Thursday, December 24, 2009

TN got 120,000 doses of recalled flu mist

By Christina E. Sanchez THE TENNESSEAN • Matthew Perrone and Marilynn March ASSOCIATED PRESS • December 24, 2009 As many as 120,000 doses of H1N1 nasal spray vaccine that came to Tennessee were part of the latest nationwide recall because they lost strength, state health officials said Wednesday. Drugmaker MedImmune's recall affects more than 4.7 million doses, and the vast majority had already been used in early October, according to the Food and Drug Administration. Agency officials said the vaccine was strong enough when it was distributed in October and November. The vaccine recall is the second this month caused by declining potency and comes as public health officials urge millions of Americans to get vaccinated against swine flu. Similar to the first recall earlier this month when Sanofi Pasteur pulled 800,000 doses of the H1N1 shots for young children, people who got the nasal spray do not need to get re-immunized, said Dr. Tim Jones, state epidemiologist for the health department. "These are lots that we got really early on in the vaccination campaign when we were giving the vaccine as quickly as we received it," Jones said. "At the time, it was perfectly potent and even if they had gotten now, it would have been fine. Our recommendations remain unchanged, and vaccination is the best way to prevent illness." Tennessee found that 120,000 doses the state received were involved in the MedImmune recall, and the doses accounted for about 6.3 percent of the 1.9 million doses distributed since October. Swine flu vaccine has been available since early October, and since then manufacturers have released more than 111 million doses for distribution in the U.S. MedImmune makes the only nasal spray version, which can be used by healthy people ages 2 to 49. FDA investigates The FDA is looking into the problem but said it's not uncommon for vaccines to lose strength over time. MedImmune's vaccine has a recommended shelf life of about four months. The company has about 3,000 doses in its warehouses but does not know how many remain in the field, according to the FDA. Last week, vaccine maker Sanofi Pasteur recalled hundreds of thousands of swine flu shots for children because tests indicated those doses lost some strength. Most of those doses had already been used, too. Tennessee had received about 11,000 of the affected Sanofi doses. Doctors and health clinics have stopped giving the recalled Sanofi and MedImmune doses, and will return them to the manufacturers. Maryland-based MedImmune, a subsidiary of London-based AstraZeneca PLC, voluntarily recalled 13 lots of its vaccine, "due to a slight decrease in potency" discovered through routine quality control testing, said spokesman Tor Constantino. "It's not a safety concern. People who have received doses from the affected lots do not need to be revaccinated. The doses were well within potency specification," he said. . William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, said all vaccines lose potency, but they are built with a buffer so they don't have to be recalled. "It's very rare that they are recalled," Schaffner said. "That's why the FDA will look at if we have to do anything different, or if it is a mark of how thoroughly the safety of the vaccine is being tested and monitored."

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