines is better than before. Which is confusing because they have not obtained FDA Approval. If they had been tested to the same rigor as other vaccines, they would have received this Approval. > implying that it can never make sense for the FDA to change how they do things. Again, that’s not what I’m implying. I’m implying that we should change how they do things in only one direction- more safe. Long term research and vigorous testing. Not rushed testing who’s new rules are dictated by industry-captured regulators.
- CyberDildonics 6y ago
  What evidence are you basing this on?
  - linuxftw 6y ago
    Below are some top results for the google search "FDA revolving door". I mean, is this a serious question? https://www.citizen.org/article/outrage-of-the-month-revolving-door-to-fda-commissioners-office-sows-distrust-in-agency/ https://www.citizen.org/article/outrage-of-the-month-revolvi... https://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry https://www.npr.org/sections/health-shots/2016/09/28/4956945... https://www.sciencemag.org/news/2018/07/fda-s-revolving-door-companies-often-hire-agency-staffers-who-managed-their-successful https://www.sciencemag.org/news/2018/07/fda-s-revolving-door...
maxerickson 6y ago
Prevention of severe disease is a perfectly reasonable standard to use to evaluate a vaccine. Just look at the hospitalization and death rates for old people in the countries with high vaccination rates.
- orblivion 6y ago
  Fair enough, I don't mean to discount the value of the metrics they did use. However I can think of two things that could be gained from testing people weekly. 1) If it actually prevents detectable infection altogether, it's some evidence of preventing spread, sooner. (as I understand we have some of that evidence now that it's in wide use) 2) If there are long term effects of even asymptomatic cases, we'd have some reason to believe that those are mitigated as well.

datenhorst 6y ago

That's a bold claim. Any sources to back it up?

joeaca04 6y ago
I am in a different Astrazeneca vaccine trial in the USA. (Got jabbed in December) I get my blood drawn monthly, and have weekly symptom check ins via smart phone. I do not get tested weekly
- raducu 6y ago
  Is there a way to detecy COVID-19 infection post vaccination from blood? I presume you already have a lot of antibodies after vaccination.
MrAlex94 6y ago
From the Oxford study[1]: "To test for asymptomatic infections, participants in COV002 in the UK were asked to provide a weekly self-administered nose and throat swab for NAAT testing from 1 week after first vaccination using kits provided by the UK Department of Health and Social Care (DHSC)." With notes: "In Brazil, there was no testing plan for asymptomatic infections. In South Africa, asymptomatic infections were detected from swabs obtained at study visits attended, but are not summarised here as there were only a small number of timepoints for detection of these cases." And you can see results here [2], which includes both symptomatic and asymptomatic cases (if someone could confirm)? From Pfizer study [3]: "Confirmed Covid-19 was defined according to the Food and Drug Administration (FDA) criteria as the presence of at least one of the following symptoms: fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea, or vomiting, combined with a respiratory specimen obtained during the symptomatic period or within 4 days before or after it that was positive for SARS-CoV-2 by nucleic acid amplification–based testing, either at the central laboratory or at a local testing facility (using a protocol-defined acceptable test)." And per their news release [4]: "Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 15 years of age will be gathered in the months ahead." [1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext#cesec100 [2] https://www.evaluate.com/vantage/articles/news/snippets/astrazeneca-looks-us-data-and-next-gen-vaccine [3] https://www.nejm.org/doi/full/10.1056/NEJMoa2034577 [4] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-publication-results-landmark

kylecordes 6y ago

Imagine a world where competent regulators require a reasonable commonality of what data is gather across all the different vaccine trials. (Plus whatever extra stuff data they want to gather - a common baseline, not a takeover) Maybe someday.

zajio1am 6y ago

> Which means the 95% efficacy for phizer/moderna is not actually correct. It is correct, it just efficacy against covid-19 disease, not against SARS-CoV-2 infection. Infection and disease are two distinct concepts.

KaiserPro 6y ago
> efficacy against covid-19 disease, not against SARS-CoV-2 infection. There is no distinction between "disease" and "infection" in medicine. There is asymptomatic infection, mild, serious and fatal. Even then its not as clear cut as that. We don't yet have clear data on asymptomatic infection for J&J, moderna, phizer or novavax. I'm not suggesting that we stop jabbing people, quite the opposite. Even if AZ is less effective, roll it the fuck out. The quicker we get 60-70% of people immune, or partially immune, the quicker this shitshow will be over.
- margalabargala 6y ago
  > There is no distinction between "disease" and "infection" in medicine. That's completely false. An infection is an invasion by a foreign pathogen, a disease is a set of observed symptoms[0]. For other examples of infection/disease distinctions, see HIV and AIDS. [0]: https://www.ncbi.nlm.nih.gov/books/NBK235412/ https://www.ncbi.nlm.nih.gov/books/NBK235412/
  - KaiserPro 6y ago
    I have made an in incorrect assertion. Obviously there is a distinction, auto immune diseases/cancer/congenintal are the overwhelming example. What I should have said is: that in this instance we are measuring infection. disease is marketing speak.
    - gwerbret 6y ago
      This is also incorrect. "Prevention of disease" and "prevention of infection" are two related but clinically-distinct objectives for these vaccines. So far, early clinical trials were generally testing the first objective, and less so the second. It is thus not "marketing speak", but precise language about what was actually tested.

maxerickson 6y ago

It's against a defined endpoint. It's a reasonable one, as a vaccine that prevents severe disease is a lot better than no vaccine. That people don't bother to understand what they read is a problem of course.