Global Vaccine Safety DataNet (GVSD)

In 2007, an international meeting was held in France to discuss the establishment of a Global Vaccine Safety DataNet (GVSD). It was attended by:

  • Experts from developed and developing countries that currently, or will soon, collect computerized information on vaccine exposure and clinical outcomes,
  • Representatives of public health agencies,
  • Pharmaceutical companies.

You can read an expert review of the meeting in this document:

Global Vaccine Safety DataNet meeting

The goals of the meeting were to:

  • Assess current capabilities and interest in establishing a global vaccine safety data network,
  • Explore the infrastructure and funding required to bring such a project to fruition,
  • Define how to best implement this project.

Several considerations prompted the urgent need for a global approach to monitoring vaccine safety:

  • Vaccine manufacturing is becoming globalized. Many countries outside North America and Europe are now producing vaccines,
  • An increasing number of new vaccines will be first introduced in developing countries that have a limited infrastructure for monitoring vaccine safety,
  • Future vaccines, such as those against HIV or malaria, will probably make use of newer technologies with limited safety information, such as DNA vaccines, live virus vectors and new adjuvants.

A globally accessible computerized database for evaluating vaccine safety would allow rapid identification of possible vaccine safety issues, based on vaccine exposure information, standardized terminology, and case definitions. Such a database would allow comparison or combination of data from different sites in collaborating countries.

For example, if a vaccine safety issue is identified and validated in one site or country, the information can be rapidly communicated via the database to other countries using the same vaccine. Global collaborations would also enable the experience and expertise of the high-income countries to be extended to immunization programmes in the low-income countries, for example:

  • Training in data management, data sharing, data governance and data protection,
  • Developing ethical policies and procedures in collecting and reporting data, including guarding against conflicts of interest,
  • Sharing protocols, agreements and methods for evaluating local vaccine signals at the global level.

The Global Vaccine Safety DataNet GVSD would also enable collaborative studies to be conducted across several countries and allow results obtained in one geographical area to be tested in different populations with a different balance of vaccine risk and immunization benefit.

Question

Think back to the example of the introduction of rotavirus vaccines and detection of the post-licensure incidence of intussusception. How could the pooling of AEFI data from several countries via a global database have influenced the outcomes of surveillance in this example?

A. Pooling of data would have increased the statistical power for identifying intussusception following rotavirus vaccination.
B. The time to establish a causal association between the AEFI and the vaccine would have increased.
C. Pooling of data would have decreased the statistical power for identifying intussusception following rotavirus vaccination.
D. The time to establish a causal association between the AEFI and the vaccine would have decreased.

Answer

Answers A and D are correct.

  • Pooling and analysing data from several countries provides additional statistical power for identifying rare adverse events, such as intussusception following rotavirus vaccination. It could reduce the time taken to investigate and establish a causal association between the AEFI and the vaccine and take appropriate action.
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