Updated Real-World Safety of the Pfizer-BioNTech COVID-19 Vaccine in Pregnancy: Data from the Organization of Teratology Information Specialists (OTIS) Pregnancy Registry

Purpose: Preliminary data indicate that pregnant women infected with COVID-19 are at increased risk of pregnancy complications (US Centers for Disease Control and Prevention, October 2022). Information on the real-world safety of COVID-19 vaccination in pregnancy is essential. We sought to describe preliminary results for pregnancy status among pregnancy registry participants enrolled in an ongoing safety study of the Pfizer-BioNTech COVID-19 vaccine to date. Method(s): This study uses data from the Organization of Teratology Information Specialists (OTIS) Pregnancy Registry as part of the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) which enrolls pregnant women residing in the US or Canada. Data are captured through maternal interviews and the ion of medical records. The study population for this descriptive analysis includes Registry participants who met eligibility criteria on or after December 11, 2020, the date the US Food and Drug Administration granted emergency-use authorization for the Pfizer-BioNTech vaccine. The target sample size is 1,100 pregnant women who received any dose of the Pfizer-BioNTech vaccine from 30 days prior to the last menstrual period through the end of pregnancy, and 900 comparison women who received no COVID-19 vaccine in pregnancy. Result(s): Among pregnant women participating in the Registry between 11 December 2020 and 22 July 2022, 1,100/1,100 participants (100.0% of the target sample) were enrolled as part of the Pfizer-BioNTech COVID-19 vaccine exposure cohort, and 635/900 participants (70.6% of the target sample) were enrolled in the comparator cohort. As of 22 July 2022, 858 (78.0%) in the vaccine exposure cohort and 313 (34.8%) in the comparator cohort had completed pregnancies. Descriptive data indicated numerically similar percentages of pregnancies ending in at least one liveborn infant, spontaneous abortions, stillbirths, and elective terminations across the exposed cohort stratified by trimester of the earliest dose of the Pfizer-BioNTech COVID-19 vaccine received in pregnancy, and overall in the unexposed comparator cohort. Conclusion(s): Preliminary data have not identified any new safety concerns thus far for pregnant women who receive the Pfizer-BioNTech COVID-19 vaccine during pregnancy. Funding(s): This study was conducted as a collaboration between the University of California San Diego and Pfizer. Pfizer is the study sponsor.

Paxlovid Prophylaxis or Treatment in Pregnancy: Data from the Organization of Teratology Information Specialists (OTIS) Pregnancy Registry

Background: The US Food and Drug Administration under an Emergency Use Authorization approved use of Paxlovid (nirmatrelavir and ritonavir) for the treatment of mild-to-moderate COVID-19 in adults and children with a positive test for SARS-Co-2 and who are at high risk for progression to severe COVID-19. Pregnant women are at increased risk of severe complications resulting from COVID-19 infection;however, minimal data on the safety of Paxlovid in human pregnancy are available. Objective(s): The objectives of this study are to assess risks of major congenital malformations, spontaneous abortion, elective termination, stillbirth, preterm delivery, small for gestational age infants at birth, or infants who were small for age at one year in pregnancies/infants prenatally exposed to Paxlovid in pregnancy compared to individuals who did not receive this treatment. Design(s): This study involves prospective data from the Organization of Teratology Information Specialists (OTIS) Pregnancy Registry which enrolls pregnant women residing in the US or Canada and captures data through maternal interviews and ion of medical records. Result(s): Among pregnant women participating in the OTIS Pregnancy Registry as of February 1, 2023, 59 reported exposure to Paxlovid in pregnancy;25.4% exposed within 30 days prior to the last menstrual period and through the first trimester, 42.4% exposed in second trimester, and 32.2% exposed in the third trimester. As of January 2023, 17 of those enrolled have completed pregnancy outcomes. One was lost to follow-up. Of the remainder, there were no adverse pregnancy outcomes reported. Conclusion(s): Very limited data are available on this potentially beneficial treatment in pregnancy. To date, no serious signals for this exposure have been detected.

COVID-19 and Well-Being in Remote Coastal Communities—A Case Study from Iceland

This study utilizes a recently developed framework for the well-being economy to evaluate the impacts of COVID-19 in the sparsely populated Westfjords region of northwestern Iceland. A total of 42 semi-structured interviews were conducted with a broad spectrum of local community members, nearly all undertaken in October 2021. Local impacts to human and social capital were very evident, whilst economic consequences to individuals and business were largely mitigated through national economic packages. The remoteness of the Westfjords and pre-existing challenges, such as exposure to nature disasters, a harsh climate, and limited infrastructure, provided a bedrock of resilience with which to tackle the pandemic. This underpinned the sustainability of the communities, and flexible approaches to work and education constrained some of the worst potential effects of social distancing and isolation. Nevertheless, some socio-demographic groups remained harder hit than others, including the elderly in nursing homes and non-Icelandic speaking foreigners, who were marginalized via isolation and lack of information provision in the early, most severe outbreaks of COVID-19. The study demonstrated the coping mechanisms and solutions that were adopted to sustain subjective and community well-being, whilst reinforcing the importance of utilizing local community strengths in tackling the many challenges induced by a pandemic crisis. © 2022 by the authors.

Social Media vs. News Platforms: A Cross-analysis for Fake News Detection Using Web Scraping and NLP

With the widespread use of social media platforms within our modern society, these platforms have become a popular medium for disseminating news across the globe. While some of these platforms are considered reliable sources for sharing news, others publicize the information without much validation. The transmission of fake news on social media impacts people's behavior and negatively influences people's decisions. During the COVID-19 outbreak, it was more evident than ever. This has led to a demand for conducting research studies to explore sophisticated approaches to assess the integrity of news worldwide. The main objective of this research paper was to outline our proposed experimental methodology to detect and access fake news using Data Mining and Natural Language Processing. The presented research effort provides a method to verify the authenticity of the news disseminated in social networks by dividing the process into four significant stages: news aggregation, publication collection, data analysis, and matching results. © 2022 ACM.

Introducing an Ethics Framework for health priority-setting in South Africa on the path to universal health coverage

Y Background. South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis. Objectives. To develop and test an Ethics Framework for use in the SA context for health priority-setting. Methods. The Framework was developed iteratively by the authors and a multidisciplinary panel (18 participants) over a period of 18 months, using the principles outlined in the 2015 NHI White Paper as a starting point. The provisional Ethics Framework was then tested with multi-stakeholder simulated appraisal committees (SACs) in three provinces. The membership of each SAC roughly reflected the composition of a potential SA HTA committee. The deliberations and dedicated focus group discussions after each SAC meeting were recorded, analysed and used to refine the Framework, which was presented to the Working Group for review, comment and final approval. Results. This article describes the 12 domains of the Framework. The first four (Burden of the Health Condition, Expected Health Benefits and Harms, Cost-Effectiveness Analysis, and Budget Impact) are commonly used in HTA assessments, and a further eight cover the other ethical domains. These are Equity, Respect and Dignity, Impacts on Personal Financial Situation, Forming and Maintaining Important Personal Relationships, Ease of Suffering, Impact on Safety and Security, Solidarity and Social Cohesion, and Systems Factors and Constraints. In each domain are questions and prompts to enable use of the Framework by both analysts and assessors. Issues that arose, such as weighting of the domains and the availability of SA evidence, were discussed by the SACs. Conclusions. The Ethics Framework is intended for use in priority-setting within an HTA process. The Framework was well accepted by a diverse group of stakeholders. The final version will be a useful tool not only for HTA and other priority-setting processes in SA, but also for future efforts to create HTA methods in SA and elsewhere.

Pericoronial writing from China and the diaspora

This article analyses what Margaret Atwood calls the literature of 'ustopia'. The portmanteau term brings together the utopia and dystopia categories because Atwood argues that one contains the germ of the other. Ustopian writing is a body of work that is helpful when it comes to understanding current destruction to lives and livelihoods, and imagining our post-coronavirus future. The present article thus explores four works of ustopian writing from China and the diaspora, three of them having been written before the current COVID-19 crisis but all shedding light on it. Fang Fang's Wuhan Diary (2020) represents the first real work of postcoronial literature in what seems likely to be an outpouring over the coming years. It is anticipated very ably by the precoronial texts also analysed here - Mo Yan's Frog ([2009] 2014), Ma Jian's China Dream (2018) and Ling Ma's Severance (2018) - which presage the post-COVID dispensation. Taken together, they form a body of work that the article terms pericoronial writing.