Considering vaccines are the ultimate exit strategy for COVID-19 pandemic, we thought it would be timely to take a look at how patients’ healthcare data has been used to understand vaccine safety effectiveness to date and consider how it might be useful to improve understanding of a COVID-19 vaccine going forward.
Background: Benefits of vaccines
Vaccines are generally considered the most effective public health interventions - theyprevent millions of deaths yearly, and are极其成本效益. Vaccines can also completely eradicate diseases, either globally (e.g. smallpox) or regionally (e.g. polio, measles), an effect seen with no other intervention.
General interest in vaccines has increased in recent years due to concerns around antimicrobial resistance (AMR), one of the biggest threats to global health, food security, and development today; with AMR related mortality estimated at10 million deaths by 2050. Areport commissioned by the Wellcome Trustidentified that developing vaccines for those pathogens highlighted by the World Health Organisation to be of urgent AMR priorities, can be highly valuable. Vaccines for H. influenzae b. and S. pneumoniae have decreased: the burden of these illnesses, the number of new strains observed, and the need to treat with antibiotics.
Development of vaccines: Is there room for efficiencies?
Theaverage costof successfully advancing at least one epidemic infectious disease vaccine from pre-clinical through to the end of phase 2a can range from $137 million–$1·1 billion. Beyond that, vaccines must undergo phase 3 clinical trials to assess safety and effectiveness before obtaining a license, which can be time consuming.
Asafe and effective COVID-19 vaccine is a global priority and vaccine development is progressing rapidly. The European Medicines Agency (EMA) has identified the need for real world data to complement evidence from clinical trials to help streamline regulatory and decision-making processes for COVID-19 vaccine development and authorisation.
Real world data can complement clinical trials by supporting clinical trial design, helping identify trial patients quicker, and addressing knowledge gaps that cannot be answered by trials. After launch, real world data can be used to monitor safety, coverage and effectiveness as well as help develop and refine guidelines for use.
Leveraging the UK's unique health data ecosystem
现实世界数据可用于在代表性的“现实世界”人群中进行基于人群的研究。使用患者荒地数据的使用使研究人员能够通过观察诸如现实世界中临床实践中记录的不良事件，副作用和死亡等结果来研究疫苗的临床效率和安全性。这些数据代表了普通人群，因此更有可能包括可能被排除在临床试验人群之外的人，例如：（怀孕）妇女，老年人，合并症患者。同样，现实世界中包含的人群的研究规模允许在较小的临床试验人群中无法观察到的低概率效应。由于这些数据库的主要用途通常用于管理目的，因此可以在连续和持续的情况下提供数据，从而允许更长的后续时间，从而使此类数据库完美地进行监视和监视。
The UK is a particularly interesting geography for vaccine studies due to the publicly funded National Health Service, which provides healthcare to the entire population which is free at the point of use. The entry-point for a person to receive healthcare is through primary care, i.e., a general practitioner (GP) allocated to the person depending on their area of residence. Most vaccines are generally administered in the primary care setting, so real world data from this setting allows for generalisable and representative population studies.
IQVIA Medical Research Dataincorporating data from THIN, a Cegedim Database, includes non-identified electronic patient health record data from over 18 million patients collected from UK GP Practices using Vision clinical systems. IQVIA implement a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while maximising the utility of the data for medical research and treatment analysis. IQVIA Medical Research Data captures coded demographic, administrative data, clinical events, prescriptions, with secondary care and death information. The date, type and doses of vaccinations are recorded as administered. IQVIA Medical Research Data covers approximately 4.5% of the UK population and provides a valuable source of nationally representative and generalisable data that can be used for robust scientific vaccine research.
Improving vaccines understanding with real world data
2015年，英国也是第一个为婴儿提供针对脑膜炎球菌B疾病的新疫苗（Bexsero®）。费率Men B decreased by 62%在接受至少2剂疫苗的孩子中。A许可后观察安全研究using IQVIA Medical Research Data is currently underway for Bexsero® in the UK to assess, over the longer term, the incidence of events such as seizures and Kawasaki disease among patients vaccinated as part of the UK National Immunisation program.
In 2018, astudy using IQVIA Medical Research Datawas conducted to assess effectiveness of the Zoster Vaccine Live (Zostavax®), a licensed vaccine on the national immunisation programme (NIP), administered to 70-79 year olds in the UK. Results confirmed that Zostavax® reduced the risk of shingles among the elderly population, and vaccine effectiveness for preventing shingles was estimated at ~65%. Conducting this study using real world data allowed us to demonstrate effectiveness of Zostavax® in lowering shingles in the larger, representative real world UK population.
The above examples show some of the ways in which real world data can support vaccine safety monitoring, effectiveness studies, adherence to guidelines, and observing coverage trends in populations (and sub-populations) over time. In light of a future, hopefully imminent vaccination campaign for COVID-19, IQVIA Medical Research Data can be considered a highly valuable real world data asset for vaccination studies, filling gaps that cannot be addressed by clinical trials, and helping monitor safety, effectiveness, and coverage post launch.
Given the pressure to get a COVID-19 vaccine launched as soon as possible, it seems likely that real world data will have an important role to play in continuing to improve the safety and effectiveness of any vaccine post launch.
For further information, please contactJames.philpott@iqvia.com.