ScienceThe COVID-19 reporting is supported by the Heising-Simons Foundation.
Several prominent virologists and vaccinologists have resigned their posts as editors of the journal Vaccines to protest the June 24 publication of a peer-reviewed article that misuses the data to conclude that “for three deaths averted by [COVID-19] vaccination, we must accept two inflicted by vaccination.
As of Friday, at least six scientists have resigned their positions as associate editors or section editors at Vaccines, including Florian Krammer, virologist at Icahn School of Medicine at Mount Sinai, and Katie Ewer, an immunologist at the Jenner Institute at Oxford University who was part of the team that developed the Oxford-AstraZeneca COVID-19 vaccine. Their resignations were first reported by Retraction Watch.
“The data has been misused because it (incorrectly) assumes that all deaths that have occurred after vaccination are due to vaccination,” Ewer wrote in an email. “[And] it is now used by anti-vaccines and COVID-19 deniers as evidence that COVID-19 vaccines are not safe. [This] is grossly irresponsible, especially for a journal specializing in vaccines.
The document is a case of “garbage in, garbage out,” says Helen Petousis-Harris, a vaccinologist who heads the Vaccine Datalink and Research Group at the University of Auckland and who has also resigned as a Vaccines editor after reading the newspaper. Diane Harper, epidemiologist at the University of Michigan, Ann Arbor, who was the founding editor of Vaccines, has also resigned, as have Paul Licciardi, immunologist at the Murdoch Children’s Research Institute in Parkville, Australia, and Andrew Pekosz, respiratory virologist at the Bloomberg School of Public Health at Johns Hopkins University.
The resignations began on Friday, the day after the newspaper was published. Early Monday, Fanny Fang, the newspaper’s editor-in-chief, wrote to members of the editorial board that Vaccines—A reputable open access journal launched in 2013 by the Basel, Switzerland-based publisher MDPI, launched an investigation into the article. “We are treating this case with the utmost seriousness and we are committed to quickly correcting the scientific record,” she wrote.
Later Monday, VaccinesThe editors of have published an expression of concern about the newspaper. “The main concern is the misrepresentation of COVID-19 vaccination efforts and the misrepresentation of the data,” they wrote.
The newspaper has attracted nearly 350,000 readers as of July 1 and has been tweeted by anti-vaccination activists with hundreds of thousands of followers.
None of the authors of the article are trained in vaccinology, virology or epidemiology. They are: Harald Walach, clinical psychologist and historian of science by training who describes himself as a health researcher at the University of Medical Sciences in Poznan in Poland; Rainer Klement, a physicist who studies ketogenic diets for cancer treatment at Leopoldina Hospital in Schweinfurt, Germany; and Wouter Aukema, a freelance data scientist in Hoenderloo, the Netherlands.
The three reviewers of the article, two of whom are anonymous, did not offer any substantive criticism of the authors’ methodology in these brief reviews. One of them, Anne Ulrich, a chemist who heads the Institute of Biological Interfaces and holds the chair of biochemistry at the Karlsruhe Institute of Technology in Germany, wrote that the authors’ analysis “is carried out responsibly… and without methodological flaws… and the results have been interpreted with the necessary caveats.
Ulrich reiterated this view in a July 1 email to ScienceInsider: “The analysis by Walach et al. was made in my opinion in a responsible and flawless manner, ”she wrote.
One of the anonymous reviewers wrote that the manuscript “is very important and should be published urgently”, offering almost no further comment.
Vaccines did not respond to a list of questions, including how the reviewers were chosen.
Petousis-Harris says: “It is clear from their reviews that they have no expertise in this area. The authors either. It’s a little sloppy when you don’t bring a great body [of expert vaccine safety scientists] in your study and manuscript review.
To draw their conclusions, the article’s authors calculated vaccine-averted COVID-19 deaths using data from a study of 1.2 million Israelis, half of whom received the Pfizer vaccine. -BioNTech and half no. They estimated that 16,000 people needed to be vaccinated to prevent one death from COVID-19 – a problematic measure, critics say, because as a vaccine is successful, the number of people who must be vaccinated to avoid a death increases by more and more.
To calculate deaths ’caused’ by vaccine side effects, they used EU data on the number of vaccine doses delivered in the Netherlands and data from that country’s national database for reporting. adverse drug reactions, which were larger than registry data from other EU countries.
The Netherlands Pharmacovigilance Center, called Lareb, is similar to the US VAERS reporting system, in which anyone can report an adverse event occurring after vaccination; the existence of a report in the database does not prove that a vaccine caused an adverse event or death. These databases are not used to systematically assess vaccine risks, but to look for early signals of rare but real side effects from vaccines, such as the bleeding disorder associated with some COVID-19 vaccines, which can then be followed by a systematic study.
The website of the Dutch register clearly notes that its reports do not imply causation. But the authors reported that using it, they found “16 serious side effects per 100,000 vaccinations and the number of fatal side effects is 4.11 / 100,000 vaccinations.” For every three vaccine-averted deaths, we have to accept two vaccine-inflicted.
On June 25, the day after the article appeared, Lareb’s head of science and research, Eugène van Puijenbroek, emailed Vaccineseditors of, criticizing the newspaper and asking for a correction or retraction.
“A reported event that occurred after vaccination is not necessarily caused by the vaccination, although our data has been presented as causally related by the authors, ”van Puijenbroek wrote. “To suggest that all reports with a fatal outcome are causally related is far from true.”
He also criticized the authors for having stated in the article that “the Dutch [registry] the data, in particular the fatal cases, were certified by medical specialists.
“This point is simply incorrect,” wrote van Puijenbroek. “The authors seem to refer to [Lareb’s] political level. However, in this plan (in Dutch) it is nowhere mentioned that the reports are “certified” by medical specialists. “
In an email to ScienceInsider van Puijenbroek also feared that the document would erode the public’s willingness to report to the Dutch register. “[People who report adverse events to us] must be confident that the data they provide will be used in a correct and scientific manner. Articles like this undermine that confidence.
Walach, the first author, says he supports the paper. He adds that the clinical trials of the vaccines that are now licensed for emergency use, which have involved tens of thousands of people, “were not large enough or long enough to really see the safety concerns you might have. “.
Aukema adds that he is satisfied with the controversy, because it means “the [COVID-19 vaccine safety] the subject receives a lot of attention. I am happy.
All three authors presented a rebuttal to VaccinesJune 29 expression of concern. In it, they write that they have interpreted Lareb’s public statements “to mean that those reports which are clearly without any basis are suppressed in such a way that the final database is at least reliable to some extent.”
The authors also insist that they did not imply that the side effects reported in the Dutch registry were necessarily caused by the COVID-19 vaccines. “Right now we only have one association, we agree, and we never said anything else.”
Petousis-Harris says she is happy with what she sees as a prompt and serious response from the management of Vaccines, and that his resignation may not be final.
“It was a good, solid and respectable newspaper. And if [the paper] is going to be retracted… so I would still be happy to be part of the team.