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Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial.
Al Kaabi, Nawal; Zhang, Yuntao; Xia, Shengli; Yang, Yunkai; Al Qahtani, Manaf M; Abdulrazzaq, Najiba; Al Nusair, Majed; Hassany, Mohamed; Jawad, Jaleela S; Abdalla, Jehad; Hussein, Salah Eldin; Al Mazrouei, Shamma K; Al Karam, Maysoon; Li, Xinguo; Yang, Xuqin; Wang, Wei; Lai, Bonan; Chen, Wei; Huang, Shihe; Wang, Qian; Yang, Tian; Liu, Yang; Ma, Rui; Hussain, Zaidoon M; Khan, Tehmina; Saifuddin Fasihuddin, Mohammed; You, Wangyang; Xie, Zhiqiang; Zhao, Yuxiu; Jiang, Zhiwei; Zhao, Guoqing; Zhang, Yanbo; Mahmoud, Sally; ElTantawy, Islam; Xiao, Peng; Koshy, Ashish; Zaher, Walid Abbas; Wang, Hui; Duan, Kai; Pan, An; Yang, Xiaoming.
  • Al Kaabi N; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • Zhang Y; China National Biotec Group Company Limited, Beijing, China.
  • Xia S; Henan Province Center for Disease Control and Prevention, Zhengzhou, Henan, China.
  • Yang Y; China National Biotec Group Company Limited, Beijing, China.
  • Al Qahtani MM; Bahrain Defence Force Royal Medical Services, Military Hospital, Kingdom of Bahrain.
  • Abdulrazzaq N; Ministry of Health and Prevention, Abu Dhabi, United Arab Emirates.
  • Al Nusair M; Prince Hamza Hospital, Amman, Jordan.
  • Hassany M; Ministry of Health, Cairo, Egypt.
  • Jawad JS; Ministry of Health, Kingdom of Bahrain.
  • Abdalla J; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • Hussein SE; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • Al Mazrouei SK; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • Al Karam M; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • Li X; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co, Ltd, Wuhan, Hubei, China.
  • Yang X; China National Biotec Group Company Limited, Beijing, China.
  • Wang W; Beijing Institute of Biological Products Co, Ltd, Beijing, China.
  • Lai B; China National Biotec Group Company Limited, Beijing, China.
  • Chen W; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co, Ltd, Wuhan, Hubei, China.
  • Huang S; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co, Ltd, Wuhan, Hubei, China.
  • Wang Q; China National Biotec Group Company Limited, Beijing, China.
  • Yang T; China National Biotec Group Company Limited, Beijing, China.
  • Liu Y; China National Biotec Group Company Limited, Beijing, China.
  • Ma R; Beijing Institute of Biological Products Co, Ltd, Beijing, China.
  • Hussain ZM; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • Khan T; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • Saifuddin Fasihuddin M; Sheikh Khalifa Medical City, Abu Dhabi Health Services Company (SEHA), Abu Dhabi, United Arab Emirates.
  • You W; Henan Province Center for Disease Control and Prevention, Zhengzhou, Henan, China.
  • Xie Z; Henan Province Center for Disease Control and Prevention, Zhengzhou, Henan, China.
  • Zhao Y; Beijing Institute of Biological Products Co, Ltd, Beijing, China.
  • Jiang Z; Beijing Key-Tech Statistical Consulting Co, Ltd, Beijing, China.
  • Zhao G; Beijing Key-Tech Statistical Consulting Co, Ltd, Beijing, China.
  • Zhang Y; Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
  • Mahmoud S; G42 Healthcare, Abu Dhabi, United Arab Emirates.
  • ElTantawy I; G42 Healthcare, Abu Dhabi, United Arab Emirates.
  • Xiao P; G42 Healthcare, Abu Dhabi, United Arab Emirates.
  • Koshy A; Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
  • Zaher WA; G42 Healthcare, Abu Dhabi, United Arab Emirates.
  • Wang H; Beijing Institute of Biological Products Co, Ltd, Beijing, China.
  • Duan K; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co, Ltd, Wuhan, Hubei, China.
  • Pan A; Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
  • Yang X; China National Biotec Group Company Limited, Beijing, China.
JAMA ; 326(1): 35-45, 2021 07 06.
Article in English | MEDLINE | ID: covidwho-1318655
ABSTRACT
Importance Although effective vaccines against COVID-19 have been developed, additional vaccines are still needed.

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.

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. 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). 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. Trial Registration ClinicalTrials.gov Identifier NCT04510207; Chinese Clinical Trial Registry ChiCTR2000034780.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: English Journal: JAMA Year: 2021 Document Type: Article Affiliation country: Jama.2021.8565

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: English Journal: JAMA Year: 2021 Document Type: Article Affiliation country: Jama.2021.8565