Authorization of the first COVID-19 emergency vaccines: The matters arising.
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ABSTRACT:
SUBMITTER: Adedokun KA
PROVIDER: S-EPMC8056048 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Pharmacists play a vital role in recommending and providing vaccines to improve public health and are on the front line of mass immunization efforts. The objective of this study is to evaluate pharmacists' perceptions on COVID-19 vaccines prior to emergency use authorization (EUA) amid a global pandemic. A voluntary, anonymous, cross-sectional survey was conducted between September and November 2020. Survey respondents included a convenience sample of licensed pharmacists in the United States. The primary outcomes were pharmacists' willingness to receive and recommend hypothetical COVID-19 vaccines. Covariates assessed in the survey included COVID-19 exposure or personal experience, primary pharmacy practice setting, background in training, geographic region, and prioritization of clinical data. The data were analyzed using descriptive and inferential statistics. This study surveyed 763 pharmacists and results from 632 participants were included in final analysis. Overall, 67.1% of the pharmacists were willing to receive a COVID-19 vaccine and 63.4% of the pharmacists were willing to recommend a COVID-19 vaccine at ≤1 year from the time of vaccine approval. At >1 year after vaccine approval, 78% of the pharmacists were willing to receive a COVID-19 vaccine and 81.2% of the pharmacists were willing to recommend a COVID-19 vaccine. Survey findings suggest that, while a majority of pharmacists surveyed indicate acceptance of hypothetical COVID-19 vaccines, there remains to be hesitancy among pharmacists to receive or recommend vaccination.
| S-EPMC8396166 | biostudies-literature
Project description:BackgroundWe previously reported on COVID-19 vaccination intent among HCP before emergency use authorization. We found widespread hesitancy and a substantial proportion of HCP did not intend to vaccinate.MethodsWe conducted a cross-sectional survey of HCP, including clinical and non-clinical staff, researchers, and trainees between February 21 and March 19, 2021. The survey evaluated vaccine attitudes, beliefs, intent and acceptance.ResultsOverall, 3,981 (87.7%) of respondents had already received a COVID-19 vaccine or planned to get vaccinated. There were significant differences in vaccine acceptance by gender, age, race, and hospital role. Males (93.7%) were more likely than females (89.8%) to report vaccine acceptance (p<0.001). Mean age was higher among those reporting vaccine acceptance (p<0.001). Physicians and scientists showed the highest acceptance rate (97.3%), while staff in ancillary services showed the lowest acceptance rate (79.9%). Unvaccinated respondents were more likely to be females, to have refused vaccines in the past due to reasons other than illness or allergy, to care for COVID-19 patients, or to rely on themselves when making vaccination decision. Vaccine acceptance was more than twice previous intent among Black respondents, an increase from 30.8% to 73.8%, and across all hospital roles with all >80% vaccine acceptance.ConclusionsThe majority of HCP were vaccinated, much higher than reporting intent before vaccine was available. However, many HCP-particularly ancillary services-are still hesitant. Feasible and effective interventions to address the hesitant, including individually-tailored education strategies are needed, or vaccine can be mandated.
| S-EPMC8513411 | biostudies-literature
Project description:BackgroundRemdesivir (RDV) was approved for treatment of coronavirus disease 2019 (COVID-19), in May 2020 under US Food and Drug Administration emergency use authorization (EUA). Clinical outcomes related to RDV use in hospitalized patients during the EUA period are not well described.MethodsWe conducted a retrospective study of patients who received RDV under EUA. The primary outcome was clinical recovery by day 14 as determined by an eight-category ordinal scale. Secondary outcomes included recovery and survival to day 28, and adverse events. Recovery and survival were calculated using a stratified log-rank Kaplan-Meier estimator and a Cox proportional hazards model.ResultsOverall, 164 patients received RDV between May and October 2020, and 153 (93.3%) had evaluable data. Most (77.1%) were hospitalized within 10 days of symptom onset, and 79.7% started RDV within 48 hours. By days 14 and 28, 96 (62.7%) and 117 patients (76.5%) met the definition of clinical recovery, respectively. Median time to recovery was 6 days [interquartile range (IQR) 4-12]. Mortality rates were 6.5% and 11.8% by days 14 and 28, respectively. Age and time to start of RDV after hospital admission were predictive of recovery and 28-day mortality.ConclusionsIn this real-world experience, outcomes after 5 days of RDV therapy were comparable to those of clinical trials. Disease severity, age, and dexamethasone use influenced clinical outcomes. Time to RDV initiation appeared to affect recovery and 28-day mortality, a finding that should be explored further. Mortality rate decreased over the analysis period, which could be related to dexamethasone use and improved management of COVID-19.
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Project description:SARS CoV-2 and its associated disease COVID-19 has devastated the world during 2020. Masks and social distancing could be efficient if done by large proportions of the population, but pandemic fatigue has decreased their efficacy. Economic shut downs come with large price tags and cannot be a long term solution either. The announcements by three vaccine manufacturers in November that their vaccines are 90% or more effective has given hope to at least those in the population who plan to get vaccinated as soon as a scientifically and medically sound vaccine becomes available. This review summarizes the underlying design strategies and current status of development of the nine vaccines that were in phase III trial on 8 November 2020. Contracts between vaccine manufacturing companies and governments aim at distributing the vaccine to a large part of the world population. Questions remain how the temperature sensitive mRNA vaccines will be transported and/or stored and how vaccination will be prioritized within each country. Additionally, current contracts do not cover all countries, with a serious gap in Africa and South America. The second part of this review will detail current distribution plans and remaining challenges with vaccine accessibility and acceptance.
| S-EPMC7826947 | biostudies-literature
Project description:The global pandemic of SARS-CoV-2, the causative viral pathogen of COVID-19, has driven the biomedical community to action-to uncover and develop antiviral interventions. One potential therapeutic approach currently being evaluated in numerous clinical trials is the agent remdesivir, which has endured a long and winding developmental path. Remdesivir is a nucleotide analogue prodrug that perturbs viral replication, originally evaluated in clinical trials to thwart the Ebola outbreak in 2014. Subsequent evaluation by numerous virology laboratories demonstrated the ability of remdesivir to inhibit coronavirus replication, including SARS-CoV-2. Here, we provide an overview of remdesivir's discovery, mechanism of action, and the current studies exploring its clinical effectiveness.
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Project description:The twenty-first century has come with a new era in vaccinology, in which recombinant genetic technology has contributed to setting an unprecedented fast pace in vaccine development, clearly demonstrated during the recent COVID-19 pandemic.
| S-EPMC7193619 | biostudies-literature
Project description:The novel coronavirus SARS-CoV-2, the cause of the COVID-19 pandemic, has inspired one of the most efficient vaccine development campaigns in human history. A key aspect of COVID-19 mRNA vaccines is the use of the modified nucleobase N1-methylpseudouridine (m1Ψ) to increase their effectiveness. In this Outlook, we summarize the development and function of m1Ψ in synthetic mRNAs. By demystifying how a novel element within these medicines works, we aim to foster understanding and highlight future opportunities for chemical innovation.
| S-EPMC8043204 | biostudies-literature
Project description:COVID-19 is a pandemic of unprecedented proportions in recent human history. Less than 18 months since the onset of the pandemic, there are close to two hundred million confirmed cases and four million deaths worldwide. There have also been massive efforts geared towards finding safe and effective vaccines. By July 2021 there were 184 COVID-19 vaccine candidates in pre-clinical development, 105 in clinical development, and 18 vaccines approved for emergency use by at least one regulatory authority. These vaccines include whole virus live attenuated or inactivated, protein-based, viral vector, and nucleic acid vaccines. By mid-2021 three billion doses of COVID-19 vaccine have been administered around the world, mostly in high-income countries. COVID-19 vaccination provides hope for an end to the pandemic, if and only if there would be equal access and optimal uptake in all countries around the world.
| S-EPMC8272971 | biostudies-literature
Project description:Synopsis This manuscript is a narrative review of the rapidly moving COVID-19 vaccine field with an emphasis on clinical efficacy established in both randomized trials and post-marketing surveillance of clinically available vaccines. We review the major clinical trials that supported authorization for general use of the Janssen (Ad.26.CoV2), Pfizer-BioNTech (BNT162b2), and Moderna (mRNA-1273) vaccines and the publicly available post-marketing information with the goal of providing a broad, clinically relevant comparison of efficacy and safety. This review is primarily focused on the United States (US) market.
| S-EPMC8802612 | biostudies-literature
Project description:Physical distancing has been argued as one of the effective means to combat the spread of COVID-19 before a vaccine or therapeutic drug becomes available. How far people can be spatially separated is partly behavioral but partly constrained by population density. Most models developed to predict the spread of COVID-19 in the U.S. do not include population density explicitly. This study shows that population density is an effective predictor of cumulative infection cases in the U.S. at the county level. Daily cumulative cases by counties are converted into 7-day moving averages. Treating the weekly averages as the dependent variable and the county population density levels as the explanatory variable, both in logarithmic scale, this study assesses how population density has shaped the distributions of infection cases across the U.S. from early March to late May, 2020. Additional variables reflecting the percentages of African Americans, Hispanic-Latina, and older adults in logarithmic scale are also included. Spatial regression models with a spatial error specification are also used to account for the spatial spillover effect. Population density alone accounts for 57% of the variation (R-squared) in the aspatial models and up to 76% in the spatial models. Adding the three population subgroup percentage variables raised the R-squared of the aspatial models to 72% and the spatial model to 84%. The influences of the three population subgroups were substantial, but changed over time, while the contributions of population density have been quite stable after the first several weeks, ascertaining the importance of population density in shaping the spread of infection in individual counties, and in their neighboring counties. Thus, population density and sizes of vulnerable population subgroups should be explicitly included in transmission models that predict the impacts of COVID-19, particularly at the sub-county level.
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