Merck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Kenilworth, NJ, USA.
Vaccine. 2018 Mar 7;36(11):1516-1520. doi: 10.1016/j.vaccine.2017.10.059.
The Centers for Disease Control and Prevention (CDC) coordinates the Vaccines For Children (VFC) program, which provides free vaccines to qualified children in the US. In 2009, the CDC issued Vaccine Storage Requirements, which were later replaced (2012) with an interim guidance and toolkit for vaccine storage and handling. The guidance called for use of Digital Data Loggers (DDL) to monitor vaccine storage temperatures. We describe a change in frequency of Incorrect Product Storage Reports (IPSRs) following issuance of the 2009 CDC guidance.
Merck & Co., Inc., Kenilworth, NJ, USA, systematically evaluates vaccine safety concerns for all products. The safety database was queried (01-Jan-2004 through 31-December-2016) to identify all IPSRs associated with 10 vaccines. We compared IPSRs received prior to and following the 2009 CDC guidance, comparing reports received from the US with those received from international sources during the same period.
Following the release of the DDL guidance, a progressive increase in IPSRs was identified in the US (1 report received in 2004, 12,993 reports in 2016). In contrast, non-US IPSRs - have not had a similar increase: no reports received in 2004, 216 reports received in 2016. US reports of IPSRs 2004 through 2016 account for 96% of reports worldwide. There were no serious reports found in the database in conjunction with IPSRs, nor were there any additional safety findings in any of the reports with additional events reported.
VFC DDL guidance was followed by an increase in IPSRs. No similar trend was seen outside the US (where no broad change in DDL guidance occurred). Despite the increase in IPSRs, there have been few associated adverse events (AEs) reported; no new safety concerns were identified. These findings suggest that the increase in IPSRs was associated with the introduction of use of DDLs, and suggests the need for further impact assessment.
疾病控制与预防中心（CDC）协调疫苗接种儿童（VFC）计划，为美国合格儿童提供免费疫苗。2009 年，CDC 发布了疫苗储存要求，随后（2012 年）被一份临时指南和疫苗储存及处理工具包所取代。该指南呼吁使用数字数据记录器（DDL）监测疫苗储存温度。我们描述了在 2009 年 CDC 指南发布后，不正确产品储存报告（IPSR）的频率发生了变化。
默克公司，新泽西州肯尼沃斯，美国，系统地评估所有产品的疫苗安全问题。安全数据库被查询（2004 年 1 月 1 日至 2016 年 12 月 31 日），以确定与 10 种疫苗相关的所有 IPSR。我们比较了 2009 年 CDC 指南发布前后收到的 IPSR，比较了同期从美国和国际来源收到的报告。
DDL 指南发布后，美国的 IPSR 逐渐增加（2004 年收到 1 份报告，2016 年收到 12993 份报告）。相比之下，非美国的 IPSR 没有类似的增加：2004 年没有收到报告，2016 年收到 216 份报告。2004 年至 2016 年，美国 IPSR 报告占全球报告的 96%。数据库中未发现与 IPSR 相关的严重报告，也未在任何报告中发现任何额外的安全发现。
VFC DDL 指南发布后，IPSR 增加。在美国以外地区没有看到类似的趋势（没有广泛的 DDL 指南变化）。尽管 IPSR 增加了，但报告的不良事件（AE）很少；没有发现新的安全问题。这些发现表明，IPSR 的增加与 DDL 的使用有关，并表明需要进一步进行影响评估。
