Low-strength H1N1 flu shots get recalled

A manufacturer of the H1N1 vaccine has voluntarily recalled its product due to a reduced level of potency, the state Department of Public Health announced Tuesday.

Connecticut received 11,360 doses of the recalled vaccine and more than 72 providers have been affected by the recall. There are no safety concerns with the lots that are being recalled, the state health department said in a news release.

Sanofi Pasteur Inc. has voluntarily recalled five lots of single-dose, pre-filled syringe pediatric vaccine and one lot of single-dose pre-filled syringe for older children and adults. This is the second lot recalled by the company. In December Sanofi Pasteur recalled a lot due to potency issues, as did a second manufacturer, MedImmune.

The most recent recall came after Sanofi Pasteur, as part of its quality-assurance program, found that the antigen content was lower than required potency levels during routine testing. Before they were shipped, the lots passed all quality controls and met 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," said Dr. J. Robert Galvin, state public health commissioner.

The affected lots were shipped to Connecticut between November and January. The slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination, the state health department said. The Centers for Disease Control and Prevention and the Food and Drug Administration are not recommending that those who have received the recalled vaccine be revaccinated, although children 9 years old or younger who received the vaccine should receive a second dose of the vaccine as originally recommended with all H1N1 vaccines.

DPH has notified providers who received the vaccine and the manufacturer will also contact them to advise how to return unused vaccine.

For information on H1N1 flu, visit: www.ct.gov/ctfluwatch.