Department of Internal Medicine, Raja Isteri Pengiran Anak Saleha (RIPAS) Hospital, Bandar Seri Begawan, Brunei Darussalam.
J Pharm Pract. 2022 Dec;35(6):947-951. doi: 10.1177/08971900211009650. Epub 2021 Apr 12.
The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer-BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb the pandemic.
美国食品和药物管理局最近发布了针对 SARS-CoV-2 病毒感染引起的 COVID-19 疾病的 2 种 mRNA 疫苗的紧急使用授权。辉瑞-生物科技的 BNT162b2 和 Moderna 的 mRNA-1273 计划用于大规模免疫计划以遏制大流行。本文简要概述了 COVID-19 mRNA 疫苗，描述了 SARS-CoV-2 RNA、mRNA 疫苗的作用机制以及 mRNA 相对于其他疫苗平台的优势。概述了辉瑞-生物科技合作的 mRNA 疫苗候选物入围之旅，最后根据安全性数据选择了 BNT162b2，并介绍了 BNT162b2 的 3 期研究结果显示其在预防 COVID-19 感染方面的有效性为 95%。描述了 Moderna 的 mRNA-1273 的研究情况，包括长达 119 天的免疫原性数据。mRNA-1273 的 3 期 COVE 研究最终显示疫苗有效性为 94.5%。为未来的 mRNA 疫苗开发提供了建议，包括正在进行的安全性监测、在先前研究中代表性不足的群体中的评估以及提高 mRNA 疫苗的热稳定性。最后，还需要在制造、储存、分发和实施大规模疫苗接种计划以遏制大流行方面进行进一步的后勤考虑。
