By Cheryl Pellerin
Washington File Staff Writer

Washington – As part of the president’s plan to prepare for a pandemic, U.S. Department of Health and Human Services Secretary Michael Leavitt announced the award of more than $1 billion to five pharmaceutical companies to accelerate development and production of new technologies for influenza vaccines in the United States.

During a May 4 press briefing, Leavitt said the goal is to have the ability in the United States, within three to five years, to manufacture 300 million courses of pandemic flu vaccine within six months of the declaration of a pandemic.

“The hard truth is that at this moment,” Leavitt said, “the capacity simply does not exist within the United States to produce vaccines with sufficient speed and quantity to reach every American, and that’s true in countries all over the world. But that’s about to begin to change.”

In November 2005, President Bush proposed $7.1 billion for a multiyear effort to prepare the nation for a pandemic, and Congress provided the first $3.8 billion in funding to implement the plan. (See related article.)

“We’re using those funds to pursue a broad strategy of preparedness,” Leavitt said, “including investing, in vaccines, investing in rapid diagnostics, investing in dose-stretching technology. We also are increasing our domestic and international surveillance and planning.”

The Bush administration unveiled a far-reaching plan May 3, the National Strategy for Pandemic Flu Preparedness Implementation Plan, that directs federal government agencies to take more than 300 actions to prepare for an outbreak of pandemic influenza.  (See related article.)

DEVELOPING NEW FLU TECHNOLOGIES

The five companies are GlaxoSmithKline ($274.75 million), MedImmune ($169.46 million), Novartis Vaccines & Diagnostics ($220.51 million), DynPort Vaccine with Baxter Healthcare ($40.97 million), and Solvay Pharmaceuticals ($298.59 million).

The companies, Leavitt said, also are “making substantial commitments of their own in terms of people, capital and resources.”

The contracts support the advanced development of cell-based production technologies for influenza vaccines and will help modernize and strengthen the nation’s influenza vaccine production by creating an alternative to producing influenza vaccines in eggs. (See related article.)

Standard egg-based vaccine production methods, developed more than 50 years ago, involve identifying which virus strains should go into a vaccine, then growing those strains in millions of fertilized chicken eggs before harvesting, purifying and killing the viruses and using them in vaccines.

The process is time consuming and uses about 100 million eggs each flu season in the United States alone. The egg-based method is especially problematic for a potential H5N1 vaccine because the virus kills chicken embryos before much of the virus can grow.

Cell-based vaccine manufacturing – a technology used in many other modern vaccines – is a more reliable, more flexible and more scalable method of producing flu vaccines.

The cell-culture method involves growing animal or human cells in the laboratory in a nutrient solution. The virus is injected into the cells, and cells and viruses multiply. Then the cells’ outer walls are removed and the virus is harvested, purified and inactivated.

Cell-culture-based flu vaccines could help meet surges in capacity needs in the event of a shortage or pandemic because cells can be frozen in advance and large volumes grown quickly.

“We have the opportunity to be the first generation that prepares for pandemic,” Leavitt said. “Our current capacity of egg-based influenza vaccine production is not sufficient to meet increased demands during an emergency. Accelerating the development of this vaccine technology and creating domestic capacity are critical to our preparedness efforts.”

BEING PREPARED

The new contracts decrease U.S. dependence on egg-based manufacturing, but the method is still useful.

Health and Human Services has contracted with vaccine makers Sanofi-Pasteur and Chiron to create nearly 4 million courses of vaccine against the H5N1 bird flu virus using conventional egg-based techniques.

The vaccines, Leavitt said, “will be stored in our strategic national stockpile until and if they are needed.”

He acknowledged that the stockpiled vaccine will not be a perfect match for a mutated virus, but said it will provide some protection until a more specific vaccine can be made available.

His department also is pursuing more advanced flu technologies. Scientists at the National Institutes of Health are collaborating with pharmaceutical companies to develop a library of live vaccine candidates against all known influenza strains that have a pandemic potential. Such a library would give researchers a head start on developing vaccines for emerging flu strains.

Researchers also are working to develop DNA vaccines, in which the genes of an influenza virus are inserted into a harmless virus that is then used as a vaccine. Such new-generation vaccines would be broadly protective against a wide range of influenza viruses. (See related article.)

The challenges to developing such vaccines “are substantial,” Leavitt said, “but if we could get there, it would take the threat of a pandemic right off the table.”

Health and Human Services is continuing to stockpile anti-viral drugs, ventilators, masks and hospital gloves, and is expanding its domestic and international surveillance efforts and enhancing our state and local preparedness.

“By leading the way to the development of new technologies,” Leavitt said, “we will also be helping other nations be prepared. We’ll be coordinating with other nations to do this, to assure that we are taking advantage as best we can of the advances that are occurring in other nations.”

The full text (PDF, 234 pages) of the National Strategy for Pandemic Flu Preparedness Implementation Plan and related information are available at the department’s Web site.