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H1N1 Vaccine Pefectly Safe, Unaffected By Recall, Officials Say
By Source Staff ? December 15, 2009
A nationwide recall of some H1N1 vaccines for children does not affect the U.S. Virgin Islands, which did not receive any of the affected vaccines, Health Commissioner Julia Sheen said Tuesday.
Because there is no affected vaccine here and because the voluntary recall is due only to that batch being a little weak, there are no safety concerns for children taking the pediatric vaccine, according to a Health Department statement.
The vaccines given at health care providers territory-wide were distributed from a cache received by the Health Department. Health employees spent Tuesday verifying lot numbers against those that are part of the recall and found none, Sheen said.
According to the U.S. Center for Disease Control and Prevention, the vaccine?s potency was slightly below the specified range and the vaccine manufacturer?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.
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According to the CDC, in recent testing of its H1N1 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 agree this is unlikely to significant reduce the vaccine's effectiveness. So no one needs to do anything beyond completing the two-dose immunization series.
Sheen emphasized all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the most effective immune response. So 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.
For questions and answers related to the withdrawn vaccine see
http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm.
You can also 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.
By Source Staff ? December 15, 2009
A nationwide recall of some H1N1 vaccines for children does not affect the U.S. Virgin Islands, which did not receive any of the affected vaccines, Health Commissioner Julia Sheen said Tuesday.
Because there is no affected vaccine here and because the voluntary recall is due only to that batch being a little weak, there are no safety concerns for children taking the pediatric vaccine, according to a Health Department statement.
The vaccines given at health care providers territory-wide were distributed from a cache received by the Health Department. Health employees spent Tuesday verifying lot numbers against those that are part of the recall and found none, Sheen said.
According to the U.S. Center for Disease Control and Prevention, the vaccine?s potency was slightly below the specified range and the vaccine manufacturer?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.
<SCRIPT type=text/javascript><!--// <![CDATA[[OA_show('stc_mid_art_3_1');// ]]> --></SCRIPT>
<NOSCRIPT></NOSCRIPT>
According to the CDC, in recent testing of its H1N1 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 agree this is unlikely to significant reduce the vaccine's effectiveness. So no one needs to do anything beyond completing the two-dose immunization series.
Sheen emphasized all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the most effective immune response. So 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.
For questions and answers related to the withdrawn vaccine see
http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm.
You can also 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.
