Ensuring Safety of Operation Warp Speed Vaccines for COVID-19.
Ontology highlight
ABSTRACT:
SUBMITTER: McDougle L
PROVIDER: S-EPMC7718775 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
Publications
Ensuring Safety of Operation Warp Speed Vaccines for COVID-19.
Journal of the National Medical Association 20201001 5
Similar Datasets
Project description:DNA is a rapidly developing vaccine platform for combatting cancer, infectious and noninfectious diseases [...].
| S-EPMC7761981 | biostudies-literature
Project description:This study is aimed to identify the adverse effects associated with three types of coronavirus disease 2019 vaccines. Approximately 1736 individuals agreed to participate in this study. The participants involved in the study were individuals who had received the first dose or full course (two doses) of the vaccine at least 30 days before the survey. A direct and interactive web-based system interview with a paper and electronic version of the questionnaire was used for all participants. A total of 1736 randomized individuals were identified. The reactogenicity of the vaccines including pain, redness, urticaria, and swelling at the site of the injection was reported in 34.56% of the participants. Local site reaction was reported in more individuals who had Pfizer and AstraZeneca vaccines than those who received the Sinopharm vaccine. The systemic events were more common with AstraZeneca and Pfizer vaccines, symptoms reported were fatigue, body pain, headache, muscle pain, fever, and gastrointestinal side effects. There were no correlations between age or gender, and the duration of the adverse effects for the three vaccines. Swelling and severe allergic reaction of the eyelids, severe hypotension, generalized body aches, shortness of breath, weakness and numbness on the injected arm, acute hyperglycemia, severe chest pain, and fever more than 39°C were among the unusual signs and symptoms reported by the participants. Pfizer, AstraZeneca, and Sinopharm vaccines were found to be safe and Sinopharm vaccine showed a lower prevalence of adverse effects compared with the other vaccines. The duration and severity of adverse effects were not affected by age or gender. Unusual side effects should be closely monitored to establish determine they are linked to the immunization.
| S-EPMC8426829 | biostudies-literature
Project description:The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities. In this Health Policy paper, we review potential challenges to success in each of these dimensions and discuss policy implications. To guide our review, we developed a dashboard to highlight key characteristics of 26 leading vaccine candidates, including efficacy levels, dosing regimens, storage requirements, prices, production capacities in 2021, and stocks reserved for low-income and middle-income countries. We use a traffic-light system to signal the potential contributions of each candidate to achieving global vaccine immunity, highlighting important trade-offs that policy makers need to consider when developing and implementing vaccination programmes. Although specific datapoints are subject to change as the pandemic response progresses, the dashboard will continue to provide a useful lens through which to analyse the key issues affecting the use of COVID-19 vaccines. We also present original data from a 32-country survey (n=26 758) on potential acceptance of COVID-19 vaccines, conducted from October to December, 2020. Vaccine acceptance was highest in Vietnam (98%), India (91%), China (91%), Denmark (87%), and South Korea (87%), and lowest in Serbia (38%), Croatia (41%), France (44%), Lebanon (44%), and Paraguay (51%).
| S-EPMC7906643 | biostudies-literature
Project description: Not available
| S-EPMC9726273 | biostudies-literature
Project description: Not available
| S-EPMC10413720 | biostudies-literature
Project description:The assessment of the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines in actual practice is extremely important, and monitoring efforts are being implemented worldwide. In Japan, a joint council in the Ministry of Health, Labour and Welfare is held every two to three weeks to summarise information on the adverse events following COVID-19 vaccination, with careful assessment of individual case safety reports and comparison with background incidence rates. In 2021, the joint council mainly reviewed anaphylaxis, death, myocarditis/pericarditis, and thrombosis with thrombocytopenia syndrome. These activities resulted in several safety-related regulatory actions, including the revision of vaccine package inserts with warnings about myocarditis/pericarditis. International sharing of vaccine safety information, as well as details of the evaluation systems, is important for international discussion and decision-making on better safety monitoring of COVID-19 vaccines.
| S-EPMC8960038 | biostudies-literature
Project description:BackgroundA developing country like Bangladesh suffers very much from the sudden appearance of the COVID-19 pandemic due to the shortage of medical facilities for testing and follow-up treatment. The Portable Health Clinic (PHC) system has developed the COVID-19 module with a triage system for the detection of COVID-19 suspects and the follow-up of the home quarantined COVID-19 patients to reduce the workload of the limited medical facilities.MethodsThe PHC COVID-19 system maintains a questionnaire-based triage function using the experience of the Japanese practice of diseases management for early detection of suspected COVID-19 patients who may need a confirmation test. Then only the highly suspected patients go for testing preventing the unnecessary crowd from the confirmation PCR test centers and hospitals. Like the basic PHC system, it also has the features for patients' treatment and follow-up for the home quarantined COVID-19 positive and suspect patients using a telemedicine system. This COVID-19 system service box contains 4 self-checking medical sensors, namely, (1) thermometer, (2) pulse oximeter, (3) blood pressure machine, and (4) glucometer for patient's health monitoring including a tablet PC installed with COVID-19 system application for communication between patient and doctor for tele-consultancy.ResultsThis study conducted a COVID-19 triage among 300 villagers and identified 220 green, 45 light-yellow, 2 yellow, 30 orange, and 3 red patients. Besides the 3 red patients, the call center doctors also referred another 13 patients out of the 30 orange patients to health facilities for PCR tests as suspect COVID-19 positive, and to go under their follow-up. Out of these (3 + 13 =) 16 patients, only 4 went for PCR test and 3 of them had been tested positive. The remaining orange, yellow and light-yellow patients were advised home quarantine under the follow-up of the PHC health workers and got cured in 1-2 weeks.ConclusionsThis system can contribute to the community healthcare system by ensuring quality service to the suspected and 80% or more tested COVID-19 positive patients who are usually in the moderate or mild state and do not need to be hospitalized. The PHC COVID-19 system provides services maintaining social distance for preventing infection and ensuring clinical safety for both the patients and the health workers.
| S-EPMC9167465 | biostudies-literature
Project description: Not available
| S-EPMC9998978 | biostudies-literature
Project description:BackgroundIn February 2021, the UK Department of Health and Social Care sought evidence on the safety and immunogenicity of COVID-19 and influenza vaccine co-administration to inform the 2021/2022 influenza vaccine policy. Co-administration could support vaccine uptake and reduce healthcare appointments. ComFluCOV was a randomised controlled trial designed to provide this evidence. This report outlines the methods used to deliver the trial in 6 months to answer an urgent public health question as part of the COVID-19 pandemic response.MethodsComFluCOV was commissioned by the Department of Health and Social Care and was managed by the Bristol Trials Centre, a UK-registered clinical trials unit. It was classed as an Urgent Public Health trial which facilitated fast-track regulatory approvals. Trial materials and databases were developed using in-house templates and those used in other COVID-19 vaccine trials. Participants were recruited by advertising, and via a trial website. Electronic trial systems enabled daily review of participant data. Weekly virtual meetings were held with stakeholders and trial sites.ResultsComFluCOV was delivered within 6 months from inception to reporting, and trial milestones to inform the Department of Health and Social Care policy were met. Set-up was achieved within 1 month. Regulators provided expedited reviews, with feedback ahead of submission. Recruitment took place at 12 sites. Over 380 site staff were trained. Overall, 679 participants were recruited in two months. The final report to the Department of Health and Social Care was submitted in September 2021, following a preliminary safety report in May 2021. Trial results have been published.ConclusionThe rapid delivery of ComFluCOV was resource intensive. It was made possible in part due to a unique set of circumstances created by the pandemic situation including measures put in place to support urgent public health research and public support for COVID-19 vaccine research. Elements of the trial could be adopted to increase efficiency in 'non-pandemic' situations including working with a clinical trials unit to enable immediate mobilisation of a team of experienced researchers, greater sharing of resources between clinical trials units, use of electronic trial systems and virtual meetings.Trial registrationISRCTN14391248, submitted on 17/03/2021. Registered on 30/03/2021.
| S-EPMC10785514 | biostudies-literature
Project description:Hospital-based surveillance for adverse events was conducted on healthcare workers after they received the first dose of coronavirus disease 2019 (COVID-19) vaccine. Among the two new platform vaccines (messenger RNA- and adenoviral vector-based vaccines), the rates of systemic adverse events were significantly higher among adenovirus-vectored vaccine recipients. Fatigue (87.6% vs. 53.8%), myalgia (80.8% vs. 50.0%), headache (72.0% vs. 28.8%), and fever (≥ 38.0°C, 38.7% vs. 0%) were the most common adverse events among adenovirus-vectored vaccine recipients, but most symptoms resolved within 2 days. Both types of COVID-19 vaccines were generally safe, and serious adverse events rarely occurred.
| S-EPMC8055510 | biostudies-literature