Bird Flu: Science and Policy

[DewDiligence]

There Are 31 Avian & Pandemic Prototype Vaccines

[c/o LJM on SI]

http://www.ifpma.org

>>
02 May 2006

The IFPMA's research-based vaccine manufacturing members are conducting a growing number of clinical trials of “prototoype” influenza vaccines, designed to counter to the threats of avian and pandemic influenza. “Industry is increasing its commitment to help minimize the global health impact of emerging influenza threats” said Dr. Harvey E. Bale, Director General of the IFPMA. “This is documented in the IFPMA summary ‘R&D for Avian / Pandemic Influenza Vaccines by IFPMA Influenza Vaccine Supply International Task Force (IVS ITF) members' published today.” This unique information resource lists all the prototype avian / pandemic influenza vaccines under development by these IFPMA member companies. As such, it covers the vast majority of R&D projects being undertaken in this field.

A total of 31 avian/pandemic prototype vaccine clinical trials are now listed by IFPMA, compared to 28 in January 2006. These vaccine trials involve 15 manufacturers, located in Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Switzerland, UK and USA. sanofi pasteur alone has no less than eight different vaccine trials either recently completed or underway. A total of eleven Phase II clinical trials of prototype vaccines are either on-going or planned for 2006. Three prototype vaccines, one from Chiron / Novartis and two from GSK, have already been submitted as “Mock Up” dossiers for approval by the EU regulatory authority (EMEA).

The majority of projects target specific strains of influenza virus (H2N2, H5N1, wild type H5N1, H5N3, H7N1, H7N7, H9N2), but Merck focuses on development of a universal influenza vaccine, using an M-2 peptide conjugate protein. Among the influenza strain-targeted projects, 26 use an inactivated virus (10 whole virus, 10 split virus, 6 surface antigen), and 4 use a live attenuated virus.

Almost all prototype vaccines use a traditional injection delivery system, although MedImmune uses a nasal spray. Sixteen projects use Aluminum salt as an adjuvant. Berna/Crucell uses a virosome carrier/adjuvant system; CSL, Aluminum phosphate; Chiron/Novartis, MF59 and GSK, a novel adjuvant system. Twenty-five projects use the traditional egg culture technology currently used to manufacture seasonal influenza vaccines, while 6 use cell culture systems.

About the IFPMA Influenza Vaccine Supply International Task Force

The IFPMA Influenza Vaccine Supply Interventional Task Force (IVS ITF), established in February 2002, brings together research-based influenza vaccine manufacturers from around the world, which are conducting the R&D necessary to develop safe, effective, high-quality vaccines agains avian and pandemic influenza threats. The IVS ITF works within the constraints of anti-trust law to address the advocacy, communication, policymaking, regulatory, scientific and technical issues related to interpandemic and pandemic influenza vaccines. IVS ITF members are committed to make their unique expertise in R&D, logistics, manufacturing, safety and regulatory issues available to help governmental and intergovernmental bodies in pandemic planning and decisionmaking.

For more information, see:
ifpma.org/pdf/pandemic_backgrounder_23Jan06.pdf.

About the IFPMA

The International Federation of Pharmaceutical Manufacturers & Associations is the global nonprofit NGO directly representing twenty-six research-based pharmaceutical, biotech and vaccine companies and sixty national industry associations in developed and developing countries. The industry's R&D pipeline contains hundreds of new medicines and vaccines being developed to address global disease threats, including cancer, heart disease, HIV/AIDS and malaria. The IFPMA Clinical Trials Portal and the IFPMA Health Partnerships Survey help make the industry's activities more transparent. The IFPMA strengthens patient safety by improving risk assessment of medicines and combating their counterfeiting. It also provides the secretariat for the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
<<