Flushed But Not Forgotten: The Rising Costs and Opportunities of Disposable Wet Wipes

The increasing popularity of single-use wet wipes across a variety of applications has caused environmental and economic challenges. Due to their convenience and low cost, disposable nonwoven wipes have become a necessity in the lives of many. However, consumers rarely consider the end-of-life of these items. Despite efforts from stakeholders, including wipes manufacturers and wastewater experts, there is frequent confusion among consumers regarding appropriate disposal. Many consumers flush wipes that are not compatible with municipal sewer systems, causing considerable damage. Additionally, wipes have poor environmental outcomes, as they often contain non-renewable plastics or are unable to biodegrade under disposal conditions. Previously, the wet wipes industry was projected to grow an average of 6% between 2021 and 2025;however, the use of these disposable items is projected to be much higher due to the COVID-19 pandemic. This paper reviews the market, key challenges, and technical properties of single-use nonwoven wipes. An emphasis is placed on the unique properties and associated challenges of flushable wipes. With strong market demands, consumers are unlikely to abandon single-use wipes, and therefore innovative solutions are required to solve the main environmental and technical challenges associated with flushable and non-flushable wipes.

Compensation programs for COVID-19 vaccine injuries

More than 200 million Americans, and billions of people worldwide, have received one or more doses of a vaccine to protect against Coronavirus Disease 2019 (COVID-19). Most common side effects to COVID-19 vaccines are mild and generally resolve in a few days. However, in rare instances, COVID-19 vaccines can cause serious adverse events. For example, roughly one person out of every 200,000 who receives an mRNA-based COVID-19 vaccine experiences a severe allergic reaction. Other reported serious adverse events, such as myocarditis and Guillain- Barré Syndrome, are rare but may be associated with some COVID-19 vaccines. Individuals who believe they are injured by COVID-19 vaccines may seek compensation for those injuries and other associated harms or costs. Absent an applicable federal law, individuals allegedly injured by a vaccine might seek redress by filing a state tort law claim against the vaccine manufacturer. However, federal law has two distinct compensation regimes that limit legal liability for vaccine manufacturers and provide potential compensation-without requiring a showing of fault-for individuals harmed by adverse reactions to vaccines. For injuries and deaths associated with most vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in the United States (such as pediatric and seasonal influenza vaccines), the National Vaccine Injury Compensation Program (VICP) may provide compensation. During public health emergencies declared under the Public Readiness and Emergency Preparedness Act (PREP Act), the Countermeasures Injury Compensation Program (CICP) may provide compensation for injuries and deaths resulting from the administration of "covered countermeasures," which may include vaccines. The VICP and CICP regimes are similar but distinct. Compensation through CICP is generally somewhat more limited than through VICP. CICP is a regulatory process administered by the Health Resources and Services Administration (HRSA), an agency within the U.S. Department of Health and Human Services (HHS). CICP compensation is available only for death or serious injuries resulting from a covered countermeasure that warrant hospitalization or lead to a significant loss of function or disability. A claimant must generally file a request form and associated documentation with HRSA within one year of the date that the covered countermeasure was administered. For injuries not listed by the Secretary of HHS on a Countermeasure Injury Table, the claimant must demonstrate that the injury was a direct result of the countermeasure's administration based on compelling medical and scientific evidence. Eligibility and compensation decisions are made by HRSA;judicial review is not available. CICP compensation is limited to reasonable medical expenses, loss of employment income, and a death benefit in cases where the claimant's death is a direct result of the administration or use of a covered countermeasure. Under the Secretary of HHS's current PREP Act Declaration for COVID-19, FDA-authorized or -approved COVID-19 vaccines are covered countermeasures. While a PREP Act declaration is in effect, CICP is the sole remedy available for injuries related to covered countermeasures, including any covered vaccines. As a result, CICP-and not VICP-will apply to injuries resulting from COVID-19 vaccinations while the public health emergency persists and the Declaration remains in force. After the termination of the PREP Act public health emergency for COVID-19, COVID-19 vaccine injuries may be compensated through VICP, contingent on additional regulatory and statutory changes. In order for VICP to apply to a COVID-19 vaccine, (1) the vaccine must be recommended by the CDC for routine administration to children or pregnant women;(2) the vaccine must be made subject by act of Congress to the excise tax that funds VICP;and (3) the Secretary of HHS must add the vaccine to the Vaccine Injury Table, which lists injuries and conditions associated with covered vaccines. Presuming all of those cha ges occur, VICP would apply to COVID-19 vaccine injuries. To receive compensation through VICP for a vaccine-related injury or death, the injured person must file a petition with the U.S. Court of Federal Claims, generally within three years of the first symptom or significant aggravation of the injury, or within two years of a death or four years of the first symptom resulting in death. To receive compensation, the injured party must show either that he or she experienced an injury listed for the vaccine in the Vaccine Injury Table within the time frame specified in the Table, or directly prove that the vaccine caused the injury. Eligibility and compensation determinations are made by a special master in a trial-like proceeding, which may be appealed to the U.S. Court of Federal Claims and the U.S. Court of Appeals for the Federal Circuit. Successful petitioners may receive medical expenses, lost income, a set death benefit, and reasonable attorneys' fees. Petitioners who are dissatisfied with the compensation they receive, or whose claims are delayed, may opt to pursue civil actions in court, subject to certain limitations on vaccine manufacturer liability. © 2022 Nova Science Publishers, Inc.

Legal issues in COVID-19 vaccine development

Private companies, universities, and governmental entities are working to develop a vaccine for coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with other information, to prepare a biologics license application (BLA) to submit to FDA. FDA approves the BLA if it determines that the vaccine is safe, potent, and pure. Because the development and review process can be lengthy, the FD&C Act provides several avenues to accelerate this process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track product and breakthrough-therapy designation at the sponsor’s request for products that are intended to fill an unmet need or improve on existing therapies. Both designations entitle the sponsor to increased communication with FDA regarding the clinical trial design and data collected, as well as rolling review of the BLA. Products may also qualify for accelerated approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. In addition, FDA may designate products for priority review. In certain emergency situations, FDA may temporarily authorize the use of unapproved products or approved products for unapproved uses through an emergency use authorization (EUA). For FDA to issue an EUA, the Secretary of Health and Human Services (HHS) must determine (1) that a qualifying emergency exists caused by a biological, chemical, radiological, or nuclear (BCRN) agent and (2) that the BCRN agent can cause a serious or life-threatening disease. The Secretary, through FDA, must also determine for each product that (3) it is reasonable to believe, based on the totality of the evidence available, that the product may treat or prevent the disease caused by the BCRN agent and that the known and potential benefits outweigh the known and potential risks, and (4) there are no approved, adequate, and available alternatives. If FDA issues an EUA, the product may be marketed and used for the authorized use while the emergency persists unless FDA revokes the EUA. FDA may also modify or waive good manufacturing practice and prescription requirements when issuing an EUA. FDA approval of a vaccine allows for its marketing, but does not guarantee that the vaccine will be widely available or affordable. Because patents grant inventors the exclusive rights in a patented invention, patents may influence COVID-19 vaccine affordability and access. Federal agencies and funding support many of the COVID-19 vaccine candidates in development, which may affect the allocation and scope of patent rights. The Bayh-Dole Act allows a federal contractor to obtain the patent on a federally funded invention, but the government retains a free license to use the invention and may “march in” to grant patent licenses to third-party manufacturers in limited circumstances. If federal support is provided through an “other transaction” agreement, however, the allocation of patent rights will depend on the terms of that contract. The federal government has several authorities that it could exercise should patent rights limit the affordability of or access to a COVID-19 vaccine. For vaccines developed with federal funding or support, the government may secure up-front guarantees on pricing or distribution via funding or purchasing contracts with vaccine developers. For vaccines protected by patents subject to the Bayh-Dole Act, the funding agency could seek to invoke march-in rights to enable other producers to manufacture the vaccine. For any U.S. patent, the federal govern ent could use its “eminent domain” powers under 28 U.S.C. § 1498, which allows the government to make and use patented inventions without license-so long as the use is by or for the United States and compensation is provided to the patent holder. As U.S. patent rights are a creation of Congress, targeted legislation is another option, subject to the constraints of the U.S. Constitution and international treaties. A COVID-19 vaccine is likely to be subject to specialized rules limiting legal liability under the Public Readiness and Emergency Preparedness (PREP) Act. To encourage the expeditious development and deployment of medical countermeasures, the Secretary of HHS has declared COVID-19 to be a public health emergency and invoked the PREP Act to limit liability for losses relating to the use of covered medical countermeasures during the public health emergency. Under HHS’s declaration, covered persons-including COVID-19 vaccine developers, manufacturers, distributors, and health care professionals who administer a vaccine-are generally immune from legal liability for losses relating to administration or use of an FDA-approved COVID-19 vaccine, except for willful misconduct resulting in death or serious physical injury. However, individuals who are injured or die as a result of receiving a COVID-19 vaccine may seek compensation through the Countermeasures Injury Compensation Program, a regulatory process administered by HHS. © 2021 by Nova Science Publishers, Inc.

Needs a little TLC: examining college students' emergency remote teaching and learning experiences during COVID-19

The recent novel coronavirus (COVID-19) crisis has affected humanity and education worldwide as continued learning amidst massive school closures required the unprecedented decision to make a rapid transition from in-person learning to remote online learning. This abrupt and temporary shift to remote online learning due to crisis circumstances was described as emergency remote teaching (ERT). Using a multi-method approach, this study aimed to explore college students' emergency remote teaching experiences during the COVID-19 crisis. Analysis of online survey data revealed the various detrimental effects of the recent outbreak of COVID-19 and emergency remote teaching on the participants' educational and personal experiences. The results revealed not only that the participants have experienced learning loss and lack of motivation, but also that the pre-existing educational and social inequities seemed exacerbated and amplified during ERT and the COVID-19 crisis. Issues in terms of accessibility, digital divide, inequity, and mental/emotional/physical health that the participants, more likely females, experienced during emergency remote learning were especially concerning. The results highlighted the importance of addressing and combating the inequities, creating and maintaining a sense of community, and most significantly providing socio-emotional support, 'TLC' (Tender Loving Care;TLC (Tender Loving Care) is an expression, describing extra attention to make someone or something look or feel better), and compassion, to college students and the instructors during the uncertain times and as we move forward.