No flu vaccine shortage expected in England

By Mike McGraw and David Goldstein

At a public clinic, almost in the shadow of the Chiron plant near the Mersey River, a poster says to “make an appointment today for your free flu jab.”

Flu vaccine may be delayed in some locations, but the shortages America is seeing are not expected here, thanks in part to early action by British health officials.

Late this summer, at the first sign of new problems at the Chiron Corp.’s long-troubled plant, the British began searching for other suppliers of flu vaccine.

“When Chiron informed us of the potential problems at the end of August, we made contingency agreements,” said Alison Langley, a spokesperson for the Medicines and Healthcare Products Regulatory Agency (MHRA), the British equivalent of the U.S. Food and Drug Administration.

Armed with essentially the same information, however, U.S. officials relied on Chiron’s early assurances that only a small portion of the flu vaccine from its Liverpool plant here was contaminated.

It was not until Oct. 5, when the British pulled Chiron’s license, that they knew half the U.S. flu vaccine supply had just disappeared, producing the lines and shortages the country is now enduring.

No matter what, the United States would have had a tougher time solving the problem than England.

For one thing, the American shortfall is more than 45 million doses, but the British relied on the Chiron plant for only about 20 percent of their total flu vaccine needs, or about 1.2 to 2 million doses.

Compared with Americans, fewer people seek flu shots in England, where vaccinations are promoted primarily for young children, those over 65, persons with HIV or other compromising conditions, and health-care workers.

“Most healthy people here don’t get a flu shot,” said Hugh Lamont, with the government’s Health Protection Agency.

The British could also fall back on a half-dozen other suppliers that had been pre-approved by British authorities. The United States had only one other major supplier, Aventis Pasteur.

But some health experts now suggest that if U.S. officials had relied less on Chiron’s early assurances and acted more swiftly, they could have at least limited the damage caused by the loss of half the U.S. supply.

David Webster, a health industry consultant and former Aventis executive, said the FDA miscalculated the potential risk in the situation.

“I don’t think they fully predicted what the impact of either the manufacturing problem or an entire shutdown of the facility would cause,” he said.

Department of Health and Human Services spokesman Tony Jewell said the federal government saw no reason to begin looking for replacement supplies in August, when the British did.

“We had no indication from the company or MHRA until October 5 that the entire 48 million doses were in jeopardy,” he said. “As soon as we learned in October, we contacted Aventis Pasteur to purchase several million more.”

Chiron, headquartered in California, first told U.S. and British officials about contamination problems on Aug. 25, saying it planned to destroy 4 million doses of flu vaccine.

Langley, the spokesperson for the British MHRA, said the company reported back Sept. 13 that the problems were still unresolved. British officials toured the plant Sept. 28 to 30 and pulled its license a week later.

Chiron officials did not return phone calls for this story.

William Schaffner, a member of the federal government’s National Vaccine Advisory Committee, said officials with the Centers for Disease Control and Prevention spoke with Chiron officials on a weekly basis, and the company always assured them that the problem was “limited.”

“Shipments would be somewhat curtailed, but basically we were going to be getting all we needed from Chiron,” said Schaffner, chairman of the department of preventive medicine at the Vanderbilt University School of Medicine.

Jewell said that based on what the U.S. government knew at the time, officials saw no need to ask Aventis to delay its shipment in case the situation eventually required some degree of vaccine rationing.

“We were repeatedly assured that things were looking up,” he said, “so you’re talking about disrupting the shipment of the other half of the vaccine supply on something that our regulators had no indication was going to be a problem.”

Aventis began shipping its vaccine in early August. An Aventis spokesman said that if the company had been aware in August that half of the flu vaccine supply was not going to be available, it would have done what it did upon learning of the shortage on Oct. 5 – consult with the CDC about how to redistribute supplies.

In recent testimony before Congress, Julie Gerberding, CDC director, said her agency had been developing contingency plans for a “worst-case scenario” since late August but that those plans were hindered by the fact that most of the remaining supply had already been contracted to private distributors.

Acting FDA Commissioner Lester Crawford added at the same hearing that, even by late August, it was too late for vaccine companies to start a new batch of vaccine. “We obviously hoped for the best,” he said.

U.S. officials now are left to try to redistribute the remaining Aventis vaccine to those who need it most.

Already, long lines are forming at supermarkets, walk-in clinics and pharmacies where elderly and other at-risk patients are hoping, sometimes in vain, to get a dose of the vaccine.

In Liverpool, however, the vaccine is available. “We are starting flu shots about now; we’re in the thick of the campaign,” Lamont said.

As a result, many Liverpool residents are unaware that their Chiron plant is at the center of an American health crisis. Others have only a vague notion, as one police officer said, that “something went amiss out at the jab plant.”