UPDATE:Novartis Opens US-Based Flu-Vaccine Manufacturing Plant
(Updates with additional information and comments from Novartis chief
executive and HHS Secretary Sebelius starting in the third paragraph)
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 government started
funding several companies including Novartis in 2006 when officials were
concerned that the H5N1 bird flu virus that was circulating in Asia might spark
the next influenza pandemic.
Novartis is one of the major manufacturers of both seasonal and H1N1 influenza
vaccines for the U.S. market along with Sanofi-Aventis SA (SNY, SAN.FR); CSL
Ltd. (CSL.AU); GlaxoSmithKline PLC (GSK, GSK.LN); and MedImmune, which is a unit
of AstraZeneca PLC (AZN, AZN.LN). MedImmune makes a vaccine that's delivered as
a mist through the nose, while the other companies make shots.
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.
Health and Human Services Secretary Kathleen Sebelius, who attended the plant
opening, described the potential of cell-culture technology as "huge and
cutting-edge."
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. Novartis has a plant in Germany that
also uses the same cell-based technology, but the bulk of its influenza vaccines
are still made in chicken eggs.
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.
Sebelius said as of Tuesday a total of 60 million H1N1 doses have been made
for the U.S.
Daniel Vasella, Novartis's chief executive, said the yield of the H1N1 vaccine
- or the amount of active ingredient produced in the eggs - was 22% less than
the level typically seen for seasonal vaccine. He said the yield is now about
70%. All of the vaccine makers faced similar yield problems.
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
11-24-091547ET
Copyright (c) 2009 Dow Jones & Company, Inc.
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