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COVID-19 疫苗:除了保护效力和安全性之外的关注点。

COVID-19 vaccines: concerns beyond protective efficacy and safety.

机构信息

Department of Internal Medicine, Kaohsiung Veterans General Hospital, Tainan Branch, Tainan, Taiwan.

Department of Pharmacy, National Taiwan University Cancer Center, Taipei, Taiwan.

出版信息

Expert Rev Vaccines. 2021 Aug;20(8):1013-1025. doi: 10.1080/14760584.2021.1949293. Epub 2021 Jul 5.

Abstract

INTRODUCTION

Several vaccine candidates have been developed using different platforms, including nucleic acids (DNA and RNA), viral vectors (replicating and non-replicating), virus-like particles, peptide-based, recombinant proteins, live attenuated, and inactivated virus modalities. Although many of these vaccines are undergoing pre-clinical trials, several large clinical trials investigating the clinical efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines have produced promising findings.

AREAS COVERED

In this review, we provide a status update on COVID-19 vaccines currently undergoing clinical trials and discuss issues of concern beyond vaccine efficacy and safety, including dosing regimens, the mixed vaccine strategy, prior severe acute respiratory syndrome coronavirus-2 infection, antibody levels, cellular immunity and protection, variants of concern, COVID-19 vaccine distribution, vaccination willingness, herd immunity, immunity passports, and vaccine indications.

EXPERT OPINION

Four vaccines have obtained emergency use authorization, 87 are at the clinical development stage, and 186 are in pre-clinical development. While the knowledge and development of COVID-19 vaccines is rapidly expanding, the benefits of COVID-19 vaccines must outweigh the potential risks of adverse events. To combat the COVID-19 pandemic, clinicians should consistently update COVID-19-associated information, and healthcare authorities and manufacturers should work together to provide adequate and appropriate vaccinations for the prevention of COVID-19.

PLAIN LANGUAGE SUMMARY

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) caused a global pandemic: the coronavirus disease 2019 (COVID-19) outbreak. The development and implementation of the COVID-19 vaccine could be an important measure to control the COVID-19 pandemic.Several phase 3 clinical trials have demonstrated the effectiveness and safety of COVID-19 vaccines for the prevention of SARS-CoV-2 infections. Several COVID-19 vaccines have obtained emergency use authorization and been implemented in many countries. Although concerns regarding unusual blood clots and low platelet counts have been raised, the benefits of COVID-19 vaccines outweigh the potential risks of adverse events.Except for children, the COVID-19 vaccine is recommended for all people, including those pregnant or immunocompromised. Healthcare authorities should advise people receiving the vaccine that they must seek medical attention if they have associated thromboembolism and thrombocytopenia symptoms. More studies are necessary to determine the appropriate vaccine dose and regimen strategy, as well as the effectiveness of COVID-19 vaccines against variants of concerns. A global effort must be made to achieve widespread vaccination and herd immunity.

摘要

简介

已使用不同平台开发了几种疫苗候选物,包括核酸(DNA 和 RNA)、病毒载体(复制型和非复制型)、病毒样颗粒、基于肽的、重组蛋白、减毒活疫苗和灭活病毒方式。尽管其中许多疫苗正在进行临床前试验,但几项大型临床试验已对 2019 年冠状病毒病(COVID-19)疫苗的临床疗效和安全性进行了调查,结果令人鼓舞。

涵盖范围

在这篇综述中,我们提供了目前正在进行临床试验的 COVID-19 疫苗的最新情况,并讨论了疫苗疗效和安全性以外的关注问题,包括剂量方案、混合疫苗策略、先前严重急性呼吸综合征冠状病毒-2 感染、抗体水平、细胞免疫和保护、关注的变体、COVID-19 疫苗的分配、接种意愿、群体免疫、免疫护照和疫苗适应证。

专家意见

有 4 种疫苗已获得紧急使用授权,87 种处于临床开发阶段,186 种处于临床前开发阶段。虽然 COVID-19 疫苗的知识和开发正在迅速扩展,但 COVID-19 疫苗的益处必须超过不良事件的潜在风险。为了应对 COVID-19 大流行,临床医生应不断更新与 COVID-19 相关的信息,卫生当局和制造商应共同努力,为预防 COVID-19 提供充足和适当的疫苗。

普通语言摘要

严重急性呼吸综合征冠状病毒-2(SARS-CoV-2)引起了全球大流行:2019 年冠状病毒病(COVID-19)爆发。COVID-19 疫苗的开发和实施可能是控制 COVID-19 大流行的重要措施。几项 3 期临床试验已证明 COVID-19 疫苗在预防 SARS-CoV-2 感染方面的有效性和安全性。几种 COVID-19 疫苗已获得紧急使用授权,并在许多国家实施。尽管已提出对异常血凝块和血小板计数低的担忧,但 COVID-19 疫苗的益处超过了不良事件的潜在风险。除儿童外,建议所有人群(包括孕妇和免疫功能低下者)接种 COVID-19 疫苗。卫生当局应告知接种疫苗的人,如果出现相关的血栓栓塞和血小板减少症症状,他们必须就医。需要更多的研究来确定 COVID-19 疫苗的适当剂量和方案策略,以及 COVID-19 疫苗对关注变体的有效性。必须共同努力,实现全球广泛接种疫苗和群体免疫。

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