A new manufacturing plant in North Carolina can create influenza vaccine
using cultured animal cells instead of the conventional process of using
fertilized eggs, according to the Department of Health and Human Services.
The plant, which was dedicated this week in Holly Springs, N.C., is the
first US facility to use a faster and more flexible technology to make
influenza vaccine. The dedication signals that the FDA could
authorize the facility to produce cell-based influenza vaccine during an
influenza pandemic, according to a
press release from HHS.
The facility is a public–private partnership of the HHS and
Novartis Vaccines and Diagnostics Inc. of Cambridge, Mass. This partnership
will be maintained under contract for at least 25 years.
“Today we’re marking the first change in influenza vaccine
manufacturing in the United States in 50 years,” said Robin Robinson,
PhD, director of the Biomedical Advanced Research and Development Authority
(BARDA) in the Office of the Assistant Secretary for Preparedness and Response
at HHS. “The pandemic readiness of this facility is a major milestone in
national preparedness for
pandemic influenza and other diseases.”
In an influenza pandemic, the new facility may be able to produce 25% of
the vaccine needed in the United States. In addition, cell-based technology
used in this facility for manufacturing seasonal and pandemic influenza
vaccines may be adapted to produce vaccines for other known and unknown
emerging infectious diseases in an emergency.
HHS and Novartis are partnering with Synthetic Genomics Vaccines of
Rockville, Md., to develop new technologies to shorten the vaccine
manufacturing timeline by optimizing vaccine virus seed strains used for
influenza vaccine production. In addition, the agency is also working with
Novartis and North Carolina State University to train international scientists
to use cell culture-based manufacturing techniques similar to what is used in
the new facility. The training program is part of a WHO initiative to
strengthen the ability of developing countries to produce influenza vaccine,
according to the HHS release.
“With the need to more rapidly produce sufficient quantities of flu
vaccine on an annual basis, this could be a big step forward in future
years,” Richard F. Jacobs, MD, from University of Arkansas for
Medical Sciences at Arkansas Children's Hospital, said.