COVID Vaccines Linked to Increase in All-cause Mortality, Italian Study Shows
A team of Italian researchers verified what they called “the real impact of the vaccination campaign” by comparing the risk of all-cause death among vaccinated and unvaccinated residents of Pescara.
One and two doses of the COVID-19 vaccines were linked to an increase in all-cause mortality in a new peer-reviewed study that analyzed data from the Italian National Healthcare System.
Based on their analysis, a team of Italian researchers verified what they called “the real impact of the vaccination campaign” by comparing the risk of all-cause death among vaccinated and unvaccinated residents of the Italian province of Pescara.
In their multivariate analysis, the researchers found the risk of all-cause death to be higher for those vaccinated with one or two doses of the COVID-19 vaccine compared to the unvaccinated.
Those who received three or four doses had roughly the same risk of all-cause death as the unvaccinated, they said, in contrast with prior research done in the same region suggesting those with three or four doses had a lower risk of all-cause death.
“We also found a slight but statistically significant loss of life expectancy for those vaccinated with 2 or 3/4 doses,” they said in the report, which they published June 30 in Microorganisms.
Dr. Peter McCullough told The Defender, “These findings call for an immediate halt of COVID-19 vaccination across the globe and a thorough investigation of what went wrong during the COVID-19 vaccine campaign.”
McCullough wrote on Substack that the paper’s main point is that “COVID-19 vaccination did not ‘save lives’ as so many in Washington have proclaimed without evidence.”
Alberto Donzelli, one of the Italian study’s authors, told The Defender the study is “an important advance” because it looks at all-cause mortality broken down by vaccination status, and accounts for confounding variables that may have affected earlier reports on COVID-19 vaccination and all-cause mortality.
Very few studies in the world have successfully done that, he said.
McCullough also told The Defender the study’s findings are “cohesive” with those of a recent German study — currently available as a preprint — which found COVID-19 vaccination was linked to increased all-cause death in 16 German states.
Researchers undertake study to correct for bias
For their study, Donzelli and his co-authors used the same data analyzed by other researchers in an earlier Italian study on COVID-19 vaccine effectiveness.
The earlier study — which followed up with people two years after the start of the COVID-19 vaccination campaign — found that those who received one or two doses had a significantly higher risk of all-cause death, while those who received three or more vaccine doses had a lower risk of death.
However, these results were likely distorted due to “immortal time bias,” Donzelli and his co-authors said.
Immortal time bias is a common study design flaw that can throw off statistical estimations between an exposure (such as a COVID-19 shot) and an outcome (such as an increased risk of death), according to the University of Oxford’s Catalogue of Bias.
Donzelli said the bias “afflicts most observational studies on mortality from COVID-19.” So he and his co-authors took the necessary steps to correct for the bias and reanalyzed the same data.
They looked at vaccination records from Jan. 1, 2021, through Dec. 31, 2022, for people ages 10 and up.
They also looked at follow-up data collected from Jan. 1, 2021, through Feb. 15, 2023, for these people, as long as they hadn’t tested positive for COVID-19 on the date of the follow-up.
They also looked at other variables, such as pathologies other than COVID-19, that may have affected people’s health.
“The results are startling,” wrote McCullough. “COVID-19 specific deaths were not reduced with vaccination, however there was a U-shaped trend of note when COVID-19 deaths were adjusted per 1000 population: unvaccinated 1.98/1000, one dose 0.27/1000, two doses 1.08/1000, and 3/4 doses 3.5/1000.”
Additionally, Donzelli and his co-authors in their multivariate analysis found that those who received one dose of the COVID-19 vaccine had a hazard risk ratio — which is a statistical estimate of risk — of 2.4 for all-cause mortality, meaning they were much more likely to die compared to the unvaccinated.
“Those vaccinated with two doses showed an almost double hazard ratio of death: 1.98,” Donzelli pointed out.
These numbers are significantly worse than what was reported in the original study that hadn’t corrected for the immortal time bias, he said. Correcting for that bias changed the results for those who were vaccinated with three or more doses, too.
The original study authors had claimed that being vaccinated three or more times reduced the risk of mortality more than four-fold. Based on his and his co-authors corrected analysis, Donzelli called the claim “implausible.”
He said, “Those vaccinated with three or more doses turned out to die at the same rate as the unvaccinated.”
CDC: COVID shots ‘save lives’
The Defender asked the Centers for Disease Control and Prevention (CDC) if it planned to modify its statement that “COVID-19 vaccines save lives” in light of the study’s findings.
A CDC spokesperson told The Defender that the CDC “does not comment on findings or claims by individuals or organizations outside of CDC.” The spokesperson declined to provide studies or data supporting the agency’s claim that the vaccines save lives.
“CDC research has continuously found that COVID-19 vaccines are safe and effective,” the spokesperson said.
US CDC Recommends Updated COVID Vaccines for Those Aged Six Months and Older
Mariam Sunny And Christy Santhosh
June 27, 2024
(Reuters) -The U.S. Centers for Disease Control and Prevention has recommended that individuals aged six months and older should be given an updated COVID-19 vaccine for the 2024-25 immunization campaign, irrespective of whether they have previously been vaccinated for the disease.
The agency's recommendation on Thursday echoed that of its panel of outside experts, who voted unanimously to recommend the use of updated COVID-19 vaccines, as authorized or approved by the FDA, in those aged six months and older.
The recommendation will take effect as soon as the new vaccines from Moderna, Novavax and Pfizer become available later this year, the CDC said.
The U.S. Food and Drug Administration asked vaccine manufacturers earlier this month to update the new shots to target the KP.2 variant if feasible, instead of the JN.1 lineage it had sought to target earlier.
Moderna and Novavax had submitted their applications to the FDA for updating the fall 2024 season shots targeting the JN.1 strain.
Novavax said it intended to make its updated vaccine available at the start of the vaccination season upon receiving FDA authorization, adding that its shot showed broad cross-neutralizing antibodies against multiple variants, including KP.2 and KP.3.
Pfizer and Moderna make messenger RNA vaccines, which can be developed more quickly than Novavax's protein-based shot.
The JN.1 variant was the dominant strain in the United States earlier this year. While it is no longer as prevalent, it is estimated to account for 4.4% of cases over the two-week period ended June 22, according to CDC data.
The KP.2 strain was estimated to account for about 20.8% of cases, while KP.3, now becoming dominant, was at 33.1%.
Pfizer said it was holding global discussions with regulators including the FDA, to assess the composition of future COVID vaccine formulations.
Moderna said it would be ready with the updated shot in time for the fall vaccination campaign, while Pfizer and partner BioNTech said they would be ready to supply their updated vaccines immediately upon approval.
Pfizer and Moderna said they were ready to supply vaccines targeting either the JN.1 or KP.2 variants.
(Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Pooja Desai)
Reuters Health Information
MedScape
This is not a good presentation of data to a population of people not familiar with statistics.
Hazard Risk Ratio and Immortal Time Bias really needs to be explained in order for an audience of non statisticians to understand this.