H1N1, seasonal flu promise one-two punch for physicians' vaccination strategies

Physicians are facing one of the most complicated influenza seasons in decades, with the seasonal flu due to arrive and influenza A(H1N1) expected to resurge.

On Aug. 24, the President's Council of Advisors on Science and Technology said the H1N1 virus could infect up to half of the U.S. population, resulting in the hospitalization of 1.8 million people. As many as 30,000 to 90,000 could die, in addition to the 30,000 to 40,000 deaths from a typical flu season, the panel said.

The dual flu threat will require physicians to swiftly distribute seasonal flu vaccine and maintain close contact with local health departments to keep abreast of H1N1 developments, experts said. It also will demand great flexibility on the part of physicians and others in adapting to the rapidly changing situation.

"Physicians need to recognize that there will be uncertainties, and dealing with influenza this season could be very unpredictable," said Ardis Dee Hoven, MD, chair-elect of the AMA Board of Trustees and an infectious disease specialist in Lexington, Ky.

There is an abundant supply of seasonal influenza vaccine, enough for nearly all Americans, and it is recommended for virtually everyone. The task is to get the vaccine distributed quickly.

"Physicians should promote the use of seasonal vaccine early and intensely," said William Schaffner, MD, president-elect of the National Foundation for Infectious Diseases and chair of the Dept. of Preventive Medicine at Vanderbilt University School of Medicine in Tennessee. The goal is to "clear the decks for when we get the word on H1N1."

The World Health Organization is predicting an "explosion" of H1N1 cases in the coming months. As of Aug. 20, 522 people in the U.S. had died from the virus and nearly 8,000 had been hospitalized, the Centers for Disease Control and Prevention reported.

Vaccine being developed

An H1N1 vaccine initially will be available in limited amounts. The first to receive doses will be pregnant women, people who live with or care for children younger than 6 months, health care and emergency personnel, people 6 months to 24 years old, and people age 25 to 64 who are at high risk due to chronic health disorders or compromised immune systems, according to the CDC's Advisory Committee on Immunization Practices. About 159 million people are in these priority groups.

An estimated 45 million to 52 million doses are expected to be available by mid-October, said Jay Butler, MD, director of the CDC's H1N1 Vaccine Task Force, at an Aug. 21 news briefing. Those initial doses will be supplemented by weekly additions of about 20 million doses until a total of 195 million are available by the end of the year, he said. Five companies are producing the vaccine.

The CDC is asking physicians to order the vaccine from state or local health departments. "Every state by now has a Web site where providers can request H1N1 vaccine," Dr. Schaffner said.

The H1N1 vaccine will be free; the federal government has purchased the entire supply. At this article's deadline, the CDC was deciding how to distribute ancillary items, such as needles and sharps containers.

Physicians should be able to charge public or private plans for administering the shots to patients, Dr. Schaffner said.

Clinical trials of the vaccine began on Aug. 7 in adults and the elderly, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. Trials in children started Aug. 19, and trials that include pregnant women were expected to begin around Sept. 1, he said.

The trials are testing the safety of the vaccine as well as whether one or two doses will be required to provide full immunization. Data should be available in mid-September.

So far, "there are no red flags regarding safety," Dr. Fauci said.

The logistics of immunization

States are gearing up for a massive H1N1 immunization effort. The Dept. of Health and Human Services is distributing $350 million in grants to help states and territories prepare for their vaccination campaigns.

Some states will use more private physicians' offices, and some will use health departments and schools to immunize people, said David Kimberlin, MD, professor of pediatrics at the University of Alabama, Birmingham.

North Carolina plans to distribute a large amount of seasonal flu vaccine in mid-September as a practice run for its H1N1 immunization, said David Tayloe, MD, a pediatrician in Goldsboro, N.C., and president of the American Academy of Pediatrics. Children are the main targets of the state's trial run, but whether vaccinations will take place in schools, clinics or physicians' offices has not been decided, Dr. Tayloe said.

Health officials are not sure if pregnant women will seek out the vaccine. These women often are reluctant to take any medications or receive vaccinations because of fears that the developing baby could be harmed.

But that should not be a concern, said Stanley Gall, MD, professor of obstetrics and gynecology at the University of Louisville School of Medicine in Kentucky.

"It's a myth that pregnant women can't receive any vaccines during pregnancy," Dr. Gall said. When a mother is immunized and makes antibodies, she passes them to the baby, and the baby is protected. "So it's a two-for-one deal. I call it a Wal-Mart special."

Physicians will have to persuade reluctant patients in priority categories to receive the H1N1 vaccine. They also will have to turn away patients who are not in priority groups, because supplies will be limited.

"I know there are going to be some people who will be upset and angry because they aren't on the list to receive the vaccine, and others who will say, 'I know I should get it, but I'm not going to get it,' " said Robert Hopkins, MD, associate professor of internal medicine at the University of Arkansas for Medical Sciences in Little Rock. "Both will be a challenge to those of us in practice."