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The COVID-19 pandemic and development of drugs and vaccinations
Published in Edward M. Rafalski, Ross M. Mullner, Healthcare Analytics, 2022
The Emergency Use Authorization (EUA) is a mechanism that allows Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD &C Act), when the Secretary of Health and Human Services (HHS) declares that an EUA is appropriate, the FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
Drug Repurposing and Novel Antiviral Drugs for COVID-19 Management
Published in Debmalya Barh, Kenneth Lundstrom, COVID-19, 2022
Shailendra Dwivedi, Aakanksha Rawat, Amit Ranjan, Ruchika Agrawal, Radhieka Misra, Sunil Kumar Gupta, Surekha Kishore, Sanjeev Misra
Remdesivir may have a place in treatment of patients with mild to moderate COVID-19 disease. Conversely, the initial studies with remdesivir failed to demonstrate clinical benefit over placebo; initially, daily doses of remdesivir for 10 days did not show any statistically significant improvement compared to standard care. However, a 5-day course showed improved outcomes compared to standard care, but the clinical impact was uncertain. On the other hand, Grein et al. (2020) found that 68% of the enrolled 61 patients with severe COVID-19 showed significant improvement after remdesivir treatment [14]. More recently, a US-based study conducted by the National Institutes of Health (NIH) with 1,062 COVID-19 patients showed encouraging results, including a reduction in recovery time and a trend towards lower mortality. This resulted in an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) and an endorsement by the European Medicines Agency (EMA) and the National Health Service (NHS) in the UK. However, more recent evidence has caused the WHO no longer to recommend the use of remdesivir in hospitalized patients with COVID-19. This is based on reports that remdesivir could not reduce mortality, the need for mechanical ventilation, or the duration of hospital stay. Consequently, further large-scale randomized clinical trials are needed to better understand the role of remdesivir in the management of patients with COVID-19.
Research and Development for COVID-19 Vaccines
Published in Srijan Goswami, Chiranjeeb Dey, COVID-19 and SARS-CoV-2, 2022
Srijan Goswami, Ushmita Gupta Bakshi
During this ongoing pandemic, we have witnessed the implementation of many experimental drugs and vaccines under EUA in order to deal with the COVID-19 situation. It is to be understood that EUA approval and regular FDA approval are not the same thing. Supported by the Secretary of Health and Human Services (HHS), the EUA is implemented to justify the emergency use of experimental unapproved drugs, vaccines, or biological products during the COVID-19 situation. None of the approved drugs or vaccines have undergone the same type of scrutiny as to receive regular FDA approval or as FDA cleared products.
Monoclonal antibody therapies in the management of SARS-CoV-2 infection
Published in Expert Opinion on Investigational Drugs, 2022
Enrique Miguez-Rey, Dasom Choi, Seungmin Kim, Sangwook Yoon, Oana Săndulescu
The FDA established the emergency Coronavirus Treatment Acceleration Program (CTAP) to facilitate the timely evaluation of novel treatments for COVID-19, and the FDA’s Center for Drug Evaluation and Research has established a specific team to oversee investigational new drug (IND) applications related to COVID-19 [6]. Additionally, the US Department of Health and Human Services declared on 1 April 2020 that “circumstances justified the authorization of emergency use of drugs and biological products during the COVID-19 pandemic” [7]. Regardless of previous approval status, medical products may be granted Emergency Use Authorization (EUA) in a public health emergency [7]. The EMA also issued guidance to accelerate medicine and vaccine development for COVID-19, and established the COVID-19 EMA pandemic Task Force (COVID-ETF) to coordinate and accelerate regulatory action, for both new products and those already authorized for other conditions.
Making US poison centers a part of the solution to the COVID-19 pandemic
Published in Clinical Toxicology, 2022
Daniel A. Spyker, Alvin C. Bronstein, Julie A. Weber
An approved FDA EUA grants a temporary allowance for the marketing of unapproved medical products to diagnose, treat, or prevent serious or life-threatening diseases when: 1) Department of Homeland Security (DHS), Health and Human Services (HHS) or Department of Defense (DOD) determines an emergency or potential emergency exits, and 2) HHS declares that circumstances exist to justify the EUA. The Project BioShield Act (2004), amended in 2013, 2016, and 2017, established the EUA process. When granted, such authorization is only for the duration of the declaration [1]. Related Medical Counter Measure (MCM) accommodations may include: emergency dispensing orders, expiry dating extensions, waivers of Current Good Manufacturing Processes (cGMP), Risk Evaluation and Mitigation Strategy (REMS) requirements, and government stockpiling. The federal Countermeasures Injury Compensation Program (CICP) was created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency [2].
Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?
Published in The American Journal of Bioethics, 2021
Holly Fernandez Lynch, Arthur Caplan, Patricia Furlong, Alison Bateman-House
Overall, this disconnect exemplifies at least two problems with the EUA approach. First, legally permissible access may not be helpful when not also accompanied by convincing evidence. For monoclonal antibodies, the challenging logistics of their administration by infusion to patients at the early stage of disease on an outpatient basis combined with insufficient proof of their efficacy at the time the first two relevant EUAs were issued led some sites to decline to make the products available (Karlin-Smith 2021a; McGinley 2020; Rodriguez 2021). Thus, the intended goal of EUAs—to get promising products to patients quickly—may be inhibited at least in part because the EUA standard deprioritizes evidence. This problem can also arise in the context of payment, with insurers unwilling to bear the costs of products without adequate evidence that they work, which in turn hinders patient access (Court 2016). We are now seeing similar problems in the context of aducanumab for Alzheimer’s disease, after FDA applied a very low evidentiary standard for approval against the advice of its advisory committee (Alexander et al. 2021).