New Onset and Exacerbations of Psoriasis Following COVID-19 Vaccines: A Systematic Review

American Journal of Clinical Dermatology, Journal Year: 2022, Volume and Issue: 23(6), P. 775 - 799

Published: Sept. 1, 2022

Language: Английский

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COVID-19 Vaccines over Three Years after the Outbreak of the COVID-19 Epidemic

Viruses, Journal Year: 2023, Volume and Issue: 15(9), P. 1786 - 1786

Published: Aug. 23, 2023

The outbreak of COVID-19 started in December 2019 and spread rapidly all over the world. It became clear that development an effective vaccine was only way to stop pandemic. first time history infectious diseases process a new conducted on such large scale accelerated so rapidly. At end 2020, vaccines were approved for marketing. March 2023, three years after pandemic, 199 pre-clinical 183 clinical development. candidate phase are based following platforms: protein subunit, DNA, RNA, non-replication viral vector, replicating inactivated virus, virus-like particles, live attenuated vector combined with antigen-presenting cell, bacterial antigen-spore expression vector. Some platforms have been human application. This review presents currently available world, procedures assurance quality safety vaccines, vaccinated population, as well future perspectives drug therapy non-infectious diseases.

Language: Английский

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Breaking the final barrier: Evolution of cationic and ionizable lipid structure in lipid nanoparticles to escape the endosome

Advanced Drug Delivery Reviews, Journal Year: 2024, Volume and Issue: unknown, P. 115446 - 115446

Published: Sept. 1, 2024

Language: Английский

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Impact of COVID-19 vaccination: a global perspective

Frontiers in Public Health, Journal Year: 2024, Volume and Issue: 11

Published: Jan. 11, 2024

Introduction The COVID-19 pandemic has caused widespread morbidity, mortality, and socio-economic disruptions worldwide. Vaccination proven to be a crucial strategy in controlling the spread of virus mitigating its impact. Objective study focuses on assessing effectiveness vaccination reducing incidence positive cases, hospitalizations, ICU admissions. presented is focused fully vaccinated population by considering data from first case reported until 20 September 2021. Methods Using multiple countries, time series analysis deployed investigate variations positivity rates, hospitalization requirements after successful campaigns at country scale. Results Analysis rates revealed substantial decline countries with high pre-vaccination rates. Within 1–3 months campaigns, these decreased 20–44%. However, certain experienced an increase emergence new Delta variant, emphasizing importance ongoing monitoring adaptable strategies. Similarly, demonstrated steady as drive rose various countries. 90 days vaccination, several achieved below 200 per million. slight hospitalizations was observed some 180 underscoring need for continued vigilance. Furthermore, patient increased across most 120 days, rate million, highlighting preventing severe cases requiring intensive care. Conclusion very much effective surveillance, variant monitoring, adaptive strategies are maximizing benefits effectively virus.

Language: Английский

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COVID-19 human challenge trials and randomized controlled trials: lessons for the next pandemic

Research Ethics, Journal Year: 2024, Volume and Issue: 20(4), P. 636 - 649

Published: Jan. 3, 2024

The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of to prevent was enormous scientific accomplishment. Further, RECOVERY Solidarity trials identified effective treatments COVID-19. But all not success. urgent need prevention treatment fueled embrace risks—to research participants reliability science itself—as allegedly necessary costs speed progress. Scientists (even) ethicists supported overturning longstanding norms protecting healthy volunteers in human challenge vaccine development, but these led no vaccines. Physicians, with approval ethics committees, designed hundreds unblinded, single-center clinical at high risk bias identification new lesson future pandemics is that acceptance greater risks or does reliably lead We are better served by upholds highest ethical methodological standards.

Language: Английский

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Vaccine process technology—A decade of progress

Biotechnology and Bioengineering, Journal Year: 2024, Volume and Issue: 121(9), P. 2604 - 2635

Published: May 6, 2024

In the past decade, new approaches to discovery and development of vaccines have transformed field. Advances during COVID-19 pandemic allowed production billions vaccine doses per year using novel platforms such as messenger RNA viral vectors. Improvements in analytical toolbox, equipment, bioprocess technology made it possible achieve both unprecedented speed scale manufacturing. Macromolecular structure-function characterization technologies, combined with improved modeling data analysis, enable quantitative evaluation formulations at single-particle resolution guided design drug substances products. These advances play a major role precise assessment critical quality attributes delivered by newer platforms. Innovations label-free immunoassay technologies aid antigenic sites robust vitro potency assays. methods, along molecular techniques next-generation sequencing, will accelerate release all Process for real-time monitoring optimization process steps implementation quality-by-design principles faster next field continue advance, bringing together improve human health.

Language: Английский

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Clinical development of variant-adapted BNT162b2 COVID-19 vaccines: the early Omicron era

Expert Review of Vaccines, Journal Year: 2023, Volume and Issue: 22(1), P. 650 - 661

Published: July 7, 2023

Introduction The Omicron BA.1 variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and subsequent sub-lineages exhibit partial escape from neutralizing antibodies elicited by vaccines containing or encoding wild-type spike protein. In response to the emergence sub-lineages, variant-adapted that contain encode for protein components have been developed.Areas covered This review presents currently available clinical immunogenicity safety data on versions BNT162b2 messenger RNA (mRNA) vaccine summarizes expected mechanism action, rationale development, these vaccines. addition, challenges encountered during development regulatory approval are discussed.Expert opinion Omicron-adapted provide a wider breadth potentially more durable protection against antigenically aligned variants when compared with original vaccine. As SARS-CoV-2 continues evolve, further updates may be required. To facilitate this, globally harmonized process transition updated is needed. Next-generation approaches broader future variants.

Language: Английский

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Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data

Human Vaccines & Immunotherapeutics, Journal Year: 2024, Volume and Issue: 20(1)

Published: Feb. 26, 2024

The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions innovators, vaccine developers, regulators, and other stakeholders ensure public access protective vaccines while maintaining regulatory agency standards. Although development timelines for against SARS-CoV-2 were much quicker than standard timelines, requirements efficacy safety evaluations, including the volume quality of data collected, upheld. Rolling review processes supported sponsors authorities enabled rapid assessment clinical as well emergency use authorization. Post-authorization pharmacovigilance activities quantity breadth post-marketing information quickly exceed that generated from trials. This paper reviews reactogenicity BNT162 candidates, BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) bivalent variant-adapted vaccines, preclinical studies, trials, surveillance, real-world an unprecedentedly large body independent evidence.

Language: Английский

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Editing approaches to treat Alpha-1 Antitrypsin Deficiency (AATD)

CHEST Journal, Journal Year: 2024, Volume and Issue: unknown

Published: Oct. 1, 2024

Language: Английский

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Project lightspeed: A case study in research ethics and accelerated vaccine development

Research Ethics, Journal Year: 2024, Volume and Issue: 20(4), P. 847 - 856

Published: April 30, 2024

The COVID-19 pathogen led to a fast expanding pandemic because it proved lethal in certain populations but could be transmitted by persons who appeared healthy. As result, researchers came under unprecedented time pressure develop vaccine. This case study focuses on the first vaccine, which was approved for use humans, known as Comirnaty, BioNTech-Pfizer vaccine or Vaccine BNT162b2. With benefit of hindsight, we show how close collaboration with regulators and trust-based decisions meant that race won without purposefully infecting healthy participants an infectious agent can cause severe illness death no rescue therapy had existed.

Language: Английский

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