ObjectivesWe intended to assess the effectiveness of all three US Food and Drug Administration approved COVID-19 vaccines at preventing SARS-CoV-2 infection and COVID-19 hospitalisation in a large cohort of individuals on immunosuppressants for a diverse range of conditions.MethodsWe studied the effectiveness of BNT162b2 (Pfizer–BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Johnson & Johnson–Janssen) vaccines among individuals who take immunosuppressants (including disease-modifying antirheumatic drugs and glucocorticoids) by comparing vaccinated (n=97688) and unvaccinated (n=42094) individuals in the Michigan Medicine healthcare system from 1 January to 7 December 2021, using Cox proportional hazards modelling with time-varying covariates.ResultsAmong vaccinated and unvaccinated individuals, taking immunosuppressants increased the risk of SARS-CoV-2 infection (adjusted HR (aHR)=2.17, 95% CI 1.69 to 2.79 for fully vaccinated and aHR=1.40, 95% CI 1.07 to 1.83 for unvaccinated). Among individuals taking immunosuppressants, we found: (1) vaccination reduced the risk of SARS-CoV-2 infection (aHR=0.55, 95% CI 0.39 to 0.78); (2) the BNT162b2 and mRNA-1273 vaccines were highly effective at reducing the risk of SARS-CoV-2 infection (n=2046, aHR=0.59, 95% CI 0.38 to 0.91 for BNT162b2; n=2064, aHR=0.52, 95% CI 0.33 to 0.82 for mRNA-1273); (3) with a smaller sample size (n=173), Ad26.COV2.S vaccine protection did not reach statistical significance (aHR=0.34, 95% CI 0.09 to 1.30, p=0.17); and (4) receiving a booster dose reduced the risk of SARS-CoV-2 infection (aHR=0.42, 95% CI 0.24 to 0.76).ConclusionsThe mRNA-1273 and BNT162b2 vaccines are effective in individuals who take immunosuppressants. However, individuals who are vaccinated but on immunosuppressants are still at higher risk of SARS-CoV-2 infection and COVID-19 hospitalisation than the broader vaccinated population. Booster doses are effective and crucially important for individuals on immunosuppressants.

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Background There is a lack of data regarding how the delta variant of coronavirus disease 2019 (COVID-19) has impacted the effectiveness of the BNT162b2 (Pfizer–BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson & Johnson–Janssen) vaccines at preventing SARS-CoV-2 infection and COVID-19 hospitalization. Methods We compared the effectiveness of the three vaccines during the pre- and post-delta variant period (before and after July 1 st, 2021) in a large cohort of vaccinated and unvaccinated patients in the Michigan Medicine healthcare system. We assessed vaccine effectiveness using two analyses: an Inverse Propensity Weighted (IPW) Kaplan-Meier (KM) analysis based on time from vaccination, and a Cox model based on calendar time with vaccination as a time-varying covariate. Results Compared to Ad26.COV2.S recipients, the risk of hospitalization for COVID-19 in the post-delta variant period was lower for BNT162b2 recipients (HR=0.37; 95% CI: [0.14-0.98]; p=0.05) and mRNA-1273 recipients (HR=0.21; 95% CI: [0.07-0.64]; p=0.006). Recipients of the mRNA-1273 vaccine had a lower risk of SARS-CoV-2 infection than Ad26.COV2.S recipients (HR=0.6; 95% CI: [0.43-0.83]; p=0.003) and BNT162b2 recipients (HR=0.64; 95% CI: [0.54-0.76]; p<0.001). After July 1 st, efficacy against SARS-CoV-2 infection declined for Ad26.COV2.S recipients (VE=76% before; VE=49% after; p=0.02), BNT162b2 recipients (VE=87% before; VE=52% after; p<0.001), and mRNA-1273 recipients (VE=92% before; VE=70% after; p<0.001). Waning immunity and the delta variant contributed independently and significantly to this decline. Discussion Although there is a substantial decline in effectiveness, the approved COVID-19 vaccines remain effective against infection and hospitalization due to the delta variant. The mRNA-based vaccines are more effective than the Ad26.COV2.S vaccine.

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