The supply of vaccine for the coming winter's flu season may be the biggest in the country's history, but with vaccination clinics barely underway, it is too early to know if it will be enough to meet the demand.
Total supply could be as high as 97 million doses, about a third more than was available last year when the sudden loss of one company's total production created a frantic search for flu shots nationwide.
Partly in response to that shortage, the government and the biggest manufacturer have taken steps to assure that vaccine goes first this year to those who need it most. Ironically, that strategy may be the reason some clinics are reporting "spot shortages" because they have not yet received their full orders.
"Right now it looks like demand is going to be good. It also looks like supply is going to be good," said Donald E. Williamson, the state health officer of Alabama and spokesman for the Association of State and Territorial Health Officials. But, he said, health care providers will not know the true demand for flu shots until they start vaccinating low-risk people -- a process that under federal guidelines is not supposed to happen until Oct. 24, and will not begin in earnest until well into November.
In the Washington region, many public health agencies and hospitals ordered more doses than in a typical year -- anticipating higher demand because of last winter's problems -- and officials are confident they will receive those supplies in full. Clinics began in early October, with few problems or shortages reported.
"Everything seems to be going according to schedule," said Danna Kauffman of Mid-Atlantic LifeSpan, which represents more than 300 senior-care organizations in Maryland and the District.
Adding to the uncertainty is publicity about the spread of H5N1 avian influenza from Asia into Europe. (Its presence in birds in Romania was confirmed yesterday.) Although the seasonal flu vaccine does not protect against bird flu, fears of a possible pandemic of the latter may have raised public consciousness about influenza in general.
In all, four companies produced vaccine for the U.S. market this year. Three made injectable vaccine, and one -- MedImmune, which has its headquarters in Gaithersburg -- made a nasal-spray containing live but weakened flu virus. It can be given only to people ages 5 to 49 who are not pregnant.
Chiron Corp., the California biotech company whose production of 48 million doses was judged unacceptable for use last fall by the Food and Drug Administration, made between 18 million and 26 million doses. Last week, the FDA tested and approved the first three lots of about 500,000 shots each.
Sanofi Pasteur, a division of a French pharmaceutical giant, made 60 million doses, the most of any company supplying the U.S. market. It shipped 33 million doses by the first week in October. With the approval of the U.S. Centers for Disease Control and Prevention, it sent nearly all its customers a part of their orders so they could start vaccinating high-risk groups. The balance will be shipped by mid-November, said Len Lavenda, a Sanofi spokesman. A new producer this year is GlaxoSmithKline, which made 8 million doses.
If Chiron meets its upper-end production estimate -- it will not announce its production totals until later this month -- the nation will have a total of 97 million doses. That is 2 million more than the 2002 record of 95 million, a year in which 12 million doses went unused.
Under federal guidelines, the people who should get shots first include nursing home residents, those older than 65, younger people with chronic illnesses such as diabetes and asthma, children between 6 months and 2 years, pregnant women and health workers.
