A Milestone in Protection from Influenza
The following is a statement released June 17 by Biomedical Advanced Research and Development Authority Director and Deputy
Assistant Secretary for Preparedness and Response, Robin Robinson, PhD.
This week, our nation reached a milestone in battling influenza, with
the U.S. Food and Drug Administration’s first approval to manufacture seasonal
influenza vaccine using cell-based technology in a U.S. facility. That
facility, owned by Novartis of Basel, Switzerland, and located in Holly
Springs, N.C., now can manufacture cell-based vaccine against seasonal as well
as pandemic influenza viruses. This new capability demonstrates the
effectiveness of a multi-use approach to emergency preparedness.
Since its establishment in 2006, the Biomedical Advanced Research and
Development Authority (BARDA), part of the U.S. Department of Health and Human
Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), has sponsored the development of new technologies for
use in emergencies, including the cell-based technology at Holly Springs. These
new technologies are flexible enough to produce vaccines and other medical
products for a variety of public health emergencies.
In pursuing new technology, BARDA leverages public-private
partnerships. We also support development of medical countermeasures – drugs,
vaccines, diagnostics and devices – that can be used to diagnose or treat
illness or injury in public health emergencies like pandemics or following acts
of bioterrorism, as well as day-to-day medical conditions. This multi-use
approach strengthens everyday systems and increases our resilience in
The Holly Springs facility was built through a partnership established
in 2009 between BARDA and Novartis to increase the domestic production capacity
of pandemic influenza vaccine and quickly provide additional influenza vaccines
to combat public health threats.
In 2012, BARDA broadened this partnership with Novartis and expanded
the Holly Springs facility’s role in emergency preparedness as one of three
national Centers for
Innovation in Advanced Development and Manufacturing. These centers provide
support for the development and manufacturing of medical countermeasures and
can transition efficiently to manufacture pandemic influenza vaccines or other
medical products for public health emergencies. The centers also aid in
bringing new medical countermeasures to the market and help train the
biopharmaceutical workforce needed in the future.
As a center, the Holly Springs facility can produce up to 200 million
doses of pandemic influenza vaccine within six months of the declaration of a
In 2012, the Holly Springs facility opened to produce cell-based
influenza vaccine that could be authorized by the FDA for use during the
emergency. That same year cell-based influenza vaccine called Flucelvax, made
by Novartis in Germany, became the first approved by FDA for use in the United
States. Now, with the approval of manufacturing the Holly Springs facility, the
capacity for seasonal influenza vaccine production in the United States has
increase by at least 50 million doses.
This latest FDA approval affirms the value and success possible through
public-private partnerships as we move forward bringing our nation the medical countermeasures needed
to protect health and save lives every day.