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澳大利亚辉瑞新冠疫苗(Spikevax)和诺瓦瓦克斯新冠疫苗(Nuvaxovid)启动剂量的短期主动安全性监测

Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia.

作者信息

Reynolds Renee, Tay Evelyn, Dymock Michael, Deng Lucy, Glover Catherine, Lopez Laura K, Huang Yuanfei Anny, Cashman Patrick, Leeb Alan, Marsh Julie A, Snelling Tom, Wood Nicholas, Macartney Kristine

机构信息

Population Health, Hunter New England Local Health District, Wallsend, NSW 2287, Australia.

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, NSW 2308, Australia.

出版信息

Vaccines (Basel). 2024 Aug 27;12(9):971. doi: 10.3390/vaccines12090971.

DOI:10.3390/vaccines12090971
PMID:39340003
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11435866/
Abstract

Australia commenced administration of the Spikevax (Moderna mRNA-1273) COVID-19 vaccine in August 2021 and Nuvaxovid (Novavax NVX-CoV2373) in January 2022. This study describes the short-term safety profile of priming doses of the Spikevax and Nuvaxovid vaccines given between September 2021 and September 2023. Online surveys were sent via AusVaxSafety, Australia's active vaccine safety surveillance system, three and eight days after vaccination. A total of 131,775 day 3 surveys were sent, with a response rate of 38.5% ( = 50,721). A total of 43,875 day 8 surveys matched with day 3 survey responses were sent, with a response rate of 71.5% ( = 31,355). Half (50.7%) of respondents reported any adverse event following immunisation (AEFI) in the 0-3 days after vaccination and 24.6% reported any AEFI 4-7 days after vaccination. Fatigue, local pain, headache, and myalgia were the most frequently reported symptoms for both vaccines in both periods. After adjusting for respondent characteristics, vaccination clinic type, jurisdiction, and medical conditions, the odds for reporting AEFI increased with age from 16-19 years to highest odds at 30-39 years, after which it declined. Females had greater odd of reporting AEFI than males across most age groups, vaccine types, and doses. Respondents with a history of anaphylaxis had greater odds of reporting any AEFI (adjusted OR range: 1.50-2.86). A total of 3.1% of respondents reported seeking medical review 0-3 days after vaccination. This study affirms the short-term safety of Spikevax and Nuvaxovid COVID-19 vaccine priming doses in a large sample in Australia.

摘要

澳大利亚于2021年8月开始接种斯皮克瓦克斯(Moderna mRNA-1273)新冠疫苗,并于2022年1月开始接种努瓦克斯奥维德(Novavax NVX-CoV2373)疫苗。本研究描述了2021年9月至2023年9月期间接种的斯皮克瓦克斯和努瓦克斯奥维德疫苗初始剂量的短期安全性概况。通过澳大利亚活跃的疫苗安全监测系统AusVaxSafety在接种疫苗后的第三天和第八天发送在线调查问卷。共发送了131,775份第三天调查问卷,回复率为38.5%(n = 50,721)。共发送了43,875份与第三天调查问卷回复相匹配的第八天调查问卷,回复率为71.5%(n = 31,355)。一半(50.7%)的受访者报告在接种疫苗后的0至3天内出现任何免疫后不良事件(AEFI),24.6%的受访者报告在接种疫苗后的4至7天内出现任何AEFI。疲劳、局部疼痛、头痛和肌痛是这两种疫苗在两个时间段内报告最多的症状。在对受访者特征、接种诊所类型、司法管辖区和医疗状况进行调整后,报告AEFI的几率从16至19岁年龄段开始随年龄增长,在30至39岁时几率最高,此后下降。在大多数年龄组、疫苗类型和剂量中,女性报告AEFI的几率高于男性。有过敏反应史的受访者报告任何AEFI的几率更高(调整后的OR范围:1.50至2.86)。共有3.1%的受访者报告在接种疫苗后的0至3天内寻求医疗检查。本研究证实了澳大利亚大量样本中斯皮克瓦克斯和努瓦克斯奥维德新冠疫苗初始剂量的短期安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/9062303dc6de/vaccines-12-00971-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/d83ba73379cc/vaccines-12-00971-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/8916e426e130/vaccines-12-00971-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/366ccf848328/vaccines-12-00971-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/9062303dc6de/vaccines-12-00971-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/d83ba73379cc/vaccines-12-00971-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/8916e426e130/vaccines-12-00971-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/366ccf848328/vaccines-12-00971-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/695c/11435866/9062303dc6de/vaccines-12-00971-g004.jpg

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