mRNA Vaccination Decreases COVID-19-Associated Morbidity and Mortality Among Organ Transplant Recipients: A Contemporary Cohort Study

Abstract

Background Organ transplant recipients (OTR) are less protected from vaccination than immunocompetent hosts. Additional vaccine doses have shown increased immunogenicity. Few studies assessed their clinical efficacy, particularly against Omicron variants, since most included patients from earlier phases of the pandemic, with higher base mortality rates. Methods We studied adult OTR who had COVID-19 between 12/15/21 and 5/25/22. We compared clinical outcomes between those who had received 2 or ≥3 doses of an mRNA vaccine and concurrent unvaccinated controls. Results Among 103 OTR, vaccination was associated with lower 90-day mortality (unvaccinated vs. 2 vs. ≥3 doses: 25% vs. 7% vs. 3%, P = 0.003), hospital (unvaccinated vs. 2 vs. ≥3 doses: 56% vs. 37% vs. 27%, P = 0.018) or ICU (unvaccinated vs. 2 vs. ≥3 doses: 25% vs. 15% vs. 3%, P = 0.001) admission rates, and peak O2 requirements (ordinal scale Kendall’s tau b=-0.309 [lower scores, i.e., O2 requirements with more vaccine doses], P = 0.003). Age (>60 years adjusted hazard ratio [aHR] 7.73, P = 0.016), administration of anti-spike monoclonal antibody (aHR 0.17, P = 0.042) and vaccination, especially with ≥3 doses (aHR 0.105, P = 0.01), were independently associated with 90-day mortality. Black (P = 0.021) or Hispanic (P = 0.016) OTR were underrepresented among the vaccinated, especially in the ≥3 dose group. Conclusions Despite lower mRNA vaccine efficacy in OTR and against Omicron variants, vaccination protects this vulnerable patient population from severe COVID-19 and death. Ethnic and racial disparities in healthcare have been exacerbated by the COVID-19 pandemic and warrant better community outreach efforts.

Outpatient anti-spike monoclonal antibody administration is associated with decreased morbidity and mortality among patients with cancer and COVID-19

“…4 ), despite concerns for lower immunological vaccine efficacy among immunocompromised patients [ 16 , 17 ], and one small study from the CCC19 registry, which showed comparable clinical outcomes between unvaccinated patients with cancer and those who had received 2 doses of an mRNA vaccine [ 19 ]. The results of the present report are consistent with those of a previously published study at our center among organ transplant recipients [ 27 ], and the updated CCC19 data [ 18 ], highlighting that vaccination of immunocompromised patients, especially with additional “booster” doses, is an essential preventive strategy against severe COVID-19 and death.…”

mRNA Vaccines against SARS-CoV-2: Advantages and Caveats

“…This is specially the case for organ-transplanted patients or patients suffering multiple sclerosis. These patients did not benefit from BNT162b2 and mRNA-1273 vaccines due to their immunosuppressive treatments [ 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 ]. On the other hand, the efficacy of these vaccines has been demonstrated in patients with several types of cancers.…”

Molnupiravir efficacy among immunocompromised patients with COVID-19: no proof of concept

“…Second, Johnson et al reference as positive studies that, in fact, contradict potential therapeutic benefits of molnupiravir. Lastly, vaccination status is a major confounder [ 1 , 2 , 4 , 5 ].…”

“…On the contrary, sotrovimab outperformed the no-intervention group, having lower hospitalization or death rates ( p = 0.045) [ 2 ]. It should be noted that, in the study by Radcliff et al 68% of patients (30/49) in the molnupiravir group had received at least three doses of mRNA vaccine or two doses of the Ad26.COV2.S vaccine, compared to 38% (18/48, χ 2 p = 0.019) of the no-intervention group, which could on its own have explained the difference in outcomes [ 2 , 4 ]. Johnson et al summarize the findings of this study without mentioning this important caveat.…”

“…Finally, as mentioned above, the MOVe-OUT trial included unvaccinated patients, and in the cohort of Radcliffe et al significantly more patients in the molnupiravir group were vaccinated compared to untreated OTRs [ 2 ]. This is particularly important, since we and others have recently and convincingly demonstrated that vaccination, especially with more vaccine doses, protects OTRs from severe COVID-19 and death [ 4 ]. To this end, the results from a recent randomized, double-blind, placebo-controlled trial (PANORAMIC) question the efficacy of molnupiravir among vaccinated patients.…”