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Related Concept Videos

Vaccine Production01:23

Vaccine Production

Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
Vaccinations01:51

Vaccinations

Overview
Vaccines01:21

Vaccines

Vaccines are among the most effective tools in preventive medicine, designed to prepare the immune system to recognize and combat infectious agents. By introducing antigens—substances that the immune system identifies as foreign—vaccines stimulate an adaptive immune response that leads to immunological memory. This immunological memory enables the body to mount a faster and more effective response upon future exposures to the actual pathogen.Vaccines can be categorized based on the type of...
Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
Development of Immunocompetence01:22

Development of Immunocompetence

The initiation of cell-mediated immunity can be observed as early as the third month of fetal growth, with active antibody-mediated immunity following approximately one month later.
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Enrichment of Native and Recombinant Extracellular Vesicles of Mycobacteria
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Enrichment of Native and Recombinant Extracellular Vesicles of Mycobacteria

Published on: December 8, 2023

Development pathway for biodefense vaccines.

Alan D T Barrett1, David W C Beasley

  • 1Sealy Center for Vaccine Development, Center for Biodefense and Emerging Infectious Diseases, Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston, TX 77555-0436, USA. abarrett@utmb.edu

Vaccine
|October 20, 2009
PubMed
Summary
This summary is machine-generated.

Developing vaccines, especially for biodefense and emerging diseases, faces unique challenges. This process requires significant investment and time, with animal models crucial for demonstrating efficacy when natural disease is rare.

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Evaluation of Host-Pathogen Responses and Vaccine Efficacy in Mice
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Evaluation of Host-Pathogen Responses and Vaccine Efficacy in Mice

Published on: February 22, 2019

Area of Science:

  • Vaccinology
  • Biodefense
  • Emerging Infectious Diseases

Background:

  • Vaccine development is a lengthy and costly process, typically taking 18-20 years and exceeding $500 million.
  • Routine vaccines have clear economic and public health justifications.
  • Vaccines for biodefense and emerging diseases present different economic and logistical challenges due to unpredictable demand and potential stockpiling.

Purpose of the Study:

  • To outline the essential components and considerations in the vaccine development pathway.
  • To highlight the specific challenges in developing vaccines for biodefense and emerging diseases.
  • To emphasize the critical role of animal models in efficacy trials for rare or non-existent natural diseases.

Main Methods:

  • The abstract describes the general vaccine development pathway, from discovery to licensure.
  • It discusses the economic and public health considerations for different vaccine types.
  • It highlights the importance of animal models in preclinical efficacy assessments.

Main Results:

  • The vaccine development pathway involves fundamental stages: basic science/discovery, preclinical development, clinical trials, registration/licensure, and implementation planning.
  • Efficacy trials for biodefense and emerging disease vaccines are often complicated by the rarity or absence of natural disease.
  • Animal models are critical for demonstrating efficacy in such cases.

Conclusions:

  • Despite unique challenges, the core vaccine development pathway remains consistent.
  • Strategic planning and robust preclinical data, including animal model studies, are essential for successful vaccine development, particularly for biodefense and emerging threats.