Coronavirus (COVID-19) is a newly discovered infectious disease. Novavax have developed a COVID-19 vaccine (Nuvaxovid), which was approved for use in the United Kingdom in February 2022.
This study will examine whether it is possible and appropriate to conduct future research into the Novavax COVID-19 vaccine using data from the Clinical Practice Research Datalink (CPRD) Aurum primary care database, in combination with other data sets on hospital care, death and deprivation.
We will count the number of patients receiving the Novavax vaccine and describe them in terms of patient characteristics such as sex, age, and ethnicity; health statuses like smoking, previous COVID-19 infection and pregnancy; and sociological other factors such as geographic region and deprivation. Additionally, we will describe their COVID-19 vaccination history including how many doses they have received (e.g. first, second, booster) and which vaccine was used for each dose.
The results will be used to inform future safety studies on the use of the Novavax COVID-19 vaccine in England, that will be shared with public bodies who ensure vaccines are both effective at reducing disease and safe to use.
Novavax have developed a COVID-19 vaccine (Nuvaxovid), which has been shown to have an overall vaccine efficacy of 89.7% in a Phase 3 clinical trial conducted in the United Kingdom (UK) and has been approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA).
The purpose of this feasibility study is to inform more detailed future surveillance studies of Nuvaxovid using the Clinical Practice Research Datalink (CPRD) Aurum and linked datasets.
For this feasibility study, monthly descriptive counts will be produced from the first date of Nuvaxovid administration in the UK through to 30 months (2.5 years) afterwards.
These reports will include counts of the number of patients receiving any dose of Nuvaxovid and a description of these patients’ characteristics. The description will include demographics (e.g. sex, age, ethnicity), health status (e.g. smoking, previous COVID-19 infection, pregnancy), and other factors (e.g. region of England, socioeconomic status). Additionally, we will describe their COVID-19 vaccination history including how many doses they have received (e.g. first, second, booster) and which vaccine was used for each dose.
Pregnancy will be determined using the CPRD Aurum Pregnancy Register, patient-level socioeconomic deprivation by the English Index of Multiple Deprivation (IMD) dataset, and previous COVID-19 infection will be investigated in the Hospital Episode Statistics (HES) datasets.
These counts and descriptions will be used to inform future safety studies regarding the use of Nuvaxovid that will be shared with regulatory agencies. This includes a proposed future observational study using CPRD.
Counts for the number of patients receiving any dose of Nuvaxovid in the CPRD Aurum Drug Issue table, stratified by dose (first, second, booster) if numbers allow.
Counts and proportions for patients who received Nuvaxovid describing:
What dose was the Novavax; COVID-19 vaccination history (number of doses, vaccine manufacturers); Completeness of vaccine batch number and lot number; COVID-19 infection history; Age at dose administration; Sex (Male or Female); Region of England; Ethnicity (English Census Categories); Body Mass Index (BMI); Smoking Status (Current, Former, Never/Unknown); Index of Multiple Deprivation (IMD) quintile; Pregnancy status at dose administration
Eleanor Axson - Chief Investigator - CPRD
Eleanor Axson - Corresponding Applicant - CPRD
Hadi Beyhaghi - Collaborator - Novavax, Inc.
Helen Booth - Collaborator - CPRD
Matthew Rousculp - Collaborator - Novavax, Inc.
Rachael Williams - Collaborator - CPRD
Sonia Coton - Collaborator - CPRD
Susan Hodgson - Collaborator - CPRD
T Christopher Mast - Collaborator - Novavax, Inc.
CPRD Aurum Pregnancy Register;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation