Laidback Al
Well-known member
Abstract from a presented paper at the 13th ICID - Kuala Lumpur, Malaysia- June 19-22, 2008
Influenza in Animals and People
June 20, 08
Progress on Pre-pandemic/Pandemic Influenza Vaccine
M. Tashiro, National Institute of Infectious Diseases, Japan, Tokyo, Japan
Abstract
As pandemic influenza is a matter of global crisis management, WHO has urged to increase international production and supply of pandemic vaccines. For this, each country should establish influenza vaccination policy depending on annual health burden and economical situation. In Asia, while only Japan and China produce seasonal influenza vaccines, several countries including India, Indonesia, Singapore, South Korea, Taiwan, Thailand, and Vietnam, are planning to establish local production of pandemic vaccines. However, pandemic vaccine policy should be based on sustained annual vaccine measures. WHO started to support these countries to implement their local vaccine production of pandemic vaccines. Technical transfer to these facilities by vaccine manufactures in developed countries is essential, but it is conflicting with business and profits of the manufactures.
To develop human H5N1 influenza vaccine, Japan experienced a low immunogenic property in humans of split-type vaccines derived from A/Hong Kong/156/97(H5N1). The Japanese project of H5N1 vaccine development aimed to develop a pandemic vaccine with highly immunogenic and to spare antigens to provide larger population with the vaccines in a short period of time. The WHO prototype vaccine strain, NIBRG-14, propagated in eggs was fixed with formalin. Based on animal experiments, alum-adjuvanted, inactivated whole virus vaccines were prepared. Phase 1 clinical studies followed by Phase 2+3 studies were conducted with 1.75, 5, and 15 mcg HA/dose in one or two doses, and subcutaneously or intramuscularly. Results of the clinical studies showed that the vaccine with 15 mcg HA was tolerable and did not cause severe adverse event. Serum antibody responses were induced efficiently by one or two shots with the high (15) or medium dose (5) , respectively, of the vaccines, meeting all of the three EMEA criteria. There results indicated that the inactivated whole virus vaccine conjugated with alum adjuvant is a practically suitable formulation of H5N1 pandemic vaccines. The serum antibody induced by the Clade 1 vaccine cross-reacted significantly with three subclades of Clade 2 viruses.
Based on the data, the Government has introduced national stockpile policy of prepandemic vaccines, now with 20 million courses. Stockpile is to scale-up annually. Before expiration of each batch, vaccination to volunteers of the prioritized groups and then general population is under discussion.
http://www.x-cd.com/isid08/prof2265.html
Hat-tip to Solitaire for identifying the link to the abstracts.
Influenza in Animals and People
June 20, 08
Progress on Pre-pandemic/Pandemic Influenza Vaccine
M. Tashiro, National Institute of Infectious Diseases, Japan, Tokyo, Japan
Abstract
As pandemic influenza is a matter of global crisis management, WHO has urged to increase international production and supply of pandemic vaccines. For this, each country should establish influenza vaccination policy depending on annual health burden and economical situation. In Asia, while only Japan and China produce seasonal influenza vaccines, several countries including India, Indonesia, Singapore, South Korea, Taiwan, Thailand, and Vietnam, are planning to establish local production of pandemic vaccines. However, pandemic vaccine policy should be based on sustained annual vaccine measures. WHO started to support these countries to implement their local vaccine production of pandemic vaccines. Technical transfer to these facilities by vaccine manufactures in developed countries is essential, but it is conflicting with business and profits of the manufactures.
To develop human H5N1 influenza vaccine, Japan experienced a low immunogenic property in humans of split-type vaccines derived from A/Hong Kong/156/97(H5N1). The Japanese project of H5N1 vaccine development aimed to develop a pandemic vaccine with highly immunogenic and to spare antigens to provide larger population with the vaccines in a short period of time. The WHO prototype vaccine strain, NIBRG-14, propagated in eggs was fixed with formalin. Based on animal experiments, alum-adjuvanted, inactivated whole virus vaccines were prepared. Phase 1 clinical studies followed by Phase 2+3 studies were conducted with 1.75, 5, and 15 mcg HA/dose in one or two doses, and subcutaneously or intramuscularly. Results of the clinical studies showed that the vaccine with 15 mcg HA was tolerable and did not cause severe adverse event. Serum antibody responses were induced efficiently by one or two shots with the high (15) or medium dose (5) , respectively, of the vaccines, meeting all of the three EMEA criteria. There results indicated that the inactivated whole virus vaccine conjugated with alum adjuvant is a practically suitable formulation of H5N1 pandemic vaccines. The serum antibody induced by the Clade 1 vaccine cross-reacted significantly with three subclades of Clade 2 viruses.
Based on the data, the Government has introduced national stockpile policy of prepandemic vaccines, now with 20 million courses. Stockpile is to scale-up annually. Before expiration of each batch, vaccination to volunteers of the prioritized groups and then general population is under discussion.
http://www.x-cd.com/isid08/prof2265.html
Hat-tip to Solitaire for identifying the link to the abstracts.
