Project description:BackgroundWe sought to compare rates of adverse events among nursing home residents who received an mRNA COVID-19 vaccine booster dose with those who had not yet received their booster.MethodsWe assessed a prospective cohort of 11,200 nursing home residents who received a primary COVID-19 mRNA vaccine series at least 6 months prior to September 22, 2021 and received a third "booster dose" between September 22, 2021 and February 2, 2022. Residents lived in 239 nursing homes operated by Genesis HealthCare, spanning 21 U.S. states. We screened electronic health records for 20 serious vaccine-related adverse events that are monitored following receipt of COVID-19 vaccination by the CDC's Vaccine Safety Datalink. We matched boosted and yet-to-be boosted residents during the same time period, comparing rates of events occurring 14 days after booster administration with those occurring 14 days prior to booster administration. To supplement previously reported background rates of adverse events, we report background rates of medical conditions among nursing home residents during 2020, before COVID-19 vaccines were administered in nursing homes. Events occurring in 2021-2022 were confirmed by physician chart review. We report unadjusted rates of adverse events and used a false discovery rate procedure to adjust for multiplicity of events tested.ResultsNo adverse events were reported during the 14 days post-booster. A few adverse events occurred prior to booster (ischemic stroke: 49.4 per 100,000 residents, 95% CI: 21.2, 115.7; venous thromboembolism: 9.9 per 100,000 residents, 95% CI: 1.7, 56.0), though differences in event rates pre- versus post-booster were not statistically significant (p < 0.05) after adjusting for multiple comparisons. No significant differences were detected between post-booster vaccination rates and prior year 14-day background rates of medical conditions.ConclusionsNo safety signals were detected following a COVID-19 mRNA vaccine booster dose in this large multi-state sample of nursing home residents.

Project description:BackgroundNursing home residents, a frail and old population group, respond poorly to primary mRNA COVID-19 vaccination. A third dose has been shown to boost protection against severe disease and death in this immunosenescent population, but limited data is available on the immune responses it induces.MethodsIn this observational cohort study, peak humoral and cellular immune responses were compared 28 days after the second and third doses of the BNT162b2 mRNA COVID-19 vaccine in residents and staff members of two Belgian nursing homes. Only individuals without evidence of previous SARS-CoV-2 infection at third dose administration were included in the study. In addition, an extended cohort of residents and staff members was tested for immune responses to a third vaccine dose and was monitored for vaccine breakthrough infections in the following six months. The trial is registered on ClinicalTrials.gov (NCT04527614).FindingsAll included residents (n = 85) and staff members (n = 88) were SARS-CoV-2 infection naïve at third dose administration. Historical blood samples from 28 days post second dose were available from 42 residents and 42 staff members. Magnitude and quality of humoral and cellular immune responses were strongly boosted in residents post third compared to post second dose. Increases were less pronounced in staff members than in residents. At 28 days post third dose, differences between residents and staff had become mostly insignificant. Humoral, but not cellular, responses induced by a third dose were predictive of subsequent incidence of vaccine breakthrough infection in the six months following vaccination.InterpretationThese data show that a third dose of mRNA COVID-19 vaccine largely closes the gap in humoral and cellular immune response observed after primary vaccination between NH residents and staff members but suggest that further boosting might be needed to achieve optimal protection against variants of concern in this vulnerable population group.

Project description:Abstract Background Infection control during COVID‐19 outbreaks in nursing facilities is a critical public health issue. Antibody responses before and after the fourth (second booster) dose of wild‐type severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccine in nursing home residents have not been fully characterized. Methods This study included 112 individuals: 54 nursing home residents (mean age: 84.4 years; 35 SARS‐CoV‐2‐naive and 19 previously infected) and 58 healthcare workers (mean age: 47.7 years; 25 SARS‐CoV‐2‐naive and 33 previously infected). Antispike and antinucleocapsid antibody responses to messenger RNA vaccination were evaluated using serum samples collected shortly and 5 months after the third dose, and shortly after the fourth dose. Results The median immunoglobulin G (IgG) level in SARS‐CoV‐2‐naive residents was similar to that in SARS‐CoV‐2‐naive healthcare workers after the fourth dose (24,026.3 vs. 30,328.6 AU/mL, p = .79), whereas after the third dose the IgG level of SARS‐CoV‐2‐naive residents was approximately twofold lower than that in SARS‐CoV‐2‐naive healthcare workers. In residents with previous SARS‐CoV‐2 infection, timing of infection in relation to vaccination affected the kinetics of antibody responses. Residents infected after the third dose showed the highest IgG levels after the fourth dose among all groups (median: 64,328.8 AU/mL), in contrast to residents infected before initiating vaccination with antibody levels similar to those of SARS‐CoV‐2‐naive residents. Conclusions Advanced aged nursing home residents, poor responders in the initial SARS‐CoV‐2 vaccine series, could achieve sufficient antibody responses after the fourth (second booster) vaccination, comparable to those of younger adults. Antibody responses before and after the fourth (second booster) dose of wild‐type SARS‐CoV‐2 mRNA vaccine in nursing home residents. The median IgG level after the fourth dose in SARS‐CoV‐2‐naive residents was similar to that in SARS‐CoV‐2‐naive healthcare workers. The IgG ratio of SARS‐CoV‐2‐naive residents to healthcare workers increased from 0.5 (50%) after the third dose to 0.8 (80%) after the fourth dose.

Project description:BackgroundThe Centers for Medicare & Medicaid Services implemented the National Partnership to Improve Dementia Care in Nursing Homes (the Partnership) to decrease antipsychotic use and improve care for nursing home (NH) residents with dementia. We determined whether the extent of antipsychotic and other psychotropic medication prescribing in AL residents with dementia mirrored that of long-stay NH (LSNH) residents after the Partnership.MethodsUsing a 20% sample of fee-for-service Medicare beneficiaries with Part D, we conducted a retrospective cohort study including AL and LSNH residents with dementia. The monthly prevalence of psychotropic medication prescribing (antipsychotics, antidepressants, anxiolytics/sedative-hypnotics, anticonvulsants/mood stabilizers, benzodiazepines, and antidementia medications) was examined. We used an interrupted time-series analysis to compare medication prescribing before (July 1, 2010-March 31, 2012) and after (April 1, 2012-December 31, 2017) the Partnership in both settings.ResultsWe identified 107,931 beneficiaries with ≥1 month as an AL resident and 323,766 beneficiaries with ≥1 month as a LSNH resident with dementia, including 1,923,867 person-months and 4,984,405 person-months, respectively. Antipsychotic prescribing declined over the study period in both settings. After the launch of the Partnership, the rate of decline in antipsychotic prescribing slowed in AL residents with dementia (slope change = 0.03 [95% CLs: 0.02, 0.04]) while the rate of decline in antipsychotic prescribing increased in LSNH residents with dementia (slope change = -0.12 [95% CLs: -0.16, -0.08]). Antidepressants were the most prevalent medication prescribed, anticonvulsant/mood stabilizer prescribing increased, and anxiolytic/sedative-hypnotic and antidementia medication prescribing declined.ConclusionsThe federal Partnership to reduce antipsychotic prescribing in NH residents did not appear to affect antipsychotic prescribing in AL residents with dementia. Given the increase in the prescribing of mood stabilizers/anticonvulsants that occurred after the launch of the Partnership, monitoring may be warranted for all psychotropic medications in AL and NH settings.

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Antibody Responses to Third-Dose mRNA Vaccines in Nursing Home and Assisted Living Residents.

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