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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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...
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...
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...
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

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Related Experiment Video

Updated: Jul 12, 2026

Fabrication of Pulsatile Polymeric Microparticles Encapsulating Rabies Antigen
07:44

Fabrication of Pulsatile Polymeric Microparticles Encapsulating Rabies Antigen

Published on: May 12, 2023

Which pharmacovigilance for vaccines?

Hervé Le Louët1, Elisabeth Loupi, Françoise Haramburu

  • 1Service de Pharmacologie, Hôpital Henri Mondor, Paris, France.

Therapie
|September 7, 2007
PubMed
Summary

Vaccines are immunological medicines requiring specialized clinical pharmacology and pharmacovigilance. Optimal vaccine safety monitoring necessitates improved data collection and public health surveillance.

Area of Science:

  • Immunology
  • Pharmacology
  • Public Health

Background:

  • Vaccines are anti-infectious medicines, primarily prophylactic, with immunological effects.
  • Standard clinical pharmacology and pharmacovigilance methods apply, with specific considerations for vaccines.
  • Past vaccination campaigns highlight data collection gaps impacting public health assessment and long-term safety evaluation.

Purpose of the Study:

  • To address insufficiencies in vaccine data collection and evaluation.
  • To enhance the pharmacovigilance of vaccines.
  • To combat misinformation and fear generated by data absence.

Main Methods:

  • Applying clinical pharmacology and pharmacovigilance principles to vaccines.
  • Analyzing data collection methods for public health impact and epidemiological relevance.

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Protocol for Recombinant RBD-based SARS Vaccines: Protein Preparation, Animal Vaccination and Neutralization Detection

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  • Reviewing existing surveillance and risk management plans for vaccination.

    • Main Results:

    • Identified insufficiencies in data collection for evaluating vaccine public health interest, epidemiological relevance, and long-term safety.
    • Recognized that data gaps can fuel public fear and anti-vaccination sentiment.
    • Highlighted the need for specific adaptations in vaccine evaluation and monitoring.

    Conclusions:

    • Vaccine pharmacovigilance requires tailored approaches beyond standard drug evaluation.
    • Improved coherence among regulatory authorities is crucial.
    • Active surveillance, population follow-up, and enhanced medical and public education are essential for optimal vaccine safety and public trust.