STORY UPDATED: check for updates below.
Did a preprint paper submitted to The Lancet on July 5, 2023, find that 74 percent of the deaths in the autopsies it reviewed were caused by the COVID-19 vaccine? Additionally, was it also a legitimate study from The Lancet? No, neither is true: The preprint paper never made it past the submission stage with the medical journal because The Lancet said it "violated our screening criteria." As a result, the paper was never peer-reviewed, which subjects it to the scrutiny of others who are experts in the same field (peers) and is considered necessary to ensure academic scientific quality.
The claims appeared in an article (archived here) published by The Daily Sceptic on July 6, 2023, and titled "Lancet Study on Covid Vaccine Autopsies Finds 74% Were Caused by Vaccine -- Study is Removed Within 24 Hours." The article opened:
A Lancet review of 325 autopsies after Covid vaccination found that 74% of the deaths were caused by the vaccine - but the study was removed within 24 hours.
This is what the post looked like on The Daily Sceptic website at the time of the writing of this fact check:
(Source: The Daily Sceptic screenshot taken on Thu Jul 6 15:12:30 2023 UTC)
The Daily Sceptic article is correct in that the full paper, called "A Systematic Review of Autopsy Findings in Deaths after COVID-19 Vaccination," which is not a study, didn't spend much time on The Lancet website. In the "Methods" section of the paper, the authors claimed they "performed a systematic review of all published autopsy and necropsy reports relating to COVID-19 vaccination through May 18th, 2023." According to the paper, the PubMed and ScienceDirect databases were used to collect the information presented.
In explaining the paper's removal shortly after submission, The Lancet said:
This preprint has been removed by Preprints with The Lancet because the study's conclusions are not supported by the study methodology. Preprints with The Lancet reserves the right to remove a paper that has been posted if we determine that it has violated our screening criteria.
The website also includes this cautionary warning about such papers submitted for review:
Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed.
Additional information about preprints in The Lancet is available here.
Centers for Disease Control and Prevention
A health communication specialist for the Centers for Disease Control and Prevention (CDC), Kristen Nordlund, said in a July 7, 2023, email to Lead Stories that data show COVID-19 vaccines are safe. She continued:
COVID-19 vaccines are undergoing the most intense safety monitoring in U.S. history. To date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the nine confirmed TTS [Thrombosis with thrombocytopenia syndrome] deaths following the Janssen vaccine.
When an adverse event, including death, is reported to CDC's Vaccine Adverse Event Reporting System [VAERS] it is classified as serious or non-serious. The code of Federal Regulation defines "serious" as: death, life threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomalies, or birth defects. For reports classified as serious, CDC requests and reviews the available medical records, examines death certificates and autopsy reports. The determination of the cause of death is done by the certifying official who completes the death certificate or the pathologist who conducts the autopsy.
Food and Drug Administration
Carly Pflaum, a press officer at the Food and Drug Administration (FDA), told Lead Stories in a July 7, 2023, email that the agency does not generally comment on third-party studies, but emphasized that nothing suggests that mRNA vaccines increase the risk of death. She wrote:
Based on available information for the COVID-19 vaccines that are authorized or approved in the United States, the known and potential benefits of these vaccines clearly outweigh their known and potential risks. Additionally, not only is there no evidence of increased risk of death following mRNA vaccines, but available data have shown quite the opposite - that being up to date on vaccination with COVID-19 vaccines saves lives compared to individuals who did not get vaccinated.
Reports of death after COVID-19 vaccination are rare. The FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it's unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. More than 672 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through March 1, 2023. During this time, VAERS received 19,476 preliminary reports of death (0.0029%) among people who received a COVID-19 vaccine. CDC and FDA clinicians review reports of death to VAERS including death certificates, autopsy, and medical records. Continued monitoring has identified nine deaths causally associated with J&J/Janssen COVID-19 vaccination. CDC and the FDA continue to review reports of death following COVID-19 vaccination and update information as it becomes available.
FDA staff also published an overview of death reports to VAERS, which concluded that the rate of death events following COVID vaccination was lower than the expected all-cause mortality rates.
Vaccine Adverse Event Reporting System
In the United States, VAERS, which the CDC co-sponsors with the FDA, operates as a crude early warning system and not as a database for the quantification of specific outcomes following vaccination.
Anyone with internet access can add a report to the VAERS list of reports. The public access link to it expressly warns against unwarranted conclusions based on VAERS material because the list only provides a tally of unverified notes about any health event people experience after they are vaccinated.
The list itself cannot be used to prove or quantify, since all it shows is a chronological correlation, not the causal link that would be more difficult to establish. It's the equivalent of a police precinct's running "blotter" reports that may serve as a starting point for police work, not an endpoint.
Several of the authors of this paper are well-known in anti-vaccine and vaccine-hesitant circles. They include:
Dr. Peter McCullough
McCullough, a Texas cardiologist and COVID-19 vaccine skeptic, has been criticized for discouraging vaccination by referencing events recorded in VAERS and by promoting the drug ivermectin as a treatment, despite FDA and CDC warnings that it is an unproven treatment that should not be taken for COVID-19 outside of a clinical trial.
He was formerly associated with Baylor Scott & White Health, which filed for a restraining order in September 2021 to prevent him from continuing to bolster his claims by citing his association with Baylor.
Lead Stories fact checks involving McCullough can be found here.
Dr. Harvey Risch
Risch, a Yale University School of Public Health professor, is a leading U.S. proponent of hydroxychloroquine as a treatment for COVID-19. On June 15, 2020, the FDA revoked the emergency use authorization (EUA) for chloroquine and hydroxychloroquine, saying the medications "are unlikely to be effective in treating COVID-19."
Lead Stories fact checks involving Risch can be found here.
Dr. Roger Hodkinson
Hodkinson is a physician in Canada and is also a pathologist. He is, perhaps, best known for his claims that COVID-19 is "the greatest hoax ever perpetrated on an unsuspecting public" and "just another bad flu." Neither of his assertions are true.
Lead Stories fact checks involving Hodkinson can be found here.
Dr. William Makis
Makis is a nuclear medicine radiologist and oncologist, who promoted the notion that the Canadian government or the College of Physicians and Surgeons of Ontario, a Canadian professional medical association, were mandating "psychiatric medication for those that refuse mRNA injections or any kind of vaccination." Neither entity endorsed such a stance. Both the Pfizer and Moderna COVID19 vaccines are mRNA shots.
Lead Stories fact checks involving Makis can be found here.
Additional Lead Stories fact checks of claims about COVID-19 vaccination can be found here.
2023-07-11T01:57:35Z 2023-07-11T01:57:35ZHeadline revised to clarify Lead Stories' findings.