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Cold and Flu on NBCNews.com

Flu vaccine supply caught in legal quagmire

Better information sharing needed between countries, says FDA Nick Ut  /  AP
Fred Mytar, 86, waits in line to get a flu shot at Pavilions pharmacy in Monrovia, Calif., Oct. 7. updated 10/11/2004 7:34:20 PM ET 2004-10-11T23:34:20

WASHINGTON — As the nation prepared for a severe shortage of flu shots, the Food and Drug Administration said Monday that problems at the British plant that manufactured vaccine withheld by British authorities likely will be used as a “test case” to lobby for better information-sharing with European regulators.

Last Tuesday, British authorities blocked Chiron Corp. from shipping 46 million to 48 million doses of flu vaccine to the United States. The FDA, which held weekly telephone conversations with Chiron since Aug. 25, said it was stunned by the last-minute about-face.

Lester Crawford, the agency’s acting commissioner, told reporters Monday that the agency lacked a data-sharing agreement that would have forced its British counterparts to disclose qualms earlier.

'Laws do not recognize each other'
British regulators considered the plant’s flu vaccine output “their jurisdiction,” he said, with confidentiality concerns limiting their discussions with the FDA.

“As far as we’re concerned, it’s our regulatory responsibility for those lots that are coming to the United States,” Crawford said. “I wouldn’t say there is a conflict here, but the two laws do not recognize each other.”

Because the number of companies making vaccines continues to shrink, and many, like Chiron, conduct such manufacturing abroad, they need to be treated like international resources, Crawford said.

An agency like the World Health Organization could be asked to clarify “the rights and privileges” of the importing country, Crawford told reporters.


On Aug. 25, Chiron told British and American regulators of bacterial contamination of eight lots of flu vaccine, imperiling up to 8 million doses. Crawford would not say if the contaminated lots were among vaccine lots the FDA had already cleared for use.

FDA inspectors were in Liverpool when the contamination concerns surfaced, but returned in favor of weekly telephone conferences monitoring Chiron’s progress remedying the problem. Crawford defended that Monday as standard operating procedure that worked well in the past.

The agency typically sends two employees to inspect Chiron’s manufacturing plant in Liverpool. After last week’s license suspension, it sent a team of five inspectors.

“There is a crisis,” Crawford said. The FDA’s fact-finding continues; Crawford expects a report as early as this week.

Flu shot seekers line up at clinics
Across the nation, flu shot seekers have lined up at clinics for the first wave of 55.4 million vaccine doses produced by Aventis Pasteur for use in the United States. The Centers for Disease Control and Prevention had hoped to offer 100 million doses of flu vaccine.

As federal authorities continue to struggle to cope with a severe vaccine shortage, one expert said early signs point to a less dangerous flu season than last year.

“My guess is we are going to have a lighter year than last year,” said Dr. Greg Poland, who predicted last year’s staggering flu season. “To date, we don’t have any of the indicators that usually portend a bad year.”

Poland, director of the Mayo Clinic’s vaccine research group and one of the government’s vaccine experts, noted that flu outbreaks, thus far, have been small and scattered, the virus hasn’t easily jumped from person to person and it has not triggered early spikes in hospitalizations and deaths.

In fact, small outbreaks in nursing home facilities in New Jersey, New York and Ontario have been the H3N2 strain of influenza A, he said. That flu strain can be tamed by antivirals, which lessen illness severity among the infected and prevent illness in most healthy adults, Poland said.

The H3N2 strain of influenza A also circulated last year, meaning people who were exposed then should be partially protected if it remains the dominant flu strain this year.

Count Dr. Theodore Eickhoff, a University of Colorado professor of medicine in the division of infectious diseases, among the skeptics.

The H3N2 strain is associated with higher death rates among high-risk people, including the elderly. “It’s still the bad actor among influenza viruses,” Eickhoff said.

The vaccines prepared for this year cover three strains of flu: the H3N2, the A strain H1N1, and a B strain.



 

Related: Cold and Flu , Lester Crawford, Food and Drug Administration, Chiron Corporation



