Real-world evidence at ECCMID 2024 further substantiates the continued significant and disproportionate risk of severe COVID-19 facing immunocompromised individuals

PUBLISHED26 April 2024

New analysis from INFORM and COVIDRIVE emphasizes the need for additional protection among high-risk immunocompromised patients not optimally protected by COVID-19 vaccines

Despite representing approximately 4% of the population, immunocompromised individuals still account for about a quarter of COVID-19 hospitalizations and deaths

New real-world data from AstraZeneca re-affirms the significant and disproportionate burden of COVID-19 on immunocompromised patients compared to the general population despite vaccination, underscoring the need for additional protection for these vulnerable populations.

The data from INFORM and COVIDRIVE is being presented at the European Society of Clinical Microbiology and Infectious Diseases (ECCMID) 2024 Congress in Barcelona, Spain.

Despite the World Health Organization declaring an end to the pandemic a year ago, COVID-19 remains a significant public health problem for immunocompromised individuals today. The INFORM (INvestigation oF cOvid-19 Risk among iMmunocompromised populations) retrospective cohort study analyzed data of nearly 12 million people 12 years of age and older in England to assess COVID-19's impact, risk and healthcare resource use among immunocompromised populations beginning in 2022 as Omicron variants became dominant.¹

INFORM data from January to June 2023 shows that despite receiving at least four COVID-19 vaccinations, many immunocompromised individuals remain insufficiently protected against the virus and are at a disproportionately high risk of severe outcomes from COVID-19, including hospitalization and death compared to the general population.²

The study also identified specific immunocompromised populations - including those with blood cancers, organ/stem cell transplant recipients, those with end-stage kidney disease on dialysis and those taking certain immunosuppressive medicines - who continue to have an increased risk of severe COVID-19 outcomes.²

In addition, a new analysis of INFORM data from 2022 found that individuals with multiple sclerosis (MS) are at increased risk of COVID-19 hospitalization and death compared to the general population, which may be due to use of immunosuppressive therapies that can cause suboptimal responses to vaccination.³

Analyses from the INFORM study showed:

• Despite representing just 4% of the study population, immunocompromised individuals account for around a quarter of all COVID-19 hospitalizations (24%) and deaths (23%) even after four or more COVID-19 vaccinations (Jan.-Jun. 2023 analysis).²
• Among those having at least four COVID-19 vaccinations, the risk of COVID-19 hospitalization was particularly high in certain immunocompromised groups compared to the general population: 18 times higher for individuals who received stem cell transplants in the last two years, a common treatment for hematological malignancies; 9 times higher for those with hematological malignancies on active treatment in the last six months, and nearly 7 times higher for organ transplant recipients in the last five years. Other patient populations with at least a 2 times greater risk of COVID-19 hospitalizations, included patients with end-stage kidney disease. (Jan.-Jun. 2023, adjusted analyses).²
• Even with at least three COVID-19 vaccinations, individuals with MS had an almost 6 times greater risk of COVID-19 hospitalization and nearly 4 times greater risk of COVID-19 deaths compared to the general population (Jan.-Dec. 2022, adjusted analyses).³

New data from COVIDRIVE analyzing more than 5,000 Europeans hospitalized for severe acute respiratory infections, also being presented at ECCMID, found:

• Among those testing positive for SARS-CoV-2 (and thus diagnosed with severe COVID-19), nearly 30% were immunocompromised (including due to immunodeficiency, organ transplant and/or cancer), despite comprising just up to 4% of the population.⁴
• The prevalence of people with immunocompromising conditions who tested positive for SARS-CoV-2 was markedly higher than those who tested negative from February 2022 onward, and greater than 50% in July 2023.⁵
• Most patients hospitalized for severe acute respiratory infection had multiple chronic conditions (20.1% had four or more), with those testing positive observed to have a slightly higher prevalence of chronic kidney disease than those who tested negative.⁴

Prof. Lance Turtle PhD FRCP DTMH, Professor of Immunity and Infectious Diseases, University of Liverpool and INFORM investigator, said: "While the overall severity, rate of hospitalization and death from COVID-19 has lessened relative to the height of the pandemic, a compelling and growing body of real-world evidence shows that immunocompromised individuals still suffer disproportionately from the virus. Repeated COVID-19 vaccinations, while helpful and save lives, do not completely close this gap. Therefore, some immunocompromised individuals are still becoming extremely ill or dying from COVID-19. Data from INFORM and COVIDRIVE plays an important role in helping clinicians identify which immunocompromised patients are at high risk of hospitalization and death and who may need additional preventive measures."

Notes

INFORM

INFORM (INvestigation oF cOvid-19 Risk among iMmunocompromised populations) is an observational, population-based, retrospective cohort study among nearly 12 million people aged 12 years and older in England to assess clinical outcomes and utilization of healthcare resources due to COVID-19. Initial results during Omicron (January-December 2022) were published in Lancet Regional Health Europe and aimed to clearly define and provide a comprehensive assessment of risk for serious outcomes from COVID-19 in immunocompromised patients.¹ Additional analyses continue to be reported.

COVID-19-related hospitalizations, intensive care unit (ICU) admissions and deaths were compared among different groups of immunocompromised individuals vs. the general population using de-identified, routinely collected electronic health data from a random 25% sample representative of the total English population 12 years of age and older using the National Health Service's databases (NHS Digital). In INFORM, immunocompromised individuals were shown to represent about 4% of the population aged 12 years and older in England but accounted for approximately 25% of COVID-19 hospitalizations, ICU admissions and deaths.¹

Two new INFORM analyses are being presented at ECCMID 2024. The first evaluated serious COVID-19 outcomes including hospitalization and death between January and June 2023 for individuals who received four or more COVID-19 vaccinations.^1,2 The second analysis evaluated COVID-19 hospitalization and deaths during 2022 among individuals with multiple sclerosis, the majority who had received three or more COVID-19 vaccinations.³

COVIDRIVE

COVIDRIVE is an ongoing noninterventional, multi-country, multi-center, hospital-based study using a test-negative case control design. The study is run by id.DRIVE, a unique public-private partnership of vaccine companies and research groups who joined forces in 2021 to collect real-world data on the effectiveness of COVID-19 vaccines in Europe.

The new data presented at ECCMID are based on an analysis of 5,280 COVIDRIVE patients who were hospitalized with severe acute respiratory infections at contributing sites in Belgium, Italy and Spain from May 1, 2021 to May 31, 2023. Immunocompromised patients were defined by the presence of a chronic immunocompromising condition or having cancer.^4,5

AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca.

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References

1. Evans R, et al. Impact of COVID-19 on Immunocompromised Populations During the Omicron Era: Insights from the Observational Population-Based INFORM Study. Lancet Regional Health Europe. Published online October 13, 2023. doi: 10.1016/j.lanepe.2023.100747
2. Dube S, et al. Continued Increased Risk of COVID-19 Hospitalization and Death in Immunocompromised Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective Health Database Study in England. Poster P0409 at ECCMID 2024
3. Turtle L, et al. Individuals with Multiple Sclerosis Are at High Risk for COVID-19 Hospitalization and Death Despite High Rates of Vaccination: Results from the England INFORM Study. Oral Presentation at ECCMID 2024
4. Meeraus W, et al. Immunocompromise, Cancer and Other Comorbidities in Patients with Severe Acute Respiratory Infection Testing Positive Versus Negative for SARS-CoV-2: A Post Hoc Analysis of COVIDRIVE Data from May 2021 to May 2023. Poster P0382 at ECCMID 2024
5. Meeraus W, et al. High Prevalence of Immunocompromising Conditions Among Patients with Severe Acute Respiratory Infection, Including SARS-CoV-2: Results from a Multicenter, Test-Negative Case Control Study. Poster P0381 at ECCMID 2024