Previous recommendations on H1N1 pandemic influenza vaccine still stand: SAGE

The World Health OrganizationMay 28 2010

SAGE concludes that its previous recommendations on priority target groups and number of doses still stand

Previous recommendations on who should be vaccinated with the H1N1 pandemic influenza vaccine still stand according to the World WHO's Strategic Advisory Group of Experts (SAGE) on Immunization, the principal advisory group to WHO for development of policy related to vaccines and immunization. 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.

Among other issues considered by the Committee during its first meeting of 2010 were 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 by national authorities in the last 12 months 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 Professor 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."

SAGE supports proposal to revise WHO's vaccine prequalification procedure

SAGE expressed strong 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.