May 4, 2006 (CIDRAP News) – In an effort to modernize vaccine production while preparing for an influenza pandemic, the US government today awarded five contracts totaling more than $1 billion to develop cell-based technologies for making flu vaccines.
The awards to five pharmaceutical companies are intended to help create an alternative to growing flu vaccines in eggs, the time-consuming production method used since the 1950s, and boost US production capacity. The money comes from $3.3 billion Congress appropriated last December for pandemic preparations by the Department of Health and Human Services (HHS).
"Today, we're taking a step closer to preparedness by investing more than $1 billion to develop vaccines more quickly and to produce them here in the United States," HHS Secretary Mike Leavitt said in a news release.
HHS listed the vaccine makers and their contract awards as follows: GlaxoSmithKline, $274.75 million; MedImmune, $169.6 million; Novartis Vaccines & Diagnostics, $220.51 million; DynPort Vaccine, $40.97 million; and Solvay Pharmaceuticals, $298.59 million.
The announcement comes a day after the Bush administration released a 228-page plan for implementing its flu pandemic strategy. One of the administration's goals is to develop the capacity for domestic production of enough vaccine for every American within 6 months of the emergence of a pandemic.
It takes about 6 months to grow seasonal flu vaccines in eggs, and the eggs must be ordered well in advance. Growing vaccines in laboratory cell cultures promises to be a somewhat faster and much more flexible approach. The method is already used for a number of other vaccines, such as polio, hepatitis A, and chickenpox.
"Our current capacity of egg-based influenza vaccine production is not sufficient to meet increased demands during an emergency," said Leavitt. "Accelerating the development of this vaccine technology and creating domestic capacity are critical to our preparedness efforts."
With cell-based production, companies can skip the step of adapting the virus strains to grow in eggs, the HHS statement said. In addition, the method will make it possible to meet increased needs in case of a shortage or pandemic, since cells can be frozen in advance and large volumes can be grown quickly, officials said.
Cell-based methods also sidestep the risk of loss of egg supplies because of various poultry diseases. Such methods also eliminate the drawback that people who are allergic to eggs can't receive vaccines grown in eggs.
The HHS announcement didn't give details on the contract requirements or timetables, but the companies offered some information in news releases. All said the contracts are for 5 years.
GlaxoSmithKline said it will use the award to speed the development of new cell-based seasonal and pandemic flu vaccines and to increase cell-culture manufacturing capability at the company's plant in Marietta, Pa. The company said that in addition to using the HHS funds, it will continue plans to invest more than $100 million in cell-culture production at the Pennsylvania plant.
MedImmune, maker of the intranasal vaccine FluMist, said it will use the contract to develop cell-based flu vaccines involving the same technology as FluMist, which uses a weakened live virus. The company, based in Gaithersburg, Md., said it plans to build "a cell-based facility in the Untied States that can produce at least 150 million doses within six months of notification of an influenza pandemic."
Swiss-based Novartis, like MedImmune, cited a goal of being able to produce 150 million doses of vaccine in a US facility within 6 months after declaration of a pandemic. The HHS contract will support product development and the design and testing of equipment.
Last fall Novartis launched a US phase 1-2 study of an investigational cell-culture-derived flu vaccine, the company said. The firm expects to file for European approval of that vaccine, made in Marburg, Germany, later this year.
DynPort Vaccine Corp. (DVC), a subsidiary of Computer Sciences Corp., said it is collaborating with Baxter Healthcare Corp. to develop cell-based flu vaccines. The firm said its HHS contract is worth $242.5 million, whereas the HHS announced listed the amount at $40.9 million.
HHS spokesman Marc Wolfson explained that the amount in excess of $40.9 million is conditional on additional appropriations as well as meeting the requirements of the contract. Wolfson is with the HHS Office of Public Health Emergency Preparedness in Washington.
DynPort said its contract supports, in addition to cell-based vaccine development, the pursuit of licensing for two flu vaccine candidates: "a split virus vaccine" for seasonal flu and a modified whole-virus vaccine for H5N1 avian flu.
Solvay, based in Brussels, Belgium, said its HHS contract covers the development of new cell-based flu vaccine and "the development of a master plan to manufacture, formulate, fill and package annual and pandemic influenza vaccines in a new U.S.-based facility."
"Our expertise gained from building our new commercial scale, cell-based influenza vaccine manufacturing facility in The Netherlands provides a strong foundation for the development of a similar facility in the U.S.," said Werner Cautreels, PhD, the company's CEO.
In April 2005, HHS awarded Sanofi Pasteur a $97 million contract to develop a cell-based flu vaccine. The company was the first to receive a federal contract for commercial scale use of new flu vaccine technology, the agency said.
Solvay news release
Jun 27, 2005, CIDRAP News story "Momentum builds for cell-culture flu vaccines"
Apr 4, 2005, CIDRAP News story "HHS funds development of cell-based flu vaccines"