Peter Doshi Peter Doshi is an associate editor at The BMJ and on the News & Views team. Based in Baltimore, he is also an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. His research focuses on policies related to drug safety and effectiveness evaluation in the context of regulation, evidence-based medicine, and debates over access to data. Doshi also has strong interests in journalism as a vehicle for encouraging better practice and improving the research enterprise. Since 2009, Doshi has worked on a Cochrane systematic review of neuraminidase inhibitors for influenza. This review has developed innovative methods for evaluating regulatory information including clinical study reports. Doshi completed a fellowship in comparative effectiveness research at Johns Hopkins and received his Ph.D. in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology.
All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected covid-19”—those with symptomatic covid-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”
With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).
If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy. But considering that influenza-like illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses, adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected covid-19 cases may be due to a different causative agent.
But why should etiology matter? If those experiencing “suspected covid-19” had essentially the same clinical course as confirmed covid-19, then “suspected plus confirmed covid-19” may be a more clinically meaningful endpoint than just confirmed covid-19.
All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbe ...
/https://media-proc.singtaousa.com/photo.php?s=https://media.singtaousa.com/wp-content/uploads/master/2024/04/2024042217504266764.jpg&f=jpeg&w=815&q=75)
一陣驚動到癌變或生小朋友基因異變點算……
/https://storage.inewsdb.com/7a2818b202388805a6c312372c0dfd13.jpg)
/https://storage.inewsdb.com/2b2587f74f7f0ee9c2e49aa8f75222e2.jpg)
/https://storage.inewsdb.com/99b9eca9f8b32ae8cacf61d9bb5a4a98.jpg)
/https://storage.inewsdb.com/11dfb285e92b7b1eea24295ed609212e.jpg)
/https://storage.inewsdb.com/4d15ce48e51c99e82987c36bf9d36370.jpg)
/https://storage.inewsdb.com/b3f0ee5e2404f792d3a7df10b9925a77.jpg)
/https://storage.inewsdb.com/4b2e5268ad1e061ea95adbc7eda08cda.jpg)
/https://www.discuss.com.hk/attachments/day_240424/20240424_59227c6f2e2f12cb1bf30GS1iT9DGZ2N.jpeg)
/https://www.discuss.com.hk/attachments/day_240424/20240424_3d66ffdb9bcc21c27ec1a2uainxurFIM.jpeg)
/https://www.discuss.com.hk/attachments/day_240424/20240424_cff9658fae61d4f67fa72xL3VgX1Z5FU.jpeg)
/https://www.discuss.com.hk/attachments/day_240424/20240424_003418098438f6fa786bxzHG8348ivbz.jpeg)
/https://www.discuss.com.hk/attachments/day_240423/20240423_17c01c654b1814d9eb2fernY4ELZYxGq.png)
/https://www.discuss.com.hk/attachments/day_240424/20240424_4d625634ace5b26ca15feaqSM6gFzOYk.jpeg)
/https://www.discuss.com.hk/attachments/day_240424/20240424_09dfb0976295b3076de8SKLF3tfI0Zl3.jpeg)
