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“Protecting the health and informed consent rights of children since 1982.”
On July 26 and 27, 2001 the FDA Vaccines and Related
Biological Products Advisory Committee reviewed an application from Aviron for
the licensing of FLuMist vaccine, a live cold adapted flu vaccine containing
three flu strains administered nasally. The vaccine manufacturer requested that
the Committee vote to approve the vaccine as safe and effective for one or two
doses to be administered annually to children ages 12 months through eight
years and one dose to be administered annually to children 9 through 17 years
and adults 18 through 64 years.
During the two days of deliberations, the Committee was
given a presentation of the supporting scientific data for licensure by Aviron
as well as an analysis of Aviron’s data prepared by FDA staff at the Centers for
Biologics Evaluation and Research (CBER). After considering the scientific evidence
as presented by Aviron and the FDA, the Committee took a vote on June 27.
There was an 8 to 7 vote supporting adequate evidence for
efficacy in children 1 to 17 years of age. The vote was 10 to 4 against
adequate evidence for proof of safety.
Following are two statements by Barbara Loe Fisher,
consumer voting member of the Committee, explaining why she voted “No” when
asked whether there was adequate proof of efficacy and safety for giving
FluMist vaccine.
“I can appreciate the complexity of trying to gather data
for a vaccine that would be used by virtually all age groups, from infants to
the elderly. It is an enormous task.
“FluMist appears to be effective in healthy children and
adults, even though there are low levels of serum antibody. But I am troubled
by the lack of understanding of the biological mechanisms for immunity and the implications
of low H1N1 antibody response compared to the other strains. This, together with the increased incidence
of influenza like illness, including fever, after FluMist vaccination versus
placebo, especially after the first dose, leads me to want to see carefully
collected efficacy data, especially in children under five years old, because
these children are receiving 37 doses of 11 vaccines during that time period.
Many of them present at the time of vaccination with a coinciding viral or
bacterial infection and I do not think this efficacy data is adequate to
reflect the real environment in which this vaccine will be given to children.
“So I would like to see at least 3,000 children under age
five, with an emphasis on children under age two, evaluated with one or two
doses over a period of four years to measure for antibody response to the
different strains; for incidence of influenza like illness; and viral shedding
with particular attention paid to whether there are individual genetic or other
biological factors, such as acute or chronic illness, which contributes to variations
in antibody responses, efficacy and the general health of the children over
time after repeated use of this vaccine.”
“I do not think we should license a new live virus flu
vaccine that will be given to children as young as one year old without
adequate pre-licensure safety data in those children. I am troubled by the lack
of adequate safety data for this vaccine on children under five years old,
particularly under two years old.
“There is an incomplete understanding of the implications
of viral shedding on transmissability to close contacts, which is particularly important
for children who are in close contact with each other. For children and adults,
there are outstanding questions about why there is more influenza like illness,
including fever, after vaccination as well as whether or not there is a real
increased risk of pneumonia, bronchitis and asthma in healthy individuals after
vaccination, and an even greater risk for these outcomes in acutely or
chronically ill individuals. I believe a practical issue that needs to be
resolved is whether variations in the way the vaccine is administered nasally
has a significant impact on whether these attenuated viruses can end up being
swallowed or find their way to the respiratory tract and cause respiratory,
abdominal or neurological complications.
“Certainly, given the fact that this vaccine will be
administered to children who are already receiving three dozen doses of other
vaccines in the first five years of life, there can be no confidence in the
true safety profile of the vaccine in the real world unless data is generated
that includes administration to several thousand children under five with
genetic diversity over at least four years, where you measure for all morbidity
and mortality outcomes, including evaluation of immunological and genetic intergrity
and general health and wellness after repeated vaccination.
“We have very limited experience of using inactivated flu
vaccine in children under five years old and it is extremely important to be
sure that widespread introduction of a new live virus flu vaccine into this
child population will not ultimately negatively impact on their long term
health and wellness, even though it may, indeed, prevent them from getting the
flu short term. This is a huge step because we are going to be shifting the entire
flu vaccination strategy from targeting adults to targeting children and we had
better be sure we are doing that safely.”
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