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3 Clinical Science
Pages 63-80

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From page 63... ... • At-risk populations, such as the immunocompromised and the elderly, must be prioritized during vaccine distribution. • Pharmacovigilance surveillance, both during clinical trials and postauthoriza tion, is critical for detecting rare but severe vaccine safety signals. Read the entire page →
From page 64... ... Preclinical and Clinical Trial Design During a pandemic, when speed is of the essence, vaccine development through clinical testing in the traditional, sequential order is time consuming. To allow the unprecedented rapid vaccine development for COVID-19, vaccine manufacturers conducted immunogenicity and efficacy trials in parallel, instead of the traditional sequential path of studies (Excler et al., 2021) Read the entire page →
From page 65... ... . Diversity in Clinical Trials Historically, diversity among participants in clinical trials examining vaccine safety and efficacy has not reflected the diversity of the population. Read the entire page →
From page 66... ... Investment in vaccine safety surveillance systems is crucial to achieve three goals: 1. Support streamlined vaccine development; 2. Read the entire page →
From page 67... ... , gender, race/ethnicity, presence of comorbidities, and pregnancy. During the COVID-19 pandemic, a novel safety surveillance system called v-safe was implemented using smartphone technology, allowing vaccine recipients to directly report potential adverse events to public health agencies Read the entire page →
From page 68... ... Instead, it is necessary to rely almost entirely on postauthorization or postapproval safety surveillance systems to capture rare adverse events. The importance of these systems during a pandemic cannot be overemphasized given our experience with observations of Guillain-Barré syndrome during the 1976 swine flu and 2009 H1N1 pandemics (Salmon et al., 2011; Sencer and Millar, 2006) Read the entire page →
From page 69... ... Clinical Trials for Influenza in Low- and Middle-Income Countries The issue of clinical trials in LMICs is an important concern in the development of seasonal and pandemic influenza vaccines. The conduct of clinical trials and participation may be more problematic in LMICs where there are limited seasonal influenza programs due to lack of funds and a lack of urgency, as other health-related issues may take priority (Kraigsley et al., 2021; Ortiz and Neuzil, 2019; Williams et al., 2021) Read the entire page →
From page 70... ... . Monitoring Vaccine Effectiveness For existing vaccine platforms, licensure of seasonal or pandemic influenza vaccines can be obtained either through a traditional approval pathway or by the accelerated approval mechanism (Weir and Gruber, 2016) Read the entire page →
From page 71... ... . While the appropriate pathway for regulatory approval for a pandemic influenza vaccine cannot be predicted, postmarket vaccine effectiveness evaluations are clearly needed for pandemic planning. Read the entire page →
From page 72... ... In the absence of clinical efficacy data for a pandemic vaccine before authorization or approval, however, it becomes crucial to monitor vaccine effectiveness to support vaccine confidence and dynamic assessments of the benefit–risk balance. The COVID-19 vaccine development story is remarkable. Read the entire page →
From page 73... ... Postauthorization Vaccine Safety Surveillance The COVID-19 pandemic has highlighted the critical role vaccine safety surveillance systems play in both detection of rare adverse events not identified in clinical trials and the effect of vaccine safety on decision making about use of vaccines in different countries. Some adverse events are so rare that they are not detected until millions of people have been vaccinated (Remmel, 2021) Read the entire page →
From page 74... ... . Additional capabilities to support vaccine safety include the ability to generate background rates for rare events, to conduct rapid signal evaluations that incorporate chart validation, and to run formal epidemiologic studies to evaluate the risk of adverse events following vaccination in subpopulations. Read the entire page →
From page 75... ... Recommendation 3-3: The International Coalition of Medicines Regu latory Authorities and the World Health Organization (Global Advisory Committee on Vaccine Safety) should ensure international coordination and collaboration on the timely and transparent review of vaccine safety data during epidemics and pandemics to support real-time deci sion making about the use of vaccines. Read the entire page →
From page 76... ... 2021. The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety. Read the entire page →
From page 77... ... 2021b. COVID-19 vaccine safety surveillance. Read the entire page →
From page 78... ... 2020. Postapproval vaccine safety surveillance for COVID-19 vaccines in the US. Read the entire page →
From page 79... ... 2019. Influenza immunization in low- and middle-income countries: Preparing for next-generation influenza vaccines. Read the entire page →
From page 80... ... 2019. Global Vaccine Safety Blueprint 2.0 (GVSB2.0) Read the entire page →

From page 63...

... • At-risk populations, such as the immunocompromised and the elderly, must be prioritized during vaccine distribution. • Pharmacovigilance surveillance, both during clinical trials and postauthoriza tion, is critical for detecting rare but severe vaccine safety signals.

3 Clinical Science Pages 63-80

3 Clinical Science
Pages 63-80