Nasal
Flu Vaccine NOT Approved -- We Can Make a Difference
Aviron
and its marketing partner, giant drugmaker American Home Products Corp.
(NYSE:AHP - news), had hoped to launch FluMist, the intranasal live virus
vaccine, in time for the upcoming flu season.
Aviron said, however, that it will not be
able to do so following the negative vote late on Friday by an advisory panel to the US Food and Drug
Administration,
Some analysts had expected FluMist to
become a $1 billion a year blockbuster, with patients embracing a needle-free means of
immunization against the influenza
virus.
But those profit visions are now on hold
after the FDA advisory panel voted 10-4 that information presented by Aviron
during a two-day meeting was insufficient to show FluMist is safe. Some members said more data might ease their
concerns and urged Aviron to continue development.
But the panel had little doubt about the
effectiveness of FluMist. The group said studies of 24,000 people showed the
nasal spray was able to prevent the illness in children as young as one year
old and adults up to age 64.
An estimated 70 million Americans get flu shots each year to prevent the
miserable aches, fatigue and fever from the seasonal scourge.
Reuters
July 30, 2001
DR. MERCOLA'S
COMMENT:
Thanks to Dawn Richardson from PROVE (Parents Requesting Open
Vaccine Education) for forwarding me the above information.
It is highly likely that the growing
anti-vaccine movement has a lot to do with this vaccine's safety being
questioned. However, based on the committee's comments, it is likely that the
vaccine will be approved next year when the company re-submits to the FDA,
with the additional safety data that they asked for.
So the victory is likely only
temporary. But it shows that we can make a difference and the influence of
the anti-vaccine movement will continue to grow as more people become
well-informed on the subject.
One other issue with this particular vaccine is that in 2 ways it is actually
much better than the current injectable flu vaccines in use. Firstly, it is
possible that intranasal vaccine is mercury-free, which the flu shot is NOT.
Secondly, it is a live virus vaccine
that enters through the same route as the natural virus, through the nasal
passages. This route would certainly seem to preferable to injecting it
directly into the body, although I still would not recommend it.
Hats off also to Barbara Loe Fischer
for helping to protect our children from the onslaught of vaccines that the
drug companies would like to provide us with.
Barbara Loe Fisher is the president of NVIC sits on the FDA advisory committee
evaluating these vaccines and is the primary voice of reason on that
committee. She provided the following comments in light of the FluMist
vaccine which was up for FDA approval.
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.
On
Efficacy:
"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."
On Safety:
"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 integrity 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."
Related
Articles:
Why I Never Get Flu
Shots
Flu Shot is Not Cost
Effective For Adults But is For Children
Beware Live Virus Flu Vaccine Is Coming
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