800,000 Children’s Doses of H1N1 Vaccine Recalled

The U.S. Centers for Disease Control and Prevention (CDC) issued a voluntary recall on December 15, 2009, of 800,000 pre-filled syringes containing the H1N1 swine flu vaccine for children aged 6 months to 3 years. During routine efficacy testing of the vaccine, four batches were shown to have lower-than-required potency levels, meaning that some of the effectiveness was lost during the shipping process.

The manufacturer of the vaccine, Sanofi Pasteur Inc., has requested that health centers and other vaccine providers remove the recalled vaccines from shelves this week. The manufacturer assures that the affected vaccines, which were shipped nationwide in November, do not pose a health risk to children.

“This is not a safety problem; it’s an issue of efficacy,” said Dr. Marc Siegel, an infectious disease expert and associate professor of medicine at New York University. “I am happy to see them testing this, because one of the things that happens is once a vaccine gets to market, it kind of gets forgotten.”

Children who received injections from the recalled batches do not need to be revaccinated, according to the CDC. In order to be protected from swine flu, however, children under the age of 10 still need to follow the recommended course of treatment and receive a second dose of the vaccine, roughly a month after the first.

The H1N1 swine flu vaccine for children is available in single shot pre-filled syringes and in multi-dose vials for children over six months of age. The recall affects Sanofi Pasteur’s pre-filled syringes, which do not contain the preservative thimerosal. Thimerosal is added to multi-dose vials to prevent contamination after opening. A nasal spray version of the medication is available under the brand name Flumist for children 2 years of age and older.