Isaacs James T, Almeter Philip J, Henderson Bradley S, Hunter Aaron N, Platt Thomas L, Lodder Robert A
Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536.
Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40506.
Contact Context. 2022;2022. doi: 10.6084/m9.figshare.19217478. Epub 2022 Feb 22.
The measles, mumps, and rubella (MMR) vaccine is a vaccine used to prevent measles, mumps, and rubella (German measles). The vaccine is mandated for children to attend public school in nearly all US states. However, measles cases have been increasing in the past decade, and quality problems have recently been noted by the US Food and Drug Administration (FDA) with the vaccine manufacturer. Intra-lot and inter-lot variability in the spectra of MMR (measles, mumps, and rubella) vaccine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). Six vials of 12 (50%) sampled from Merck lot U006488 appeared 14.5 SDs from the other vials on a subcluster detection test, suggesting that they represent different material. Spectra of 198 vials from 12 lots in the spectral library contained 140 vials in one tight ellipsoidal group, and 58 vials (30%) were outside that group (39.7 SDs using a subcluster detection test), suggesting that the library vials also contain differing materials.
麻疹、腮腺炎和风疹（MMR）疫苗是一种用于预防麻疹、腮腺炎和风疹（德国麻疹）的疫苗。在美国几乎所有州，儿童必须接种该疫苗才能进入公立学校。然而，在过去十年中麻疹病例一直在增加，美国食品药品监督管理局（FDA）最近指出了该疫苗制造商存在的质量问题。在药品质量研究（DQS）中，使用傅里叶变换近红外光谱法（FTNIR）检测到MMR（麻疹、腮腺炎和风疹）疫苗光谱存在批次内和批次间的变异性。在亚群检测试验中，从默克公司U006488批次中抽取的12瓶中有6瓶（50%）与其他瓶相比相差14.5个标准差，这表明它们代表不同的物质。光谱库中来自12个批次的198瓶疫苗的光谱，其中140瓶在一个紧密的椭球组中，58瓶（30%）在该组之外（在亚群检测试验中相差39.7个标准差），这表明光谱库中的瓶也含有不同的物质。
