Nor did any of the reports on Moderna’s vaccine. Nor did its publication in the New England Journal of Medicine. There is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t mention the 3410 “suspected covid-19” cases. Needs more info trial#With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent-namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants-seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic. However, if confirmed covid-19 is on average more severe than suspected covid-19, we must still keep in mind that at the end of the day, it is not average clinical severity that matters, it’s the incidence of severe disease that affects hospital admissions. Needs more info plus#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.īut 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. 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. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote). Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 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. Indeed this makes it all the more urgent to understand. With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. 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. But these numbers were dwarfed by a category of disease called “suspected covid-19”-those with symptomatic covid-19 that were not PCR confirmed. Here I outline new concerns about the trustworthiness and meaningfulness of the reported efficacy results.Īll 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. While some of the additional details are reassuring, some are not. Today, two journal publications and around 400 pages of summary data are available in the form of multiple reports presented by and to the FDA prior to the agency’s emergency authorization of each company’s mRNA vaccine. It is available here.įive weeks ago, when I raised questions about the results of Pfizer’s and Moderna’s covid-19 vaccine trials, all that was in the public domain were the study protocols and a few press releases. Here you will find a list of all recitals.On 5 February 2021 we published a clarification to this piece. Needs more info free#If you find the page useful, feel free to support us by sharing the project. The European Data Protection Regulation is applicable as of May 25th, 2018 in all member states to harmonize data privacy laws across Europe. All Articles of the GDPR are linked with suitable recitals. Needs more info pdf#Here you can find the official PDF of the Regulation (EU) 2016/679 (General Data Protection Regulation) in the current version of the OJ L 119, cor.
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