FDA批准新流感疫苗

hy2007

FDA Marketing Approval For Afluria - New Influenza Vaccine

CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, announced today that the U.S. Food and Drug Administration (FDA) has approved Afluria (influenza virus vaccine) for active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Today's approval marks the company's first entry into the U.S. vaccine market.

Afluria will be made available in both single-dose, thimerosal-free, pre-filled syringes and in multi-dose vials to provide choice and convenience to caregivers who administer it. CSL Biotherapies intends to deliver all shipments to the U.S. before the end of October, 2007, an objective that affirms the company's commitment to helping address a critical U.S. public health need.

\"CSL Biotherapies is proud to bring our 40-year heritage in influenza vaccines to the U.S. market, where boosting the supply of available flu vaccine and increasing vaccination rates is a priority public health goal,\" said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations. \"In addition, we are particularly pleased to be offering Afluria in a thimerosal-free formulation in pre-filled syringes, representing a greater degree of choice for patients and healthcare professionals.\"

\"Health authorities continue to emphasize the importance of flu vaccination as a front-line defense against a common and serious public health threat that still claims lives every year in the U.S.,\" said Kathryn M. Edwards, MD, of Vanderbilt School of Medicine in Nashville, Tennessee, and principal investigator in the National Institutes of Health-funded clinical trial that assessed the CSL influenza vaccine in the U.S. \"With today's approval of Afluria, we welcome the expanded diversity of vaccine suppliers and applaud CSL Biotherapies' efforts to increase the availability of thimerosal-free flu vaccine in the U.S. Now, healthcare professionals have the ability to offer flu vaccination to more people and significantly decrease the burden of this preventable disease in America.\"