Moldy FluMist Holds Up Final FDA Approval

Moldy FluMist Holds Up Final FDA Approval

by Barbara Loe Fisher

Until June 2003, when the FDA approved the first live virus flu vaccine, FluMist, the only flu vaccine that was used in the US was the killed or inactivated flu vaccine injected into the arm. FluMist manufactured by MedImmune was the first vaccine designed to be squirted up the nose and given to healthy children and adults.

Generally, Americans have not been enthusiastic about squirting live virus flu vaccine up their noses. Call it irrational. Call it the "yuck" factor. Call it instinct. FluMist has largely remained a non-starter.

The fact that the FDA had to recently slap MedImmune on the hands after inspectors reportedly found excessive amounts of mold and bacteria during early stages of the production process of FluMist doesn't help. A September 10, 2007 Washington Post article said the company was cited for "significant deviations for current good manufacturing practice."
http://www.washingtonpost.com/wp-dyn/content/article/2007/09/09/AR2007090901612.html?nav=rss_business

In pre-licensure clinical trials of FluMist, there was an increased risk of asthma, upper respiratory infections, musculoskeletal pain, otitis media and croup for some children and an increased risk for upper respiratory symptoms in adults after inhaling the live vaccine. FluMist contains attenuated live flu viruses and poses a risk of transmission of live flu virus from the recently vaccinated to close contacts. When I was sitting on the FDA Vaccines and Related Biological Products Advisory Committee in 2002, I voted "no" when asked if safety had been proven. http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3912t1-03.pdf

Among other things, I said "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 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 populations to receive flu vaccine, it's a very serious step to move to the use of a live virus vaccine for the majority of healthy individuals, and a standard for proof of safety must be very high. I don't think that standard has yet been met by the data which have been presented so far."

Initially, the FDA approved the vaccine for healthy children over 5 and adults under 49. Both MedImmune and vaccine distributor, Wyeth, thought they had a blockbuster on their hands. In the summer and fall of 2003, the companies launched a $100 million ad campaign that featured Wal Marts offering to squirt the vaccine up the noses of shoppers.(MedImmune, Inc. [Investors] News Releases. September 10, 2003 "FluMist Available in Pharmacies This Fall."). At a cost of between $46 and $150 a dose, the companies were projecting between $120 million and $140 million in sales.

But by late October 2003, it became apparent that few of the four million doses of FluMist that MedImmune had produced were being purchased. By January 2004, the company was trying to give it away. MedImmune has been trying to capture market share for FluMist ever since the disastrous FluMist debut in the 2003-2004 flu season.

Now, the FDA has given MedImmune (recently acquired by British drug firm Astra Zeneca) another chance by approving FluMist for healthy children over two years. But still, the warning remains about not giving FluMist to anyone with asthma or children under five with a history of wheezing. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01705.html

What healthy adults and parents of healthy children need to ask themselves is: why do healthy people need to deliberately inhale live flu viruses when the majority of healthy people don't get that sick from the flu and recover without any complications?

Keep reading NVIC's E-News for further reports on the Flu and You as the flu season approaches and the Flu Patrol gears up to scare the living daylights out of you so you inhale deeply or roll up your sleeve without giving it a second thought.

In the News:

"The FDA sent the Gaithersburg firm a lengthy warning letter in May, citing "significant deviations from current good manufacturing practice." Agency officials were concerned that MedImmune had not properly followed up after excessive levels of mold and bacteria were found during early stages of the production process. The FDA said the vaccine had not been contaminated. The FDA's warning letter has held up shipments of FluMist. It also put on hold MedImmune's efforts to win regulatory approval for use of the vaccine by children under 5. Expanding the vaccine's use in that important market has been a cornerstone of the firm's efforts to boost the prospects for FluMist, which has not been a hit in the marketplace. It is now approved only for people ages 5 to 49. FDA and MedImmune officials said the process to win approval for use by younger children could now continue. Less than two weeks before the warning letter was issued, an FDA advisory panel unanimously agreed that FluMist worked in children under 5. The panel was mixed on whether FluMist was safe enough for children younger than 2." - Michael Rosenwald, Washington Post (September 10, 2007)
http://www.washingtonpost.com/wp-dyn/content/article/2007/09/09/AR2007090901612.html?nav=rss_business

"The U.S. Food and Drug Administration today approved expanding the population for use of the nasal influenza vaccine FluMist to include children between the ages of 2 and 5. Approval for the vaccine, which contains a weakened form of the live virus and is sprayed in the nose, was previously limited to healthy children 5 years of age and older and to adults up to age 49.......Children under the age of 2 should not receive FluMist because there was an increased risk of hospitalization and wheezing for this age group during the clinical trials. Commonly observed adverse events from the vaccine were generally mild and most often included runny nose and/or nasal congestion, as well as a slight fever in children 2 to 6 years of age. FluMist should not be administered to anyone with asthma or to children under the age of 5 years with recurrent wheezing because of the potential for increased wheezing after receiving the vaccine. People who are allergic to any of FluMist's components, including eggs or egg products, should also not receive the vaccine....." - FDA Press Release (September 19, 2007) http://www.fda.gov/bbs/topics/NEWS/2007/NEW01705.html MedImmune Says FluMist Problems