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 - they prevent millions of deaths yearly, and are extremely cost effective. 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 at 10 million deaths by 2050. A report commissioned by the Wellcome Trust identified 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?
The average cost of 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.
A safe 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
Real world data can be used to conduct population-based studies in a representative “real world” population. The use of patient heath data enables researchers to study the clinical effectiveness and safety of vaccines by observing outcomes such as adverse events, side effects and death recorded during real world clinical practice. These data are representative of the general population and so are more likely to include people who may be excluded from the clinical trial population, e.g.: (pregnant) women, the elderly, patients with comorbid conditions. Similarly, the study size of the population included in real world data allow for low-probability effects that may not be observable in smaller clinical trial populations. Because these databases’ primary use is often for administrative purposes, availability of data in continuous and ongoing, allowing longer follow-up time, making such databases perfect choices for surveillance and monitoring.
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 Data incorporating 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
In 2015, the UK was also the first country to offer a new vaccine against meningococcal B disease to babies (Bexsero®). Rates of Men B decreased by 62% among children who received at least 2 doses of the vaccine. A post-licensure observational safety study 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, a study using IQVIA Medical Research Data was 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.
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