ABSTRACT
Background. Immunocompromised individuals (ICI) are at high risk for infections, some of which are preventable by vaccines. The Israeli MOH recommends PCV13 and PPSV23 vaccines for ICI, but vaccine coverage is suboptimal. The aim of this study was to assess the effectiveness of a project to improve pneumococcal vaccination (PV) rate among ICI in outpatient settings. Methods. An automated validated, population-based registry of patients with ICI was developed in an Israeli health organization, Maccabi Healthcare Services, serving over 2.5 million members. Included in the registry were patients aged 18 and above, receiving immunosuppressive therapy (IT);patients living with HIV (PLWH);solid organ and bone marrow transplant recipients (TR);patients with advanced kidney disease (AKD);and patients with asplenia. Based on the registry and the Israeli MOH vaccination guidelines, a nationwide quality improvement project aimed at improving PV was implemented which began in October 2019. As part of the project, ICI were waived the need for preapproval for PCV13. During an eligible patient visit, physicians and nurses were prompted with an EHR alert reminding them to consider providing pneumococcal vaccine. In addition, eligible patients were invited via their patient health record (both desktop and mobile) to vaccinate. Vaccination rates during pre- and post-intervention periods were compared using the Chi square test. Results. A total of 32,297 ICI were identified. Of them, 22,721 were on IT, 1651 PLWH, 1829 were TR ,5267 had AKD, and 1920 were asplenic. During the period October 2019 to October 2021, PCV13 vaccination rates went up from 12% to 54.1% (p< 0.0001), and PPSV23 vaccination rate improved from 44.7% to 62.6% (P < 0.0001). Conclusion. Using one of the first real-world automated registries for ICI and implementation of targeted automated patient and provider alerts, markedly improved pneumococcal vaccine uptake was observed in this vulnerable population. Similar interventions may be used to increase the adherence for other vaccines, including COVID-19 vaccines.
ABSTRACT
Background: While short-term safety data of COVID-19 vaccination has been reassuring, it is theoretically possible that the vaccineassociated immune activation could trigger immune dysregulation and thus exacerbation of IBD. We used the epi-Israeli IBD Research Nucleus (IIRN) database to perform a population-based study exploring the effect of COVID-19 vaccination on disease course in IBD patients. Methods: We included all IBD patients insured in two of the four Israeli HMOs, covering 35% of the population, by validated algorithms, and selected those who received two doses of Pfizer BNT162b2 vaccine. These were matched to unvaccinated IBD patients by demographics, parameters of disease severity at baseline generated by hierarchical clustering of laboratory data, and length of time from previous exacerbation to baseline. The primary outcome was rate of IBD exacerbation as defined by proxies of hospitalizations, treatment escalation, and commencement of corticosteroid or enema. The study period was December, 2020 to June, 2021 Results: 707 pairs of vaccinated and unvaccinated IBD patients were compared. The pairs matched exactly for gender, district, IBD type and disease severity, and ±1 year for age at IBD diagnosis and at vaccination. Mean age was 38.5±13.5 years and median follow-up was 98 days (IQR 16-143). No difference in the outcome was found between the groups from the 2nd vaccination to the end of follow-up, with risk of exacerbation in vaccinated patients of 29% and risk in unvaccinated patients 26% (p=0.3). Conclusion: COVID-19 vaccinated IBD patients demonstrated a rate of IBD exacerbation following vaccination that was no different from that of unvaccinated patients. The multifaceted immune activation induced by the vaccine did not result in worsening IBD disease course. These results provide further reassurance for IBD patients receiving the vaccine.
ABSTRACT
Background: Some studies have shown decreased serological response to vaccination in patients on anti-tumor necrosis factor (TNF) medications. While the large majority of these patients do seroconvert after vaccination, titers have generally been lower and one study showed reduced neutralizing and inhibitory functions. One real-world population- based study compared found no increased infection rate in anti- TNF treated patients, but infection rates were low. The low event rate mandates exploration in longer-term population-based data. We used the epi-Israeli IBD Research Nucleus (IIRN) database to explore the effectiveness of COVID-19 vaccination in IBD patients in Israel. Methods: We included all IBD patients insured in two of the four Israeli HMOs, covering 35% of the population, by validated algorithms, and selected those who received two doses of Pfizer BNT162b2 vaccine. These were matched by date of vaccination ±3 days and demographic variables to non-IBD controls. The primary outcome was incidence of positive COVID-19 PCR following vaccination between December, 2020 to June, 2021. Results: 12,640 IBD patients received two vaccine doses;the matched cohort included 4,946 matched pairs (total 9,892 subjects). Mean age was 50.5±16.1 years and median follow-up was 22 weeks (range 4.1-24.4). Fifteen (0.3%) vaccinated IBD patients tested positive compared with 15 (0.3%) vaccinated non-IBD controls (OR=1 [95%CI 0.49-2.05], p=1.0). Patients on anti-TNF and/or corticosteroids did not have a higher incidence of positivity - neither compared to the entire group nor to IBD patients treated with vedolizumab/ustekinumab, even after precise matching for demographics, underlying diseases and IBD severity. Conclusion: In a large population-based cohort of IBD patients in Israel, vaccine effectiveness was equivalent to non-IBD controls and was not influenced by treatment with anti-TNF or corticosteroids. Notwithstanding previous findings of impaired serological response in anti-TNF treated IBD patients, this real-world large-scale study shows that vaccine protection is robust in IBD patients, including those on immunosuppressive medications.