Forget the shot, and take a whiff of vaccine

FluMist supply, demand both rise

It’s not a shot in the arm, but the nasal flu vaccine will be a new form of relief to some hospitals seeking vaccine supply.

MedImmune of Gaithersburg, MD, announced it would be able to produce about 2 million extra doses of FluMist by late November, in addition to the 1.1 million already available.

Because FluMist is not approved for some high-risk groups, such as the elderly, chronically ill, or children younger than 5, its supply will not be re-directed by the Centers for Disease Control and Prevention.

Hospitals have been slow to embrace the new vaccine product, which is a live vaccine administered nasally. It is approved for healthy people ages 5 to 49, which means hospitals would need to screen health care workers for health risks.

Until the announcement that Chiron Corp. would not be providing any flu vaccine this year, MedImmune was donating doses to hospitals. That program halted immediately, and MedImmune said it was "only providing doses for hospitals that had previously applied or enrolled in the program."

Instead, hospitals that had avoided using the live vaccine began calling in orders. "There was very strong interest in the [FluMist] program even before the Chiron announcement. That interest has gone up and has gone up markedly," says Jeffrey Stoddard, MD, senior director of medical affairs at MedImmune.

Last year, questions about the live vaccine combined with its high price led to low demand for FluMist, as only 450,000 doses were administered out of 5 million produced. This year, MedImmune lowered the price from $46 per dose to $23.50 for returnable doses and $16 for nonreturnable doses and announced it would supply between 1 million and 2 million doses. It initially had 1.1 million available, but was able to use frozen bulk vaccine to produce an additional million doses.

Some employee health professionals questioned whether health care workers taking FluMist would need to be furloughed. But the recommendations from the Advisory Committee on Immunization Practices (ACIP) stated that only health care workers with direct patient contact with "severely immunocompromised patients," such as those undergoing bone marrow transplant, should refrain from caring for those patients for seven days. "No preference exists for inactivated vaccine use by health care workers or other persons who have close contact with persons with lesser degrees of immunosuppression," ACIP explained.1

"There’s been a lot of misunderstanding about the safety profile of our vaccine," says Stoddard. "The safety profile of FluMist is very solid. There really has been consistent evidence of safety of this vaccine shown again and again in multiple clinical trials. The apprehension and misunderstanding relates mostly to theoretical risks that people get concerned about with any new vaccine and particularly live attenuated vaccines."

Some employee health professionals have expressed concern about studies that showed people using FluMist could shed virus particles. In one day-care study, one child transmitted the virus to another, although the second child did not develop influenza.1

The virus is cold-adapted and cannot replicate in the respiratory system, says Stoddard. "In that study, we showed that there were no adverse events. That child basically got a partial free vaccine," he says. "You’ll only find that in a percentage of people who get that vaccine, and you’ll only find it for a short period of time."

William Schaffner, MD, chair of the department of preventive medicine at Vanderbilt University in Nashville, TN, and a representative of the Infectious Disease Society of America on ACIP, predicts that FluMist eventually will gain acceptance for healthy health care workers. "I think FluMist has very real potential."

MedImmune is continuing studies and hopes to eventually expand the FluMist approval to children younger than 5 and adults 50 to 64, Stoddard says.

Reference

1. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2004; 53(RR06):1-40.