Flu vaccines for all?

An advisory group to the federal government is considering recommending that all Americans receive annual flu vaccinations, a step that would result in the largest vaccination effort in United States history.

Although millions of Americans are vaccinated for a number of other diseases, such as tetanus, diphtheria, and measles, those inoculations require at most a new vaccination every 10 years. But a flu- vaccine program would require yearly inoculations because of constantly changing strains of the disease.

Advocates say the program would reduce incidence of the disease and, quite possibly, reduce fatalities. It would also give drug manufacturers a larger and predictable market for their vaccines, so that shortages would not occur during major epidemics. But some observers are balking. Many Americans have ethical, medical, or religious objections to being vaccinated, they point out. Others suffer from side effects of the vaccine.

"There are a couple of big implications here," says Keiji Fukuda, an epidemiologist at the Centers for Disease Control and Prevention (CDC) in Atlanta. Right now, "there is no vaccine program which targets everybody in the country to get annually vaccinated. The logistics of something like this would be really immense. It would simply be much larger than any other vaccination program in the country."

The discussion also represents an ongoing change in philosophy at the Advisory Committee on Immunization Practices, the group that is advising the CDC on vaccination policy. "It's a direction toward which the ACIP has been moving in the past few years in terms of broadening its recommendations for who should get vaccinated," Dr. Fukuda says in a phone interview. He presented the issue of nationwide vaccination to the ACIP last month.

Not everyone is comfortable with the idea. Although the new standards would remain recommendations, they would set in motion a number of steps that would pressure all Americans to comply, says Barbara Loe Fisher, president of the National Vaccination Information Center. The Vienna, Va., group advocates a cautious approach toward vaccinations. "I think the move is to universal use by all citizens," she says by phone. "And I think that's a very questionable step."

When the CDC puts a universal-use label on a vaccine, "we know that mandates will follow," Ms. Fisher says. For example, it would be a signal to states "to add it to the mandatory vaccination requirements for children who want to go to school." Employers might require it. And the vaccines would probably be covered under the National Childhood Vaccine Injury Act, which protects vaccine manufacturers from liability suits from those who feel they've been harmed.

In settings such as schools where vaccinations are required, only about one-third of states offer exemptions based on philosophical or personal beliefs. And "they are very hard to come by," Fisher says. "When doctors give them, many times state health officials come in and second-guess the doctor and make the doctor's life miserable. So very few doctors do give medical exemptions."

All states but two offer religious exemptions, she says, but these can also be difficult to obtain. "We have cases where parents who have tried to exercise their religious exemption to vaccination have been hauled into rooms with lawyers and grilled for four hours about ... the sincerity of their religious beliefs."

While Fisher represents a minority view, many others see universal vaccination as desirable and inevitable. "I think it is something that is going to happen, and I think it's something that is called for," says Len Novick, executive director of the National Foundation for Infectious Diseases (NFID). The Bethesda, Md., coalition represents private and public healthcare groups and industries, including drug manufacturers.

The CDC currently recommends vaccinations for children between 6 and 23 months old, adults 50 and older, pregnant women, and others with certain medical conditions. During this flu season, some 29 percent of Americans were vaccinated. A recommendation for universal coverage would probably include all Americans over 6 months of age.

Fukuda says the universal standard has at least two potential major benefits. "It is possible, not proven, that you would increase the protection of people who are at higher risk," he says, such as the elderly, by reducing the number of people around them carrying the flu virus. And a more robust manufacturing and distribution system for vaccines would be very useful when and if a major pandemic hits.

Last fall an early spike in reports of flu in the western US resulted in alarming nationwide headlines predicting a severe flu season. As the public rushed to get inoculated, spot shortages of vaccine added to public fears. Healthcare professionals tried to calm the concerns, the NFID's Mr. Novick says, by pointing out that every flu seasons is different and that an early surge in reported cases does not necessarily portend an especially severe year.

That appears to be true this year, as reported cases have dropped dramatically and are now well below the average for this time of year. CDC officials tentatively describe this year's flu season, which is now winding down, as average or slightly worse than average.

An ACIP subgroup on influenza will continue to research the issue of universal coverage and report back to the full committee, Fukuda says. "I think the earliest it would go for a vote would be some time in October 2005," he says, with its earliest use as a standard coming in 2006.