Stunned U.S. health officials met with British regulators Thursday to discuss the suspension of flu vaccine production that has slashed supplies across the United States and planned to inspect the British factory to see whether any impounded vaccine could be salvaged.
U.S. officials said they had been expecting only that Britain would withhold a small amount of the vaccine because of contamination with a bacterium called Serratia. Just two weeks ago, Americans were assured that U.S. monitoring showed no contamination during retesting of the rest.
“We anticipated the loss of 6 to 8 million doses. We did not anticipate the license would be suspended,” Health and Human Services Secretary Tommy Thompson said.
Officials defend closure of factory
British officials defended the way they handled the closure of the Chiron Vaccines factory in Liverpool, a move that shut down the supplier and held up the 46 million doses destined for the United States.
A spokesman for Britain’s drug regulator told The Associated Press the agency decided Tuesday morning to suspend the influenza manufacturing license of the factory.
“The FDA (the U.S. Food and Drug Administration) were informed along with all European member states ... within 90 minutes of the company being notified of the license suspension,” said the spokesman for Britain’s Medicines and Healthcare Products Regulatory Agency, or MHRA.
The official, speaking on condition of anonymity, said “commercial confidentiality” prevented the agency from explaining fully that day what the problem with the vaccine was, but he said Thursday the vaccines were contaminated by Serratia bacteria.
The official said Chiron had alerted the regulatory agency about the problem in mid-September.
FDA scientists meet with British regulators
Six top FDA scientists — including vaccine chief Dr. Jesse Goodman — met with British regulators in London on Thursday to examine the test results or inspections that prompted the license suspension.
The meeting was to see “where the disputes are and how we might be able to reconcile them, if at all possible,” Thompson said Wednesday. “It does not look promising at this point, but we are going through all the procedures.”
The FDA scientists also will meet with local Chiron officials Friday and inspect the Liverpool factory Saturday and Sunday. Their goal is to see whether any of the impounded vaccine could be salvaged.
Chiron had shipped more than 1 million doses to the United States before Tuesday but had not released any.
“Irregardless of any U.K. regulatory decision or recommendation, we look carefully at all the information,” Goodman said before leaving for England. “For the vaccine that’s here, obviously we would take very seriously any safety concerns raised by the MHRA. We are looking forward to their detailed report.”
In the United States, health officials have urged healthy adults and schoolchildren to skip the flu shot so that people who need it most can count on the remaining supply.
Vaccinations usually begin in September and continue through the flu season, with demand often peaking in October and November.
Chiron, the company, also warned previously of a possible problem with this year’s supplies.
“Chiron announced a while back that they were having a problem releasing some of their doses of flu vaccine because of potential sterility issues,” said Nick Kitchin, medical director of Aventis Pasteur MSD, a competitor of Chiron’s in England.
“Obviously, the impact is large, especially in the U.S. But I don’t think this is an extraordinary occurrence in the way it happened. The market is a global one. If the FDA took action against a plant in the U.S., it could affect the U.K. and Europe in the same way.”
'Human error' led to tainted shots
In late August, Chiron announced it had found tainted doses at its factory. The company’s chief executive, Howard Pien, said it would hold up shipment of about 50 million shots — half the supply U.S. health officials hoped to have on hand this year — while it investigated what went wrong and determined whether the vaccine was safe to use.
Chiron would not detail the nature of the contamination, which Pien said had been found in a small number of batches at the company’s factory in Liverpool. The company supplies about half the U.S. flu vaccine. Aventis Pasteur supplies most of the rest.
Pien said the company still hoped to ship between 46 million and 48 million doses by early October, about a month later than usual. He said in conference calls with analysts and reporters Tuesday that said “human error” apparently led to the tainted shots.
U.S. health officials said then that some people may not get flu shots when they wanted this year, but that they were hopeful Chiron’s production problems were only temporary.
Last week Pien assured a U.S. congressional hearing that the company had lost only 4 million doses and fully expected to help meet the nation’s flu vaccine needs.
“Chiron deeply regrets that we will be unable to meet public health needs this season,” Pien said then. “What happened was unexpected.”