Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China DOI Creative Commons
Xiaojing Li, Jin Su,

Shuyang Guo

и другие.

Vaccines, Год журнала: 2024, Номер 12(12), С. 1436 - 1436

Опубликована: Дек. 20, 2024

The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during COVID-19 pandemic, where platform technology enabled rapid development approval vaccines, optimizing processes, enhancing global public health responses. As a transformative tool, streamlines product development, allowing for reduction in number clinical trials or exemption from certain facilitating cross-referencing submissions. Despite significant efforts establish standardized procedures, challenges remain, particularly achieving unified definition application across regions. This paper explores evolution, applications, strategies technology, with focus on China's experience this field. approach, encompassing risk assessment, expedited emergency offers valuable insights into coordination. By analyzing contributions practices, highlights potential address future pandemics, including "Pathogen X", underscores importance harmonizing strengthen preparedness response.

Язык: Английский

From space vaccinology to molecular mechanisms of choice, vaccinology needs molecular biology DOI
Tobias R. Kollmann, Manish Sadarangani, Richard B. Kennedy

и другие.

Journal of Molecular Biology, Год журнала: 2024, Номер 436(22), С. 168817 - 168817

Опубликована: Окт. 5, 2024

Язык: Английский

Процитировано

0

Vaccine, vaccination & personal decision making DOI Open Access

Samiran Panda

The Indian Journal of Medical Research, Год журнала: 2024, Номер 160, С. 255 - 258

Опубликована: Ноя. 13, 2024

Процитировано

0

SARS-CoV-2 Neutralizing Antibodies 2.0 DOI Creative Commons

Youchun Wang

Viruses, Год журнала: 2024, Номер 16(11), С. 1791 - 1791

Опубликована: Ноя. 19, 2024

As the SARS-CoV-2 mutates, especially into those variants causing immune escape, COVID-19 continues to wreak havoc [...].

Язык: Английский

Процитировано

0

Kinetic patterns of single cell gene expression discriminate between the murine cellular responses to live attenuated and inactivated Yellow Fever vaccines DOI Creative Commons
Budhaditya Chatterjee, Christopher T. Boughter,

Katrina Gorga

и другие.

bioRxiv (Cold Spring Harbor Laboratory), Год журнала: 2024, Номер unknown

Опубликована: Дек. 3, 2024

Abstract The success of the live attenuated Yellow Fever vaccine (YF17D) that elicits immunity lasting over thirty years has made it a widely used model to understand generation durable protection. We compare early single-cell level transcriptional response in mice YF17D and an adjuvanted-inactivated, but less effective version (InYF). Within first week, we identify 70 kinetic patterns 45 cellular clusters, majority which discriminate between two formulations, some tissue sex-specific manner. Intriguingly, differential transcripts fall into categories, one whose association with or InYF is maintained even when decoupled from their cell-type expression other where such cell-plus-gene pairing critical maintain marker status. demonstrate applications this resource, by identifying B cells varied interferon antigen responsiveness relation each vaccine. This high-resolution dataset amenable further biomarker discovery hypothesis generation.

Язык: Английский

Процитировано

0

Autoimmune‐Like Hepatitis Related to SARSCoV‐2 Vaccination: Towards a Clearer Definition DOI Open Access
Cumali Efe, Sarp Uzun, Matthias S. Matter

и другие.

Liver International, Год журнала: 2024, Номер 45(1)

Опубликована: Дек. 14, 2024

ABSTRACT Vaccines are the most effective tool against COVID‐19 and generally safe. Very rare heterogeneous cases of acute liver injury associated to all types SARS‐CoV‐2 vaccines have been reported, mostly with autoimmune features. Epidemiological studies used diagnostic criteria included different populations. Immunological in selected linked mRNA suggest that it has a unique pathophysiology, vaccine‐encoded spike protein playing central role triggering aberrant immune response. In series, was observed more often following second vaccine dose. Latency from vaccination diagnosis hepatitis 1–147 days after last Raised immunoglobulin G levels positive anti‐nuclear and/or anti‐smooth muscle antibodies frequent. The vast majority reported treated corticosteroids, azathioprine. Outcome is favourable, but requiring transplantation or causing death reported. clinical entity includes patients long‐term immunosuppression, similarly hepatitis, self‐limiting damage, possibly representing form autoimmune‐like which we being referred as vaccine‐associated (SVALI). Further needed investigate pathogenic mechanisms related response viral liver.

Язык: Английский

Процитировано

0

Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China DOI Creative Commons
Xiaojing Li, Jin Su,

Shuyang Guo

и другие.

Vaccines, Год журнала: 2024, Номер 12(12), С. 1436 - 1436

Опубликована: Дек. 20, 2024

The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during COVID-19 pandemic, where platform technology enabled rapid development approval vaccines, optimizing processes, enhancing global public health responses. As a transformative tool, streamlines product development, allowing for reduction in number clinical trials or exemption from certain facilitating cross-referencing submissions. Despite significant efforts establish standardized procedures, challenges remain, particularly achieving unified definition application across regions. This paper explores evolution, applications, strategies technology, with focus on China's experience this field. approach, encompassing risk assessment, expedited emergency offers valuable insights into coordination. By analyzing contributions practices, highlights potential address future pandemics, including "Pathogen X", underscores importance harmonizing strengthen preparedness response.

Язык: Английский

Процитировано

0