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Introduction: Patients with Multiple Sclerosis (pwMS) treated with Ocrelizumab (OCR) and Fingolimod (FNG) have shown a blunted humoral response to the first two doses of the BNT162b2 mRNA Covid-19 vaccine. The assessment of the safety and the humoral response to a third booster dose of the same vaccine is therefore relevant within this population. Aim(s): To investigate the safety and the humoral response to a third booster dose of the BNT162b2 mRNA Covid-19 vaccine in pwMS on OCR/FNG, comparing it with age- and sex-matched healthy controls (HCs). Method(s): Serum samples were collected from HCs and pwMS treated with OCR or FNG at the following scheduled time points: before the first of two vaccine doses (T0);8 (T1), 16 (T2), 24 (T3) weeks after the first dose;within 8 weeks before (T0b) and after (T1b) the booster dose. IgG antibodies to SARS-CoV-2 trimeric spike protein (Anti-TSP IgG) were quantified and expressed as binding antibody units (BAU)/mL. Result(s): 40 HCs and 47 pwMS (28 on OCR and 19 on FNG) were included in the study. All (100%) HCs mounted a positive (>33.8 BAU/mL) humoral response at T1 and preserved it until (T2-T3- T0b) and after (T1b) the third booster dose. At T0b only 12 (42.9%) pwMS on OCR and 6 (31.6%) on FNG were positive while, at T1b 16 (57.14%) pwMS on OCR and 16 (84.2%) on FNG, passed the threshold of positivity. Anti-TSP IgG titers in HCs were significantly higher than those of pwMS on OCR and on FNG at all time points, while no differences were found at all time points between pwMS on OCR and those on FNG. HCs showed a significant higher (relative) increase of Anti-TSP IgG levels at T1b with respect to OCR (p<.001) and FNG (p=.032) groups. The increase of Anti-TSP IgG levels in the pwMS on FNG was significantly higher than those in the OCR group (p<.001). No socio-demographic, clinical, or laboratory variables were able to predict the increase of anti-TSP IgG levels between T0b and T1b. Neither clinical relapses nor severe adverse events were reported in pwMS after each of the three doses of vaccine during the follow- up period. Conclusion(s): The administration of a third booster dose of BNT162b2 mRNA Covid-19 vaccine to OCR- and FNG-treated pwMS is able to revive the humoral response, independently of any demographic, clinical or laboratory variable, and confirms a good safety and tolerability profile, not only in terms of adverse events but also in terms of MS relapses.
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In this paper, we examine a set of complexly related education policy issues that concern changes to the form and technologies of the state, and changing modalities of government and processes of policy and service delivery, and concomitantly, the re-agenting of education policy within extensive but exclusive policy networks. We also explore the role of the state in creating opportunities for business and social purpose organisations within the delivery and management of state education in response to the ambitions of EdTech (Education Technology) companies seeking to sell their products within the state system. The time is that of COVID-19 and lockdown (2020-2021) and the case is the English Oak National Academy (ONA) – a national platform for remote teaching and learning resources that was conceived and created in England in April 2020, with funding from government and various philanthropists, and designed and run by a team of third sector and business policy entrepreneurs. Alongside and in relation to the ONA we consider a series of UK government policy papers on EdTech, interrogate the membership of the EdTech Leadership Group (ELG) and of the EdTech Advisory Forum. © 2022
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Introduction: Since the worldwide launch of the SARS-CoV-2 vaccine campaign, there have been many uncertainties regarding the immune response to vaccination in patients with multiple sclerosis (pwMS), particularly those on high efficacy disease-modifying therapies (DMTs). Aim: To evaluate humoral response to NT162b2-mRNACovid- 19 vaccine in pwMS on high efficacy DMTs compared to healthy controls (HCs). Methods: We collected serum samples before the first dose and 7 days after the second dose of the NT162b2-mRNA-Covid-19 vaccine from 54 HCs and 93 pwMS on high efficacy DMTs (Ocrelizumab/OCR, Fingolimod/FNG, Natalizumab/NTZ). Exclusion criteria: history of Covid-19, baseline positive SARSCoV- 2 IgG antibodies, steroids administration within the month prior to the first dose of vaccine. Sera were tested using the LIAISONRSARS-CoV-2 TrimericSIgG assay for the detection of IgG antibodies to SARS-CoV-2 spike protein. The IgG-titers were expressed in Binding Antibody Units (BAU) with 33.8 BAU/mL as cut-off. Results: Sera of 51 HCs and 80pwMS (31 OCR, 25 FNG, 24 NTZ) were analyzed, while 3 HCs and 13 pwMS (4OCR, 5FNG, 4NTZ) were kept out due to exclusion criteria. Age, sex, and disease duration were similar across groups. Seven days after the second dose of the vaccine, SARS-CoV-2 IgG antibodies were detected in all HCs and pwMS on NTZ, in 17(54.8%) pwMS on OCR and 10(40%) pwMS on FNG. pwMS on OCR (median 59.8 BAU/mL;P25-75 4.81-598) and FNG (median 21.5;P25-75 7.49-116) showed a significant blunted response (p<0.0001, both) when compared with HCs (median 1860;P25-75 1180-4865) and NTZ patients (p<0.0001, both). pwMS on NTZ mounted a humoral response (median 3015;P25-75 1495-4905) similar to HCs (p=0.52). Interestingly, we observed a positive association between humoral response and time elapsed since the last OCR infusion (rho 0.46,p=0.001) and an inverse correlation between humoral response and treatment duration in pwMS on FTY (rho -0.57,p=0.004). No correlation was found with CD20 levels in the OCR group. Discussion: We found a clear blunted humoral response to NT162b2-mRNA-Covid-19 vaccine in pwMS treated with OCR and FNG, with a significant relationship with treatment duration in FNG-treated pwMS and time elapsed since the last infusion in the OCR-treated pwMS. Contrariwise, we found an efficient humoral response in NTZ-treated pwMS. Further data are needed to inform which strategy could optimize the response to vaccines in pwMS on OCR and FTY.
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Background and aims: Since the worldwide launch of the SARS-CoV-2 vaccine campaign, several concerns apply on the response to vaccines in people with multiple sclerosis (pwMS) particularly those on high efficacy disease modifying therapies (DMTs). We report preliminary data on humoral response to Covid-19 vaccine assessed on four pwMS treated with ocrelizumab (OCR) and compared to that measured in a sample of healthy subjects (HS) enrolled in a surveillance programme at our Clinic. Methods: We collected serum samples -at 0,14,21 days after the first dose and 7 days after the second dose of NT162b2-mRNA-Covid-19 vaccine of: i) 55 health-care workers, and ii) four relapsing MS patients on OCR, that were vaccinated with the same Covid-19 vaccine. All subjects did not have a history of Covid-19 infection. Sera were tested using the LIAISON®SARS-CoV-2 TrimericS-IgG assay (DiaSorin-S.p.A.), for the detection of IgG antibodies to SARS-CoV-2 spike protein. The IgG-titers were expressed in Binding Antibody Units (BAU). Results: Seven days after the second dose of NT162b2-mRNA-Covid-19 vaccine, all HS mounted a significant humoral response (geometric mean 2010.4 BAU/mL C.I.95%1512.7–2672), while all the four pwMS showed a very low response (range 4,9–175 BAU/mL). Conclusions: As expected and in agreement with previous data, we found a blunted humoral response to NT162b2-mRNA-vaccine in pwMS treated with OCR. Further data are urgently needed in order to confirm and expand these preliminary, yet significant results and to inform if there is any strategy to optimize the response to vaccines such as the count of circulating CD20 cells, time-elapsed since the last anti-CD20 drug administration.
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This article deals with the COVID-19 pandemic as a point of acceleration for the emergence of a distinctive and yet unstable problematization of the 20th-century school form. Focusing on the Italian public and policy debate on education and adopting an archaeological analytics, it explores what 'other' coordinates for the forms of schooling are emerging through the encounters, clashes and co-options between different epistemological standpoints. Mapping the knowledge production about the space(s), time(s) and subjectivity(/ies) of schooling, we discuss the emergence of a problematization of the school form articulated around the concept of 'blending' and unfolding around a distinctive set of organizing dualisms: developmentalizing/securing, normalization/pluralization and individual/population. We offer a preliminary sketch of the contours and tensions that constitute the epistemic space where this problematization unfolded. First, we show how medical, economic, digital and educational knowledges converge around the imperative to blend the school form and make it secure and productive through the 'digital'. Second, we describe the paradoxical traits of the emerging figure of the blended-school form at the intersection between different possible configurations of the space(s) and time(s) of schooling and isolate four strategies for the (self-)governing of its subjectivities: therapy, prudentialism, discipline and enhancement.