In the published article, there was an error. At one text position, the level of significance stated as “p-value of 0.0012” is incorrect, given too high by exactly an order of magnitude.
A correction has been made to Paragraph 5. This sentence previously stated:
“In continuation of Polack et al. (1), interestingly, the authors of (7) finally counted 15 (vaccinated) and 14 (placebo) dead during eleven weeks, then evidently giving numbers for complete trial groups (see their Supplementary Table S4; 21,920 persons). If our German-based estimate (25 deaths in 21,620 persons) is assumed to be the expected value of a binomial probability distribution then the corresponding standard deviation is quite exactly 5. A corresponding binomial test reveals that the 14 dead in the placebo group are significantly different from prognosticated 25 deaths, at a p-value of 0.0012. Hence, counting just 14 dead in Thomas et al. (7) is already utterly unlikely to be explainable by chance; and the 4 dead reported in Polack et al. (1) are an entirely impossible count, which can only reflect some preliminary data analysis. In stark disaccord, the data reported in Polack et al. (1) should without doubt stand on their own and not rely on additional publications, as this was a public dissemination of both safety and efficacy probed by a pivotal vaccine trial. Publishing another, later (6-month) safety data set as in Thomas et al. (7), or even secondary reports like, e.g., by the USA's “Food and Drug Administration,” should not be required when disseminating a primary endpoint assessment of safety (mortality).”
The corrected sentence appears below:
“In continuation of Polack et al. (1), interestingly, the authors of (7) finally counted 15 (vaccinated) and 14 (placebo) dead during 11 weeks, then evidently giving numbers for complete trial groups (see their Supplementary Table S4; 21,920 persons). If our German-based estimate (25 deaths in 21,620 persons) is assumed to be the expected value of a binomial probability distribution then the corresponding standard deviation is quite exactly 5. A corresponding binomial test reveals that the 14 dead in the placebo group are significantly different from prognosticated 25 deaths, at a p-value of 0.012. Hence, counting just 14 dead in Thomas et al. (7) is already utterly unlikely to be explainable by chance; and the four dead reported in Polack et al. (1) are an entirely impossible count, which can only reflect some preliminary data analysis. In stark disaccord, the data reported in Polack et al. (1) should without doubt stand on their own and not rely on additional publications, as this was a public dissemination of both safety and efficacy probed by a pivotal vaccine trial. Publishing another, later (6-month) safety data set as in Thomas et al. (7), or even secondary reports like, e.g., by the USA's “Food and Drug Administration,” should not be required when disseminating a primary endpoint assessment of safety (mortality).”
The authors apologize for this error and state that this does not change the scientific conclusions of the article in any way. The original article has been updated.
Statements
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
Summary
Keywords
pivotal clinical trial, SARS-CoV-2, mortality, prognosis, vaccine
Citation
Günther M, Mörl F and Rockenfeller R (2023) Corrigendum: Where have the dead gone?. Front. Med. 10:1310746. doi: 10.3389/fmed.2023.1310746
Received
09 October 2023
Accepted
17 October 2023
Published
30 October 2023
Volume
10 - 2023
Edited and reviewed by
Alberto Cagigi, Nykode Therapeutics ASA, Norway
Updates
Copyright
© 2023 Günther, Mörl and Rockenfeller.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Michael Günther s7gumi@uni-jena.de
Disclaimer
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.