Nationwide Effectiveness of First and Second SARS-CoV2 Booster Vaccines During the Delta and Omicron Pandemic Waves in Hungary (HUN-VE 2 Study)
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Abstract
In Hungary, the pandemic waves in late 2021 and early 2022 were dominated by the Delta and Omicron SARS-CoV-2 variants, respectively. Booster vaccines were offered with one or two doses for the vulnerable population during these periods.
Methods and Findings
The nationwide HUN-VE 2 study examined the effectiveness of primary immunization, single booster, and double booster vaccination in the prevention of Covid-19 related mortality during the Delta and Omicron waves, compared to an unvaccinated control population without prior SARS-CoV-2 infection during the same study periods. The risk of Covid-19 related death was 55% lower during the Omicron vs. Delta wave in the whole study population (n=9,569,648 and n=9,581,927, respectively; rate ratio [RR]: 0.45, 95% confidence interval [CI]: 0.44–0.48). During the Delta wave, the risk of Covid-19 related death was 74% lower in the primary immunized population (RR: 0.26; 95% CI: 0.25–0.28) and 96% lower in the booster immunized population (RR: 0.04; 95% CI: 0.04–0.05), vs. the unvaccinated control group. During the Omicron wave, the risk of Covid-19 related death was 40% lower in the primary immunized population (RR: 0.60; 95% CI: 0.55–0.65) and 82% lower in the booster immunized population (RR: 0.18; 95% CI: 0.16–0.2) vs. the unvaccinated control group. The double booster immunized population had a 93% lower risk of Covid-19 related death compared to those with only one booster dose (RR: 0.07; 95% CI. 0.01–0.46). The benefit of the second booster was slightly more pronounced in older age groups.
Conclusions
The HUN-VE 2 study demonstrated the significantly lower risk of Covid-19 related mortality associated with the Omicron vs. Delta variant and confirmed the benefit of single and double booster vaccination against Covid-19 related death. Furthermore, the results showed the additional benefit of a second booster dose in terms of SARS-CoV-2 infection and Covid-19 related mortality.
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SciScore for 10.1101/2022.03.27.22273000: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the Central Ethical Committee of Hungary (OGYÉI/10296-1/2022 and IV/1722-1/2022/EKU) and followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines (17). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Nevertheless, our study has some …
SciScore for 10.1101/2022.03.27.22273000: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the Central Ethical Committee of Hungary (OGYÉI/10296-1/2022 and IV/1722-1/2022/EKU) and followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines (17). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Nevertheless, our study has some limitations. The proportion of undetected cases might have been high and could have increased during the wave dominated by the Omicron variant. Therefore, we refrained from analyzing registered infections. We made an exemption when we estimated the impact of double booster and single booster vaccination, because we wanted to see how much the effect size is different in the case of SARS-CoV-2 infection and Covid-19 related mortality. Although the infection rates might be underestimated, we assume that the ascertainment bias was not likely to significantly affect the relative rates, as the proportion of unregistered cases among all cases was not likely to substantially differ in the two compared groups. We studied the effect of vaccination by age, and adjusted for age when studying total populations, but an important limitation of our study is that we could not adjust for other potential confounders, most importantly for chronic diseases. As chronic diseases represent an indication for early vaccination as well as booster vaccination, and are closely related to mortality, this confounding may have influenced our results to a certain extent. However, as booster and second booster vaccinations were especially recommended for elderly people with chronic diseases, our estimates are conservative. Our study is one of the very few demonstrating the benefit of second booster vaccination. Despite declining effectiveness against symptomatic disease caused...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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