Immunization highlights: 2011
Ensuring safe vaccines of assured quality
Chinese national regulatory authority meets international standards
A WHO-led team concluded on 1 March 2011, at the end of a comprehensive review by experts from six countries, that the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, meet WHO indicators for a functional vaccine regulatory system. With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for WHO prequalification of specific products.
It is expected that vaccines from China could be prequalified one to two years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.
WHO receives prestigious award for validation of the shake test
In April 2011, WHO and partners were presented with the Ludwig Rajchman Prize of the Committee of the Scientific Council of the National Institute of Public Health of Poland, during a ceremony held in Warsaw. The prize was awarded for the research work validating the shake test for detecting freeze damage to adsorbed vaccines. Good temperature control during the storage and transport of vaccines is critical to ensure their potency and safety. Liquid formulations of aluminium-based vaccines against diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type b, alone or in combination, should not be frozen. However, practices that expose vaccines to sub-zero temperatures are widespread in both developed and developing countries. The shake test is designed to determine whether adsorbed vaccines have been affected by freezing.
Advisory Committee concludes that new meningitis vaccine is safe
Following review of new data for the meningococcal A conjugate vaccine, MenAfriVac, WHO's Global Advisory Committee on Vaccine Safety concluded that the experience from the first three countries to introduce this vaccine did not indicate any reasons for concern about the vaccine’s safety.
The data reviewed by the Advisory Committee in June were collected in Burkina Faso, Mali and Niger during the September and December 2010 vaccination campaigns and from the surveillance systems. Although the Committee recognized that it would not be practical to conduct active surveillance on a widespread basis during future immunization activities, it highlighted the need for continuous surveillance as the vaccine is rolled out to ensure that further data on the safety profile of the vaccine can be obtained.
Global vaccine safety Blueprint
WHO, together with partners, has developed the global vaccine safety Blueprint. This Blueprint is a strategic plan for strengthening vaccine pharmacovigilance capacity in low- and middle-income countries focuses on how national and international immunization players can better collaborate to address gaps in vaccine management and communication infrastructure with respect to safety.
Vaccine pharmacovigilance ― defined as the science and activities relating to the detection, assessment, understanding and communication of adverse events following immunization and other vaccine- or immunization-related issues, and to the prevention of untoward effects of the vaccine or immunization ― is a critical component in global immunization activities that requires further strengthening. Implementation of the 8 following objectives included in the Blueprint could contribute significantly to this purpose:
- strengthen vaccine safety monitoring systems;
- strengthen ability to evaluate vaccine safety signals;
- develop vaccine safety communication plans, understand perceptions of risk, and prepare for prompt management of any adverse events following immunization (AEFI) and crises;
- develop internationally harmonized tools and methods for vaccine pharmacovigilance;
- establish a legal, regulatory and administrative framework at all levels;
- strengthen regional and global technical support platforms for vaccine pharmacovigilance;
- make expert scientific advice on vaccine safety issues available; and
- put in place systems for appropriate interaction between national governments, multilateral agencies, and manufacturers
Blueprint implementation will be led by WHO and its partners and activities will be aligned with other related WHO capacity-building efforts. This includes, in particular, immunization programme and national regulatory authorities strengthening together with the development of national expert advisory bodies.