Recalled Pediatric Vaccines Not Found in the Virgin Islands

Health Commissioner Julia Sheen said Tuesday that there are no safety concerns for children six months to 35 months who received H1N1 vaccines that are part of a voluntary recall by a manufacturer of pediatric vaccines.

The vaccines used at various health care providers territorywide were distributed from a cache received by the Health Department and employees spent Tuesday verifying lot numbers against those that are part of the recall and found none territorywide, Sheen said.

According to the U.S. Center for Disease Control and Prevention (CDC), the vaccine’s potency was slightly below the specified range and that the company, Sanofi Pasteur, which routinely performs testing as part of its quality assurance program, notified officials as well as the Food and Drug Administration about the voluntary recall. 

“Both the CDC and the FDA have determined that there are no safety concerns for children who have received this vaccine,” Sheen said.

According to the CDC, in recent testing of its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL) vaccine with antigen content lower than a pre-specified limit. 

While the antigen content of these lots is below the specification limit for the product, CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason, the CDC said, there is no need to revaccinate persons who have received vaccine from these lots and that parents of children who received the 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.

Parents are also reminded that all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine. 

Sheen said that while none of the recalled products were found in the Virgin Islands, providers nationwide are being asked to return any vaccine to the manufacturer in the following lots that remains unused. The lots are:

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

For More Information

For Questions and Answers related to the withdrawn vaccine see http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm

Call CDC’s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, which is available 24 hours a day, every day.

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