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Open Forum Infectious Diseases ; 9(Supplement 2):S924, 2022.
Article in English | EMBASE | ID: covidwho-2190038


Background. Vaccination strategies that provide enhanced immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants are needed. We evaluated the safety and immunogenicity of a bivalent omicron containing vaccine, mRNA-1273.214 (50 mug), administered as a second booster dose in adult participants. Methods. In this ongoing phase 2/3 trial, 50 mug of the bivalent vaccine mRNA-1273.214 (25 mug each ancestral Wuhan-Hu-1 and omicron BA.1 spike mRNAs) or 50 mug of the authorized mRNA-1273 were administered as second boosters in adults who previously received a 2 dose (100 mug) primary series and a first booster (50 mug) dose of mRNA-1273 (>= 3 months prior). Primary objectives were safety and reactogenicity and immunogenicity 28 days post-booster dose. Results. In participants with no prior SARS-CoV-2 infection who received booster doses of mRNA-1273.214 (n=334) or mRNA-1273 (n=260), neutralizing antibody (nAb) geometric mean titers (GMTs [95% confidence interval (CI)]) against omicron BA.1 were 2372.4 (2070.6-2718.2) and 1473.5 (1270.8-1708.4), respectively. The model-based GMT ratio (GMR [97.5% CI]) of mRNA-1273.214 compared to mRNA-1273 was 1.75 (1.49-2.04), meeting the pre-specified superiority criterion against omicron BA.1. The pre-specified criterion for non-inferiority against the ancestral SARS-CoV-2 strain was also met. Additionally, mRNA-1273.214 elicited higher GMTs (727.4 [632.8-836.1]) than mRNA-1273 (492.1 [431.1-561.9]) against omicron subvariants BA.4/BA.5 [GMR (95% CI) 1.69 [1.51-1.90])]. Binding antibody responses against alpha, beta, gamma, delta, and omicron were numerically higher in the mRNA-1273.214 group compared to mRNA-1273. mRNA-1273.214 GMTs were consistently higher across age (18-< 65 and >= 65 years) and pre-booster SARS-CoV-2 infection subgroups (Figure). Safety and reactogenicity were similar for both vaccine groups. Conclusion. The bivalent omicron containing mRNA-1273.214 elicited superior nAb responses against omicron 28 days post-immunization compared to mRNA-1273 regardless of age and prior SARS-CoV-2 infection;no new safety concerns were identified. (Figure Presented).

British Journal of Surgery ; 109(Supplement 4):iv2-iv3, 2022.
Article in English | EMBASE | ID: covidwho-2134867


Introduction: WHO declared a pandemic of COVID-19 in March 2020. This study analyses the impact of COVID-19 on beta-cell replacement therapy in the UK. Method(s): Pancreas and islet donation and transplant activity in the period March 2020/2021 was compared with the same period the previous year. Result(s): 2,180 patients had a functioning graft during March 2020/2021. 5.8%(n=126) tested positive for COVID-19 and two died (1%). In this period there was a 43% reduction in solid organ donors n=1,615, compared with the previous year, n=2,840. Of the 625 solid organ donors with a pancreas offered, 32% had the pancreas retrieved compared with 51% the previous period. 97 whole pancreas and islet transplants were performed in the UK down 54% from the prior period. Of the 84 pancreas transplant recipients;four tested positive for COVID-19 but none died, and two grafts failed within the first week from vascular thrombosis (neither were COVID-19 positive). Of the 13 SIK and islet alone transplant recipients, two tested positive for COVID-19 but neither died. Of these SIK transplants, one is known to have failed within a month and this is equivalent to that seen in the previous time period. To our knowledge, no patient receiving beta cell replacement therapy died of COVID during the first year of the pandemic despite immunosuppression. Conclusion(s): In the UK, pancreas, and islet transplantation have continued during the pandemic at a lower rate. Outcomes following transplantation within the COVID era are, so far, similar to those in the period prior. Take-home message: Outcomes following transplantation within the COVID era are, so far, similar to those in the period prior.

BMJ supportive & palliative care ; 01:01, 2020.
Article in English | MEDLINE | ID: covidwho-953186


BACKGROUND: Paediatric palliative care makes frequent use of orodispersible and transmucosal drug delivery routes. The limited published experience of this practice suggests that it enables the delivery of needle-free symptom relief, with the potential to train family carers to administer anticipatory medications without reliance on trained health professionals. AIMS: To identify orodispersible and potential transmucosal alternatives that may be used in adults in the event of a patient having no oral or intravenous route and no access to subcutaneous injections. METHODS: The author panel identified medications through review of multiple drug formularies, review of the published evidence and their experience. Where possible, licensed alternatives were identified and any 'off label' or unlicensed medications clearly highlighted. RESULTS: A list of 27 medications is provided, which could be used either via the orodispersible or transmucosal alternative route for healthcare professionals delivering end of life care to consider when the licensed alternative routes are unavailable. All users of this guide are encouraged to use their professional judgement whenever selecting a medication for a patient, recognising that this review is neither a guideline nor a systematic review, and taking account of licensing considerations, adverse effects, potential unpredictability of time to effect and contraindications. CONCLUSION: Should it be necessary to use these orodispersible or transmucosal alternatives then any experience gained should be reported in the literature. Combined with further research, this experience offers the possibility of reducing injection frequency and inherent delays in medication administration, particularly in the community setting during the COVID-19 pandemic.