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In the ongoing debate surrounding vaccine efficacy, a new preprint study has emerged that challenges conventional assumptions about the effectiveness of COVID-19 and influenza vaccines in preventing hospitalizations. This research, conducted by a team led by Steve Kirsch and including experts such as Dr. Paul Marik, proposes a novel approach to assessing vaccine efficacy and presents findings that warrant careful consideration.
Reexamining Hospital Data
The study, titled "A Novel Practical Approach for Directly Assessing COVID-19 Vaccine Efficacy against Hospitalization," analyzes data from a previous JAMA-published study of patients admitted to U.S. Veterans Administration (VA) hospitals for either COVID-19 or influenza between October 1, 2022, and January 31, 2023. The researchers' findings suggest that neither the COVID-19 vaccines nor the influenza vaccines were effective in reducing the risk of hospitalization during this period.
A New Method for Assessing Efficacy
The researchers propose comparing vaccination rates between groups hospitalized for different vaccine-preventable diseases as a direct method to estimate vaccine efficacy against hospitalization. This approach, they argue, avoids reliance on potentially problematic mathematical models and provides a more accurate real-world assessment.
"If ideal vaccines existed that prevented hospitalization entirely for each virus, one would expect the two cohorts to differ dramatically in the percent (%) vaccinated for the corresponding disease resulting in hospitalization," the authors explain. However, their analysis revealed a very different picture.
Surprising Similarities in Vaccination Rates
After adjusting for various factors through propensity score weighting, the study found that 55.43% of those hospitalized for influenza and 54.54% of those hospitalized for COVID-19 had received booster shots for their respective diseases. This negligible difference raises questions about the effectiveness of both vaccines in preventing hospitalizations.
The authors note, "Even more troubling, of those who took the COVID-19 booster (which should have had the largest difference between the two cohorts if the vaccine performed as expected), actually had the smallest difference of any of the 21 baseline characteristics measured in the study: a standardized mean difference (SMD) value of only .01."
Challenging Previous Efficacy Claims
These findings contrast sharply with previous claims about vaccine efficacy. The researchers point out that if the COVID-19 vaccines demonstrated a 90% reduction in hospitalization rates, as reported by some health authorities, and if the influenza vaccine showed a 50% reduction, we would expect to see dramatically different vaccination rates between the two groups.
Instead, the data showed almost no difference, leading the researchers to conclude that "neither vaccine provided any protection against hospitalization."
Consistency with Other Research
The authors argue that their findings align with some previous research. They cite a 2020 study of 170 million cases and 7.6 million deaths that showed the influenza vaccine had no hospitalization or mortality benefit for the elderly. They also reference a recent meta-analysis by Wu et al. that revealed a marked decline in the effectiveness of COVID-19 vaccines over time, with effectiveness dropping to near zero between 168 and 195 days after injection.
Implications and Recommendations
Given these findings, the researchers suggest that "health authorities worldwide should reconsider the decision to approve both of these vaccines until such time as a real public health benefit can be demonstrated from the data using the method described in this paper, along with other complementary analytic methods."
They propose that these findings "reinforce recommendations to halt the global distribution of both the influenza vaccine and the COVID-19 vaccines" until further research can be conducted.
Addressing Potential Limitations
The authors acknowledge potential limitations of their approach. They note that this method should not be used to directly assess mortality risk, as patients are not hospitalized for mortality per se, and patients can die outside of the hospital. However, they argue that "the lack of any significant reduction in hospitalization is strongly suggestive that both COVID-19 and influenza vaccines are unlikely to confer a mortality risk reduction for those diseases."
They also address the potential for confounding factors, noting that the original study by Xie et al. used propensity score weighting to account for multiple covariates, including key comorbidities such as diabetes, cardiovascular disease, and hypertension.
The Precautionary Principle and mRNA Vaccines
It's important to note that mRNA vaccines, including those used for COVID-19, represent a relatively new technology in widespread use. Unlike traditional vaccines that have decades of long-term safety data, mRNA vaccines do not yet have the benefit of long-term studies to assess their safety and efficacy over extended periods.
The precautionary principle, which is often applied in public health and environmental decisions, suggests that in the absence of scientific consensus or long-term data, the burden of proof that an action is not harmful falls on those taking the action. In the context of vaccines, this principle would advocate for thorough, long-term safety studies before widespread implementation.
Call for Further Research
While the researchers believe their method offers a simpler way to assess vaccine efficacy, they emphasize that it should be complemented by clinical trial data and other methods to ensure a comprehensive assessment.
"This approach bears some similarities to case-control vaccine effectiveness studies," they explain, "in which the investigators match controls to cases (often via propensity scoring) or use the scores as a covariate weighting method."
The authors argue that their method effectively obviates the "healthy vaccinee effect" that often confounds other investigations of vaccine efficacy. This effect refers to the tendency for healthier individuals to be more likely to get vaccinated, which can lead to overestimations of vaccine effectiveness.
Conclusion: A Need for Ongoing Evaluation
This study presents a significant challenge to current understanding of vaccine efficacy, particularly for COVID-19 and influenza vaccines. By proposing a novel method for directly assessing vaccine effectiveness against hospitalization, the researchers have opened up new avenues for investigation and debate.
These findings underscore the importance of ongoing, rigorous evaluation of public health interventions. As we navigate the complex landscape of infectious disease prevention, studies like this remind us of the need for critical thinking, open dialogue, and a willingness to reassess our assumptions in light of new evidence.
The authors conclude their paper with a call for further research and a reevaluation of current vaccine policies. As the scientific community grapples with these findings, it's clear that continued investigation and open discussion are essential to ensuring public health decisions are based on the most current and comprehensive data available.
References
Kirsch, Steve, Paul Marik, Claire Rogers, Kirstin Cosgrove, and M. Nathaniel Mead. "A Novel Practical Approach for Directly Assessing COVID-19 Vaccine Efficacy against Hospitalization." Preprints.org, August 6, 2024. https://doi.org/10.
Xie, Yan, Taeyoung Choi, and Ziyad Al-Aly. "Risk of Death in Patients Hospitalized for COVID-19 vs Seasonal Influenza in Fall-Winter 2022-2023." JAMA 329, no. 19 (2023): 1697-1699. https://doi.org/10.
Anderson, Michael L., Carlos Dobkin, and Devon Gorry. "The Effect of Influenza Vaccination for the Elderly on Hospitalization and Mortality: An Observational Study With a Regression Discontinuity Design." Annals of Internal Medicine 172, no. 7 (2020): 445-452. https://doi.org/10.
Wu, Nan, Keven Joyal-Desmarais, Paula A.B. Ribeiro, André M. Vieira, Jovana Stojanovic, Chisom Sanuade, Darshan Yip, and Simon L. Bacon. "Long-term effectiveness of COVID-19 vaccines against infections, hospitalisations, and mortality in adults: findings from a rapid living systematic evidence synthesis and meta-analysis up to December, 2022." The Lancet Respiratory Medicine 11, no. 5 (2023): 439-452. https://doi.org/10.
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