Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced that its pandemic influenza vaccine for human use Emerflu, has been granted marketing authorization from the Australian Therapeutic Goods Administration (TGA). Emerflu vaccine is now approved for the prevention of pandemic influenza in Australia upon official declaration of a pandemic. Emerflu vaccine is intended to be manufactured and distributed with the identified pandemic strain and used in Australia in accordance with official Australian government guidance.
The Australian approval of Emerflu vaccine granted today follows the positive recommendation by the Australian Drug Evaluation Committee (ADEC) on February 13 2009, based on a review of results from clinical trials, which began in late 2004 on H5N1 alum-adjuvanted inactivated influenza vaccine candidates. These trials evaluated the safety and ability of Emerflu vaccine to elicit a protective immune response to the H5N1 strains currently identified by global health authorities and experts as a potential source for the next pandemic.
"The Australian TGA's recommendation of Emerflu vaccine marks a new milestone in pandemic preparedness," said Wayne Pisano, President and CEO of sanofi pasteur.
According to the World Health Organization (WHO), influenza vaccines are considered to be the most important and potentially effective intervention for mitigating the effects of an influenza pandemic. The optimal choice of strain and formulation for an effective vaccine will be possible when the pandemic influenza strain has emerged. "As the world's leading influenza vaccine manufacturer, sanofi pasteur aims at contributing to the efforts of WHO, Australia and other countries around the world to safeguard human health in the event of an influenza pandemic," added Pisano.
Sanofi pasteur is actively involved in pandemic preparedness and has invested in a major expansion of its influenza vaccine production capacity in the US, France, China and Mexico. Sanofi Pasteur is also committed to continuing its robust research and development program by exploring strategies for protecting more people. This includes the evaluation of new vaccine formulations to generate immune responses against other strains of the H5N1 virus as well as the use of adjuvants or immunostimulators to increase the response to the vaccine.