中国2007—2020年流感疫苗批签发特征分析

Characteristics of influenza vaccines lot release in China,2007 to 2020

目的分析中国2007—2020年流感疫苗批签发特征,为我国流感疫苗研发生产及流感防控工作提供参考。方法从中国食品药品检定研究院(简称"中检院")网站汇总截至2021年2月底公开的生物制品批签发数据,分析流感疫苗批签发特征,采用Joinpoint回归模型分析流感疫苗批签发量变化趋势。结果Joinpoint回归模型显示,2007/08—2009/10流行季,流感疫苗批签发量年度变化百分比(APC)为67.3%(95%CI:11.3%~151.5%),呈递增趋势;2009/10—2018/19流行季,APC为-14.8%(95%CI:-18.5%~-11.0%),呈递减趋势;2018/19—2020/21流行季,APC为72.3%(95%CI:14.6%~158.9%),呈递增趋势;整体来看,2006/07—2020/21流行季,平均年度变化百分比(AAPC)为5.3%(95%CI:-2.3%~13.5%),流感疫苗批签发量变化无统计学意义(P>0.05)。流感疫苗生产厂家缩减并趋于稳定。流感疫苗以三价裂解疫苗为主,四价裂解疫苗和三价流感减毒活疫苗相继获批上市使用;当前适用于6月龄~3岁儿童的流感疫苗仅有三价裂解疫苗,其批签发量远低于适用3岁及以上人群的批签发量(29.1%vs 70.9%);超过90%的流感疫苗能够在10月底前获得批签发。结论近年来,流感疫苗批签发量下降和生产企业数减少的趋势得到改善,流感疫苗种类逐渐增多,未来需增加6月龄~3岁儿童流感疫苗产量、研发上市新型流感疫苗。

Objective To analyze the characteristics of influenza vaccines lot release in China from 2007 to 2020,so as to provide references for the research,development and vaccines production,and for influenza outbreak prevention and control in China.Methods The targeted lot release data of biological products by end of February 2021 were downloaded from the website of National Institutes for Food and Drug Control(NIFDC).Relevant lot release characteristics of influenza vaccines were analyzed eventually.To quantify the possible trend of influenza vaccines lot release volumes,a Joinpoint regression model analysis was conducted.Results The Joinpoint regression model showed that in the influenza seasons from 2007/08 to 2009/10,the annual percent change(APC)of influenza vaccines lot release volumes was 67.3%(95%CI:11.3%-151.5%),indicating a trend of increasing in influenza vaccines lot release volumes.In the influenza seasons from 2009/10 to 2018/19,the APC was-14.8%(95%CI:-18.5%--11.0%),showing a trend of decreasing.In the influenza seasons from 2018/19 to 2020/21,the APC was 72.3%(95%CI:14.6%-158.9%),showing the trend of increasing.Over all,the average annual percent change(AAPC)in the influenza seasons from 2006/07 to 2020/21 was 5.3%(95%CI:-2.3%-13.5%).There was no statistically significant difference(P>0.05)in the influenza vaccines lot release volumes.The number of influenza vaccine manufacturers reduced and tended to maintain.Trivalent split influenza vaccines were the dominant influenza vaccine in China,and quadrivalent split influenza vaccines and trivalent live attenuated influenza vaccine were approved in 2018 and 2020 separately.At present,trivalent split influenza vaccines is the only product for children aged 6 months to 3 years,and the lot release volume is much lower than that for persons aged 3 years and older(29.1%vs 70.9%).More than 90%of influenza vaccines can be approved and released before end of October.Conclusions The decline trend of influenza vaccine lot release volumes and the manufacturers has changed in recent years,and the types of influenza vaccines were gradually increasing.It is necessary to increase influenza vaccines for children aged 6 months to 3 years and develop other novel influenza vaccines in the future.