More nasal-spray flu vaccine on the way

Oct 22, 2004 (CIDRAP News) – MedImmune will produce another million doses of its nasal-spray influenza vaccine, FluMist, which could free up some injectable flu vaccine for high-risk groups, Health and Human Services (HHS) Secretary Tommy Thompson announced yesterday.

"MedImmune notified me today that we'll have an additional 1 million doses of FluMist nasal-spray vaccine this year," Thompson announced at a late-afternoon teleconference. The extra doses will bring MedImmune's production for this year to 3 million doses and the nation's total flu vaccine supply to 61 million, he added.

FluMist involves live virus and is licensed only for healthy people between the ages of 5 and 49; therefore it can't be given to most of the high-risk people who have priority for injectable vaccine during the current flu vaccine shortage. But some in the priority categories—healthcare workers and out-of-home caregivers and household contacts of children younger than 6 months—could receive FluMist if they are younger than 50.

Noting that FluMist is for healthy people who should not be getting the injectable vaccine, Thompson added, "We also hope some healthcare workers involved in direct patient care will avail themselves of FluMist, because that frees up injectable vaccine."

HHS has been scrambling for more flu vaccine since up to 48 million doses of Chiron flu vaccine were determined to be potentially unsafe. The determination came after British regulators shut down Chiron's plant in Liverpool, England, on Oct 5 because of contamination problems.

The elimination of the Chiron vaccine left Aventis Pasteur and MedImmune as the only producers of flu vaccine for the US market. Aventis has said it will produce a total of about 58 million doses of injectable vaccine.

Thompson said about 21 million doses of Aventis vaccine remains and will be shipped over the next 7 weeks to facilities serving high-risk groups, such as nursing homes and community clinics. He urged people seeking the shot not to stand in line but to be patient and persistent.

"The fact that a clinic doesn't have the vaccine today does not mean they won't have it next week or in 2 weeks or 3 weeks," Thompson said. "That information hasn't been getting out there. Everybody thinks all the vaccine has been shipped and if their doctor doesn't have it, it won't be there.

"We have about 21 million doses that's going to be shipped at a rate of about 2 1/2 to 3 million doses each week for the next 7 weeks. And the first or second week of January there'll be an additional 2.6 million doses. So if you're out there and you don't have vaccine or your doctor says he doesn’t have vaccine, please be persistent and call back."

Lester Crawford, acting commissioner of the Food and Drug Administration (FDA), said the FDA is involved in negotiations that could add about 5 million doses of vaccine from foreign manufacturers to the US supply.

For sources of vaccine that have "some degree of probability, the numbers would be about 5 million, including the doses that have previously been indicated from Canada," he said. ID Biomedical, a Canadian firm, has been mentioned previously as a possible source of about 1.5 million doses.

MedImmune had produced about 1.1 million doses of FluMist before the Chiron vaccine was eliminated, David Mott, the company's president and CEO, said at the teleconference. Shortly after the Chiron problem surfaced, the company said it could produce an additional 1 million doses. The extra doses announced yesterday will bring the company's total production to about 3 million.

"We now have begun producing two to three lots per week in our Philadelphia facility; that should be resulting next week or the following week in about 400,000 doses per week," Mott said. He said the company expects to finish making the 2 million extra doses by early to mid-December.

In response to questions, Mott noted that MedImmune lowered the price of FluMist from $46 last year to $23.50 this year, putting it much closer to the price of injectable vaccine.

Yesterday Thompson repeated his previous message that the nation should have enough doses of flu antiviral drugs this season to treat about 40 million people. That includes a federal stockpile for about 7 million people and private supplies and production capacity for 33 million, he said.

"The combination of the existing 61 million doses of vaccine and the antivirals gives us the ability to stave off the effects of the flu this season," he said.

The high-risk groups that should get injectable vaccine, according to HHS, include children aged 6 to 23 months, adults aged 65 and older, people aged 2 to 64 years with chronic medical conditions, women who will be pregnant during flu season, residents of nursing homes and long-term care facilities, healthcare workers caring directly for patients, and out-of-home caregivers and household contacts of babies younger than 6 months.

Pregnant women should not be given FluMist, nor should children and adolescents on long-term aspirin treatment, according to the Centers for Disease Control and Prevention (CDC). The CDC also says that injectable vaccine is preferred over FluMist for healthcare workers and others in close contact with anyone with a severely weakened immune system.

See also:

Oct 21 HHS news release
http://archive.hhs.gov/news/press/2004pres/20041021.html

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