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Evaluating the Long-term Efficacy of Coronavirus Disease 2019 (COVID-19) Vaccines.

ABSTRACT: Large-scale deployment of safe and durably effective vaccines can curtail the coronavirus disease-2019 (COVID-19) pandemic. However, the high vaccine efficacy (VE) reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about 2 months, and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled VE in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term VE.

SUBMITTER: Lin DY

PROVIDER: S-EPMC7989522 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Evaluating the Long-term Efficacy of Coronavirus Disease 2019 (COVID-19) Vaccines.

Lin Dan-Yu DY Zeng Donglin D Gilbert Peter B PB

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20211101 10

Large-scale deployment of safe and durably effective vaccines can curtail the coronavirus disease-2019 (COVID-19) pandemic. However, the high vaccine efficacy (VE) reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about 2 months, and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants ove ...[more]

PMID: 33693529

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Project description:BackgroundThere is a lack of data regarding how the Delta variant of coronavirus disease 2019 (COVID-19) has impacted the effectiveness of the BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson & Johnson-Janssen) vaccines at preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 hospitalization.MethodsWe compared the effectiveness of the three vaccines during the pre- and post-Delta variant period (before and after 1 July 2021) in a large cohort of vaccinated and unvaccinated patients in the Michigan Medicine healthcare system. We assessed vaccine effectiveness (VE) using 2 analyses: an inverse propensity weighted (IPW) Kaplan-Meier (KM) analysis based on time from vaccination, and a Cox model based on calendar time with vaccination as a time-varying covariate.ResultsCompared to Ad26.COV2.S recipients, the risk of hospitalization for COVID-19 in the post-Delta variant period was lower for BNT162b2 recipients (hazard ratio [HR] = 0.37; 95% confidence interval [CI]: [.14-.98]; P = .05) and mRNA-1273 recipients (HR = 0.21; 95% CI: [.07-.64]; P = .006). Recipients of the mRNA-1273 vaccine had a lower risk of SARS-CoV-2 infection than Ad26.COV2.S recipients (HR = 0.6; 95% CI: [.43-.83]; P = .003) and BNT162b2 recipients (HR = 0.64; 95% CI: [.54-.76]; P < .001). After 1 July, efficacy against SARS-CoV-2 infection declined for Ad26.COV2.S recipients (VE = 76% before; VE = 49% after; P = .02), BNT162b2 recipients (VE = 87% before; VE = 52% after; P < .001), and mRNA-1273 recipients (VE = 92% before; VE = 70% after; P < .001). Waning immunity and the Delta variant contributed independently and significantly to this decline.ConclusionsAlthough there is a substantial decline in effectiveness, the approved COVID-19 vaccines remain effective against infection and hospitalization due to the Delta variant. The mRNA-based vaccines are more effective than the Ad26.COV2.S vaccine.

Project description:BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has posed increasing challenges to global health systems. Vaccination against COVID-19 can effectively prevent the public, particularly healthcare workers (HCWs), from being infected by this disease.ObjectivesWe aim to understand the factors influencing HCWs' acceptance of COVID-19 vaccines.MethodsWe searched PubMed, Embase and Web of Science to collect literature published before May 15, 2022, about HCWs' acceptance of COVID-19 vaccines. The Newcastle-Ottawa quality assessment scale was used to assess the risk of bias and the quality of the included studies. We utilized Stata 14.0 software for this meta-analysis with a random-effects model, and odds ratios (ORs) with 95% confidence intervals (CIs) were reported. This meta-analysis was conducted in alignment with the preferred reporting items for systematic review and meta-analysis (PRISMA) guideline.ResultsOur meta-analysis included 71 articles with 93,508 HCWs involved. The research showed that the acceptance of vaccines had significantly increased among HCWs compared to non-HCWs (OR = 1.91, 95% CI: 1.16-3.12). A willingness to undergo COVID-19 vaccination was observed in 66% (95% CI: 0.61-0.67) of HCWs. Among the HCWs involved, doctors showed a generally increased intention to be vaccinated compared with nurses (OR = 2.22, 95% CI: 1.71-2.89). Additionally, males were found to hold more positive attitudes toward vaccination than females (OR = 1.81, 95% CI: 1.55-2.12). When the effectiveness of COVID-19 vaccines was improved, the vaccination acceptance of HCWs was greatly increased accordingly (OR = 5.03, 95% CI: 2.77-9.11). The HCWs who were willing to vaccinate against seasonal influenza showed an increased acceptance of COVID-19 vaccines (OR = 3.52, 95% CI: 2.34-5.28). Our study also showed that HCWs who were willing to be vaccinated against COVID-19 experienced a reduced rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (OR = 0.78, 95% CI: 0.66-0.92).ConclusionsOur analysis revealed that the five factors of occupation, gender, vaccine effectiveness, seasonal influenza vaccines, and SARS-CoV-2 infection presumably affected the acceptance of COVID-19 vaccines among HCWs. It is essential to boost the confidence of HCWs in COVID-19 vaccines for the containment of the epidemic.

Dataset Information

Evaluating the Long-term Efficacy of Coronavirus Disease 2019 (COVID-19) Vaccines.

Publications

Evaluating the Long-term Efficacy of Coronavirus Disease 2019 (COVID-19) Vaccines.

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