Vaccine making outdated

The swine flu has become the vehicle for a homeland security message former Sens. Bob Graham and Jim Talent have been trying to deliver over the past year: Quit cracking eggs to vaccinate the public.

The Florida Democrat and Missouri Republican, who presided over a congressional panel charged with assessing terrorist threats and weapons proliferation, say that even though bioterrorism — not nuclear proliferation — is the nation’s leading terrorist threat, the country isn’t equipped to respond quickly.

“This is an epidemic that didn’t just attack us by ambush, we’ve had much time to prepare, yet many people who want to get the vaccine have been denied so because of inadequate technology,” Mr. Graham said, referring to the growth and spread of the H1N1 virus since April.

The rush to manufacture millions of doses of the H1N1 influenza virus highlighted problems with a vaccine-manufacturing process developed before the Cold War that has never been updated.

“The question is, ‘Why do you stick with this fragile, yet time-honored process of growing it in eggs?’” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

The typical vaccination process works well for the seasonal flu — updating the vaccine starting in the winter, then manufacturing it over the course of six to eight months before the next flu season starts, Dr. Fauci said.

Pharmaceutical manufacturers have not had the financial incentive to spend the billions of dollars necessary to upgrade the manufacturing process (a vaccine is sold and administered far less frequently than other, more profitable medications) which is why the government needs to support any effort, he said.

“The real endgame is to bring the technology into the 21st century and use molecular biological techniques so you can really have control about making the purified proteins that you want,” he explained.

The federal government has established efforts to address the problem but has yet to funnel the money needed into the lead program, the former lawmakers say.

“To date, the U.S. government has invested the largest portion of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism. Only by elevating the priority of preventing bioterrorism will it be possible to substantially improve U.S. and global biosecurity,” the two former lawmakers wrote in their December 2008 report.

The federal Biomedical Advanced Research and Development Authority has been operating its Bioshield program on a relatively hamstrung budget of about $300 million a year. Mr. Graham and Mr. Talent say the project needs $3.4 billion over the next five years to warehouse enough vaccines to cover at least 90 percent of the population in the case of a bioterrorist threat.

“If you can stockpile enough countermeasures, then you can effectively take a [weapon of mass destruction] off the list,” Mr. Talent said. “It’s the urgent crowding out the important, which is a classic problem in government.”

It was easier to focus public and political attention on the threat of nuclear weapons because the era literally started with a bang, Mr. Graham said.

“I’m a little concerned that there is this tendency to talk about this threat solely in the nuclear context,” Mr. Graham said, noting President Obama’s trip to Asia and his focus on nuclear capabilities.