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Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

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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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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Cancer Vaccines01:30

Cancer Vaccines

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Cancer treatment vaccines are a rapidly evolving field that offers a promising approach to immunotherapy. Unlike traditional vaccines that prevent diseases, cancer treatment vaccines are designed to treat existing cancers by stimulating the immune system to recognize and attack cancer cells.
Cancer vaccines come in two categories: preventive (prophylactic) and treatment (active). Preventive vaccines, such as the Human Papillomavirus (HPV) vaccine, protect against viruses that cause certain...
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Vaccinations01:51

Vaccinations

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Overview
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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Status Report on COVID-19 Vaccines Development.

Arun Kumar1, William E Dowling1, Raúl Gómez Román1

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Current Infectious Disease Reports
|April 19, 2021
PubMed
Summary

The development of COVID-19 vaccines has been accelerated by new tools and global collaboration. While current vaccines show efficacy, emerging SARS-CoV-2 variants may necessitate updated or multivalent vaccine strategies.

Keywords:
Animal modelsAssays and standardsCOVID-19 vaccinesPreclinical and clinical developmentSARS-CoV-2SARS-CoV-2 variants

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Area of Science:

  • Virology
  • Immunology
  • Vaccinology

Background:

  • The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has impacted global health, necessitating rapid vaccine development.
  • Accelerated vaccine development has been achieved through advanced testing models, immunogenicity assays, and international data sharing.

Purpose of the Study:

  • To review traditional and novel approaches for COVID-19 vaccine development.
  • To assess the immunogenicity and efficacy of various vaccine candidates.
  • To address the challenge of emerging SARS-CoV-2 variants and their impact on vaccine effectiveness.

Main Methods:

  • Summarization of inactivated, attenuated, nucleic acid, vector, and protein-based vaccine strategies.
  • Critical assessment of humoral and cell-mediated immune responses.
  • Analysis of vaccine efficacy against emerging SARS-CoV-2 variants.

Main Results:

  • Over 300 SARS-CoV-2 vaccines are in development, with 9 approved for emergency use, demonstrating 50-95% efficacy.
  • Emerging SARS-CoV-2 variants, particularly those with mutations in the Spike protein, may evade immune responses and reduce vaccine effectiveness.
  • Current vaccines offer partial to complete protection against some variants, but updates may be required.

Conclusions:

  • Novel and traditional vaccine platforms are being employed for COVID-19.
  • Comparative immunogenicity profiles of vaccines are being established through clinical trials.
  • Future vaccine strategies may involve strain-specific updates or multivalent vaccines to address evolving SARS-CoV-2 variants.