November 24, 2009 / 8:16 PM / 10 years ago

Novartis opens new flu vaccine plant in U.S.

HOLLY SPRINGS, North Carolina (Reuters) - The bioreactors are empty and running just for show for now, but Novartis opened its first U.S. flu vaccine plant on Tuesday, the first in the country to make flu vaccines out of cells instead of eggs.

Novartis employees clean the area where MF-59, a distinguishing immune response booster used by Novartis in Europe, is added to vaccines at the Novartis flu vaccine facility in Holly Springs, North Carolina, November 24, 2009. REUTERS/Jason Arthurs

Health and Human Services Secretary Kathleen Sebelius toured the plant, whose cell-based technology is designed to be cleaner, quicker and more predictable than the current way most influenza vaccines are made using eggs and will help alleviate the U.S. dependence on imported vaccines.

The bioreactors used to incubate the cells with the virus should also be able to scale up more quickly to make larger quantities of vaccine when needed — such as during pandemics.

It will be years before the facility makes any real vaccine, so it is of no use during the current pandemic of H1N1 swine flu, in which the government is struggling to vaccinate Americans in the face of slow-arriving supplies.

“Cell culture technology for influenza vaccines is not yet approved in the United States; however, part of the HHS contract support for Holly Springs includes funding for the development of a flu cell culture vaccine,” Novartis said in a statement.

“If licensed in an emergency, the facility will be ready to respond to a pandemic as early as 2011. The plant is planned to be running at full scale commercial production in 2013,” it added.

The company operates a cell culture flu vaccine plant in Marburg, Germany, which makes vaccine for the European Union, Iceland and Norway.

The U.S. Centers for Disease Control and Prevention estimates 22 million Americans have been infected with H1N1 flu and it wants to vaccinate at least 160 million people. But just over 50 million H1N1 vaccines have been distributed.

The Health and Human Services Department invested $487 million to help Novartis build the plant in the hopes of making the U.S. flu vaccine supply more reliable.

BILLION DOLLAR INVESTMENT

“The total investment in the facility is nearly $1 billion, through a partnership between Novartis and HHS to support the design, construction, validation and licensing of the manufacturing facility in Holly Springs,” the company said.

When it gets up and going, Novartis says the Holly Springs facility will be able to make 50 million doses of seasonal flu vaccine a year and up to 150 million doses of pandemic vaccine within six months of a pandemic being declared.

“As Congress heard in H1N1 preparedness hearings, the United States needs vaccine production that is more reliable and domestically produced,” David Price, the U.S. House of Representatives member who represents Holly Springs as part of his district, told a ceremony at the plant.

“Since the vast majority of influenza vaccinations are made abroad, Novartis ... will put the United States in a better position to meet future influenza threats,” he said.

Wary of uncertain flu vaccine supplies, HHS has contracted with five different companies to make influenza immunizations for the U.S. market — Novartis, Sanofi Aventis, CSL, AstraZeneca unit MedImmune and GlaxoSmithKline.

In 2004, British authorities closed a contaminated plant making vaccine for the U.S. market, cutting in half the U.S. seasonal flu vaccine supply.

Sanofi has a flu vaccine plant in Pennsylvania, but other flu vaccines for the U.S. market are made in other countries.

Many experts have cautioned that in the event of a very serious pandemic, countries would be likely to seize any vaccines made within their own territories.

Writing by Maggie Fox; Editing by David Storey

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