The impact of COVID-19 vaccination on the long-term effects of COVID among adults in England diagnosed with COVID prior to Omicron dominance

Study type
Protocol
Date of Approval
Study reference ID
22_002431
Lay Summary

COVID-19 is a respiratory disease caused by infection with the severe acute respiratory syndrome-coronovirus-2. Since the first confirmed case in the United Kingdom in January 2020, around 993,000 people have been hospitalised and more than 207,000 have died with COVID-19 as of November 2022.

A wide range of symptoms are associated with COVID-19; respiratory-related symptoms can include dry cough, breathlessness, and fever. While many people fully recover after COVID-19, 3.3% continue to experience long-term complications such as persistent tiredness, chronic pain or breathing difficulties – often referred to as long COVID.

Previous research in this area includes a systematic review which included four studies that assessed the impact of vaccination on preventing long COVID. Most of these studies suggested COVID vaccine prior to infection significantly reduced the risk of developing long COVID however, only one of these studies was UK-based (a technology-based research study), study sample sizes varied, and in three studies, the types of vaccines evaluated do not fully reflect those administered within the UK. Hence, generalisability of the study findings may be limited to the UK general population.

This study aims to fill these research gaps by generating evidence on the impact of vaccination status on incidence, healthcare resource use and associated costs related to long COVID. The findings from this study will provide an evidence base to inform patient healthcare and policy and may be used to inform the UK vaccination strategy towards improved patient outcomes and efficient of management of the long-term effects of COVID.

Technical Summary

Aim: This study aims to use UK primary care data, with linkage to secondary care data, to evaluate the incidence, healthcare resource use (HCRU) and economic burden of long COVID by vaccination status, for the overall population and by immune system status, among adult patients diagnosed with COVID-19 from August 2020 through 1st December 2021 who have received > 1 dose of the Pfizer/BioNTech vaccine or are unvaccinated.

Objectives: To: i) compare incidence of long COVID; ii) compare HCRU and associated direct healthcare costs, iii and iv) compare incidence of long COVID, stratified by COVID risk status at baseline and COVID severity and; v and vi) compare HCRU and associated direct healthcare costs by vaccination status stratified by COVID-19 risk status and acute COVID-19 severity, between groups defined by COVID-19 vaccination status (unvaccinated, 1 dose, 2 doses or 3 doses), for the overall population and by immune system status;.

Methods: A retrospective cohort study using UK primary care data (CRPD Aurum), with linkage to secondary care Hospital Episode Statistics (HES) and Office for National Statistics (ONS) datasets, of confirmed COVID-19 patients identified as having long COVID during the study index period (August 2020 – Dec 2021).

Exposures: Immunocompromised status; COVID-19 vaccination status; those at risk of severe COVID-19 outcomes (the risk groups within The Green Book, chapter 14a) and COVID-19 severity.

Outcomes: Primary care (GP) consultations; hospitalisations; readmissions; total direct healthcare costs and long COVID.

Data Analysis: For descriptive analysis, counts, means, medians, standard deviation (SD), 25th and 75th percentile values will be reported for continuous variables, whilst relative frequencies and proportions/percentages for categorical variables. For inferential analysis, an entropy balancing based methodology will be implemented to minimise confounding and evaluate the treatment effect in the entire population.

Health Outcomes to be Measured

Long COVID-related healthcare resource use (primary care general practice consultations, hospitalisations, readmissions, total direct healthcare costs); and Incidence of long COVID

Collaborators

Jingyan Yang - Chief Investigator - Pfizer Inc - US Headquarters
Kiran Rai - Corresponding Applicant - Adelphi Real World
Bethany Backhouse - Collaborator - Adelphi Real World
Charles Reynard - Collaborator - Pfizer Ltd - UK
Kayte Andersen - Collaborator - Pfizer Inc - US Headquarters
Lucy Massey - Collaborator - Adelphi Real World
Olivia Massey - Collaborator - Adelphi Real World
Poppy Payne - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Tamuno Alfred - Collaborator - Pfizer Inc - US Headquarters
Theo Tritton - Collaborator - Adelphi Real World

Former Collaborators

Olivia Massey - Collaborator - Adelphi Real World

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation