Project description:The novel coronavirus, SARS-CoV-2, or COVID-19, has affected the world on a pandemic scale resulting in catastrophic outcomes and deaths. Currently, there is limited safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown. We report an updated literature review of current information and evidence available to aid in the decision whether to vaccinate against COVID-19 currently being made by pregnant individuals and their healthcare providers so that they are able to make a well-informed recommendation and decision.
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.
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.
Project description:Since the emergence of COVID-19, caused by the SARS-CoV-2 virus at the end of 2019, there has been an explosion of vaccine development. By 24 September 2020, a staggering number of vaccines (more than 200) had started preclinical development, of which 43 had entered clinical trials, including some approaches that have not previously been licensed for human vaccines. Vaccines have been widely considered as part of the exit strategy to enable the return to previous patterns of working, schooling and socializing. Importantly, to effectively control the COVID-19 pandemic, production needs to be scaled-up from a small number of preclinical doses to enough filled vials to immunize the world's population, which requires close engagement with manufacturers and regulators. It will require a global effort to control the virus, necessitating equitable access for all countries to effective vaccines. This review explores the immune responses required to protect against SARS-CoV-2 and the potential for vaccine-induced immunopathology. We describe the profile of the different platforms and the advantages and disadvantages of each approach. The review also addresses the critical steps between promising preclinical leads and manufacturing at scale. The issues faced during this pandemic and the platforms being developed to address it will be invaluable for future outbreak control. Nine months after the outbreak began we are at a point where preclinical and early clinical data are being generated for the vaccines; an overview of this important area will help our understanding of the next phases.
Project description:The ongoing COVID-19 pandemic and its unprecedented global societal and economic disruptive impact highlight the urgent need for safe and effective vaccines. Taking substantial advantages of versatility and rapid development, two mRNA vaccines against COVID-19 have completed late-stage clinical assessment at an unprecedented speed and reported positive results. In this review, we outline keynotes in mRNA vaccine development, discuss recently published data on COVID-19 mRNA vaccine candidates, focusing on those in clinical trials and analyze future potential challenges.
Project description:Given the interest in the COVID mRNA vaccines, we sought to investigate how the RNA modification N1-methylpseudouridine (and its related modification, pseudouridine) is read by ribosomes and reverse transcriptases. By looking at reverse transcriptase data, we can gain information on how the modification affects duplex stability, which may have important consequences for the tRNA-mRNA interactions found in the ribosome.
Project description:SARS-CoV-2, the causative agent of COVID-19, has imposed a major public health threat, which needs effective therapeutics and vaccination strategies. Several potential candidate vaccines being rapidly developed are in clinical evaluation. Considering the crucial role of SARS-CoV-2 spike (S) glycoprotein in virus attachment, entry, and induction of neutralizing antibodies, S protein is being widely used as a target for vaccine development. Based on advances in techniques for vaccine design, inactivated, live-vectored, nucleic acid, and recombinant COVID-19 vaccines are being developed and tested for their efficacy. Phase3 clinical trials are underway or will soon begin for several of these vaccines. Assuming that clinical efficacy is shown for one or more vaccines, safety is a major aspect to be considered before deploying such vaccines to the public. The current review focuses on the recent advances in recombinant COVID-19 vaccine research and development and associated issues.
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.