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Novartis, the Swiss-based drug manufacturer, today announced plans to build what it says will be the first US plant to make cell-culture-based influenza vaccines.


The facility will be built in Holly Springs, N.C., at a total cost of about $600 million, the company said in a news release. It will be able to produce about 50 million doses of seasonal trivalent (three-strain) flu vaccine annually.


"In the event of an influenza pandemic, the site is planned to have a capacity of up to 150 million monovalent doses annually within six months of a pandemic declaration," the company said.


The US government awarded Novartis a $220 million contract in May for development of cell-based flu vaccines in the United States. That money will go toward the cost of the new facility, officials said.


Depending on validation testing and approval, the plant could begin production as early as 2011 and be ready for full production as early as 2012, a Novartis spokesperson told CIDRAP News by e-mail.


Novartis also announced today it has submitted a cell-based flu vaccine for approval by the European Union's Committee for Medicinal Products for Human Use. The company said it filed in June after successfully completing phase 3 clinical trials of the vaccine. Officials said this marks the first such submission in the EU.


Flu vaccines have been grown in chicken eggs since the 1950s, but a number of companies are developing techniques for growing them in laboratory cell cultures instead. Cell-culture production offers a number of potential advantages, including faster start-up, greater flexibility, less risk of contamination, and freedom from dependence on the availability of eggs.


"We are taking the lead in moving cell culture vaccine manufacturing closer to a commercial reality now that the site for a U.S. manufacturing plant has been chosen and the first EU submission for a flu cell culture vaccine have been completed," Novartis Chairman and CEO Dr. Daniel Vasella said in the news release.


The company is currently conducting a phase 1 and 2 clinical trial of a cell-based flu vaccine in the United States. The company spokesperson said by e-mail, "Our phase I/phase II trial in the US is fully enrolled, and immunogenicity data are satisfactory. We are in ongoing dialog with the US Food and Drug Administration to evaluate the data received to date and achieve an optimal design for our phase III program."


The vaccines for the European and US trials were developed and produced in Marburg, Germany, the company said.


In May the US Department of Health and Human Services awarded more than $1 billion worth of contracts to five companies for developing cell-based flu vaccines, including the $220 million to Novartis. The money comes from $3.8 billion that Congress appropriated last December for flu-pandemic preparedness.


The other contractors and their awards were GlaxoSmithKline, $274.75 million; MedImmune, $169.6 million; DynPort Vaccine, $40.97 million; and Solvay Pharmaceuticals, $298.59 million. The contracts are for 5 years

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