Immunization, Vaccines and Biologicals

Immunization highlights: 2010

Ensuring safe vaccines of assured quality

Expert Committee endorses revised procedure for WHO prequalification of vaccines

A young Nigerian child holds out her hand to show the mark on her fingernail indicating that she has been vaccinated
Global Polio Eradication Initiative
The revised prequalification procedure will mean that vaccines of assured quality will reach those who need them more quickly

A revised procedure for WHO prequalification of vaccines was endorsed by WHO's Expert Committee on Biological Standardization (ECBS) in October. A key reason for the revision is the increasing diversity and complexity of products submitted for prequalification. A second is the increased demand for investigation into potential safety and quality issues, which is diverting staff resources from processing of files submitted for prequalification.

Under the revised procedure there will be increased collaboration with national regulatory authorities (NRAs) during the initial evaluation and also for post-prequalification activities. This will allow WHO to concentrate it's resources on issues not covered by the NRA.

The revised procedure also defines, for the first time, specifications for critical and desirable characteristics of vaccines from the perspective of immunization programmes. This will help make clear to manufacturers what is required for prequalification. As a result of the changes, prequalification of vaccines is expected to become quicker, with products better suited to their target populations. The target date for implementation of the new procedure is January 2012.

Other documents adopted by the Expert Committee in 2010

  • Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks (to replace Technical Report Series (TRS) 878, Annex 1);
  • Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines (to replace TRS 872, Annex 2);
  • Guidelines for independent lot release of vaccines by regulatory authorities (new); and
  • Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products (new).

These documents are expected to be available on the ECBS web site by early May 2011.

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New online database for WHO prequalified vaccines

A new database to enable immunization programme managers, procurement agencies, regulatory authorities, and other partners to search for vaccines prequalified by WHO by type of vaccine, manufacturer and country of manufacture came online in 2010. Summary pages for each prequalified vaccine include information such as:

  • date of prequalification;
  • vaccine presentation;
  • route of administration;
  • shelf life;
  • packaging; and
  • cold chain requirements.

A total of 22 vaccines were prequalified by WHO in 2010. Information on quality issues related to specific vaccines can also be found on the prequalification pages of the WHO web site.

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New meningitis vaccine is safe and should be offered to pregnant women

Pregnant and nursing mothers queue outside a clinic
GACVS agreed that MenAfriVac should be offered to pregnant and lactating women residing in the African meningitis belt

The Global Advisory Committee on Vaccine Safety (GACVS) reviewed the safety monitoring data for the meningococcal A conjugate vaccine (MenAfriVac) from the pilot introduction in Burkina Faso, Mali and Niger in September 2010 at its meeting in December 2010. Based on this early experience, limited to approximately 1 million vaccinated people, GACVS found that no outstanding safety issues related to the use of this vaccine had been identified so far.

The Committee supported WHO’s technical guidance that MenAfriVac should be offered to pregnant and lactating women residing in the meningitis belt during any stage of pregnancy or lactation. The Committee also emphasized the need for additional post-marketing surveillance to provide more complete information about the safety profile of the vaccine, including its effects in specific groups such as pregnant women.

The Committee continues to review vaccine safety issues of potential global importance as required. Other issues reviewed during 2010 include: safety of pandemic A (H1N1) vaccines; febrile seizures after use of seasonal influenza vaccine in Australia; porcine circoviruses and rotavirus vaccines; rotavirus vaccines and intussusception; and safety issues relating to administering yellow fever vaccine to breastfeeding women.

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