The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18–59 years: A phase I randomized, double-blinded, controlled trial

Pu, Jing; Yu, Qin; Yin, Zhifang; Zhang, Ying; Li, Xueqi; Yin, Qiongzhou; Chen, Hongbo; Long, Runxiang; Zhao, Zhihui; Mou, Tangwei; Zhao, Heng; Shao, Feng; Xie, Zhihui; Wang, Lichun; He, Zhanlong; Liao, Yun; Fan, Shengtao; Jiang, Ruiju; Wang, Jianfeng; Zhang, Lingli; Li, Jing; Zheng, Huiwen; Cui, Pingfang; Jiang, Guorun; Guo, Lei; Xu, Mingjue; Yang, Huijuan; Lu, Shan; Wang, Xuanyi; Gao, Yang; Xu, Xingli; Cai, Linrui; Zhou, Jian; Yu, Li; Chen, Zhuo; Chen, Hong; Du, Dan; Zhao, Hang; Li, Yan; Ma, Kaili; Ma, Yunfei; Liu, Donglan; Yao, Shibao; Li, Changgui; Che, Yanchun; Li, Qihan

doi:10.1016/j.vaccine.2021.04.006

Cited by 43 publications

(54 citation statements)

References 18 publications

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“…The main detailed reasons for the decline of vaccination among those 145 unvaccinated subjects included the concern about the vaccine safety, decline by vaccination staff, pregnancy or lactation ( Table 5 ). Studies demonstrated that the inactivated COVID-19 vaccine is safe [ 2 , 4 , 35 , 36 ], which is also observed in the present survey ( Tables S1 and S2 ). Actually, the chronic diseases under controlled conditions, such as hypertension, diabetes mellitus, supplement of thyroid hormone and others, are not the contradiction of vaccination [ 37 , 38 ].…”

Section: Discussionsupporting

confidence: 88%

Real-World Acceptance of COVID-19 Vaccines among Healthcare Workers in Perinatal Medicine in China

Gao

Zhang

et al. 2021

Vaccines

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Surveys showed that vaccine hesitancy may influence the acceptance of COVID-19 vaccines in healthcare workers (HCWs) and the general population. Currently, the actual acceptance of COVID-19 vaccination in HCWs has rarely been reported. In the present survey, we investigated the real-world acceptance of COVID-19 vaccination in HCWs in perinatal medicine during the first three-month period of vaccination in China and to identify the main reason for the decline of vaccination. HCWs (1087) who participated in a Chinese national symposium on perinatal medicine during 16–18 April 2021 were invited to answer a 27-question questionnaire online. A total of 1051 HCWs completed the questionnaire. Of them, 86.2% (906/1051) accepted the COVID-19 vaccination and 13.8% (145/1051) declined the vaccination. Because of the vaccine hesitancy, one-fourth of the vaccinated participants did not accept the vaccination until consulted with others or requested by employers. The main reason for the decline of vaccination in 145 unvaccinated HCWs was the concern about vaccine safety. The results indicate that vaccination request by employers may promote vaccine acceptance. More convincing data on the safety of COVID-19 vaccines appears to be important to increase the acceptance of vaccination.

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Section: Discussionsupporting

confidence: 88%

Real-World Acceptance of COVID-19 Vaccines among Healthcare Workers in Perinatal Medicine in China

Gao

Zhang

et al. 2021

Vaccines

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“…Previous studies [ 12 , 13 , 16 – 20 ] have shown that the three immunization programs (0, 14 procedure, 0, 21 procedure or 0, 28 procedure) induce varying degrees of immune effect, but the optimal interval of injections remains unclear. Furthermore, there is lack of studies on the immunogenicity and safety of inactivated SARS-CoV-2 vaccine in high-risk occupational population.…”

Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial

et al. 2021

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Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational population. Methods In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data analysis. Results A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0–14, 0–21, and 0–28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95% CI: 88.4–108.4) in the 0–14 group, which was significantly lower compared with 134.4 (95% CI: 123.1–145.7) in the 0–21 group (P < 0.001 vs 0–14 group) and 145.5 (95% CI: 131.3–159.6) in the 0–28 group (P < 0.001 vs 0–14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were mild. Conclusions Both a two-dose of inactivated SARS-CoV-2 vaccine at 0–21 days and 0–28 days regimens significantly improved SARS-CoV-2 neutralizing antibody level compared to the 0–14 days regimen in high-risk occupational population, with seroconversion rates of 100.0%. Trial registration Chinese Clinical Trial Registry, ChiCTR2100041705, ChiCTR2100041706. Registered 1 January 2021, www.chictr.org.cn. Graphical Abstract

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“…In June 2021, Anvisa approved, under special conditions, limited importation of two COVID-19 vaccines: Covaxin [108,109] and Sputnik V. Covaxin is an immunizer BBV152, which is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a Toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). The Indian company Bharat Biotech, in collaboration with the National Institute of Virology and the Indian Council of Medical Research, produced this vaccine.…”

Section: Characteristics Of Available Vaccinesmentioning

confidence: 99%

“…The Indian company Bharat Biotech, in collaboration with the National Institute of Virology and the Indian Council of Medical Research, produced this vaccine. It was approved for clinical trials for clinical testing in June 2020, with phase I and II results released in December last year [108,109].…”

Section: Characteristics Of Available Vaccinesmentioning

confidence: 99%

The COVID-19 Vaccination Strategy in Brazil—A Case Study

et al. 2021

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Brazil is among the countries which have faced two devastating infection waves of COVID-19 in the past year. Despite the fact the country has one of the world’s leading immunization programs, Brazil only slowly established a national COVID-19 vaccination strategy and campaign. This case study is based on an integrative review of primary and secondary literature sources. Different search strategies on Medline and Google Scholar were performed for the case presentation, for the management and outcome of the COVID-19 outbreak and for the state of the COVID-19 vaccination program. Official documents from the Brazilian Ministry of Health, the website of the World Health Organization and pharmaceutical companies were also reviewed. Searches were limited to English, French, German, Portuguese and Spanish. This article describes the Brazilian COVID-19 vaccination campaign and the drivers and barriers to its implementation; and evaluates further investigations needed to have a conclusive overview over the constantly evolving situation. Healthcare inequalities, which were widened during the pandemic, a lack of coordination at the federal level, the absence of federal government support for scientific research and the lack of endorsement and commitment to the mitigation of the COVID-19 pandemic set the country’s COVID-19 vaccination campaign off to a challenging start. However, Brazil had a well-developed primary care system and national vaccination program prior to the pandemic, which are both important facilitators. At the time of writing, six vaccines are currently available in the country, and the program is advancing. The scientific community needs to continue to investigate the country’s vaccination strategy and its implementation to make sure that maximum effort is undertaken for the health of the Brazilian population.

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The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18–59 years: A phase I randomized, double-blinded, controlled trial

Cited by 43 publications

References 18 publications

Real-World Acceptance of COVID-19 Vaccines among Healthcare Workers in Perinatal Medicine in China

Real-World Acceptance of COVID-19 Vaccines among Healthcare Workers in Perinatal Medicine in China

Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial

The COVID-19 Vaccination Strategy in Brazil—A Case Study

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