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:BackgroundCOVID-19 mRNA vaccines were authorized in the United States in December 2020. Although vaccine effectiveness (VE) against mild infection declines markedly after several months, limited understanding exists on the long-term durability of protection against COVID-19-associated hospitalization.MethodsCase control analysis of adults (≥18 years) hospitalized at 21 hospitals in 18 states March 11 - December 15, 2021, including COVID-19 case patients and RT-PCR-negative controls. We included adults who were unvaccinated or vaccinated with two doses of a mRNA vaccine before the date of illness onset. VE over time was assessed using logistic regression comparing odds of vaccination in cases versus controls, adjusting for confounders. Models included dichotomous time (<180 vs ≥180 days since dose two) and continuous time modeled using restricted cubic splines.Results10,078 patients were included, 4906 cases (23% vaccinated) and 5172 controls (62% vaccinated). Median age was 60 years (IQR 46-70), 56% were non-Hispanic White, and 81% had ≥1 medical condition. Among immunocompetent adults, VE <180 days was 90% (95%CI: 88-91) vs 82% (95%CI: 79-85) at ≥180 days (p < 0.001). VE declined for Pfizer-BioNTech (88% to 79%, p < 0.001) and Moderna (93% to 87%, p < 0.001) products, for younger adults (18-64 years) [91% to 87%, p = 0.005], and for adults ≥65 years of age (87% to 78%, p < 0.001). In models using restricted cubic splines, similar changes were observed.ConclusionIn a period largely pre-dating Omicron variant circulation, effectiveness of two mRNA doses against COVID-19-associated hospitalization was largely sustained through 9 months.
| S-EPMC9129194 | 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.
| S-EPMC8474339 | biostudies-literature
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:Background: This study aimed to determine the real-world safety and effectiveness of remdesivir in hospitalized adult COVID-19 patients with moderate-to-critical disease in Indonesia. Methods: A multicenter, retrospective cohort study was conducted at four COVID-19 referral hospitals in Jakarta. A total of 587 patients were included, of whom 243 received remdesivir within 72 h of admission. The safety endpoints were the proportions of patients with any adverse event (AE), any grade 3 AE, and AE of each system organ class. The effectiveness endpoints were ICU admission >24 h from baseline, live discharge and mortality at day 14, live discharge and mortality at day 28, and virologic conversion. Patients who received remdesivir within 72 h of admission were considered the treatment group, and those who did not were the control group. Multivariate adjustments were performed using a modified Poisson regression. Results: The study found no significant differences in safety endpoints between the two groups. However, the effectiveness endpoints showed that remdesivir was associated with a decreased risk of ICU admission >24 h from baseline (RR 0.71, 95% CI 0.52-0.96), an increased probability of live discharge at day 14 (RR 1.37, 95% CI 1.08-1.74), and an increased probability of live discharge at day 28 (RR 1.28, 95% CI 1.05-1.57). The rate of virologic conversion was not significantly different between the two groups. Conclusion: The study concludes that remdesivir is safe and effective in the treatment of moderate-to-critical COVID-19 in a real-world setting in Indonesia.
| S-EPMC10347402 | 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.
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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.
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Project description:This article is a narrative review of the rapidly moving coronavirus disease 2019 vaccine field with an emphasis on clinical efficacy established in both randomized trials and postmarketing 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 postmarketing information with the goal of providing a broad, clinically relevant comparison of efficacy and safety. This review is primarily focused on the US market.
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