The Group reached this conclusion following review of the latest data on pandemic influenza A(H1N1) 2009 vaccines, and the results are published in the WHO Weekly Epidemiological Record today.
SAGE also reviewed safety data on the H1N1 vaccines following administration of more than 350 million doses. “The data indicate a similar safety profile to that of seasonal vaccines,” said Professor David Salisbury, SAGE Chair.
Other issues considered by the Committee during its first meeting of this year include recent progress towards polio eradication and a process for revising WHO’s vaccine prequalification procedure, a service provided by WHO to ensure that vaccines purchased by United Nations agencies meet international standards of quality, safety and efficacy.
Robust and independent oversight of new strategic plan on polio eradication needed
SAGE recognized the substantial progress made in the last 12 months by national authorities in reducing transmission of wild poliovirus, particularly in northern Nigeria, northern India and many re-infected countries, but cautioned against excessive enthusiasm. Members emphasized the importance of ensuring robust and independent monitoring of major milestones of the Global Polio Eradication Initiative’s new Strategic Plan for 2010-2012. They further recommended the rapid development, implementation and monitoring of corrective action in all countries in which a major milestone is seen to be at risk. SAGE recognized that insufficient financing is now the single greatest threat to polio eradication.
“Recent progress suggests that interruption of transmission of poliovirus is now within our grasp,” said Salisbury, “It is critical that international immunization and development communities help close the US$ 1.3 billion funding gap for 2010-2012 activities so this momentum can be maintained.”
Proposal to revise WHO’s vaccine prequalification procedure
SAGE expressed support for a proposed process to revise WHO’s procedure for prequalification of vaccines, but emphasized that the quality of the service must be maintained and resources be sufficient to meet increased demand. An improved process is needed in order to better meet the challenges of the increasing volume and complexity of prequalification requests from manufacturers. Working papers have been developed on issues such as programmatic suitability of vaccines, new approaches to testing, and regulatory oversight of vaccines manufactured in multiple sites. The broad consultative process on these papers is now under way, with the proposed revisions expected to be submitted to the WHO Executive Board in May 2011 for approval.
SAGE advises WHO on overall global policies and strategies, ranging from vaccine and technology research and development, to delivery of immunization and linkages between immunization and other health interventions.
The Group is comprised of 15 members, serving in their personal capacity. Members are acknowledged experts from around the world in fields relating to vaccines and immunization.
The Group meets at least twice a year, with working groups established for detailed review of specific topics prior to discussion by the full group.
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