Swine Flu Shot Recall: H1N1 Vaccine for Young Children Not Strong Enough

About 800,000 H1N1 swine flu vaccinations for children were recalled this week because they have lost their potency. However, the U.S. Centers for Disease Control and Prevention (CDC) indicates that there are no safety concerns associated with the shots, and parents of children who received shots from the recalled lots do not need to revaccinated.

A statement was released by the CDC on Tuesday announcing that four lots of pre-filled swine flu vaccine syringes by Sanofi Pasteur were recalled for non-safety issues. The swine flu shot recall came after testing by Sanofi Pasteur on December 7 indicated that the strength of some of the vaccines had declined since production to the point where they failed to meet the manufacturer’s specifications for potency.

The affected vaccinations are pediatric shots designed for children three years of age and younger. Vaccines for older children and adults are not affected. The CDC said that the recalled shots’ strength is only slightly below specifications, so it does not recommend that children who received shots from the affected batches get re-vaccinated. However, the CDC reminded parents that all children under the age of 10 need to get two shots to be fully vaccinated.

The announcement is the second major recall of swine flu vaccines in the last month. In late November, officials placed a hold on a batch of 170,000 vaccines manufactured by GlaxoSmithKline and distributed across Canada. Concerns arose over the batch after GlaxoSmithKline received at least six reports of severe allergic reactions to doses from the batch, more than double the typical number of reactions expected.

The recalled Sanofi Pasteur swine flu vaccines were distributed nationwide in pre-filled 0.25 ml syringes. The recalled H1N1 shots include 10-packs of 0.25 ml pre-filled syringes with lot numbers UT023DA, UT028DA and UT028CB, and recalled 25 packs of 0.25 ml pre-filled syringes with the lot number UT030CA.

The cause of the problem is still under investigation by the manufacturer. The vaccines passed quality control testing before they were shipped, according to the CDC. The problem with declining potency has not been detected in the same vaccine in pre-filled syringes for adults and older children.