Posted on 10/10/2004 3:22:52 PM PDT by kingu
1.1 million doses of the nasal spray available in U.S. By Cheryl Clark UNION-TRIBUNE STAFF WRITER
October 10, 2004
Marcia Tolin spent the better part of a day last week trying to find FluMist, the nasal spray that's now the only option for healthy people ages 5 to 49 who want vaccine protection against the flu this fall.
"I called my doctor. I called the health department. I called the immunization projects. No one seems to have a clue what it is or where to find it," said Tolin, a La Mesa real estate agent. "I've just been running around in circles."
FluMist, a paltry 1.1 million doses in this year's batch, received clearance from the U.S. Food and Drug Administration late last week and is now en route to customers who ordered it, said a spokesman for FluMist's manufacturer, MedImmune in Gaithersburg, Md.
That includes a handful of outlets in San Diego County such as Burns Drugs in La Jolla, Around The Clock (ATC) Testing in Mission Valley and Community Pharmacy in Valley Center, none of which expects to have much.
Last week's sudden demand for FluMist came as health officials announced a major vaccine shortage because almost half the nation's supply of injectable vaccine – 48 million doses from the Chiron Corp.'s Liverpool plant – was found to be contaminated with a potentially deadly bacteria.
California doctors are now prohibited by a public health order from giving the remaining doses – 55 million nationally manufacturered by Aventis Pasteur – to healthy people so seniors and others more likely to suffer lethal consequences from influenza infection can get vaccinated first.
But with about 90 million high-risk people in the nation trying to receive only 55 million doses, no vials will be left over for healthy people, health officials say.
That has prompted a national frenzy that crowded MedImmune's phone lines with drug stores and doctors trying to order FluMist.
FluMist is not for everyone.
Approved by the FDA for the first time for use last fall, FluMist consists of a mixture of three prevailing strains of influenza virus in circulation this year, just like the Chiron and Aventis products, to provoke immune response.
When sprayed into each nostril, FluMist stimulates the production of protective antibodies.
But unlike the injectable vaccines, which contain killed viral strains, FluMist is made with live, although weakened, viruses. And while it can't cause serious illness, FDA officials don't advise it for young children or high-risk adults.
FluMist's potential side effects include runny nose and headache in both children and adults. Children also might experience muscle aches, vomiting and fever, while adults may also experience sore throat and cough.
Last fall, the first time FluMist was available, several local doctors said they either discarded or returned many FluMist doses for several reasons.
Previously about $65 apiece, FluMist's price was considered too high and many insurance plans wouldn't cover it. FluMist must be administered by a pharmacy or doctor. And the vials cannot be stored in ordinary frost-free freezers because they must be kept below minus-15 degrees Celsius at all times, and frost-free freezers temperatures can vary above that. FluMist must be thrown away if it isn't used within 24 hours after thawed.
"Because of the cost and (lack of) insurance coverage, we didn't have any of our patients use it last year," said Chula Vista's Dr. Vernon White, who said older patients weren't eligible for it anyway. "We returned our whole inventory, and this year didn't order it."
A FluMist spokeswoman acknowledged that last year's demand was lower than supply, so MedImmune didn't make as much this year. But this year, MedImmune cut the wholesale price by nearly half, so consumer prices will be about $25, retailers said.
FluMist is effective. In a large study of children 5 months to 7 years old, the nasal-spray flu vaccine reduced the occurrence of flu by 92 percent compared with a placebo. In adults, 19 percent of those who took the mist had fewer severe respiratory-tract illnesses involving fever and 23 percent to 27 percent fewer days of illness.
Public health officials are hoping this year's flu season is not severe. Health officials estimate 36,000 people a year die from the flu and thousands are hospitalized. Each influenza patient requiring hospitalization costs about $3,251 for a 4.3-day stay, an expense often borne by taxpayers.
Many drug stores are wishing they had stocked more FluMist.
"We're expecting 200 to 500 (doses) next week," said Bill Raupp of ATC. "But we tried to increase it to 10,000. They've said they don't know if they can deliver that."
FluMist's spokeswoman said MedImmune planned a total of 2.1 million doses, including the 1.1 million being shipped, but because of the shortage, it will try to make an additional 1 million.
Coincidentally, the FluMist vaccines were made in Liverpool in the same industrial park where Chiron's contaminated vaccines were made, but in a different building in a separate area of the park. She said MedImmune and Chiron have no affiliation.
Cheryl Clark: (619) 542-4573; cheryl.clark@uniontrib.com
Thank you John Edwards.
Who's John Edwards? Is he that guy who was on that stupid 'Crossing Over' show or something?
I'd rather have one made in the USA. I wonder where Aventis manufactures their vaccine?
Chiron has quite a presence here in California, but I believe that the reason why they opened the English plant was to avoid some of the more odd enviromental laws here. Well, that, and EU health authorities buy EU first, elsewhere after.
It would be great to have them manufacture the vaccine over here. (Of course, how long until they get both right wing and left wing protestors out front..)
I agree, but it's not that easy. I'm a process engineer at a fairly large pharmaceutical company. Vaccines are not so much manufactured, as grown from live virus. Few companies have the facilities and/or expertise to do this.
And, from a profit standpoint, vaccines are at best a loss leader. Once someone is vaccinated for any number of diseases, they may never need another dose, or require only a periodical booster (tetanus, etc). Compare this to an oral solid or liquid dose of a product taken for several weeks to a lifetime which has to be constantly purchased by a patient.
Sure glad I bought stock in MedImmune last year........
How long will this little bubble last for them, in your opinion?
Marcia Tolin doesn't need FluMist; she needs to talk to a therapist about her hypochondria.
I was at my doctor's office last week and the nurse said forget about the traditional IM vaccine.
Also, remember, FluMist is contraindicated in patients over 49 years old. Most chronic illness patients are older than that.
Disclaimer!! I'm in the science/production end of things! Never mistake me for a financial advisor!
Thanks, that was my take on it too. I like hearing my thoughts re-affirmed, hence, I post here. ((SMILE))
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