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U.K. Health Authorities Block
Chiron's Flu-Vaccine Shipments
A WALL STREET JOURNAL ONLINE NEWS ROUNDUP
October 5, 2004 12:25 p.m.
Chiron Corp. said it won't be able to supply any of its Fluvirin vaccine for this winter's influenza season, following a move by British health authorities to block shipments by the company.
Earlier in the day, the U.K. Medicines and Healthcare products Regulatory Agency, or MHRA, suspended Chiron's manufacturing license for three months because of manufacturing problems. Chiron said Tuesday it has initiated discussions with the MHRA to determine the appropriate corrective actions.
As a result of missing the flu season, Chiron won't record any sales for Fluvirin, and will cuts its earnings estimate by more than $1 a share, to 35 cents to 45 cents a share, from $1.50 to $1.60 a share previously. Chiron said it hasn't released any Fluvirin into any territory, and therefore doesn't need to recall or withdraw any vaccine. (See Chiron's statement.)
After being halted for the news, Chiron shares were down $8.29, or 18%, to $37.13 on the Nasdaq Stock Market.
Surprised by Ruling
Chiron, which produces the Fluvirin vaccine, had previously said that factory tests revealed that some batches of vaccine failed sterility testing -- suggesting contamination -- and that all doses that the company was producing would be held up for additional tests. It said Tuesday that it believed that its testing showed that the Fluvirin batches it planned to release were safe, and was surprised by the regulator's ruling. "While the MHRA's conclusions are unexpected, we respect the regulatory authority's judgment," said John Lambert, president of Chiron Vaccines.
"We apologize unreservedly to the public and our customers for being unable to meet our commitments this year," he said.
Chiron is based in Emeryville, Calif., but manufactures the Fluvirin vaccine in the U.K., having acquired the product in its purchase of PowerJect Pharmaceuticals last year.
In Washington, Health and Human Services spokesman Anthony Jewell said it isn't yet clear how the British sanction will affect U.S. supplies. Food and Drug Administration officials are working with their counterparts in Britain and Chiron to determine that, he said. "We are just learning the details," he said.
Shortage Possible
Flu-shot campaigns usually start in October, a month before the flu season typically begins in the U.S. In an average year, flu kills 36,000 people and hospitalizes another 114,000, mostly the elderly. Chiron had planned to provide the U.S. between 46 million and 48 million flu shots this year, almost half the nation's supply.
"The implications may be significant. There could be a shortage,'' said Klaus Stohr, influenza chief at the World Health Organization. "It may be resolvable but that would require a lot of adjustment on the part of the other companies.''
World-wide, Chiron is the second leading flu vaccine maker, behind French pharmaceutical company Aventis, which makes about 45% to 50% of the world's supply, Dr. Stohr said.
The timing of the license suspension is particularly worrying because vaccine production goes in cycles. The manufacturing cycle for the Northern Hemisphere vaccine finished in August and manufacturers are now gearing up to make the shots for the Southern Hemisphere. Vaccine makers don't have a lot of spare stock because they produce on demand.
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WARNING - POSSIBLE FLU SHOT SHORTAGES
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Bill Glasheen
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WARNING - POSSIBLE FLU SHOT SHORTAGES
Get your flu shots this month. And don't make me say "I told you so!"
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Dana Sheets
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Alternative for Healthy People 5-49
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FluMist to supply extra doses of vaccine
Company will produce more inhaled drug in wake of shot shortage
The Associated Press
Updated: 6:37 p.m. ET Oct. 8, 2004
COLLEGE PARK, Md. - The maker of FluMist, a relatively new nasal flu vaccine, said Friday it would nearly double the number of doses it makes to help meet demand caused by a shortage of flu shots.
The inhaled vaccine is an option for people who do not fall into the high-risk groups who are targeted for the nation’s limited supply of flu shots. FluMist must be given by a health care professional and is approved only for healthy people ages 5-49.
Last year, the nasal vaccine cost two to three times more than the flu shot. But on Friday, a supermarket chain quoted a price that is more competitive with the shot.
In two weeks, Giant Food will offer FluMist at around $30 per dose at pharmacies in 34 of its Virginia stores, according to spokesman Barry Scher. Last fall, Giant sold FluMist for $59.95 per dose. Giant charges $20 for a flu shot, although the cost for shots can vary widely depending on where it’s offered.
Also Friday, some health insurance companies, including Aetna and Empire Blue Cross Blue Shield of New York, said they would cover FluMist during the upcoming flu season.
Not for seniors or toddlers
The nasal vaccine is made with a weakened live virus and is not approved for use by the elderly or toddlers, two of the groups that health officials say should be first in line for the limited number of flu shots.
The Food and Drug Administration set age limits for FluMist over concern it could increase the risk of asthma attack in young children and might not be as effective for the elderly as a flu shot.
Gaithersburg, Md.-based MedImmune had only made 1.1 million doses for this flu season, following disappointing sales last year. But the Centers for Disease Control and Prevention asked MedImmune to step up production to help cover this year’s flu shot shortage.
The company said it would rely on frozen supplies of vaccine already on hand to produce nearly 1 million more doses. The extra FluMist could be available to the public by late November, said spokeswoman Clarencia Stephen.
MedImmune made 4 million doses of FluMist in 2003, predicting strong demand for the needle-free vaccine. But the limits on those who can use it, difficult storage requirements and a high price led to dismal sales.
The company has slashed its wholesale price from the roughly $46 per dose it charged last year. Wholesale prices this year will be $23.50 for returnable doses and $16 each for nonreturnable doses. The company does not put a suggested retail price on the vaccine, Stephen said.
MedImmune also scrapped a marketing campaign aimed at the general public. It chose to focus instead on persuading doctors to use FluMist while it awaited the release of a new formulation, expected in 2007.
FluMist to supply extra doses of vaccine
Company will produce more inhaled drug in wake of shot shortage
The Associated Press
Updated: 6:37 p.m. ET Oct. 8, 2004
COLLEGE PARK, Md. - The maker of FluMist, a relatively new nasal flu vaccine, said Friday it would nearly double the number of doses it makes to help meet demand caused by a shortage of flu shots.
The inhaled vaccine is an option for people who do not fall into the high-risk groups who are targeted for the nation’s limited supply of flu shots. FluMist must be given by a health care professional and is approved only for healthy people ages 5-49.
Last year, the nasal vaccine cost two to three times more than the flu shot. But on Friday, a supermarket chain quoted a price that is more competitive with the shot.
In two weeks, Giant Food will offer FluMist at around $30 per dose at pharmacies in 34 of its Virginia stores, according to spokesman Barry Scher. Last fall, Giant sold FluMist for $59.95 per dose. Giant charges $20 for a flu shot, although the cost for shots can vary widely depending on where it’s offered.
Also Friday, some health insurance companies, including Aetna and Empire Blue Cross Blue Shield of New York, said they would cover FluMist during the upcoming flu season.
Not for seniors or toddlers
The nasal vaccine is made with a weakened live virus and is not approved for use by the elderly or toddlers, two of the groups that health officials say should be first in line for the limited number of flu shots.
The Food and Drug Administration set age limits for FluMist over concern it could increase the risk of asthma attack in young children and might not be as effective for the elderly as a flu shot.
Gaithersburg, Md.-based MedImmune had only made 1.1 million doses for this flu season, following disappointing sales last year. But the Centers for Disease Control and Prevention asked MedImmune to step up production to help cover this year’s flu shot shortage.
The company said it would rely on frozen supplies of vaccine already on hand to produce nearly 1 million more doses. The extra FluMist could be available to the public by late November, said spokeswoman Clarencia Stephen.
MedImmune made 4 million doses of FluMist in 2003, predicting strong demand for the needle-free vaccine. But the limits on those who can use it, difficult storage requirements and a high price led to dismal sales.
The company has slashed its wholesale price from the roughly $46 per dose it charged last year. Wholesale prices this year will be $23.50 for returnable doses and $16 each for nonreturnable doses. The company does not put a suggested retail price on the vaccine, Stephen said.
MedImmune also scrapped a marketing campaign aimed at the general public. It chose to focus instead on persuading doctors to use FluMist while it awaited the release of a new formulation, expected in 2007.
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