By Miriam Raftery
December 15, 2009 (San Diego) – The Centers for Disease Control and Prevention (CDC) have issued a voluntary recall of 800,000 doses of H1N1 flu vaccine in pre-filled syringes for children ages 6 to 36 months. Testing by manufacturer Sanofi Pasteur found reduced potency in four lots distributed nationwide, including 3,100 doses distributed in San Diego County.
Each of the County’s seven clinics received and administered 100 doses from the lots that were recalled. The doses were received on November 30. An additional 500 doses received by the County were set aside from doses received December 2 to be used in schools, of which 280 remain in inventory with the County and will be returned per the manufacturer’s instructions. Another 1,900 doses were distributed to private providers in San Diego County on December 2.
The CDC advises that infants and children who received the recalled vaccines should not be revaccinated, as the vaccine is still expected to be effective despite the slightly reduced antigen levels. However children under ten who have received only one dose should received a second dose of H1N1 as already recommended in the vaccine guidelines.
Potency of vaccines for older children and adults were not affected. There are no safety concerns with the recalled vaccines, the CDC has stated.
Other options for vaccination against H1N1 influenza are available. For children 6 months of age and older vaccine is available in multidose vials; these have not had any drop in potency. However multi-dose vials contain thimerosal, a preservative. For healthy children over two years of age, nasal spray containing live vaccine is also an option. Nasal spray vaccines do not contain thimerosol.
The recalled lot numbers are:
0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):
For additional information visit the CDC website at http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm.