MEDIMMUNE ALLOWED TO USE NEW TECHNOLOGY FOR INFLUENZA VACCINES
The FDA recently approved MedImmune's supplemental biologics license application to use a new technology to develop two influenza vaccines, according to the company.
The agency is allowing MedImmune to use reverse genetics, also known as plasmid rescue technology to produce two seasonal flu vaccines, FluMist and CAIV-T. Reverse genetics, a method where genes are assembled to develop a treatment, is seen as a quicker, safer approach than traditional egg-based methods.
The government has been increasingly supportive of cell-based technology in an effort to prepare for a potential flu pandemic. MedImmune has received nearly $170 million as part of this government initiative. As part of this effort, the NIH began enrolling participants last month in a Phase I study of an intranasal H5N1 influenza vaccine candidate based on MedImmune's live, attenuated vaccine technology, which also utilized reverse genetics technology.
Currently licensed influenza vaccines are produced in chicken eggs in a labor-intensive process that takes nearly nine months. Scientists must first select the virus strains they anticipate will be the predominant strains circulating in the U.S. during the following season. These strains are then adapted to grow in eggs. Manufacturers inject each adapted virus strain separately into millions of fertilized eggs, which are then harvested and blended into a single vaccine product that includes all influenza virus strains.
The cell-based approach also allows potentially harmful attributes of the virus to be removed, the company added. This process will benefit people who are allergic to eggs and cannot take the current vaccines.
MedImmune recently submitted its first lots of commercial FluMist for the 2006-2007 influenza seasons to the FDA for approval and release. MedImmune anticipates shipping its first doses of FluMist for the upcoming season to customers by the end of July. The company expects to have all lots approved and released for commercial sale by the first week in September.