By Lisa Wade McCormick
ConsumerAffairs.com
December 16, 2009
Health officials today announced the recall of approximately 800,000 doses of H1N1 vaccinations for children ages 6-35 months because the immunizations lost their potency.
The recalled vaccines, distributed nationwide in pre-filled syringes, do not pose any safety concerns to children who received them, the Centers for Disease Control and Prevention (CDC) said today. Children who received the recalled vaccines also do not need to be re-inoculated.
"The vaccine potency is only slightly below the 'specified' range," the CDC said in a statement. "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."
Tests by the vaccine's maker, Sanofi Pasteur, a division of Sanofi Aventis, revealed the potency or strength of one batch of the pre-filled syringes dropped below a pre-specified limit, the CDC said.
After discovering that problem, the drug maker tested additional lots of the vaccine. Those tests showed the potency levels in three other lots had also dropped below pre-specified limits, the agency added.
"This means that doses from these four vaccine lots no longer meet the manufacturer's specifications for potency," the health agency said, adding drug companies routinely run "stability tests" on vaccines because the potency levels can decrease over time.
The CDC said the potency problems only involve four specific lots of Sanofi Pasteur's pediatric H1N1 vaccine in 0.25 mL pre-filled syringes. Those recalled doses have the following lot numbers:
• 0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB;
• 0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70): UT030CA
The same H1N1 vaccine in other dosing forms, including pre-filled syringes for older children and adults, and multi-dose vials, still meet all the required specifications, the CDC said.
All the recalled lots passed tests for purity, potency, and safety before Sanofi Pasteur distributed them to health care providers across the country, the agency said. The recalled vaccinations also met the required specifications at the time of release and shipment to distribution.
The CDC said infants and children vaccinated with the recalled lots do not need to be re-inoculated.
But children younger than 10 should get two doses of the H1N1 vaccine, according to the agency. Those doses should be given approximately one month apart.
Health officials said parents who are worried about this recall do not need to take any action, except to complete the recommended two-dose immunization series.
Sanofi Pasteur is investigating what caused the problem, the CDC said. The company is also notifying health care providers who received the recalled doses.
More information about this action is available on the CDC's Web site.
