Novartis Gets US Contract For Flu Vaccination Plant

(CIDRAP News) -- The US government has awarded Novartis a $487 million contract to help build a plant in North Carolina that the company says will be capable of producing 150 million doses of cell-based pandemic influenza vaccine within 6 months after the start of a pandemic.

Because of the advantages of growing flu vaccines in cell culture instead of in chicken eggs, the conventional method, the Novartis facility is expected to increase the US capacity to make pandemic flu vaccine by 25%, the Department of Health and Human Services (HHS) said in a news release.

The facility, which Novartis said is already under construction in Holly Springs, N.C., also will make prepandemic flu vaccines, HHS said. The contract calls for HHS and Novartis to share the cost of the facility, with HHS providing 40% and the company paying 60%.

"We currently anticipate that by 2012 the site will provide jobs for more than 300 highly skilled people with the capability to produce cell-based flu vaccine, prepandemic vaccine and 150 million doses of pandemic vaccine within six months of the declaration of an influenza pandemic," said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, in a news release.

Dr. Robin Robinson, director of HHS's Biomedical Advanced Research and Development Authority (BARDA), told CIDRAP News that $317 million of the contract is for facility construction and $170 million is for buying prepandemic and/or seasonal flu vaccines.

Under the contract, Novartis is to supply "two commercial-scale lots" of prepandemic vaccine per year for 3 years, according to the company announcement. Robinson said that could amount to at least 3 million doses per year and explained that the contract actually provides for either seasonal or prepandemic cell-based vaccine. The contract also gives HHS the option to continue buying vaccine for 17 more years.

Novartis already makes a cell-based seasonal flu vaccine that was approved by the European Union in May 2008, Robinson noted. He said the company also has applied to the EU for licensure of a cell-based H5N1 prepandemic vaccine.

"This year Novartis will be making a regulatory submission for [US] licensure of a seasonal influenza vaccine using this cell-based technology," Robinson said. "It's likely that by the end of this year or early next year that product will be licensed." That vaccine will initially be made in Germany, he added.

HHS awarded Novartis a $220 million contract in May 2006 to speed the development of cell-based flu vaccines. Although the company announced plans for the North Carolina facility in July 2006, Robinson said the earlier contract was for development of cell-based flu vaccines, not for the facility. Most of the vaccine development has been done in a plant in Marburg, Germany, he said.

The HHS statement said, "Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic or developed rapidly in response to an epidemic. Cell-based vaccine production also dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods."

As noted by HHS, all current US-licensed flu vaccines are grown in eggs, a method that has changed little since the 1950s. "In place of eggs, cell-based vaccine production uses laboratory grown cells that are capable of hosting a growing virus. The virus is injected into the cells where it multiplies," the agency said. Later the cell walls are removed and the viruses are harvested, purified, and killed.

"We believe this is the capstone for the original plan we set out for pandemic preparedness and medical countermeasures" and to build up US flu vaccine production capacity, Robinson commented.

He noted that HHS has a goal of establishing a US capability to produce 600 million doses of pandemic vaccine within 6 months of the declaration of a pandemic. Besides Novartis, Sanofi Pasteur and other companies are also expected to produce pandemic vaccines, he said.

The new contract also includes about $2 million for clinical studies to show that vaccines made in the North Carolina facility are comparable with Novartis vaccines made in Germany, Robinson reported.