Doctors prepare for swine flu, await final word from federal officials

Now that the H1N1 vaccine has been approved, primary care physicians are waiting to hear whether 1 or 2 shots will be required for adult patients.

Federal health officials now believe that only one regimen of the 2009 H1N1 influenza vaccine may be required for healthy adults. Original estimates from the National Institute of Allergy and Infectious Diseases called for two shots for adults when clinical trials on the H1N1, or swine flu, vaccine were launched in July.

Reports emerging from those trials indicate that the vaccine is well-tolerated in healthy adults and is inducing a strong immune response when administered in a single, unadjuvanted, 15-mcg dose, according to Anthony Fauci, MD, director of the NIAID.

“We are encouraged by the reports,” says Fauci. He cautions, however, that more data are forthcoming from other trials and that no decision on recommended adult regimen has been made.

The NIAID might not determine the number of shots needed for adults until after the vaccination program begins, according to the Centers for Disease Control and Prevention. CDC spokesman Tom Skinner says the agency is still targeting mid-October for the launch date of the vaccination program, although some batches might be available earlier in the month.

The Food and Drug Administration approved the H1N1 vaccine on September 15.

The CDC expects to have 45 million to 50 million doses of the vaccine ready at the beginning of the program and an average of 20 million doses weekly thereafter through the end of the year.

Federal health officials anticipate as many as 60 million to 120 million cases of swine flu in America this season, an estimate derived from the President’s Council of Advisors on Science and Technology.

Based on the history of the influenza vaccine, the CDC expects primary care physicians to be “big players in this campaign,” according to Skinner, and are likely to administer most of the H1N1 vaccinations. He points to the last National Immunization Survey (conducted in 2007), which showed most people received their seasonal flu shots at a primary care office.

An adult requirement of one shot, rather than two, would allow more people to receive the vaccine earlier. Initially, the vaccination program will target healthy young people from birth through age 24, pregnant women, and adults age 25 to 64 who have underlying medical conditions, as well as healthcare workers. Children under age 9 will be given a two-dose vaccine.

A single shot for adults would also mean less likelihood of confusion in primary care offices, as physicians juggle administration of the H1N1 vaccine with the seasonal influenza vaccine and regularly scheduled appointments. Physicians such as David Ellington, MD, of Lexington, Virginia, have devised strategies for patient reminders in the event that two shots are required over a three-week span.

“We’re preparing for the potential of two shots, but hoping it turns out that just one is needed,” Ellington says.

Pediatric practices, meanwhile, will still need to administer two shots for younger patients. Pediatric Associates of Mt. Carmel, near Cincinnati, Ohio, plans to add a receptionist and medical assistant for the flu season, in case there is an uptick in the number of sick patients. “We may have a high volume of ill patients, and we may have some of our employees unable to work some days because of illness or illness within their families,” says Michael Chamberlin, MD, a pediatrician in the practice. “An additional person will come in handy.”

Jay Butler, director of the CDC’s H1N1 Vaccine Task Force, says it is important for primary care physicians to prepare for an unpredictable but potentially severe influenza season. “We don’t know what lies ahead in the coming weeks and months. It’s essential that we plan and prepare for lots of flu activity. We expect to see both the H1N1 virus and the seasonal influenza viruses causing illness.”