Wednesday, December 9, 2009

Novartis moves forward with USG-sponsored cell-based vaccine plant/ WP

The vaccine/bioterrorism industry is expert at making silk purses out of sows' ears. Novartis, the company that failed to get its 50% share of swine flu vaccine out in a timely manner, and has a long history of vaccine failures, received a $400 million grant to open a vaccine plant in the US.
However, the University of Minnesota informs us that HHS has actually invested $767 million in Novartis' development of the technology and building costs.
Daniel Vasella, chairman and chief executive of Novartis, gives Health and Human Services Secretary Kathleen Sebelius, left, and North Carolina Gov. Beverly Perdue (D) a tour of the drugmaker's new facility in Holly Springs, N.C.

Daniel Vasella, chairman and chief executive of Novartis, gives Health and Human Services Secretary Kathleen Sebelius, left, and North Carolina Gov. Beverly Perdue (D) a tour of the drugmaker's new facility in Holly Springs, N.C. (Photos By Jim R. Bounds/bloomberg)

Progress has been made, Sibelius said. A new facility that can make flu vaccine using cells instead of eggs opened last week in Holly Springs, N.C., after Novartis received more than $400 million in federal funding. But that factory would still be able to produce perhaps only half the vaccine the nation would need in a pandemic, and that process is still prone to delays, she said.

"There are gaps at every stage in the process, from the laboratory to the factory floor, that are slowing or stalling the development of key countermeasures," Sebelius said, referring to the nation's reliance on research conducted at the National Institutes of Health and the Defense Department, which is often not focused on government priorities, as well as the lack of incentive for companies to invest in making new products for public health emergencies.

"In this age of growing public health threats against which countermeasures are often our best defense, that's dangerous," she said.

Novartis has kept a very close hold on the clinical data generated by its MF59 (squalene-containing) adjuvant, both in terms of effectiveness and safety. A French review in Prescrire that I cited months ago found increased side effects but no increased efficacy when MF59-containing flu vaccines were used in the elderly, the only group for which it is approved. I previously cited a statement from FDA indicating concern with the presence of extraneous DNA in vaccine made from the canine kidney cell line to be used by Novartis at the new factory.

The plant has been built and can start making MF59 this month, even though its vaccine production method has not received FDA approval yet, nor has the use of MF59 in US vaccines ever been approved.

"Novartis is one of five companies that were awarded large HHS contracts in 2006 to develop cell-culture technology for making flu vaccines. One of the other four contracts was terminated earlier this year, and a second company has put its efforts on hold. Also, Sanofi Pasteur, which makes the largest share of seasonal flu vaccine in the United States and which received an HHS contract for cell-based vaccine development in 2005, says it is sticking with the traditional egg-based production."

But with nearly $800 million of US government money already invested in the Novartis facility, and a roughly equivalent amount invested in 4 other firms' cell-based vaccine development, is there any doubt FDA approval will be forthcoming?

According to the Novartis press release, "If licensed in an emergency, the facility will be ready to respond to a pandemic as early as 2011." Clearly Novartis knows how the game works, and may be counting on an emergency to get their products out to the public.

The post above, by Dr. Sherri Tenpenny, discusses this issue in more depth.

UMinn's CIDRAP dug deep to provide very useful information. For example:

MedImmune, which makes nasal-spray seasonal and pandemic H1N1 flu vaccines, has put its cell-based development efforts on hold, Dr. George Kemble, the company's vice president for research and development, said today.

Kemble said the company has a disagreement with the Food and Drug Administration (FDA) over the direction of clinical trials for its cell-based flu vaccine. MedImmune officials were aiming to conduct trials to determine if cell-based and egg-based versions of the same vaccine were equally immunogenic, he said.

But the FDA said it wanted the company to proceed with an efficacy trial to determine if the cell-based vaccine actually protects people from seasonal flu. "That added years and hundreds of millions of dollars to the program," he said. [Imagine that! The company was being held to an honest efficacy standard by FDA, instead of being allowed to squeak through licensure using cherry-picked surrogate markers--and has the temerity to complain about it!--Nass]

In view of the FDA's position, Kemble said MedImmune decided to "take a step back," reevaluate the program, and discuss it with HHS officials before deciding what to do next. [Does this mean they will try to go around FDA to get the go-ahead from its parent agency?--Nass]

Meanwhile, Sanofi Pasteur has experimented with cell-based flu vaccines and concluded they offer little advantage, company spokeswoman Donna Cary said today.

In the current pandemic response, egg-based and cell-based facilities produced clinical lots of vaccine and achieved regular production in about the same amounts of time, Cary added.

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