TUESDAY, Oct. 5, 2004 (HealthDayNews) -- British health authorities on Tuesday suspended the license of a key maker of influenza vaccine in the United States, leaving health officials scrambling to replace nearly half of the country's supply amid talk of rationing what will be available.
Just a month ago, top U.S. health officials expressed confidence that there would be 100 million doses of flu vaccine for the upcoming season even though a key manufacturer, Chiron Corp., reported that some of its vaccine was tainted and would delay the shipment.
All that changed dramatically when the U.K.'s Medicines and Healthcare Products Regulatory Agency temporarily suspended Chiron's license to manufacture the vaccine, known as Fluvirin, in a Liverpool plant. The three-month suspension is "preventing the company from releasing any of the product during the 2004-2005 influenza season," Chiron said in a statement.
Howard Pien, president, CEO, and chairman of the board of Chiron, said in a news teleconference Tuesday that the company got word of the suspension at 3 a.m. Pacific time. The move immediately halted the manufacture of flu vaccine at its Liverpool facility, which is the only one authorized to supply flu vaccine to the United States.
"It is with profound regret, with profound regret, that we will be unable to meet public health needs this influenza season," Pien said.
The problem was with the sterility of the vaccine, which Pien said was confined to a limited number of lots. Chiron had gotten to the root of the problem, he added.
The British move "is disappointing and unexpected, but we respect the regulatory authorities' judgment because it is based on concerns over safety," Pien said.
The announcement left U.S. health officials doing a complete U-turn about the availability of flu shots at the worst possible time, when facilities start scheduling vaccinations. Whereas in recent weeks they said anyone who wanted a flu shot could get one this season, they now are left to a major triage operation.
"This is very disappointing news that creates a serious challenge to our vaccine supply for the upcoming flu season," U.S. Health and Human Services Secretary Tommy Thompson said at a separate news conference Tuesday. "We are proceeding with contingency plans to make sure that existing vaccine supply is used for those who need it most."
In the meantime, officials are seeking help from the public as well as the medical community to ration what will be available. "Our immediate focus will be on making sure that the supply of vaccine reaches those who are most vulnerable," Thompson said.
HHS said it anticipated having approximately 54 million doses of vaccine from Aventis Pasteur of Swiftwater, Pa., and another 1 million to 2 million doses of FluMist, a nasal spray made by MedImmune Vaccines, Inc., of Gathersburg, Md. This falls far short of what authorities had planned: HHS had expected to have the largest amount of flu vaccine ever, 100 million doses, available this season, compared with a demand of about 87 million doses last flu season.
Dr. Julie Gerberding, director of the U.S. Centers for Disease Control and Prevention, said that the CDC's Advisory Committee for Immunization Practice had met and recommended that priority be given to children 6 months to 23 months (that vaccine supply is not affected because Aventis makes all of it), adults 65 and older, persons aged 2 to 64 who have serious underlying medical conditions, all women who will be pregnant during flu season, and residents of nursing homes and long-term care facilities as well as their caregivers.
"We're expecting that the 50 million-plus doses will come close to meeting demand in this group," Gerberding said. "We don't have much leeway, and we're going to have to be very careful and parsimonious in actual geographic distribution."
And she added, "Healthy people who are not household contacts or caregivers should defer their vaccination."
The news left some health-care providers stunned and angry.
"This is the result of the policy of putting all our eggs in one manufacturing basket," said Dr. Charles Gonzalez, an infectious diseases expert at New York University Medical Center. "This is going to lead to a certain amount of rationing and restricting. The flu season is here. We have to start vaccinating now."
"The impact may be significant in that we may have to ration the flu vaccine, particular in pediatrics," added Dr. Adam Aponte, director of North General Diagnostic and Treatment Center and chair of pediatrics and ambulatory care at North General Hospital in New York City.
Also, this year, for the first time, health officials are recommending that the youngest young -- children 6 to 23 month olds old -- get vaccinated. "That's new for this season, so we have that population as well," Aponte said.
HHS said it was exploring whether more flu vaccine could be manufactured but it also admitted that this was a long shot, a sentiment echoed elsewhere.
"It's just not going to happen," Gonzalez said.
In August, the CDC announced that Chiron's supply would arrive about a month late because some doses appeared to be contaminated. It was not clear whether this was the same problem that led British authorities to suspend the company's license.
Flu shots start becoming available in October. According to the CDC, the flu kills about 36,000 people and causes 114,000 to be hospitalized in an average year.
"As a health-care provider, you never want to deny anyone anything, particularly flu vaccine," Aponte said. "We should not be in this situation. Why is it that we place ourselves in this position every year when we are hustling to get flu vaccine?"
The U.S. Centers for Disease Control and Prevention has more on influenza.