FOR IMMEDIATE RELEASE Connecticut Department of Public Health
February 2, 2010 Contact: William Gerrish
Recall Due to Low Antigen Levels and is Non-Safety Related
Hartford – The state Department of Public Health (DPH) announced that a manufacturer of the H1N1 vaccine has issued a voluntarily recall of their product due to reduced level of potency. Connecticut received 11,360 doses of the recalled vaccine and over 72 providers have been affected by the recall. There is no safety concern with the lots that are being recalled.
Sanofi Pasteur, Inc. has voluntarily recalled five distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL) vaccine and one distributed lot of single-dose pre-filled syringe for older children and adults (0.5 mL) vaccine. The vaccine was recalled after the manufacturer, as part of their quality assurance program, found that the antigen content was lower than required potency levels during routine testing. Before they were shipped, the lots currently being recalled passed all quality controls and met all specifications for safety, purity and potency.
“It is important to stress that the vaccine is still considered safe and was recalled for non-safety-related issues,” stated DPH Commissioner Dr. J. Robert Galvin. “Vaccines still remain our best protection against many diseases, including the flu. The single, most effective way to protect yourself from the flu is to get vaccinated.”
The affected lots were shipped to Connecticut between November 2009 and January 2010. The slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) do not recommend that those who have received the recalled vaccine be revaccinated. Children 9 years old or younger who received the vaccine should receive a second dose of the vaccine as recommended with all H1N1 vaccines.
DPH has notified all providers who received the vaccine and the manufacturer will also contact the affected providers advising them how to return any unused vaccine.
For more information on H1N1 flu, please go to www.ct.gov/ctfluwatch.
The Connecticut Department of Public Health is the state’s leader in public health policy and advocacy with a mission to protect and promote the health and safety of the people of our state. To contact the department, please visit its website at www.ct.gov/dph or call (860) 509-7270.