4 ms·

Does the FDA think these data justify the full approval of a Covid-19 vaccine?

17 points by nanis 5y ago

cowvin 5y ago
It seems like most of his criticisms are around the efficacy of the vaccine past 6 months? Even if the vaccine only grants up to 6 months of protection, why would that be an argument not to approve it? If anything, it sounds like we should approve it an encourage booster shots every 6 months.
nanis 5y ago
> Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%. Also, about the author[1], before the usual crowd descends upon me with the downvotes/flags w/o reading. > Peter Doshi is a senior editor at The BMJ and on the News & Views team. Based in Baltimore, he is also an associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. His research focuses on the drug approval process, how the risks and benefits of medical products are assessed and communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications. Doshi campaigns for greater transparency of clinical trial data and leads the Restoring Invisible and Abandoned Trials (RIAT) initiative, which aims to ensure clinical trial publications are accurate, complete, and data are publicly available. Doshi also has strong interests in journalism as a vehicle for encouraging better practice and improving the research enterprise. Doshi completed a fellowship in comparative effectiveness research at Johns Hopkins and received his PhD in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology. [1]: https://faculty.rx.umaryland.edu/pdoshi/ https://faculty.rx.umaryland.edu/pdoshi/
NoPie 5y ago
I think it does. Ultimately it is a policy decision. There is no exact criteria what should be risk/benefit ratio before we can approve drug for unrestricted (but still doctor supervised) use. If we as the society agree that, let's say saving 10 lives at the expense of 1 dead person (just hypothetical example, I am sure the actual benefit is much, much higher), then that's it. If we are more risk averse and demand that for 1 death there should be at least 1000 people saved, then we have a higher bar and that's also ok if the society agrees with it.

17 points by nanis 5y ago

It seems like most of his criticisms are around the efficacy of the vaccine past 6 months? Even if the vaccine only grants up to 6 months of protection, why would that be an argument not to approve it? If anything, it sounds like we should approve it an encourage booster shots every 6 months.

nanis 5y ago

> Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%. Also, about the author[1], before the usual crowd descends upon me with the downvotes/flags w/o reading. > Peter Doshi is a senior editor at The BMJ and on the News & Views team. Based in Baltimore, he is also an associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. His research focuses on the drug approval process, how the risks and benefits of medical products are assessed and communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications. Doshi campaigns for greater transparency of clinical trial data and leads the Restoring Invisible and Abandoned Trials (RIAT) initiative, which aims to ensure clinical trial publications are accurate, complete, and data are publicly available. Doshi also has strong interests in journalism as a vehicle for encouraging better practice and improving the research enterprise. Doshi completed a fellowship in comparative effectiveness research at Johns Hopkins and received his PhD in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology. [1]: https://faculty.rx.umaryland.edu/pdoshi/ https://faculty.rx.umaryland.edu/pdoshi/

NoPie 5y ago

I think it does. Ultimately it is a policy decision. There is no exact criteria what should be risk/benefit ratio before we can approve drug for unrestricted (but still doctor supervised) use. If we as the society agree that, let's say saving 10 lives at the expense of 1 dead person (just hypothetical example, I am sure the actual benefit is much, much higher), then that's it. If we are more risk averse and demand that for 1 death there should be at least 1000 people saved, then we have a higher bar and that's also ok if the society agrees with it.