Quality analysis of a domestic quadrivalent split-virion influenza vaccine for children in 2022
Objective To review and evaluate the key quality indicators of quadrivalent split-virion influenza vaccine for children(QSIVC)manufactured by a domestic company,and analyze the safety and effectiveness indicators and Inter-batch consistency of vaccines.Methods In total,14 batches of the QSIVC samples produced by the domestic company were taken as the study samples,and the hemagglutinin content,total protein content,protein/hemagglutinin ratio,ovalbumin content,bacterial endotoxin content,and free formaldehyde content of the samples were detected,and compared with the registration standards,China Pharmacopoeia standards and WHO standards.At the same time the standard deviation(s)was calculated to evaluate the product quality.Results The content of hemagglutinin(31.9-35.9 μg/mL,s 0.6-1.2),total protein(223.4-256.0 μg/mL,s 9.0),total protein/hemagglutinin(1.7-1.8,s 0.06)and ovalbumin(0.84-2.32 ng/mL,s 0.47),bacterial endotoxin(0.03-0.04 EU/mL,s 0.004),free formaldehyde(2.05-2.70 μg/mL,s 0.23)in 14 batches of the QSIVC samples met the standard requirements.Conclusions The test results of 14 batches of this domestic QSIVC all meet the standards of enterprise registration,China Pharmacopoeia and WHO,and have good consistency between batches and good safety and effectiveness.
Quadrivalent split-virion influenza vaccine for chidrenOvalbuminBacterial endotoxinFree formaldehydeHemagglutininTotal protein content
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