- The Washington Times - Thursday, November 19, 2009

Four of the five manufacturers of the novel H1N1 vaccine Wednesday told lawmakers, frustrated about the slowdown in production and distribution of dosages, that the low yields and outdated egg-based technology were largely beyond their control.

As of Wednesday only 49.9 million doses were available for the states to order, compared with the goal of having 120 million by the end of October.

Paul Perreault, president of CSL Biotherapies Inc., blamed June H1N1 “seed lots,” the virus samples that the government distributes to the companies, with producing amounts of H1N1 vaccine “approximately one-third to one-half” of what had been expected. He said improvements have been made in the manufacturing process and the seed since that time.

In his remarks to two subcommittees of the House Energy and Commerce Committee, the first appearance of flu-vaccine manufacturers before Congress, Mr. Perreault said revised delivery schedules were sent to the U.S. Department of Health and Human Services, which has purchased the vaccine from the five companies for $1.3 billion.

The production delays, along with distribution-system breakdowns, have bedeviled the industry and caused widespread frustration among a public primed by an expensive government education program to expect rapid delivery of millions of vaccine doses.

Dr. Vas Narasimhan, president of Novartis Vaccines USA, blamed the government to some extent, telling the panel that “HHS prioritized seasonal influenza production,” leaving his company less than three months to produce novel H1N1 vaccine.

The hearing, which brought together members of the subcommittee on health and the subcommittee on oversight and investigations, followed a similar event held Tuesday by the Senate Homeland Security and Governmental Affairs Committee.

At the House hearing, lawmakers wanted to know why “adjuvants,” or additives that seem to produce immunity without actually being the vaccine itself, could not be used to stretch the amounts available.

Dr. Narasimhan, whose company’s adjuvant is under study but not yet approved for use in the U.S., told the House members that the government needed to accelerate the licensing process for this material and urged adoption of “a number of more modern methods” to test pandemic vaccine potency and sterility, along with the establishment of a “strategic national stockpile of likely pandemic strains.”

Lawmakers pressed for details from government authorities about relationships with manufacturers and about their interaction with state and local distributors.

Why, asked Rep. Frank Pallone Jr., New Jersey Democrat, did New York give Wall Street firms the vaccine ahead of others likely to be on a higher priority list? If you leave distribution to those who do it best, he said, what of people who may have a higher need but not be as assertive in getting their needs met?

Though Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, tried to explain CDC’s decentralized system and national standards, Mr. Pallone asked: “Wouldn’t it be better to have another federal mechanism?”

He said he wanted a report later from CDC officials explaining why they think “their kind of distribution is better.”

Rep. Greg Walden, Oregon Republican, asked Dr. Nicole Lurie, assistant secretary for preparedness and response at HHS, “Did manufacturers not get straight with you?” about vaccine estimates on their production schedules.

“There are many different points where things can break down,” she began, but Mr. Walden wanted specifics. “When did you first learn that vaccine production would be delayed?”

It was over the summer, she said, adding that her agency got information “every step along the way.”

“We are all frustrated,” she said.

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