2021年流感病毒裂解疫苗血凝素及卵清蛋白含量趋势分析

Trend analysis of hemagglutinin and ovalbumin content for influenza virus split vaccines in 2021

目的 对2021年批签发工作中流感病毒裂解疫苗血凝素(hemagglutinin,HA)及卵清蛋白含量进行趋势分析,评估疫苗质量和质控水平。方法 收集和整理2021年国内2家企业流感病毒裂解疫苗的HA及卵清蛋白含量数据,根据企业该年度前40批数据计算平均值及标准差,建立警戒限及行动限,对上述指标进行趋势分析,评估产品质量的稳定性和批间一致性。将批签发机构在签发过程中抽检批次的检测结果与企业结果进行统计学数据比对及一致性分析。结果 通过对A、B 2家疫苗公司四价流感病毒裂解疫苗进行回顾性数据分析,发现2家企业的H1N1亚型HA和卵清蛋白含量,以及B企业Bv系HA含量存在超趋势(out of trend,OOT)情况,其余项目趋势稳定。批签发机构抽检样品中配对t检验或Wilcoxon符号秩和检验结果显示,2家企业除Bv系HA(t分别为1.094、0.742)和卵清蛋白含量(w分别为-64、36)差异无统计学意义(P> 0.05)外,H1N1(t=3.862,w=232)、H3N2(t分别为8.225、3.473)和By HA含量(t分别为5.616、4.934)差异均有统计学意义(P <0.05),且企业结果普遍高于批签发机构。Bland-Altman一致性检验分析发现,A企业HA含量的检测数据与批签发机构的数据一致性优于B企业。结论 2021年四价流感病毒裂解疫苗批签发有效成分和主要杂质的趋势稳定性及一致性总体较好。趋势分析能够发现疫苗生产的潜在问题,企业应认真落实趋势分析工作,有效监控疫苗的质量。

Objective To analyze the trend of the hemagglutinin(HA) and ovalbumin contents in the lot release of influenza virus split vaccines in 2021,and evaluate the quality and quality control level of the vaccines.Methods The HA and ovalbumin content data of influenza virus split vaccines from two domestic enterprises in 2021 were collected and collated.The mean value and standard deviation were calculated according to the first 40 batches of data of the enterprise in the year,and the warning limit and action limit were established.The trend analysis of the above indexes was carried out to evaluate the stability and consistency of the product quality of the enterprise.Statistical data comparison and consistency analysis were made between the test results of the batch inspected by the lot release institution and the results of the enterprise.Results Through the retrospective data analysis of quadrivalent influenza virus split vaccines from two vaccine enterprises A and B,it was found that the content of H1N1 subtype HA and ovalbumin in the two enterprises and the content of Bv HA in the B enterprise had out of trend(OOT)situations,while the trend of other items was stable.The results of paired student's t test or Wilcoxon signed-rank test of the samples inspected by the lot release institution showed that except Bv subtype HA(t = 1.094 and 0.742 respectively)and ovalbumin(w =-64 and 36 respectively)contents showed no statistically significant difference(P > 0.05),the HA contents of H1N1(t = 3.862,w = 232),H3N2(t = 8.225 and3.473 respectively)and By(t = 5.616 and 4.934 respectively)of the two enterprises had significant differences(P <0.05).The results of enterprises were generally higher than the lot release institution.Bland-Altman test analysis found that the consistency between the test data of enterprise A's HA content and the data of the lot release institution was better than that of enterprise B.Conclusion The stability and consistency of data trends of active ingredients and main impurity ingredients of quadrivalent influenza virus split vaccine batches in 2021 were generally good.The trend analysis can identify potential problems in vaccine production,and enterprises should carefully implement trend analysis and effectively monitor the product quality of vaccines.