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UNITED WAY/COMBINED FEDERAL CAMPAIGN

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"Protecting the health and informed consent rights of children since 1982."

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KWilliams Note:

NVIC Co-founder and President Barbara Loe Fisher, who ended her four years of service on the FDA Vaccines and Related Biological Products Advisory Committee as the voting consumer member yesterday, made the statement below when she voted on whether MedImmune had proven that the live virus nasal flu vaccine, FLUMIST, was safe to use in children and adults. She was the sole dissenting "No" vote that safety had not been proven for individuals aged five to 50.

The reference to polio vaccine in her statement was in response to an exchange she had earlier in the meeting with another Committee member, Sam Katz, M.D., who had made the argument that the fact that recipients of FLUMIST could transmit vaccine strain flu viruses to close contacts was a positive selling point for the vaccine rather than a negative consequence. He likened the effect to passive vaccination of close contacts of those recently vaccinated with live oral polio vaccine. Barbara reminded Dr. Katz that America no longer uses the live oral polio vaccine precisely because recipients and close contacts could come down with vaccine strain polio and be permanently crippled or die.

The transcripts of the last four years of FDA Advisory Committee meetings in which Barbara participated are available on the FDA website. Here is what she said when she voted that the safety of FLUMIST had not been proven:

"The data are inadequate to support the safety of FLUMIST in individuals five to 64 years of age. The increased risk of asthma in young children and the increased risk for some children of URI's, musculoskeletal pain, otitis media and croup as well as URI symptoms in adults suggests that an unknown number of healthy but genetically vulnerable individuals across all age groups will not be able to handle this vaccine well.

This will, over the long term, lead to the public perception that when you get the flu vaccine, you get the flu. And this is an important consideration long term because when you make healthy people sick after they get a vaccination, whether it is with live virus polio vaccine or live virus flu vaccine even though you have inactivated vaccines that do not cause disease symptoms, then you are going to pay a price in terms of the public perception of the risks associated with vaccination. You were able to successfully make the argument to prevent polio but, as I said before, flu is not polio and because most healthy children and adults are not permanently injured or die from the flu, I think careful thought needs to be given to this issue.

The fact that live vaccine flu virus is shed in 80 percent of recipients poses an additional risk for our population at large, particularly for immune compromised individuals across all age groups. The outstanding questions about the true rate of transmission of vaccine strain viruses among children needs to be clarified as does the retention of the attenuation of the shed viruses and the high frequency of nucleotide changes. Because this live virus nasal vaccine is not indicated for high risk health groups, which have historically been the targeted population to receive the flu vaccine, it is a very serious step to move to use a live virus vaccine for the majority of healthy individuals and the standard for proof of safety must be very high. I do not think that standard has been met by the data which have been presented so far.

I would like to see a trial of a genetically diverse group of American children and adults which addresses safety and efficacy of simultaneous vaccination with FLUMIST and other vaccines; revaccination; vaccine shedding and rate of household transmission to unvaccinted individuals as well as genetic stability."

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FROM THE NEW YORK TIMES

December 18, 2002

Nasal - Spray Flu Vaccine Gets Initial OK

By THE ASSOCIATED PRESS

Filed at 9:14 a.m. ET

WASHINGTON (AP) -- Government scientists gave a tentative endorsement to the first nasal-spray flu vaccine, while stressing that it's useful only for certain healthy people, not those most at risk of severe influenza.

Called FluMist, the long-awaited vaccine would be squirted up noses instead of injected into arms.

But advisers to the Food and Drug Administration cautioned Tuesday that if it's allowed to be sold, FluMist won't be for the people who need flu vaccination most: toddlers, the elderly and anyone with asthma or other chronic diseases.

Indeed, FluMist initially was created with the hope of giving toddlers a needle-free vaccine. Then researchers discovered it seems to increase the risk of asthma attacks in children under age 5.

So in its second attempt at winning FDA approval in two years, the vaccine's maker withdrew plans to sell FluMist for toddlers, saying it instead would target healthy people ages 5 to 64.

But the FDA's advisers endorsed only part of that plan Tuesday, recommending that FluMist be approved for sale just for people ages 5 to 49. They concluded there was too little evidence that FluMist protects people 50 and over, an age when the immune system begins to weaken.

As for people over 65, who are most at risk of dying from the flu, manufacturer MedImmune Inc. hasn't yet studied the nasal spray in that age group.

MedImmune, based in Gaithersburg, Md., wants to sell FluMist in time for next winter's flu season. But the question is whether the FDA, which isn't bound by its advisers' recommendations, will let a vaccine with so many restrictions be sold.

If so, those curbs would severely limit how often doctors would offer FluMist instead of the flu shots that 70 million Americans get every year.

A big unanswered question is whether FluMist is as good as a standard flu shot. FluMist is made of a weakened but live flu virus, while flu shots are made of killed virus. MedImmune hasn't compared the two vaccines.

Calling that question ``the elephant in the room,'' FDA adviser Dr. Julie Parsonnet of Stanford University complained that without such data, doctors won't know which product to offer which patient.

``They are issues that are going to be highly problematic,'' agreed Dr. Dixie Snider of the federal Centers for Disease Control and Prevention.

Flu kills 20,000 Americans each year and hospitalizes 100,000. Those most at risk of flu complications are people over age 65 and anyone with certain illnesses, including asthma and heart disease. Also, this year for the first time, pediatricians are being encouraged to vaccinate babies and toddlers, who are hospitalized with flu as often as the elderly and are key spreaders of infection through day care and to elderly grandparents.

Flu experts have longed for a needle-free alternative as a way to persuade more people to get annual flu vaccinations.

The nasal vaccine works by stimulating the immune system through the same nose tissue where the flu virus attacks. But in July 2001, FDA's advisers blocked FluMist's sale, saying it wasn't yet proven safe for children.

Tuesday, MedImmune argued its case again.

The vaccine proved 93 percent protective against flu in a study of 1,600 healthy children ages 15 months to 6 years. Side effects primarily included runny nose, muscle aches and fever.

But up to 1.5 percent of children under age 5 who received FluMist suffered asthma attacks or asthma-like wheezing, rates almost four times higher than children who received a dummy vaccine, the FDA said.

The FDA's advisers agreed with MedImmune's subsequent decision to target FluMist only to children over 5, who didn't seem to have that asthma risk.

In adults, FluMist didn't work as well. In a study of 4,561 healthy, working adults ages 18 to 64, FluMist recipients were just as likely as people given a dummy vaccine to experience a flulike illness, although vaccination did cut severe illness by about 17 percent.

The FDA said FluMist didn't protect people ages 50 to 64 at all. MedImmune argued that those people didn't get as sick as the unvaccinated, but FDA's advisers ultimately said the company hadn't proved its case.

Another key concern is that sneezing children occasionally spread the FluMist virus, raising questions about whether the spray vaccine would endanger grandparents or asthmatic playmates who aren't inoculated.

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