Impact of COVID-19 on Infants Followed After Discharge from the Neonatal Intensive Care Unit via a Telemedicine Model

Background: While the prevalence of SARS-CoV-2 has remained low among newborns, there is increasing evidence that the COVID-19 pandemic impacted healthcare for families with infants in the neonatal intensive care unit (NICU). However, little is known about the impact of COVID-19 on families with infants discharged from the NICU. During the initial pandemic shutdown, our Neonatal Follow-Up Program (NFP) transitioned to a virtual platform and implemented a survey about new/worsened obstacles families might be facing due to the pandemic as standard of care. We aimed to: 1) evaluate for patient-level differences in virtual neonatal follow-up visit rates;and 2) characterize the social impact of the pandemic on families followed via a large, urban NFP. Methods: All infants scheduled for NFP visits during our telemedicine epoch (March 13, 2020- July 31, 2020) were eligible for inclusion. We compared the family demographics and medical history of infants whose televisits occurred to those for whom televisits did not occur as scheduled. Secondly, we conducted a descriptive analysis of caregiver responses to the pandemic-specific challenges survey. Given the known disproportionate impact of SARS-CoV-2 on communities of color, we also assessed for differences in responses by self-identified race. Data was manually extracted by three coders from the electronic medical record who showed high interrater agreement. Results: After excluding visits cancelled by the provider team, we found 499 clinic encounters for 678 scheduled visits during the study period (i.e. a show-rate of 73.6%). When comparing patients who completed their virtual visit to those who did not, we found no differences in infants' sex, birthweight or gestational age at birth, nor in their reliance on medical technology at discharge. (Table 1). There were also no differences by caregiver self-reported race/ethnicity, but infants whose visits did not occur were more often covered by public insurance. (Table 1). In addition, 43.9% of caregivers reported that their employment had changed since the onset of the shutdown and 6.1% reported housing changes. (Table 2). Eight percent of families endorsed having trouble accessing at least one basic infant necessity (i.e. formula, diapers or medical supplies) due to cost issues and 10% of families endorsed having trouble accessing such necessities due to availability. Non-Hispanic Black caregivers reported this challenge and other infant food-related challenges more often than non-Hispanic White caregivers. Conclusion: We found socioeconomic disparities with respect to virtual follow-up visit rates after discharge from the NICU during the initial COVID-19 shutdown. In addition to navigating the discharge of their infant, families also reported pandemic-enhanced stressors related to difficulty accessing basic infant needs as well as employment and housing changes. Our study highlights the importance of proactive strategies to screen for and mitigate the unique economic vulnerabilities of families discharged from the NICU even beyond the pandemic. (Table Presented).

10 years of pharmacovigilance legislation: the perspective of a national agency

In 2012, the new pharmacovigilance legislation came into force, which established a uniform standard for the safety monitoring of medicines in Europe. These new legal requirements resulted in impactful changes, including the creation of a further scientific committee at the European Medicines Agency’s (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC). It also resulted in a new framework for signal management, the establishment of a periodic safety update report (PSUR) single assessment and additional requirements for risk management plans (RMPs). This article reflects upon the past 10 years’ experience, including the recent pandemic. Suggestions are made on areas where the legal framework may need to be further adapted to a changing regulatory environment.

HIGH NEUTRALIZING CONVALESCENT PLASMA RESULTS in RAPID CLEARANCE of SARS-CoV-2

Background: Neutralizing antibodies are recognized as a principal correlate for protection induced by SARS-CoV-2 vaccines and have been considered for antiviral treatment as an active component in convalescent plasma therapy (CPT) and as monoclonal antibody therapeutics. However, unless used at a very early stage of infection, antibody-based SARS-CoV-2 therapies have not achieved the substantial disease-modulating effect hoped for. Methods: Here, we conducted a proof-of-principle study of CPT based on a phase I trial in thirty hospitalized COVID-19 patients with a median interval between the onset of symptoms and the first transfusion of 9 days (IQR, 7-11.8 days). A comprehensive longitudinal monitoring of the virologic, serologic, and disease status of recipients in conjunction with detailed post-hoc seroprofiling of transfused convalescent plasma allowed deciphering of parameters on which plasma therapy efficacy depends. Results: In this study, CPT was safe as evidenced by the absence of transfusion-related adverse events. We also observed an overall low mortality (3.3%). Treatment with highly neutralizing plasma was significantly associated with faster virus clearance, as demonstrated by Kaplan-Meier analysis (p = 0.034) and confirmed in a parametric survival model including viral load and comorbidity (adjusted hazard ratio (HR) = 3.0 [95% confidence interval (CI) 1.1;8.1], p = 0.026) (Figure 1). Endogenous immunity had strong effects on virus control. Lack of endogenous neutralizing activity at baseline was associated with a higher risk of systemic viremia. The onset of endogenous neutralization had a noticeable effect on viral clearance but, importantly, even after adjusting for their endogenous neutralization status recipients benefitted from plasma therapy with high neutralizing antibodies (HR= 4.0 [95% CI 1.3;13], p = 0.017). Conclusion: In summary, our data demonstrate a clear impact of neutralizing antibody therapeutics on the rapid clearance of viremia and with this provide directions for improved efficacy evaluation of current and future SARS-CoV-2 therapies beyond antibody-based interventions. In particular, incorporating an assessment of the endogenous immune response and its dynamic interplay with viral production is critical for determining therapeutic effect.

Mask-invariant Face Recognition through Template-level Knowledge Distillation

The emergence of the global COVID-19 pandemic poses new challenges for biometrics. Not only are contactless biometric identification options becoming more important, but face recognition has also recently been confronted with the frequent wearing of masks. These masks affect the performance of previous face recognition systems, as they hide important identity information. In this paper, we propose a mask-invariant face recognition solution (MaskInv) that utilizes template-level knowledge distillation within a training paradigm that aims at producing embeddings of masked faces that are similar to those of non-masked faces of the same identities. In addition to the distilled knowledge, the student network benefits from additional guidance by margin-based identity classification loss, ElasticFace, using masked and non-masked faces. In a step-wise ablation study on two real masked face databases and five mainstream databases with synthetic masks, we prove the rationalization of our MaskInv approach. Our proposed solution outperforms previous state-of-the-art (SOTA) academic solutions in the recent MFRC-21 challenge in both scenarios, masked vs masked and masked vs non-masked, and also outperforms the previous solution on the MFR2 dataset. Furthermore, we demonstrate that the proposed model can still perform well on unmasked faces with only a minor loss in verification performance. The code, the trained models, as well as the evaluation protocol on the synthetically masked data are publicly available: https://github.com/fdbtrs/Masked-Face-Recognition-KD. © 2021 IEEE.