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Recalled H1N1 vaccine distributed in area counties
STAFF REPORTS ? December 15, 2009
Sanofi Aventis is voluntarily recalling 800,000 doses of pediatric H1N1 flu vaccine in prefilled syringes because routine tests disclosed that its potency has diminished, federal officials said today.
The Centers for Disease Control and Prevention issued an alert about the recall this morning, noting that the vaccine was fine when it was shipped, but its potency apparently faded during a month of storage.
According to the Indiana State Health Department, the recalled vaccine was distributed to health departments in Tippecanoe, Benton, Boone, Cass, Clinton, Howard and Montgomery counties.
Other counties receiving the recalled vaccine (outside the Journal & Courier circulation area) include Allen, Bartholomew, Clark, Crawford, DeKalb, Dearborn, Delaware, Elkhart, Floyd, Gary City, Grant, Hamilton, Hancock, Hendricks, Henry, Jackson, Johnson, Kosciusko, LaPorte, Lake, Lawrence, Madison, Marion, Miami, Monroe, Morgan, Noble, Porter, Putnam, Rush, Shelby, St. Joseph, Vanderburgh, Vigo, Warrick and Wayne counties.
Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, says there's no reason for parents to worry, because demand for the vaccine is so great that the doses were most likely administered before its potency faded.
"There's no need for parents to call pediatricians. We think the doses given are protective and safe," Schuchat said. The manufacturer is now notifying health providers who received the affected lots to discard the syringes, meant for children from 6 to 35 months of age.
The agency recommends that children in that age group get two doses, about a month apart.
Injectible vaccine is licensed to be stable for 18 months, while the nasal spray should last for 18 weeks. Seasonal flu vaccine is typically dated to expire in June of the year after it was produced, but Shuchat says that "month to month" its potency may drop, but usually not enough to limit its effectiveness.
The following is a statement from State Health Commissioner Judy Monroe regarding the recall and what area parents should do:
I want to reassure parents the recent recall of some lots of the 2009 H1N1 flu vaccine is NOT due to safety concerns. According to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), there is also no need to re-vaccinate persons who have received the vaccine from these lots. Indiana received about 10,000 doses of the affected lots, and the Indiana State Department of Health is working closely with local health departments and other providers of the H1N1 flu vaccine to locate any unused vaccine from the affected lots that have been shipped to Indiana, so they can be returned to the manufacturer.
Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series, if not already completed. These vaccine lots were routinely tested after distribution and were found to have a decreased level of antigen, which decreases the potency of the vaccine. The slightly reduced concentration of vaccine antigen found in retesting these lots is still expected to be effective in stimulating a protective response.
Again, there is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children younger than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. So, children younger than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.
Sanofi Pasteur has discontinued distribution of the 0.25 mL syringes of H1N1 pediatric vaccines. For children 6 months of age and older, vaccine is available in multi-dose vials. The vaccine in multi-dose vials is a safe and effective vaccine for children. One difference between vaccine in prefilled syringes and the multi-dose vials is that the multi-dose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened. The standard dose for this preparation for administration to infants 6-35 months old is the same as for the prefilled syringes, 0.25 mL. For healthy children at least 2 years of age, the nasal spray (live, attenuated influenza vaccine) is also an option. The nasal spray vaccine is produced in single units that do not contain thimerosal.
Parents with questions can visit www.in.gov/flu or call (877) 826-0011.
STAFF REPORTS ? December 15, 2009
Sanofi Aventis is voluntarily recalling 800,000 doses of pediatric H1N1 flu vaccine in prefilled syringes because routine tests disclosed that its potency has diminished, federal officials said today.
The Centers for Disease Control and Prevention issued an alert about the recall this morning, noting that the vaccine was fine when it was shipped, but its potency apparently faded during a month of storage.
According to the Indiana State Health Department, the recalled vaccine was distributed to health departments in Tippecanoe, Benton, Boone, Cass, Clinton, Howard and Montgomery counties.
Other counties receiving the recalled vaccine (outside the Journal & Courier circulation area) include Allen, Bartholomew, Clark, Crawford, DeKalb, Dearborn, Delaware, Elkhart, Floyd, Gary City, Grant, Hamilton, Hancock, Hendricks, Henry, Jackson, Johnson, Kosciusko, LaPorte, Lake, Lawrence, Madison, Marion, Miami, Monroe, Morgan, Noble, Porter, Putnam, Rush, Shelby, St. Joseph, Vanderburgh, Vigo, Warrick and Wayne counties.
Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, says there's no reason for parents to worry, because demand for the vaccine is so great that the doses were most likely administered before its potency faded.
"There's no need for parents to call pediatricians. We think the doses given are protective and safe," Schuchat said. The manufacturer is now notifying health providers who received the affected lots to discard the syringes, meant for children from 6 to 35 months of age.
The agency recommends that children in that age group get two doses, about a month apart.
Injectible vaccine is licensed to be stable for 18 months, while the nasal spray should last for 18 weeks. Seasonal flu vaccine is typically dated to expire in June of the year after it was produced, but Shuchat says that "month to month" its potency may drop, but usually not enough to limit its effectiveness.
The following is a statement from State Health Commissioner Judy Monroe regarding the recall and what area parents should do:
I want to reassure parents the recent recall of some lots of the 2009 H1N1 flu vaccine is NOT due to safety concerns. According to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), there is also no need to re-vaccinate persons who have received the vaccine from these lots. Indiana received about 10,000 doses of the affected lots, and the Indiana State Department of Health is working closely with local health departments and other providers of the H1N1 flu vaccine to locate any unused vaccine from the affected lots that have been shipped to Indiana, so they can be returned to the manufacturer.
Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series, if not already completed. These vaccine lots were routinely tested after distribution and were found to have a decreased level of antigen, which decreases the potency of the vaccine. The slightly reduced concentration of vaccine antigen found in retesting these lots is still expected to be effective in stimulating a protective response.
Again, there is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children younger than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. So, children younger than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.
Sanofi Pasteur has discontinued distribution of the 0.25 mL syringes of H1N1 pediatric vaccines. For children 6 months of age and older, vaccine is available in multi-dose vials. The vaccine in multi-dose vials is a safe and effective vaccine for children. One difference between vaccine in prefilled syringes and the multi-dose vials is that the multi-dose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened. The standard dose for this preparation for administration to infants 6-35 months old is the same as for the prefilled syringes, 0.25 mL. For healthy children at least 2 years of age, the nasal spray (live, attenuated influenza vaccine) is also an option. The nasal spray vaccine is produced in single units that do not contain thimerosal.
Parents with questions can visit www.in.gov/flu or call (877) 826-0011.
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