RETRACTED ARTICLE: Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Drug Safety Pub Date : 2024-12-01 Epub Date: 2024-05-13 DOI:10.1007/s40264-024-01432-6
Upinder Kaur, Aakanksha Jaiswal, Ayushi Jaiswal, Kunal Singh, Aditi Pandey, Mayank Chauhan, Mahek Rai, Sangeeta Kansal, Kishor Patwardhan, Vaibhav Jaisawal, Sankha Shubhra Chakrabarti
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引用次数: 0

Abstract Image

BBV152 冠状病毒疫苗在青少年和成人中的长期安全性分析:印度北部为期一年的前瞻性研究结果。
背景和目的:有关 COVID-19 疫苗长期安全性的证据很少。在此,我们延续之前公布的短期安全性结果,提供有关 BBV152 疫苗在青少年和成人中长期安全性的数据:这是一项前瞻性观察研究,研究时间为 2022 年 1 月至 2023 年 8 月。接种BBV152疫苗的青少年和成人在接种1年后接受了有关长期特别关注不良事件(AESIs)的电话访问。结果发现了AESI的风险因素和持续至少1个月的AESI:结果:在 1024 名接种者中,有 635 名青少年和 291 名成人在 1 年的随访期间取得了联系。在此期间,304 名青少年(47.9%)和 124 名成人(42.6%)报告了病毒性上呼吸道感染。新发皮肤和皮下疾病(10.5%)、一般疾病(10.2%)和神经系统疾病(4.7%)是青少年常见的 AESI。成人常见的 AESI 为一般疾病(8.9%)、肌肉骨骼疾病(5.8%)和神经系统疾病(5.5%)。4.6%的女性参与者出现月经异常。分别有 2.7% 和 0.6% 的参与者出现眼部异常和甲状腺功能减退。在严重的 AESI(1%)中,分别有 0.3% 和 0.1% 的参与者出现中风和格林-巴利综合征。在青少年中,女性、有过敏史者和接种疫苗后患伤寒者发生AESI的风险分别高出1.6倍、2.8倍和2.8倍。大多数 AESI 在 1 年的随访中持续存在。女性、接种COVID-19疫苗前的青少年、有并发症的青少年和接种伤寒疫苗后的青少年发生持续AESI的几率分别高出1.6倍、2倍、2.7倍和3.2倍。有并发症的成年人发生AESI和持续AESI的几率高出2倍多:结论:接种 BBV152 后出现 AESI 的模式与接种其他 COVID-19 疫苗以及青少年和成人之间的模式不同。由于大多数 AESI 会持续很长时间,因此有必要对接种过 COVID-19 疫苗的人进行长期监测,以了解晚发 AESI 的过程和结果。严重的 AESI 可能并不少见,因此有必要提高意识并开展更大规模的研究,以了解接种 COVID-19 疫苗后免疫介导现象的发生率。今后的研究应探讨AESI与性别、合并疾病、接种COVID-19疫苗前以及非COVID疾病之间的关系。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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