WASHINGTON June 17
A flu vaccine that is the first to be delivered by a squirt up
the nose instead of a needle in the arm has been approved by the
Food and Drug Administration for healthy people from 5 to 49.
The vaccine, called FluMist, was approved by the FDA even though
it was given only a tentative endorsement by an advisory panel last
the December. The panel said the drug would not be appropriate for
people who most need vaccine protection from influenza: toddlers,
the elderly and people with asthma or other chronic diseases.
For children from 5 to 8, the approval requires two doses of
FluMist six weeks apart. Patients from 9 to 49 need only one dose,
the agency said.
The safety and effectiveness of FluMist has not been proven for
people 50 and over. The FDA encouraged those patients to get the
injected flu vaccine.
FluMist was not approved for children under 5, because in
clinical trials researchers found that young children treated with
the nasal mist vaccine had a higher rate of asthma attacks and
wheezing within 42 days of the vaccination, compared to children who
received a placebo.
Approval of FluMist achieves a goal of many flu experts: a
needle-free alternative to the annual shot. Some believe this may
encourage more people to become vaccinated against flu.
FluMist contains each of the three influenza live virus strains
expected to be active during the 2003-2004 flu season. These include
two types of influenza A, which causes severe illness, and one type
of influenza B, which causes a milder form of the disease. The live
virus in the vaccine has been modified and weakened so that it
produces immunity without causing illness.
Influenza is the cause of 36,000 deaths annually in the United
States. Most of the victims are patients with other health problems,
children under 2 and people over 65.
"This new vaccine provides another option for protection against
influenza and will potentially increase the availability of the
injected killed virus vaccine for those at highest risk," Dr. Mark
B. McClellan, the FDA commissioner, said in a statement.
There have been vaccine shortages at the beginning of some flu
seasons in the past, because there are few manufacturers of the drug
and the formula must be changed each year to match the changes in
the circulating virus.
FluMist is manufactured by MedImmune Vaccines, Inc. of
Gaithersburg, Md. A company spokesperson said that the firm is now
taking orders for the drug and that four to six million doses will
be available by October, the start of the flu season. The company
said FluMist will cost about $46 a dose. This is more than twice the
typical cost of injected flu vaccine.
The company in July 2001 sought FDA approval to market FluMist
for children, but FDA's advisers said the drug had not been proven
safe for them. MedImmune revised its application and it was
endorsed, with reservations, by the advisers last year.
Clinical studies showed that although FluMist provided flu
protection for 93 percent of the 1,600 healthy children tested,
there was a 1.5 percent incidence of asthma attacks or wheezing
among children under 5.
The advisory panel agreed with MedImmune's decision to limit
childhood use of FluMist to those over 5.
Studies showed that FluMist did not provide the same flu
protection for adults from 50 to 64 as vaccinations. For adults from
18 to 49, the studies suggested FluMist reduced severe illness.
An FDA statement said FluMist should not be given to persons with
compromised immune systems, such as patients with AIDS, cancer or
organ transplants. The agency also said that the safety of the nasal
vaccine has not been demonstrated for patients with asthma or some
other reactive breathing diseases.
People with underlying medical conditions who would be most
seriously affected by a flu infection should receive the injected
form of vaccine, the agency said.
FluMist also is not recommended for people who are allergic to
eggs or who have demonstrated an earlier allergic reaction to flu
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