December 23, 2009

State of Alabama
Press Release: Public Health, Alabama Department of

H1N1 vaccine recall should not affect Alabamians who have received vaccine

FOR IMMEDIATE RELEASE

CONTACT: Jim McVay, DrPA
(334) 206-5600

The Alabama Department of Public Health estimates 61,800 doses of H1N1 influenza nasal mist vaccine involved in a current recall were shipped to providers in the state. The doses were shipped to vaccine providers in October, during a time when the effectiveness of the vaccine was likely still at or above the recommended level. The manufacturer is recalling doses from these lots that have not been used. The recall was issued for reasons unrelated to vaccine safety.

This recall does not affect any vaccine administered by injection. Some doses of nasal spray H1N1 vaccine were recalled because the potency in the affected lots dropped below a pre-specified limit over time. This was determined through routine, ongoing analysis. All lots successfully passed testing for safety, purity and potency before their release.

Persons who received nasal spray vaccine from the recalled lots do not need to take any special actions. The vaccine potency was only slightly below the "specified" range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen. According to the Centers for Disease Control and Prevention, there is no need to re-administer a dose to those who received vaccine from these lots.

As is recommended for all 2009 H1N1 vaccines, all children younger than 10 years old should get the recommended two doses of 2009 H1N1 vaccine approximately one month apart to receive optimal protection. Children younger than 10 who have only received one dose of the nasal spray vaccine thus far should still receive a second dose of 2009 H1N1 vaccine. It is best to use the same type of vaccine for the first and second doses.

The vaccine being recalled was manufactured by MedImmune. The company performs ongoing testing of vaccine after it has been distributed to ensure that vaccine continues to meet required specifications.

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12/23/09



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