Next flu season gets checkup

At the end of one of the rockiest flu seasons in decades, officials of the Centers for Disease Control and Prevention are looking worriedly toward this fall and the start of the next flu season.

There are many uncertainties, but this is at the top of the list of questions: Will there be an ample supply of flu vaccine or another shortage?

Officials won't know for another couple of months. And even if there is enough vaccine, the effect on this season's debacle -- best known for the long lines of frantic vaccine seekers -- on future demand for flu shots is unclear.

''It's really important in the long run, because we'd like to see the use and demand for this vaccine increase steadily each year,'' says Lance Rodewald of the CDC. ''In a year when there's a serious disruption in the vaccine supply, we're worried those efforts might be hampered.''

The shortage occurred on the eve of the flu season last fall when Chiron, one of only two flu-shot makers supplying the USA, had its license suspended because some of the vaccine made at its plant in England was found to be contaminated with bacteria. Chiron's promised 48 million vaccine doses had to be destroyed, leaving only Aventis Pasteur (now Sanofi Pasteur) to supply the country with 57 million doses. MedImmune made 3 million doses of nasal spray vaccine FluMist.

''Right now there's uncertainty how many doses will be available, so we have to work on messages that will help us out if there are fewer doses than last year, or as many or a lot of vaccine,'' Rodewald says. ''We don't know which of these will happen. We think there's going to be quite a bit of vaccine for next year, but we won't know for a couple of months.''

Steps are being taken to strengthen the supply.

On Friday, the Department of Health and Human Services announced a $97 million award to Sanofi to speed development of cell-based flu vaccine technology, which would allow quicker production of vaccine.

Though the immediate goal is to make sure there is vaccine for a pandemic, HHS spokesman Mark Wolfson said the objective is ''broadening or diversifying the way we get influenza vaccine. We don't want to rely on one manufacturing process.''

There may be greater diversity in vaccine makers as well. ID Biomedical and GlaxoSmithKline plan to file license applications with the Food and Drug Administration by midyear, hoping for speedy approval so they can supply vaccine in the USA this fall. And the FDA says it plans a full inspection of Chiron's plant and could restore the company's license this year.

Even if there is plenty of vaccine to go around, CDC officials worry that those who skipped a flu shot will decide not to bother with it next time around or that doctors might choose to avoid the hassle of ordering and administering the shots and let health departments, employers or retail stores do it.

The CDC estimates 185 million people are in groups for whom annual vaccination is advised, but there has never been a year when more than 83 million actually got the shot. ''So we have a lot of work to do,'' Rodewald says.

''There are a number of (health care) providers who didn't get vaccine,'' Rodewald says. ''We want them to be willing to come back and try.''

The CDC is planning to take the pulse of the public before the start of the next flu season by conducting research, probably through focus groups, on consumer attitudes toward flu vaccine and how people are likely to react to future vaccine campaigns, says CDC spokesman Curtis Allen.

''We'll be looking at parents' attitudes and high-risk people, probably through focus groups and other methods,'' he says.

Already, a framework for prioritizing people who should get vaccine during a shortage has been proposed by the CDC's panel of vaccine experts, the Advisory Committee on Immunization Practices, as a way to help state and local health officials make difficult choices.

One of the lessons of the waning flu season is that millions of people stepped aside to let those who are older or sicker get shots. Once the shortage is resolved, they say, they'll go back to doing what they usually do.

Barbara Mooney, 61, a school administrator in Wilmington, Del., usually gets a flu shot every year. But she's not in a high-risk group, so she didn't get one this season. And she got sick.

''I usually get through winter with no problems,'' she says, but ''right now I've got whatever everyone at our school has got. I've seen a tremendous amount of sickness at school this year.''

She's not sure that what is causing all that illness is influenza or some other respiratory virus, but next season, if flu vaccine is available, she's ready to roll up her sleeve. ''To me it's protection,'' she says. Her confidence in vaccine safety is unchanged. ''Nothing's really, totally safe.''

Pixie Cohn of Austin agrees with that. ''Just because the government says (a drug) is safe doesn't mean it is,'' she says.

A couple of years ago, Cohn, 62, had a bad reaction to a cholesterol-lowering drug; now she has constant muscle pain. Though she is still active and athletic, the incident undermined her confidence in drug safety. ''I think people have a distrust of the government as far as what they say is safe and not safe.''

Still, Cohn says, until this season, she and her husband have had flu shots each year and hope to get back on schedule this fall.

Why? ''I've seen what flu can do to people, so that would be the main reason.''

For most young, healthy people, the flu means a week or more of fever, fatigue and body aches. But for people who are elderly, have weak immune systems or chronic illnesses such as asthma or diabetes, the flu can be deadly. It sends an estimated 200,000 people to the hospital and causes an estimated 36,000 deaths each year, CDC researchers say.

''Vaccine is still the best way for people to protect themselves, and it's very important for people to get vaccinated,'' Rodewald says.

That was difficult this year, says Ashland, Ky., doctor Larry Fields, president-elect of the American Academy of Family Physicians. But, he says, doctors' trust in the vaccine is unshaken.

''I did see more (flu) in the office this year than I normally see,'' Fields says. ''I'm sure that's partially the result of not being able to immunize people in a timely manner to protect them.''

Chiron's license has been restored by British regulators but not yet by the FDA. Agency spokeswoman Lenore Gelb says FDA officials won't comment on when that might happen, but in a statement last month, Jesse Goodman, director of the Center for Biologics Evaluation and Research, said the FDA will ''continue to closely monitor Chiron's progress as manufacturing proceeds. When all critical stages of manufacturing are in full swing, and needed corrective actions can be fully evaluated, FDA plans to conduct a comprehensive inspection of Chiron's Liverpool facility to assure that Chiron can produce a safe and effective vaccine.''

Lloyd Van Winkle, a family doctor in Castroville, Texas, believes that will be enough to allay any concerns about vaccine safety. ''When the FDA says it's pure and effective, it's pure and effective,'' he says. ''No patient goes to the doctor and says, 'Who did you buy your flu vaccine from?' I order more flu vaccine every year, and I never have any left over.''

No vaccine is 100% effective, and flu vaccine is no exception as Carol Heinberg of Ashburn, Va., learned when her 89-year-old mother came down with flu, despite having been immunized. Her mother spent a week in the hospital in February, but ''I feel if she hadn't had it, maybe she'd have been in even worse shape with this illness.''

Heinberg said she and her husband, both 62, get flu shots each year and ''we haven't had flu in all the years we've gotten the shot.'' She suspects some of that might be psychological. ''We also got a pneumonia shot and mentally, I believe I'm not going to get flu and pneumonia. I can't see not getting the shot and making myself that vulnerable.''

For some, though, the vaccine shortage of 2004 barely registered.

''I wasn't paying much attention to it,'' says Jim King, 62, of Austin. He hasn't had a flu shot since 1966 and almost never gets sick.

''The thing with flu, for a healthy person, it's not the end of the line,'' he says. ''I'd rather take my chances.''

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