Risk of Glomerular Diseases, Proteinuria and Hematuria Following mRNA (BNT162b2) and Inactivated (CoronaVac) SARS-CoV-2 Vaccines

Franco Wing Tak Cheng; Carlos King HoWong; Simon Xiwen Qin; Celine Sze Ling Chui; Francisco Tsz Tsun Lai; Xue Li; Eric Yuk Fai Wan; EstherW. Chan; ChiHoAu; Xuxiao Ye; Sydney ChiWai Tang; Ian Chi KeiWong


Nephrol Dial Transplant. 2023;38(1):129-137. 

In This Article

Abstract and Introduction


Background: With accruing case reports on de novo or relapsing glomerular diseases (GD) following different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, we evaluated the risk of GD following BNT162b2 and CoronaVac vaccines.

Methods: A modified self-controlled case series analysis was conducted using anonymized, territory-wide SARS-CoV-2 vaccination records in Hong Kong. All Hong Kong residents aged 18 years or above with outcomes of interest were included. Outcomes of interest were GD, proteinuria or hematuria within 42 days following each dose of SARS-CoV-2 vaccines. Incidence per 100 000 doses of SARS-CoV-2 vaccines administered was calculated, and incidence rate ratios (IRRs) were estimated using conditional Poisson regression with seasonality adjustment.

Results: Between 23 February 2021 and 31 March 2022, 4062 patients had an incident diagnosis of GD, proteinuria or hematuria, with 2873 of them being vaccinated during the observation period. The incidences of the composite events 1–41 days after vaccination were 3.7 (95% CI 3.1–4.4) per 100 000 doses of BNT162b2 administered, and 6.5 (95% CI 5.7–7.5) per 100 000 doses CoronaVac administered. There was no significant increase in the risks of composite events following the first (BNT162b2: IRR = 0.76, 95% CI 0.56–1.03; CoronaVac: IRR = 0.92, 95% CI 0.72–1.19), second (BNT162b2: IRR = 0.92, 95% CI 0.72–1.17; CoronaVac: IRR = 0.88. 95% CI 0.68–1.14) or third (BNT162b2: IRR = 0.39. 95% CI 0.15–1.03; CoronaVac: IRR = 1.18. 95% CI 0.53–2.63) dose of SARS-CoV-2 vaccines.

Conclusions: There was no evidence of increased risks of de novo or relapsing GD with either BNT162b2 or CoronaVac vaccines.


Since the coronavirus disease 2019 (COVID-19) outbreak due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in early 2020, tremendous efforts have gone into preventive vaccination. Several types of vaccines are approved for emergency use for immunization against the SARS-CoV-2 virus, and population-based vaccination campaigns have been promoted across the globe within a short period since the World Health Organization's declaration of the pandemic. A nationwide safety analysis of BNT162b2 in Israel demonstrated a reduced risk of acute kidney injury (AKI) after vaccination, plausibly due to protection against undiagnosed COVID-19.[1] On the contrary, there is an increasing number of case reports published for de novo or relapse of different glomerular diseases (GD) since the widespread rollout of SARS-CoV-2 vaccination programs across the globe. These case reports include antineutrophil cytoplasmic antibodies associated with vasculitis (AAV) and nephritis,[2–7] crescentic glomerulonephritis,[8] membranous nephropathy,[6,7,9] anti-glomerular basement membrane nephritis,[6,7,10] IgA vasculitis and nephritis,[6,7,11–16] minimal change disease (MCD),[6,7,17–19] IgG4-related nephritis[20] and lupus nephritis.[21] Furthermore, 14% of patients with urologic side effects reported hematuria post-SARS-CoV-2 mRNA vaccines in the US Vaccine Adverse Event Reporting System (VAERS).[22] Among the published cases, BNT162b2 appeared to be the most frequent vaccine preceding GD.[23]

In Hong Kong Special Administrative Region, China, a territory-wide vaccination program with BNT162b2 (Comirnaty, BioNTech/Pfizer/Fosun) and CoronaVac (Sinovac Life Sciences) commenced on 6 March and 23 February 2021, respectively. BNT162b2 vaccine was the first SARS-CoV-2 mRNA vaccine approved by the US Food and Drug Administration,[24] while CoronaVac is an inactivated whole-virion SARS-CoV-2 vaccine using the adjuvant aluminium hydroxide.[25–27] The Department of Health of Hong Kong received spontaneous reports of nephropathy following SARS-CoV-2 vaccination.[28] Hence, the regulatory-initiated pharmacovigilance programme [The COVID-19 Vaccines Adverse Events Response and Evaluation (CARE)][29] conducted this population-based, retrospective study to evaluate and compare the incidences of GD, proteinuria and hematuria following SARS-CoV-2 vaccines.