Science‘s COVID-19 reporting is supported by the Heising-Simons Foundation
A nursing home worker in the Netherlands gets a COVID-19 vaccine. A Dutch database lies at the heart of a controversy around a paper on vaccine safety.
PHOTO: PIROSCHKA VAN DE WOUW/POOL/REUTERS
The journal Vaccines on 2 July retracted a peer-reviewed article after the angry resignations of at least six editors. They were protesting the publication of a study 1 week earlier that had misused data in a Dutch vaccine adverse events registry to make a startling claim: “For three deaths prevented by [COVID-19] vaccination, we have to accept two inflicted by vaccination.”
The retraction, signed by the Vaccines Editorial Office, declared: “Serious concerns were brought to the attention of the publisher regarding misinterpretation of data. … The article contained several errors that fundamentally affect the interpretation of the findings.”
The editors who resigned also feared the paper would feed antivaccine conspiracy theories. Days after it was published, Katie Ewer, an immunologist at the University of Oxford, wrote in an email to Science that the paper “is now being used by antivaxxers and COVID-19-deniers as evidence that COVID-19 vaccines are not safe. [This] is grossly irresponsible, particularly for a journal specialising in vaccines.”
The paper had drawn 425,000 readers as of 6 July and has been tweeted by antivaccination activists with hundreds of thousands of followers.
The disaffected editors say they haven’t been told what went wrong in the peer-review and editorial processes. To rejoin the board, “I would need a much better description of how this article ever made it through peer and editorial review, given the spectacularly huge flaws listed in the retraction document,” says Andrew Pekosz, a respiratory virologist at the Johns Hopkins University Bloomberg School of Public Health who resigned as a section editor.
But another editor who resigned, Diane Harper, an epidemiologist at the University of Michigan, Ann Arbor, and the journal’s founding editor-in-chief, rejoined the board after the retraction was published. “The journal management and leadership has acted quickly to retract the article and to change editorial internal processes about review,” she wrote in a 2 July email. A third, Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, applauded the retraction but says he will not rejoin.
Damaris Critchlow, head of publication ethics for the journal publisher, MDPI, wrote in an email that the journal’s academic editor, Ralph DiClemente, a health psychologist at New York University, made the decision to publish the article. Now, Critchlow wrote, “We are … consulting the Editor-in-Chief and Editorial Board to establish further ways to support our Academic Editors.”
The paper’s three authors are Harald Walach, a clinical psychologist and science historian who does complementary medicine research at Poznan University of Medical Sciences in Poland; Rainer Klement, a physicist who studies tailored diets in cancer treatment at the Leopoldina Hospital in Schweinfurt, Germany; and Wouter Aukema, an independent data scientist in Hoenderloo, Netherlands. In a 29 June statement, the authors said they stand by their findings.
The authors computed COVID-19 deaths prevented by vaccines by using data from a study of 1.2 million Israelis. They estimated that 16,000 people needed to be vaccinated to prevent one COVID-19 death. To compute deaths “caused” by vaccine side effects, they used EU data on vaccines delivered in the Netherlands and data from the Netherlands Pharmacovigilance Center. That registry, also called Lareb, is a passive surveillance system in which anyone can file a report of an adverse event after vaccination, whatever the cause. Such databases are not used to assess vaccine risks, but to search for early signs of rare vaccine side effects for follow-up studies.
The website of the Dutch registry clearly notes its reports do not imply causality. But the authors used it that way. The day after the paper’s publication, Lareb’s head of science and research, Eugène van Puijenbroek, sent an email to Vaccines‘s editors criticizing the paper’s use of Lareb’s data, and requesting a correction or retraction. He called the assumption that vaccination caused all the reported deaths “far from truth.”
The three peer reviewers on the paper offered no substantial criticism of the authors’ methodology in brief reviews. One, Anne Ulrich, a chemist who is chair of biochemistry at the Karlsruhe Institute of Technology in Germany, wrote that the authors’ analysis “is performed responsibly … and without methodological flaws.” Another reviewer, this one anonymous, wrote that the manuscript “is very important and should be published urgently,” offering almost no other comment.
“It’s very evident from their reviews that [the reviewers] don’t have any topic expertise,” says another editor who resigned, Helen Petousis-Harris, director of the Vaccine Datalink and Research Group at the University of Auckland. “The authors don’t either,” she adds. “It’s a bit remiss.” But once the retraction was published, she said she was “happy to stay on” as an editor.