Novartis Opens US-Based Flu-Vaccine Manufacturing Plant
By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES
HOLLY SPRINGS, N.C. -(Dow Jones)- Swiss drug maker Novartis AG (NVS, NOVN.VX)
opened a vaccine-manufacturing plant Tuesday designed to make influenza vaccines
without relying on decades-old technology that employs millions of chicken eggs
to grow viruses.
However, under the current timeline, the plant still needs to be licensed by
the Food and Drug Administration and likely won't be producing flu shots for the
U.S. market until at least 2013. But Novartis officials said the plant could be
brought online in two years if licensed under emergency procedures.
The $1 billion-plus project is being funded with $487 million in funds from
the U.S. government and about $600 million from Novartis.
The plant is capable of producing 150 million doses of a single-strain vaccine
in about six months, such as the one being made to fight the H1N1 influenza
pandemic. Vaccines for seasonal influenza are made from three strains of
influenza viruses. Novartis officials said the current facility could be
expanded.
Currently, Novartis goes through 1 million chicken eggs a day to make
influenza vaccines. They are injected with influenza viruses and incubated for
11 days in order to produce the active ingredient in the vaccines. It takes
about six to nine months for vaccine to be made and tested.
The Holly Springs plant will use a cell-culture system derived from a dog
kidney that can be continually grown in a laboratory, which cuts up to a month
off the start of the egg-based process.
The cells are infected with influenza viruses, which grow in 1,250-gallon
steel tanks for three days before being extracted and purified and later placed
inside a shot. Cell cultures also eliminate the need for a continual supply of
chicken eggs.
The cell cultures potentially allow influenza viruses to grow faster. One
problem with the H1N1 vaccine is that the virus grew more slowly in chicken eggs
than is typical for seasonal influenza vaccines.
For most vaccine sold in Europe, Novartis uses an adjuvant, or an ingredient
that's designed to boost the body's immune response to a vaccine. So far the FDA
has been reluctant to sign off on the additional ingredient.
The agency did approve GlaxoSmithKline PLC's (GSK) cervical cancer vaccine
recently, which is made with an adjuvant.
Andrin Oswald, chief executive of Novartis's vaccines and diagnostics
division, said the FDA has "theoretical concerns about the safety of adjuvants."
The concern involves whether boosting the immune system to respond to the flu
shot has health consequences.
Although the agency approved Glaxo's cervical cancer vaccine, that vaccine is
given once over a three-dose series while influenza shots are given annually.
The FDA wants to see long-term safety data about adjuvants. Novartis started
such studies earlier this year.
The agency may also want to see larger studies. Last week, an FDA advisory
panel narrowly rejected another cell-culture vaccine being developed by Protein
Sciences Corp., a private firm based in Meriden, Conn. The panel said a larger
study should be required to make sure the new cell-culture technology is safe.
The company uses a different method than does Novartis.
While Novartis's new plant is designed to use adjuvant in flu shots, the
facility could also be used to make flu shots without it.
Separately, Novartis officials said they've shipped 22 million doses of H1N1
vaccine to the U.S. market. The company is making about 90 million of the 250
million H1N1 doses the government has purchased from five suppliers. The company
won't finish delivering the vaccine until the first part of 2010.
The other major supplier, a unit of Sanofi-Aventis SA (SNY), has said it will
deliver its 75 million doses of vaccine by the end of this year.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
(END) Dow Jones Newswires
11-24-091439ET
Copyright (c) 2009 Dow Jones & Company, Inc.
|