THE RATE OF ADVERSE EVENTS AFTER COVID-19 VACCINATION IS SIMILAR IN PATIENTS WITH CELIAC DISEASE AND NON-CELIAC POPULATION: RESULTS OF A LARGE INTERNATIONAL CROSS-SECTIONAL STUDY

Background Patients with celiac disease (CeD) reported increased COVID-19 vaccine hesitancy due to a fear of adverse events (AEs). However, the risk of AEs post-COVID-19 vaccination in patients with CeD is unknown. Purpose To assess whether the rate of common side effects (SEs) and AEs due to COVID vaccines are higher in patients with CeD compared to a non-CeD population. Method We conducted a collaborative international cross-sectional study in 16 countries between April 2022 and July 2022. An online survey was distributed to patients with CeD through patients' local societies, and to non-CeD from the general population in each country through social media posts, word-of-mouth, and through academic institutions. We collected data on participant demographics, medical conditions, CeD diagnosis, GFD adherence, history of COVID-19 vaccinations (type and doses) and self-reported SEs and AEs post-COVID-19 vaccine. SEs included pain/swelling at the site, fatigue, fever, chills, nausea and/or headaches. AEs included thrombosis, myocarditis, anaphylactic reaction, and hospitalization related to the vaccine. Logistic regression models were used to assess predictors such as CeD diagnosis, age, gender, vaccine type and comorbidities on the likelihood of reporting SEs and AEs post-vaccine. Result(s) : A total of 17,795 participants completed the survey, 13,638 with CeD (median age of 45[27]) and 4,157 non-CeD controls (median age of 43[20]). There were no significant differences in sex between CeD and controls. Overall, CeD patients had similar odds of SEs compared with non-CeD individuals (aOR=1.02;95% CI=0.92-1.14). SEs were slightly increased only in the second dose of the vaccine in the CeD population compared to non-CeD individuals (aOR= 1.35;95% CI=1.19-1.53). The most common reported SEs in CeD and controls were pain/swelling at the injection site (29% vs 23 %, p< 0.0001) and fatigue (29% vs 24%, p<0.0001). The odds of SEs were higher with Moderna Spikevax, AstraZeneca/Oxford and Johnson and Johnson vaccines than after the Pfizer vaccine (p< 0.0001). The overall rate of AEs post-vaccine was similar between patients with CeD and non-CeD individuals (aOR= 1.29;95% CI= 0.89-1.87). Overall, female gender, older age, GFD adherence, respiratory conditions, obesity and receiving immunosuppressive medications increased the odds of SEs, while only age and a history of allergies increased the odds of AEs. Conclusion(s) In this large international study, patients with CeD reported similar rates of SEs and AEs post-COVID vaccine compared to non-CeD individuals. This information is highly relevant as it addresses the main concern leading to COVID-19 vaccine hesitancy in CeD patients. Disclosure of Interest None Declared

Potentially preventable hospitalisations for physical health conditions in community mental health service users: a population-wide linkage study.

AIMS: Mental health (MH) service users have increased prevalence of chronic physical conditions such as cardio-respiratory diseases and diabetes. Potentially Preventable Hospitalisations (PPH) for physical health conditions are an indicator of health service access, integration and effectiveness, and are elevated in long term studies of people with MH conditions. We aimed to examine whether PPH rates were elevated in MH service users over a 12-month follow-up period more suitable for routine health indicator reporting. We also examined whether MH service users had increased PPH rates at a younger age, potentially reflecting the younger onset of chronic physical conditions. METHODS: A population-wide data linkage in New South Wales (NSW), Australia, population 7.8 million. PPH rates in 178 009 people using community MH services in 2016-2017 were compared to population rates. Primary outcomes were crude and age- and disadvantage-standardised annual PPH episode rate (episodes per 100 000 population), PPH day rate (hospital days per 100 000) and adjusted incidence rate ratios (AIRR). RESULTS: MH service users had higher rates of PPH admission (AIRR 3.6, 95% CI 3.5-3.6) and a larger number of hospital days (AIRR 5.2, 95% CI 5.2-5.3) than other NSW residents due to increased likelihood of admission, more admissions per person and longer length of stay. Increases were greatest for vaccine-preventable conditions (AIRR 4.7, 95% CI 4.5-5.0), and chronic conditions (AIRR 3.7, 95% CI 3.6-3.7). The highest number of admissions and relative risks were for respiratory and metabolic conditions, including chronic obstructive airways disease (AIRR 5.8, 95% CI 5.5-6.0) and diabetic complications (AIRR 5.4, 95% CI 5.1-5.8). One-quarter of excess potentially preventable bed days in MH service users were due to vaccine-related conditions, including vaccine-preventable respiratory illness. Age-related increases in risk occurred earlier in MH service users, particularly for chronic and vaccine-preventable conditions. PPH rates in MH service users aged 20-29 were similar to population rates of people aged 60 and over. These substantial differences were not explained by socio-economic disadvantage. CONCLUSIONS: PPHs for physical health conditions are substantially increased in people with MH conditions. Short term (12-month) PPH rates may be a useful lead indicator of increased physical morbidity and less accessible, integrated or effective health care. High hospitalisation rates for vaccine-preventable respiratory infections and hepatitis underline the importance of vaccination in MH service users and suggests potential benefits of prioritising this group for COVID-19 vaccination.

Unrealized potential of drug repositioning in europe during COVID-19 and beyond: a physcian's perspective.

Drug repositioning is the scientific strategy of investigating existing drugs for additional clinical indications. The advantages of drug repositioning are that it benefits patients and that it adds new indications to existing drugs for lower costs compared to de novo drug development. Clinical research groups recognizing efficacy of these "old" drugs for a new indications often face an uphill struggle due to a lack of funding and support because of poor structural and regulatory support for clinical drug development. The current framework for drug repositioning allows "venture capital" companies to abuse loopholes in the legislation to gain long-term market authorization among with excessive high pricing. A new regulatory framework is needed to prevent abuse of the legislation and promote clinical investigator-driven drug repositioning. The COVID-19 pandemic has boosted funding and regulatory support for drug repositioning. The lessons learned from the COVID-19 pandemic should be implemented in a new clear blueprint for drug repositioning. This blueprint should guide clinicians through legislation for drug repositioning in the EU. This review summarizes the routes for registration and discusses the current state of drug repositioning in Europe.