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December 17th, 2009
Children’s Swine Flu Vaccine Recalled due to Loss of Drugs’ Potency

There has been a recall for 800,000 H1N1 swine flu vaccinations for children, called by the manufacturer Sanofi Pasteur Inc, because of a loss in potency.

Federal health officials made this announcement after the company finished a routine testing of the vaccine and found that four batches had lower potency levels than is required. The vaccine, meant for children aged 6 months to almost 3 years, no longer met the specifications for effectiveness.

“This is not a safety problem; it’s an issue of efficacy,” declared Dr. Marc Siegel, an infectious disease expert and associate professor of medicine at New York University.

Siegel believes that this recall is good news, demonstrating that the vaccine is still being tested after it has been shipped like most Canadian prescription drugs. “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,” said Siegel.

The recalled vaccine doses were single shot pre-filled syringes that did not include the thimerosal preservative. Children under 10 are required to receive two of these shots, about a month apart, in order to be protected from Swine Flu.

It is not a surprise that the problem is occurring in the single-dose vaccine because, “this process is very labor-intensive. The more intensive the process, the more likely we will see variation in efficacy,” said Siegel.

Although this vaccine has been recalled, it is still safe. Tests done before the vaccine was released passed for purity, potency and safety.

This means that because the vaccine being recalled is only “slightly” below desired potency rates, children who already received the immunization do not need to get another shot.

“The children that received this vaccine are very likely to have a significant amount of immunity, because the immune response as tested in studies was profound,” confirms Siegel.

The CDC is quick to promote multi-dose vials of the vaccine for children over 6 months. This medication has not had a drop in potency and remains pure and safe.

However, the multi-dose vaccinations contain thimerosal to limit contamination after the vial has been opened. Children who are aged 2 or older can take the H1N1 vaccine in the form of a nasal spray called Flumist, not available from any online pharmacy.

Since swine flu vaccinations began in early October, over 95 million doses of H1N1 vaccine have been delivered throughout the United States.

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