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:

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Flu Shot is Not Cost Effective For Adults But is For Children

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