Non-specific effects of vaccinations in high-income settings: How to address the issue?

Donzelli, Alberto; Schivalocchi, Alessandro; Giudicatti, Giulia

doi:10.1080/21645515.2018.1502520

Cited by 6 publications

(7 citation statements)

References 25 publications

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“…23 Further, the measles vaccine has been shown to have survival benefits beyond the expected protection against the measles virus alone, as suggested by a 30% reduction in all-cause mortality in vaccinated children, with only 4% explained by prevention of measles-related deaths. 24 More studies are necessary to understand any potential role of trained immunity with influenza vaccine and COVID-19 infection.…”

Section: Discussionmentioning

confidence: 99%

Impact of the influenza vaccine on COVID-19 infection rates and severity

Conlon

Ashur

Washer

et al. 2021

American Journal of Infection Control

151

149

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Background With a unique influenza season occurring in the midst of a pandemic, there is interest in assessing the role of the influenza vaccine in COVID-19 susceptibility and severity. Methods In this retrospective cohort study, patients receiving a laboratory test for COVID-19 were identified. The primary outcome was comparison of positive COVID-19 testing in those who received the influenza vaccine versus those who did not. Secondary end points in patients testing positive for COVID-19 included mortality, need for hospitalization, length of stay, need for intensive care, and mechanical ventilation. Results A total of 27,201 patients received laboratory testing for COVID-19. The odds of testing positive for COVID-19 was reduced in patients who received an influenza vaccine compared to those who did not (odds ratio 0.76, 95% CI 0.68 to 0.86; P < 0.001). Vaccinated patients testing positive for COVID-19 were less likely to require hospitalization (odds ratio, 0.58, 95% CI 0.46 to 0.73; P < 0.001), or mechanical ventilation (odds ratio, 0.45, 95% CI 0.27 to 0.78; P = 0.004) and had a shorter hospital length of stay (risk ratio, 0.76, 95% CI 0.65 to 0.89; P <0.001). Conclusion Influenza vaccination is associated with decreased positive COVID-19 testing and improved clinical outcomes and should be promoted to reduce the burden of COVID-19.

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Section: Discussionmentioning

confidence: 99%

Impact of the influenza vaccine on COVID-19 infection rates and severity

Conlon

Ashur

Washer

et al. 2021

American Journal of Infection Control

151

149

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“…Alternatively, vaccines could induce immunopathology in females directly, without a mediating effect of other diseases. In humans, females consistently report more frequent and severe local and systemic reactions to vaccines than males [16,17,49]; however, this hypothesis is not consistent with the apparent absence of detrimental NSEs in populations with a low burden of infectious and parasitic diseases [50].…”

Section: Discussionmentioning

confidence: 91%

Rabies Vaccination of 6-Week-Old Puppies Born to Immunized Mothers: A Randomized Controlled Trial in a High-Mortality Population of Owned, Free-Roaming Dogs

et al. 2020

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To achieve global elimination of human rabies from dogs by 2030, evidence-based strategies for effective dog vaccination are needed. Current guidelines recommend inclusion of dogs younger than 3 months in mass rabies vaccination campaigns, although available vaccines are only recommended for use by manufacturers in older dogs, ostensibly due to concerns over interference of maternally-acquired immunity with immune response to the vaccine. Adverse effects of vaccination in this age group of dogs have also not been adequately assessed under field conditions. In a single-site, owner-blinded, randomized, placebo-controlled trial in puppies born to mothers vaccinated within the previous 18 months in a high-mortality population of owned, free-roaming dogs in South Africa, we assessed immunogenicity and effect on survival to all causes of mortality of a single dose of rabies vaccine administered at 6 weeks of age. We found that puppies did not have appreciable levels of maternally-derived antibodies at 6 weeks of age (geometric mean titer 0.065 IU/mL, 95% CI 0.061–0.069; n = 346), and that 88% (95% CI 80.7–93.3) of puppies vaccinated at 6 weeks had titers ≥0.5 IU/mL 21 days later (n = 117). Although the average effect of vaccination on survival was not statistically significant (hazard ratio [HR] 1.35, 95% CI 0.83–2.18), this effect was modified by sex (p = 0.02), with the HR in females 3.09 (95% CI 1.24–7.69) and the HR in males 0.79 (95% CI 0.41–1.53). We speculate that this effect is related to the observed survival advantage that females had over males in the unvaccinated group (HR 0.27; 95% CI 0.11–0.70), with vaccination eroding this advantage through as-yet-unknown mechanisms.

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“…It seems there is a clear need for further large, pragmatic RCTs by independent institutions and researchers, with a long extension [35]. A previous article suggested a way to overcome the “ethical concerns” fairly, by recruiting only women who were still hesitant even after having received balanced information about the pros and cons of vaccination during pregnancy, at the present state of knowledge [35].…”

Section: Results and Their Discussionmentioning

confidence: 99%

Influenza Vaccination of Pregnant Women and Serious Adverse Events in the Offspring

Donzelli¹

2019

IJERPH

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Pregnant women are increasingly considered a priority group for influenza vaccination, but the evidence in favor relies mainly on observational studies, subject to the “healthy-vaccinee bias”. Propensity score methods—sometimes applied—reduce but cannot eliminate residual confounding. Meta-analyses of observational studies show relative risks far from the thresholds that would confirm the efficacy of universal vaccination for pregnant women without needing randomized controlled trials (RCTs). Critical articles have shown that in the four RCTs investigating the outcomes of this vaccination, there was a tendency towards higher offspring mortality. In the largest RCT, there was a significant excess of presumed/serious neonatal infections, and also significantly more serious adverse events. Many widely acknowledged observational results (about hormone replacing therapy, vitamin D, omega-3 fatty acids, etc.) were confuted by RCTs. Therefore the international drive to consider this vaccination a “standard of care” is not justified yet. Moreover, there is the risk of precluding further independent RCTs for “ethical considerations”, so as “to not deny the benefits of influenza vaccinations to pregnant women of a control group”. Instead, before promoting national campaigns for universal vaccination in pregnancy, further large, independent, and reassuring RCTs are needed, even braving challenging a current paradigm. Until then, influenza vaccination should be offered to pregnant women only once open information is available about the safety uncertainties, to allow truly informed choices, and promoting also other protective behaviors.

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Non-specific effects of vaccinations in high-income settings: How to address the issue?

Cited by 6 publications

References 25 publications

Impact of the influenza vaccine on COVID-19 infection rates and severity

Impact of the influenza vaccine on COVID-19 infection rates and severity

Rabies Vaccination of 6-Week-Old Puppies Born to Immunized Mothers: A Randomized Controlled Trial in a High-Mortality Population of Owned, Free-Roaming Dogs

Influenza Vaccination of Pregnant Women and Serious Adverse Events in the Offspring

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