国药中国生物集团旗下北京所、武汉所的两款灭活新冠疫苗，三期临床中期详细分析数据5月26日正式发布，此次选择发表的期刊是医学顶级期刊JAMA。
附件也详细披露了临床试验方案、统计分析方案等各项细节，信息非常详实。
很多人低估临床试验进行的难度。要知道，这样超万人的大型跨国临床试验，距离首例患者入组不到一年就披露详细文献报告，已是创造国内历史了，这个发布速度可能仅次于前面两个mRNA疫苗、阿斯利康的腺病毒载体疫苗（规模还没有国药的大），世界有史以来第四名？参考旧文分析：新冠疫苗来之不易，吹毛求疵大可不必
5月初WHO已经以PPT形式发布了一些基础信息，内容基本一致WHO：国药中生灭活疫苗临床数据评估报告
致敬这一年来疫苗研发中付出无数心血的科研、临床、数统、生产研究者以及受试者。希望大家尽快接种疫苗，不要辜负疫苗研发工作者的努力。
摘要：
Objective To evaluate the efficacy and adverse events of 2 inactivated COVID-19 vaccines.
Design, Setting, and Participants
Prespecified interim analysis of an ongoing randomized, double-blind, phase 3 trial in the United Arab Emirates and Bahrain among adults 18 years and older without known history of COVID-19.
Study enrollment began on July 16, 2020. Data sets used for the interim analysis of efficacy and adverse events were locked on December 20, 2020, and December 31, 2020, respectively.
目前数据时间截止还是在2020年末。
Interventions
Participants were randomized to receive 1 of 2 inactivated vaccines developed from SARS-CoV-2 WIV04 (5 µg/dose; n = 13 459) and HB02 (4 µg/dose; n = 13 465) strains or an aluminum hydroxide (alum)–only control (n = 13 458); they received 2 intramuscular injections 21 days apart.
Main Outcomes and Measures
The primary outcome was efficacy against laboratory-confirmed symptomatic COVID-19 14 days following a second vaccine dose among participants who had no virologic evidence of SARS-CoV-2 infection at randomization. The secondary outcome was efficacy against severe COVID-19. Incidence of adverse events and reactions was collected among participants who received at least 1 dose.
Results
Among 40 382 participants randomized to receive at least 1 dose of the 2 vaccines or alum-only control (mean age, 36.1 years; 32 261 [84.4%] men), 38 206 (94.6%) who received 2 doses, contributed at least 1 follow-up measure after day 14 following the second dose, and had negative reverse transcriptase–polymerase chain reaction test results at enrollment were included in the primary efficacy analysis.
中和抗体情况
During a median (range) follow-up duration of 77 (1-121) days, symptomatic COVID-19 was identified in 26 participants in the WIV04 group (12.1 [95% CI, 8.3-17.8] per 1000 person-years), 21 in the HB02 group (9.8 [95% CI, 6.4-15.0] per 1000 person-years), and 95 in the alum-only group (44.7 [95% CI, 36.6-54.6] per 1000 person-years), resulting in a vaccine efficacy, compared with alum-only, of 72.8% (95% CI, 58.1%-82.4%) for WIV04 and 78.1% (95% CI, 64.8%-86.3%) for HB02 (P < .001 for both).
不良事件情况，安全性良好
Two severe cases of COVID-19 occurred in the alum-only group and none occurred in the vaccine groups. Adverse reactions 7 days after each injection occurred in 41.7% to 46.5% of participants in the 3 groups; serious adverse events were rare and similar in the 3 groups (WIV04: 64 [0.5%]; HB02: 59 [0.4%]; alum-only: 78 [0.6%]).
Conclusions and Relevance
In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19, and serious adverse events were rare. Data collection for final analysis is pending.
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