Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study.

BACKGROUND: Vaccine effectiveness studies have not differentiated the effect of the delta (B.1.617.2) variant and potential waning immunity in observed reductions in effectiveness against SARS-CoV-2 infections. We aimed to evaluate overall and variant-specific effectiveness of BNT162b2 (tozinameran, Pfizer-BioNTech) against SARS-CoV-2 infections and COVID-19-related hospital admissions by time since vaccination among members of a large US health-care system. METHODS: In this retrospective cohort study, we analysed electronic health records of individuals (≥12 years) who were members of the health-care organisation Kaiser Permanente Southern California (CA, USA), to assess BNT162b2 vaccine effectiveness against SARS-CoV-2 infections and COVID-19-related hospital admissions for up to 6 months. Participants were required to have 1 year or more previous membership of the organisation. Outcomes comprised SARS-CoV-2 PCR-positive tests and COVID-19-related hospital admissions. Effectiveness calculations were based on hazard ratios from adjusted Cox models. This study was registered with ClinicalTrials.gov, NCT04848584. FINDINGS: Between Dec 14, 2020, and Aug 8, 2021, of 4 920 549 individuals assessed for eligibility, we included 3 436 957 (median age 45 years [IQR 29-61]; 1 799 395 [52·4%] female and 1 637 394 [47·6%] male). For fully vaccinated individuals, effectiveness against SARS-CoV-2 infections was 73% (95% CI 72-74) and against COVID-19-related hospital admissions was 90% (89-92). Effectiveness against infections declined from 88% (95% CI 86-89) during the first month after full vaccination to 47% (43-51) after 5 months. Among sequenced infections, vaccine effectiveness against infections of the delta variant was high during the first month after full vaccination (93% [95% CI 85-97]) but declined to 53% [39-65] after 4 months. Effectiveness against other (non-delta) variants the first month after full vaccination was also high at 97% (95% CI 95-99), but waned to 67% (45-80) at 4-5 months. Vaccine effectiveness against hospital admissions for infections with the delta variant for all ages was high overall (93% [95% CI 84-96]) up to 6 months. INTERPRETATION: Our results provide support for high effectiveness of BNT162b2 against hospital admissions up until around 6 months after being fully vaccinated, even in the face of widespread dissemination of the delta variant. Reduction in vaccine effectiveness against SARS-CoV-2 infections over time is probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection. FUNDING: Pfizer.

Association of Pre-End-Stage Renal Disease Hemoglobin with Early Dialysis Outcomes.

BACKGROUND: Incident hemodialysis patients have a high mortality risk within the first months after dialysis initiation. Pre-end-stage renal disease (ESRD) factors like anemia management may impact early post-ESRD outcomes. Therefore, we evaluated the impact of pre-ESRD hemoglobin (Hgb) and pre-ESRD Hgb slope on post-ESRD mortality and hospitalization outcomes. METHODS: The study included 31,472 veterans transitioning to ESRD. Using Cox and negative binomial regression models, we evaluated the association of pre-ESRD Hgb and Hgb slope with 12-month post-ESRD all-cause and cardiovascular mortality and hospitalization rates using 4 levels of hierarchical multivariable adjustment, including erythropoietin use and kidney decline in slope models. RESULTS: The cohort was 2% female, 30% African-American, and on average 68 ± 11 years old. Compared to Hgb 10-< 11 g/dL, both low (< 10 g/dL) and high (≥12 g/dL) levels were associated with higher all-cause mortality after full adjustment (HR 1.25 [95% CI 1.15-1.35] and 1.09 [95% CI 1.02-1.18], respectively). Similarly, Hgb exhibited a U-shaped association with CV mortality, while only lower Hgb was associated with a higher hospitalization rate. Neither an annual pre-ESRD decline in Hgb nor increase was associated with higher post-ESRD mortality risk after adjustment for kidney decline. However, we observed a modest J-shaped association between pre-ESRD Hgb slope and post-ESRD hospitalization rate. CONCLUSIONS: Lower and higher pre-ESRD Hgb levels are associated with a higher risk of early post-ESRD mortality, while there was no association between the pre-ESRD slope and mortality. An increase in pre-ESRD Hgb slope was associated with higher risk of post-ESRD hospitalization. Additional studies aimed at anemia management prior to ESRD transition are warranted.

A Digital Library for Increasing Awareness About Living Donor Kidney Transplants: Formative Study.

BACKGROUND: It is not common for people to come across a living kidney donor, let alone consider whether they would ever donate a kidney themselves while they are alive. Narrative storytelling, the sharing of first-person narratives based on lived experience, may be an important way to improve education about living donor kidney transplants (LDKTs). Developing ways to easily standardize and disseminate diverse living donor stories using digital technology could inspire more people to consider becoming living donors and reduce the kidney shortage nationally. OBJECTIVE: This paper aimed to describe the development of the Living Donation Storytelling Project, a web-based digital library of living donation narratives from multiple audiences using video capture technology. Specifically, we aimed to describe the theoretical foundation and development of the library, a protocol to capture diverse storytellers, the characteristics and experiences of participating storytellers, and the frequency with which any ethical concerns about the content being shared emerged. METHODS: This study invited kidney transplant recipients who had received LDKTs, living donors, family members, and patients seeking LDKTs to record personal stories using video capture technology by answering a series of guided prompts on their computer or smartphone and answering questions about their filming experience. The digital software automatically spliced responses to open-ended prompts, creating a seamless story available for uploading to a web-based library and posting to social media. Each story was reviewed by a transplant professional for the disclosure of protected health information (PHI), pressuring others to donate, and medical inaccuracies. Disclosures were edited. RESULTS: This study recruited diverse storytellers through social media, support groups, churches, and transplant programs. Of the 137 storytellers who completed the postsurvey, 105/137 (76.6%) were white and 99/137 (72.2%) were female. They spent 62.5 min, on average, recording their story, with a final median story length of 10 min (00:46 seconds to 32:16 min). A total of 94.8% (130/137) of storytellers were motivated by a desire to educate the public; 78.1% (107/137) were motivated to help more people become living donors; and 75.9% (104/137) were motivated to dispel myths. The ease of using the technology and telling their story varied, with the fear of being on film, emotional difficulty talking about their experiences, and some technological barriers being reported. PHI, most commonly surnames and transplant center names, was present in 62.9% (85/135) of stories and was edited out. CONCLUSIONS: With appropriate sensitivity to ensure diverse recruitment, ethical review of content, and support for storytellers, web-based storytelling platforms may be a cost-effective and convenient way to further engage patients and increase the curiosity of the public in learning more about the possibility of becoming living donors.

Recommendations for Systematizing Transplant Education Within a Care Delivery System for Patients With Chronic Kidney Disease Stages 3 to 5.

CONTEXT: Early tailored transplant education could help patients make informed transplant choices. OBJECTIVE: We interviewed 40 patients with chronic kidney disease (CKD) stages 3 to 5, 13 support persons, and 10 providers at Kaiser Permanente Southern California to understand: (1) barriers to transplant education and (2) transplant educational preferences and recommendations based on CKD stage and primary language spoken. DESIGN: A grounded theory analysis identified central themes related to transplant education barriers, preferences, and recommendations. RESULTS: Barriers included confusion about diagnosis and when transplant may be necessary, concerns about transplant risks, families' lack of transplant knowledge, financial burdens, transportation and scheduling, and the emotional overload of chronic illness. Hispanic and Spanish-speaking participants reported difficulty in understanding transplant education and medical mistrust. Recommendations included providing general education, earlier introduction to transplant, wait-listing information, transplant education for support persons, living donation education for patients and potential donors, opportunities to meet living donors and kidney recipients, information on the benefits of transplant, recovery, and available financial resources, flexible class scheduling, online and print resources, and more provider follow-up. Spanish-speaking and Hispanic participants recommended using bilingual educators, print, video, and online resources in Spanish, and culturally responsive education. Patients with CKD stages 3 to 4 wanted information on slowing disease progression and avoiding transplant. CONCLUSION: Increasing access to culturally responsive transplant education in multiple languages, pairing appropriate content to the disease stage, and increasing system-wide follow-up as the disease progresses might help patients make more informed choices about transplant.