Statement by HHS Secretary Kathleen Sebelius on Approval of Cell-Based Flu Vaccine

Statement

By:  Kathleen Sebelius
Date: Nov. 20, 2012
Location: Washington, DC

Today the U.S. Food and Drug Administration approved our nation's first cell-based vaccine, Flucelvax, to protect against seasonal influenza. This newly approved vaccine is a milestone in protecting Americans' health during flu season and in future pandemics. The cell-based vaccine is as safe and effective as traditional egg-based vaccine and the technology used to manufacture it is more flexible and reliable than the traditional technology. In the event of an influenza pandemic, this cell-based technology could provide a more rapid start-up of the vaccine manufacturing process, potentially increasing our nation's health security.

The approval of this vaccine, manufactured by Novartis, demonstrates what can be accomplished through public-private partnership. The Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), has supported industry partnerships to develop vaccines and other medical products as part of the national pandemic influenza preparedness strategy. The goal is simple: provide additional and better influenza vaccines sooner to combat public health threats including pandemics.

To this end, ASPR and Novartis partnered to move this vaccine forward in the development process and both partners funded the studies needed to reach approval. In 2009, ASPR entered into a public-private partnership with Novartis to build the first facility in the United States capable of manufacturing cell-based influenza vaccine. This year, ASPR expanded that partnership and established a Center for Innovation in Advanced Development and Manufacturing at this facility, with a future goal of manufacturing this new cell-based flu vaccine at this new facility. This will allow a substantial increase in the capacity to produce pandemic flu vaccine within the United States. Novartis will be working toward that in the coming months.

In 2010, after responding to the first flu pandemic the world had experienced in decades, this Administration recognized the need to produce medical countermeasures rapidly in the face of any attack or threat. Today's announcement from the FDA brings our nation one step closer to this goal.