Flumist

FluMist available Monday for Anne Arundel residents FluMist will be available from 4 p.m. to 7 p.m. Monday on a walk-in basis to Anne Arundel County residents, health officials said yesterday. The newly developed nasal vaccination spray is approved for healthy people ages 5 to 49 and will be available at the main county health services building, 3 Harry S. Truman Parkway near Annapolis. A wider flu vaccination program ended in the fall. The department will accept $20 donations for each dose.

Baltimore County Executive Kevin Kamenetz this week joined forces with state and local health officials to promote flu shot season in the county, and was scheduled to get a flu shot himself during a Towson press conference on Oct. 9. Dr. Gregory Wm. Branch, director of the county's Department of Health and Human Services, and LaVerne Naesea, executive director of the Maryland Board of Pharmacy, also unveiled a "Super Saturday" slate of flu vaccination...

MedImmune Inc. said yesterday that a new version of its FluMist influenza vaccine, which is given as a nasal spray, was more effective than standard flu shots in a study of small children. The company's stock gained 4.54 percent. In a clinical trial of 8,492 children, ages 6 months to 5 years, the influenza infection rate of those who received MedImmune's CAIV-T nasal spray was 3.9 percent, compared with 8.6 percent among children who got a standard flu shot, Medimmune said in a statement on its Web site.

Gaithersburg-based MedImmune announced Tuesday evening a voluntary recall of early batches of its nasal spray vaccine against swine flu after tests revealed that the doses lost strength within months of being shipped. The recall affects 4.7 million doses of FluMist, though most were distributed in October and early November when tests showed that the vaccine was at full strength, said officials at the Food and Drug Administration. Because of that, people who got vaccinated should be protected from the H1N1 virus and do not need to worry about getting vaccinated again, officials said.

Gaithersburg-based MedImmune announced Tuesday evening a voluntary recall of early batches of its nasal spray vaccine against swine flu after tests revealed that the doses lost strength within months of being shipped. The recall affects 4.7 million doses of FluMist, though most were distributed in October and early November when tests showed that the vaccine was at full strength, said officials at the Food and Drug Administration. Because of that, people who got vaccinated should be protected from the H1N1 virus and do not need to worry about getting vaccinated again, officials said.

WASHINGTON -- MedImmune Inc. said yesterday that U.S. regulators approved its new British manufacturing plant for making the FluMist influenza vaccine in 2006, when the company expects an easier-to-use version to be approved for sale. MedImmune, which is supplying 3 million doses of FluMist this year, will be able to produce up to 15 million doses a month with the new plant in Speke, England, the company said. MedImmune will start making FluMist in 2006 at the plant, which also might be used to make a version now under regulatory review and to produce vaccine for a potential flu pandemic, the company said in a statement.

The U.S. Food and Drug Administration said yesterday that MedImmune has addressed problems at its FluMist manufacturing plant in Europe. The move clears the way for the agency to also consider an application requesting that a new version of the influenza vaccine be approved for use in children younger than 5. In May, the FDA sent a warning letter to the Gaithersburg company and said it would withhold approval of the drug for younger children until problems...

When Gaithersburg-based MedImmune Inc. first introduced a needle-free flu vaccine five years ago, shareholders were as excited as the kids who needed it. So far, the product has fallen short of expectations. But that could change after a federal panel that advises the U.S. Centers for Disease Control and Prevention recommended yesterday that all children, from six months of age to 18, be vaccinated for the flu. If adopted by the CDC, an additional 30 million children would need immunizations.

Several of the nation's major health insurers reversed course yesterday and will now cover FluMist nasal spray influenza vaccine, and at least two other carriers say they are sticking with last year's decisions to pay for MedImmune Inc.'s innovative inoculation. Cigna HealthCare, Aetna and Empire Blue Cross Blue Shield all announced that they would cover the FluMist vaccine during the 2004-2005 flu season after British regulators blocked shipment of Chiron Corp.'s flu shot vaccine, cutting off nearly half the U.S. supply.

MedImmune Inc., maker of the new FluMist nasal spray, expects to miss its sales and profits targets because it and its marketing partner bet wrongly that consumers would gladly pay a huge premium for a flu vaccine that sidesteps a painful injection. MedImmune reduced its fourth-quarter and year-end guidance on earnings and revenue yesterday, due to "lower than expected product demand for FluMist," while emphasizing that its other businesses remain very strong. MedImmune, a Gaithersburg biotechnology company, and partner Wyeth , of Madison, N.J., rolled out FluMist this year with a $25 million advertising campaign.

FluMist vaccine for students Free FluMist vaccine will be offered to all Anne Arundel County public school students through a partnership with the Anne Arundel County Department of Health, Oct. 5-15. Administered to healthy children between the ages of 5 and 11, the nasal spray vaccine contains the live but attenuated flu virus. Students must provide a written parental consent form. Permission forms must be returned to the school no later than Sept. 25. Forms can be found on the schools Web site at aacps.

School redistricting meetings to be held Two school redistricting committees have scheduled public meetings this week. The Mountain Road corridor committee will meet at 7 p.m. tomorrow at Marley Elementary School, 715 Cooper Road, Glen Burnie. The committee is looking at redistricting options for the Northeast and Chesapeake feeder systems. The committee studying redistricting in the southern part of the county will meet at 7 p.m. Tuesday at Davidsonville Elementary School, 962 Central Ave. West.

When Gaithersburg-based MedImmune Inc. first introduced a needle-free flu vaccine five years ago, shareholders were as excited as the kids who needed it. So far, the product has fallen short of expectations. But that could change after a federal panel that advises the U.S. Centers for Disease Control and Prevention recommended yesterday that all children, from six months of age to 18, be vaccinated for the flu. If adopted by the CDC, an additional 30 million children would need immunizations.

Most kids can't stand getting mandatory vaccine shots, making it tough for parents to subject them to voluntary ones. But a move by the Food and Drug Administration yesterday means needles are no longer required - at least when it comes to preventing the flu. The regulatory agency approved a new version of the nasal spray vaccine FluMist for use in children age 2 to 5. The development potentially boosts Gaithersburg manufacturer MedImmune Inc.'s patient...

The U.S. Food and Drug Administration said yesterday that MedImmune has addressed problems at its FluMist manufacturing plant in Europe. The move clears the way for the agency to also consider an application requesting that a new version of the influenza vaccine be approved for use in children younger than 5. In May, the FDA sent a warning letter to the Gaithersburg company and said it would withhold approval of the drug for younger children until problems...

MedImmune Inc. failed to address multiple problems - including bacterial contamination - identified last year at a FluMist manufacturing plant in Europe, "substantially increas[ing] the risk of product failures" in batches of its nasally inhaled influenza vaccine, according to a warning letter released by the U.S. Food and Drug Administration yesterday. Last week, the Gaithersburg biotechnology company said the federal agency was withholding approval of its application to expand FluMist's use to include most children younger than age 5 until the concerns are resolved.

Conceding that last flu season's launch of the FluMist nasal-spray influenza vaccine was mishandled, MedImmune Inc. said yesterday that it will spend more than $100 million to take sole control of the troubled product. Wyeth announced late Monday that it was bailing out of its FluMist collaboration with MedImmune. Yesterday, the Gaithersburg biotechnology company discussed what had gone wrong and the financial impact of Wyeth's decision. In a conference call with investors and analysts, MedImmune's top executives said it has become clear that for FluMist - and a successor product - to succeed, one company had to take control.

With the threat of a large-scale avian influenza epidemic looming, the federal government has enlisted Maryland-based MedImmune Inc. to help it prepare for such a possibility. The Gaithersburg company announced yesterday that it would collaborate with the National Institute of Allergy and Infectious Diseases to develop a library of vaccines -- based on its seasonal FluMist nasal spray -- that could be rapidly manufactured in the event of a widespread flu outbreak. MedImmune will provide the prototype vaccines, and the institute will run them through clinical trials.

A flu spray made by Gaithersburg-based MedImmune Inc. is effective for young children, the Food and Drug Administration said yesterday, signaling that the company might soon win approval to market the vaccine for use in children younger than 5. Some health experts say FluMist would be a welcome tool in combating the flu because it would help immunize children who could otherwise get the illness and spread it to others. An FDA advisory panel will take up the issue tomorrow, with the expectation that the agency will make a decision before the end of May. Approval could greatly increase sales of the nasal spray vaccine by MedImmune, which agreed last month to be purchased by London-based AstraZeneca PLC for $15.6 billion.