scholarly journals Vaccine Regulation, Licensing and Approval in USA

Author(s):  
S. Shashank ◽  
M. P. Venkatesh

Vaccines are the foremost effective public and personal preventive health interventions, leading to vital reductions in vaccine-preventable diseases and in substantial price savings to the United States health care system. A vaccine is a biological preparation that will increase the immunity to a particular illness. Vaccine development is commonly found to be difficult and needs sharp understanding and information of recent developments by physicians and experts to confirm that safe and effective vaccines are manufactured with minimum risk. A strict regulative method to see the safety, efficacy, and quality should be achieved throughout the event of vaccine development for its authorization. The Office of Vaccines Research and Review at the CBER of the US-FDA is the federal administrative body charged with guaranteeing the safety, purity, and efficacy of vaccines within US. The licensing rules are published in the Title 21 CFR Part 60. Current authority for the regulation of vaccines is in Section 351(a) of the Public Health Service Act (PHS). Vaccine licensure, development of recommendations to be used, and implementation of these recommendations resulting in uptake, community protection, and result on illness burden represent a posh system that needs collaboration within the areas of basic science, public health, vaccine delivery and outcome observance, and public perception.

2021 ◽  
Author(s):  
Zidian Xie ◽  
Xueting Wang ◽  
Yan Jiang ◽  
Yuhan Chen ◽  
Shengyuan Huang ◽  
...  

Background: COVID-19 vaccines play a vital role in combating the COVID-19 pandemic. Social media provides a rich data source to study public perception of COVID-19 vaccines. Objective: In this study, we aimed to examine public perception and discussion of COVID-19 vaccines on Twitter in the US, as well as geographic and demographic characteristics of Twitter users who discussed about COVID-19 vaccines. Methods: Through Twitter streaming Application Programming Interface (API), COVID-19-related tweets were collected from March 5th, 2020 to January 25th, 2021 using relevant keywords (such as "corona", "covid19", and "covid"). Based on geolocation information provided in tweets and vaccine-related keywords (such as "vaccine" and "vaccination"), we identified COVID-19 vaccine-related tweets from the US. Topic modeling and sentiment analysis were performed to examine public perception and discussion of COVID-19 vaccines. Demographic inference using computer vision algorithm (DeepFace) was performed to infer the demographic characteristics (age, gender and race/ethnicity) of Twitter users who tweeted about COVID-19 vaccines. Results: Our longitudinal analysis showed that the discussion of COVID-19 vaccines on Twitter in the US reached a peak at the end of 2020. Average sentiment score for COVID-19 vaccine-related tweets remained relatively stable during our study period except for two big peaks, the positive peak corresponds to the optimism about the development of COVID-19 vaccines and the negative peak corresponds to worrying about the availability of COVID-19 vaccines. COVID-19 vaccine-related tweets from east coast states showed relatively high sentiment score. Twitter users from east, west and southern states of the US, as well as male users and users in age group 30-49 years, were more likely to discuss about COVID-19 vaccines on Twitter. Conclusions: Public discussion and perception of COVID-19 vaccines on Twitter were influenced by the vaccine development and the pandemic, which varied depending on the geographics and demographics of Twitter users.


2017 ◽  
Vol 22 (3) ◽  
pp. 138-151
Author(s):  
Angela K. Shen ◽  
Alice Y. Tsai ◽  
Guthrie S. Birkhead

Purpose The purpose of this paper is to outline the organization and governance of the US vaccine and immunization enterprise. It describes the major components of the US system including the various relationships between major federal government entities, stakeholders, and advisory committees that inform government policymaking at various points in the system. Design/methodology/approach The authors describe the complex interdependent network of partners that engage in a wide range of activities such as disease surveillance, research, vaccine development, regulatory licensure, practice recommendations, financing, service delivery, communications, and post-licensure monitoring. Findings The US system of governance is highly participatory and focuses on a transparent and open engagement, with input from a wide range of partners to inform decision-making. This collaborative framework allows many inputs to be heard and helps support the US vaccine and immunization system as it evolves to meet the continued public health needs in the USA through the optimal use of safe and effective vaccines. Originality/value This is an invited article on the US vaccine and immunization enterprise. The development and availability of vaccines in the USA has had profound impact on mortality and morbidity and public health (Centers for Disease Control and Prevention, 2011). The success of this enterprise is a result of a blended public and private sector system with partnerships at the federal, state, and local levels of government to optimize the use of safe and effective vaccines. Governance structures have been established to support the interaction and decision-making among the federal and non-federal actors toward the common goal of controlling and preventing infectious diseases.


Author(s):  
Marie-Helen Maras ◽  
Michelle D. Miranda

AbstractIn the fall of 2014, the US was faced with the reality that a deadly, foreign virus had entered its borders. Ebola, a disease thought to be of little threat to the US yet classified as a major bioterrorism agent, became a reality for the American government and its citizens. The introduction of Ebola unveiled many deficiencies in the country’s health care system, international travel policies, and ability to control or restrict the movement of exposed individuals in order to protect the larger population. The need to review and establish legal guidelines and policies to deal with these deficiencies is paramount: the inherent lack of training and education; weaknesses in monitoring, maintenance, and treatment; and the lack of uniform guidelines to isolate international travelers have all demonstrated that the country may not be able to control a larger-scale threat in the future.


2021 ◽  
Vol 55 (2) ◽  
pp. 395-418
Author(s):  
Akwasi Owusu-Bempah

Canada has received praise and international attention for its departure from strict cannabis prohibition and the introduction of a legal regulatory framework for adult use. In addition to the perceived public health and public safety benefits associated with legalization, reducing the burden placed on the individuals criminalized for cannabis use served as an impetus for change. In comparison to many jurisdictions in the United States, however, Canadian legalization efforts have done less to address the harms that drug law enforcement has inflicted on individuals and communities. This article documents the racialized nature of drug prohibition in Canada and the US and compares the stated aims of legalization in in both jurisdictions. The article outlines the various reparative measures being proposed and implemented in America and contrasts those with the situation in Canada, arguing, furthermore that the absence of social justice measures in Canadian legalization is an extension of the systemic racism perpetuated under prohibition.


2008 ◽  
Vol 56 (4) ◽  
pp. 429-433 ◽  
Author(s):  
K. Harlander

Bioethanol is made from sugar- or starch-containing plants that are also used in food production. In the public perception this has led to an emotional resistance against biofuels, which in real terms is not substantiated. Generally biofuels are a political product. Triggered by the oil crisis in the 1970s, fuel ethanol programmes were first launched in Brazil and in the United States. Concerns regarding energy security and sustainability, together with the option of new markets for surplus agricultural production, have led to similar measures in the EU and other countries in recent years. Accordingly, the industry invested heavily in new bioethanol plants — especially in the US — and created an additional demand for maize and wheat, with some record-breaking prices noted in late 2007. A look back into statistics shows a drastic decline in real prices for decades, which have now simply returned to the level of 30 years ago. The grain used for bioethanol is currently only 1.6% in the EU and is therefore unlikely to be the real driver of price development. The European Commission concludes in its review of agricultural markets that Europe can do both: nutrition and biofuels.


2020 ◽  
Author(s):  
Daisy Massey ◽  
Chenxi Huang ◽  
Yuan Lu ◽  
Alina Cohen ◽  
Yahel Oren ◽  
...  

BACKGROUND The coronavirus disease 2019 (COVID-19) has continued to spread in the US and globally. Closely monitoring public engagement and perception of COVID-19 and preventive measures using social media data could provide important information for understanding the progress of current interventions and planning future programs. OBJECTIVE To measure the public’s behaviors and perceptions regarding COVID-19 and its daily life effects during the recent 5 months of the pandemic. METHODS Natural language processing (NLP) algorithms were used to identify COVID-19 related and unrelated topics in over 300 million online data sources from June 15 to November 15, 2020. Posts in the sample were geotagged, and sensitivity and specificity were both calculated to validate the classification of posts. The prevalence of discussion regarding these topics was measured over this time period and compared to daily case rates in the US. RESULTS The final sample size included 9,065,733 posts, 70% of which were sourced from the US. In October and November, discussion including mentions of COVID-19 and related health behaviors did not increase as it had from June to September, despite an increase in COVID-19 daily cases in the US beginning in October. Additionally, counter to reports from March and April, discussion was more focused on daily life topics (69%), compared with COVID-19 in general (37%) and COVID-19 public health measures (20%). CONCLUSIONS There was a decline in COVID-19-related social media discussion sourced mainly from the US, even as COVID-19 cases in the US have increased to the highest rate since the beginning of the pandemic. Targeted public health messaging may be needed to ensure engagement in public health prevention measures until a vaccine is widely available to the public.


2021 ◽  
Author(s):  
Tao Hu ◽  
Siqin Wang ◽  
Wei Luo ◽  
Mengxi Zhang ◽  
Xiao Huang ◽  
...  

BACKGROUND The COVID-19 pandemic has imposed a large, initially uncontrollable, public health crisis both in the US and across the world, with experts looking to vaccines as the ultimate mechanism of defense. The development and deployment of COVID-19 vaccines have been rapidly advancing via global efforts. Hence, it is crucial for governments, public health officials, and policy makers to understand public attitudes and opinions towards vaccines, such that effective interventions and educational campaigns can be designed to promote vaccine acceptance OBJECTIVE The aim of this study is to investigate public opinion and perception on COVID-19 vaccines by investigating the spatiotemporal trends of their sentiment and emotion towards vaccines, as well as how such trends relate to popular topics on Twitter in the US METHODS We collected over 300,000 geotagged tweets in the US from March 1, 2020 to February 28, 2021. We examined the spatiotemporal patterns of public sentiment and emotion over time at both national and state scales and identified three phases along the pandemic timeline with the significant changes of public sentiment and emotion, further linking to eleven key events and major topics as the potential drivers to induce such changes via cloud mapping of keywords and topic modelling RESULTS An increasing trend of positive sentiment in parallel with the decrease of negative sentiment are generally observed in most states, reflecting the rising confidence and anticipation of the public towards vaccines. The overall tendency of the eight types of emotion implies the trustiness and anticipation of the public to vaccination, accompanied by the mixture of fear, sadness and anger. Critical social/international events and/or the announcements of political leaders and authorities may have potential impacts on the public opinion on vaccines. These factors, along with important topics and manual reading of popular posts on eleven key events, help identify underlying themes and validate insights from the analysis CONCLUSIONS The analyses of near real-time social media big data benefit public health authorities by enabling them to monitor public attitudes and opinions towards vaccine-related information in a geo-aware manner, address the concerns of vaccine skeptics and promote the confidence of individuals within a certain region or community, towards vaccines


Arts ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. 112
Author(s):  
Kevin C. Moore

Steven Soderbergh’s pandemic thriller Contagion (2011) was trending strongly on streaming services in the US in the early days of COVID-19 restrictions, where the fiction took on an unforeseen afterlife amid a real pandemic. In this new context, many viewers and critics reported that the film seemed “uncanny,” if not prophetic. Frameworks such as Priscilla Wald’s notion of the “outbreak narrative,” as well Richard Grusin’s “premediation,” may help to theorize this affective experience on the part of viewers. Yet the film was also designed as a public health propaganda film to make people fear and better prepare for pandemics, and the present account works to recover this history. Although the film takes liberties with reality, in particular by proposing an unlikely vaccine-development narrative, Soderbergh and screenwriter Scott Z. Burns consulted prominent scientists and policymakers as they wrote the film, in particular Larry Brilliant and Ian Lipkin. These same scientists were consulted again in March 2020, when an effort spearheaded by Columbia University’s Mailman School of Public health reunited the star-studded cast of Contagion, who created at home a series of public health announcement videos that might be thought of as a kind of re-adaptation of the film for the COVID-19 era. These public service announcements touch on key aspects of pandemic experience premediated by the original film, such as social distancing and vaccine development. Yet their very production as “work-from-home” illustrates how the film neglected to address the status of work during a pandemic. Recovering this history via Contagion allows us to rethink the film as a cultural placeholder marking a shift from post-9/11 security politics to the pandemic moment. It also becomes possible to map the cultural meaning of the technologies and practices that have facilitated the pandemic, which shape a new social order dictated by the fears and desires of an emerging work-from-home class.


2019 ◽  
Vol 10 (3) ◽  
pp. 257-271
Author(s):  
Elizabeth R. Earle

This study examines the recent developments in the #MeToo and Time’s Up Movements in the United States and how these developments have been portrayed in the US media. Through examining examples of US media, this article shows the media’s portrayal of the movement as politicized and polarized changed and developed after the appointment of Brett Kavanaugh to the US Supreme Court. The article argues that after Kavanaugh’s appointment, the media began to downplay the tensions of race and class in the #MeToo movement. Instead of focusing on tensions of race and class, the media shifted to focus on the polarization of #MeToo along political party lines.


2020 ◽  
Vol 45 (6) ◽  
pp. 967-981 ◽  
Author(s):  
Sarah E. Gollust ◽  
Rebekah H. Nagler ◽  
Erika Franklin Fowler

Abstract The coronavirus public health crisis is also a political-communication and health-communication crisis. In this article, the authors describe the key communication-related phenomena and evidence of concerning effects manifested in the United States during the initial response to the pandemic. The authors outline the conditions of communication about coronavirus that contribute to deleterious outcomes, including partisan cueing, conflicting science, downplayed threats, emotional arousal, fragmented media, and Trump's messaging. The authors suggest these have contributed to divergent responses by media sources, partisan leaders, and the public alike, leading to different attitudes and beliefs as well as varying protective actions taken by members of the public to reduce their risk. In turn, these divergent communication phenomena will likely amplify geographic variation in and inequities with COVID-19 disease outcomes. The authors conclude with some suggestions for future research, particularly surrounding communication about health inequity and strategies for reducing partisan divergence in views of public health issues in the future.


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