H1N1 vaccines recalled

Recall of vaccines

Reports show that 800,000 doses of H1N1 vaccine have been recalled by manufacturer Sanofi-Aventis due to the influenza vaccine losing its potency since it was shipped from the factory.

Thankfully, the reports seem to suggest that the recall isn't safety-related, but is instead part of a routine "quality assurance program". According to Dr. Anne Schuchat, who is director of the Centers for Disease Control and Prevention's (CDC) National Center for Immunization and Respiratory Diseases, "There are now 94.6 million doses of vaccine available, so this is not as big a deal as it might have been earlier". She continued to emphasize that the issue presented no safety concerns.

Total recall

The recall, which affects doses of re-filled syringes made for children ages six months to 35 months, first came to light yesterday. According to reports in the New York Times, Sanofi-Aventis voluntarily recalled 800,000 doses of low-dose, thimerosal-free vaccine; though, since most of the vaccine was released a month ago, it presumably has already been used. As such, the recall is really intended to alert doctors to return any supplies they have left.

Despite concerns over "low potency", Schuchat did comment that the CDC believes that those children who already got the vaccine are fully protected, assuming they got the two shots that were recommended for that age bracket. "We don't think parents need to contact their doctors," she added.

Thimerosal-free

The low potency concerns are related to the lack of thimersoal in the product. Thimerosal, a mercury-based preservative that federal health officials consider harmless, has been criticised by some parents on the basis that anti-vaccine activists blame it for autism and other ills. As such, the ingredient was left out of vaccines intended for children under two years old, largely in an effort to quell such concerns.

However, low doses in multidose vials, which contain thimerosal to kill any bacteria or fungus accidentally introduced by needles piercing the rubber stopper, remain available for infants.

Two-year-olds, meanwhile, can use the nasal spray vaccine, which contains no thimerosal.

Reports also show that Sanofi, which is one of five vaccine manufacturers whose products are approved in the United States, routinely check their products for potency at regular intervals; none of the others manufacturers are yet to  report any problems.

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