4 ms·

Some quick points about this. The British Medical Journal and Royal Society of medicine have published a number of concerns about this vaccine. "Will covid-19

Some quick points about this. The British Medical Journal and Royal Society of medicine have published a number of concerns about this vaccine. "Will covid-19 vaccines save lives? Current trials aren’t designed to tell us" https://www.bmj.com/content/371/bmj.m4037 https://www.bmj.com/content/371/bmj.m4037 "All these data for the different vaccines are potentially very promising, but none of the phase III trials have been published in peer reviewed journals or analysed by age group, gender and case description... As public health professionals, we believe that the results of clinical trials, whether interim or final, should be subject to an appropriate systematic process, and then published in peer-reviewed professional journals. Reporting the covid-19 vaccine trial results in press releases before publication in journals is neither good scientific practice nor does it help to build public trust in vaccines" https://blogs.bmj.com/bmj/2020/11/27/covid-19-vaccines-where-are-the-data/ https://blogs.bmj.com/bmj/2020/11/27/covid-19-vaccines-where... "When good science is suppressed by the medical-political complex, people die Politicians and governments are suppressing science. They do so in the public interest, they say, to accelerate availability of diagnostics and treatments. They do so to support innovation, to bring products to market at unprecedented speed. Both of these reasons are partly plausible; the greatest deceptions are founded in a grain of truth. But the underlying behaviour is troubling." https://www.bmj.com/content/371/bmj.m4425 https://www.bmj.com/content/371/bmj.m4425

johncearls 6y ago
Why is this downvoted? These are valid concerns with respectable citations.
mcv 6y ago
Publication in a peer reviewed journal can take a lot of time, and I don't think that should be required in an urgent situation like this. Though of course the trials should still be reviewed somehow.
lbeltrame 6y ago
The FDA released today all the data they're using for the upcoming Dec 10th discussion, and it is quite detailed: https://www.fda.gov/media/144245/download https://www.fda.gov/media/144245/download Writing a peer-reviewed paper two weeks after the data are out is hard, even more so when you have an emergency use authorization ongoing (which requires far more data).
mft_ 6y ago
1) BMJ is rabble-rousing. Endpoints for any pivotal trial will be agreed with regulators in advance. In this case, while I don’t know the numbers themselves, I suspect that given the low rate of serious complications of Covid overall, waiting for sufficient numbers of outcomes such as hospitalisation, intensive care visits, or death, would increase the duration, size, and cost of the trial, and maybe significantly so. 2) Bitching about skipping the peer-review process in the face of a global pandemic is self-important nonsense. Peer review isn’t necessary for the drug approval process, and takes a significant amount of time and effort that the people involved probably didn’t have. If it’s between writing a regulatory submission versus a manuscript, in this situation prioritising the activity that will likely directly save lives is reasonable. The manuscripts and ever-so-important peer review will follow soon.
- rualca 6y ago
  > Bitching about skipping the peer-review process in the face of a global pandemic is self-important nonsense. Making results available to peers is the basis of science, which is a short word that means being sure things work as we think they do. Without peer review, no one has any idea of what the vaccine does. What if the vaccine is nothing but a big old placebo? How can we tell? It's far more than mere "bitching". Way more than that. The Royal Society's motto is 'Nullius in verba', which means "take nobody's word for it". Think about it. Of all places to hear that blend of anti-science, I wasn't expecting to read it here.
  - newen 6y ago
    Peer review is the specific process of sending your well edited manuscript to a select few reviewers of a journal in order to get that manuscript published in that journal. It is different from having your results available to your peers, which I'm not sure they did that here, but point being peer review is this specific time consuming process (that can take months, sometimes years).
    - irthomasthomas 6y ago
      You are picking on one point out of many. Anyway, I think I would sleep better just knowing that they published everything, even if it doesnt get the formal peer review.
zaroth 6y ago
> ...but none of the phase III trials have been published in peer reviewed journals or analysed by age group, gender and case description... What’s this then? https://twitter.com/wgibson/status/1336298050315313158?s=21 https://twitter.com/wgibson/status/1336298050315313158?s=21
konamicode 6y ago
N.B. Oxford have since published[0] a peer-reviewed study of phase 3 trial in The Lancet. [0] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

johncearls 6y ago

Why is this downvoted? These are valid concerns with respectable citations.

mcv 6y ago

Publication in a peer reviewed journal can take a lot of time, and I don't think that should be required in an urgent situation like this. Though of course the trials should still be reviewed somehow.

lbeltrame 6y ago

The FDA released today all the data they're using for the upcoming Dec 10th discussion, and it is quite detailed: https://www.fda.gov/media/144245/download https://www.fda.gov/media/144245/download Writing a peer-reviewed paper two weeks after the data are out is hard, even more so when you have an emergency use authorization ongoing (which requires far more data).

mft_ 6y ago

1) BMJ is rabble-rousing. Endpoints for any pivotal trial will be agreed with regulators in advance. In this case, while I don’t know the numbers themselves, I suspect that given the low rate of serious complications of Covid overall, waiting for sufficient numbers of outcomes such as hospitalisation, intensive care visits, or death, would increase the duration, size, and cost of the trial, and maybe significantly so. 2) Bitching about skipping the peer-review process in the face of a global pandemic is self-important nonsense. Peer review isn’t necessary for the drug approval process, and takes a significant amount of time and effort that the people involved probably didn’t have. If it’s between writing a regulatory submission versus a manuscript, in this situation prioritising the activity that will likely directly save lives is reasonable. The manuscripts and ever-so-important peer review will follow soon.

rualca 6y ago
> Bitching about skipping the peer-review process in the face of a global pandemic is self-important nonsense. Making results available to peers is the basis of science, which is a short word that means being sure things work as we think they do. Without peer review, no one has any idea of what the vaccine does. What if the vaccine is nothing but a big old placebo? How can we tell? It's far more than mere "bitching". Way more than that. The Royal Society's motto is 'Nullius in verba', which means "take nobody's word for it". Think about it. Of all places to hear that blend of anti-science, I wasn't expecting to read it here.
- newen 6y ago
  Peer review is the specific process of sending your well edited manuscript to a select few reviewers of a journal in order to get that manuscript published in that journal. It is different from having your results available to your peers, which I'm not sure they did that here, but point being peer review is this specific time consuming process (that can take months, sometimes years).
  - irthomasthomas 6y ago
    You are picking on one point out of many. Anyway, I think I would sleep better just knowing that they published everything, even if it doesnt get the formal peer review.

zaroth 6y ago

> ...but none of the phase III trials have been published in peer reviewed journals or analysed by age group, gender and case description... What’s this then? https://twitter.com/wgibson/status/1336298050315313158?s=21 https://twitter.com/wgibson/status/1336298050315313158?s=21

konamicode 6y ago

N.B. Oxford have since published[0] a peer-reviewed study of phase 3 trial in The Lancet. [0] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6...