About 3,920 doses of swine flu vaccine for children have been distributed in Hawaii from four lots recalled voluntarily by the manufacturer, but safety is not an issue, emphasized state health spokeswoman Janice Okubo.

The potency level of the vaccine is lower than required, but children from ages 6 months to 35 months who received the vaccine are protected from the H1N1 influenza and do not need to be vaccinated again, she said.

Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, distributed 800,000 pre-filled syringes across the nation last month, and most have already been used, according to the U.S. Centers for Disease Control and Prevention.

Federal and state health officials stressed that the vaccine is safe, and parents do not need to worry if their child got one or two shots from the recalled product.

Sanofi Pasteur discovered the antigen content was lower than required potency levels in recent routine testing of one lot. The vaccine tested fine when it was shipped out earlier this fall, but testing last week showed the potency in three other lots had fallen about 12 percent below the government standard, said Len Laveda, a Sanofi Pasteur spokesman.

    H1N1 vaccine recall for Hawaii

 

 

Nearly 5,000 vaccines in Hawaii are being recalled, but some of them have already been administered to children.

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The Sanofi Pasteur notice said, “;There is no need to re-vaccinate infants and toddlers who have received the vaccine from these lots. However, per the Advisory Committee on Immunization Practices recommendations, all children less than age 10 years should receive two doses of H1N1 vaccine approximately a month apart for optimal immune response.”;

Hawaii's health officials tracked the recalled vaccine yesterday to 47 providers, with 2,720 doses distributed to 29 Oahu providers, 1,100 doses to 17 Big Island providers and 100 doses to one Maui provider.

The recalled doses will be exchanged for multidose vials, Okubo said.

Providers who received direct shipments of the vaccine from the manufacturer will receive instructions for returning unused vaccine from the lots in question.

Those who received affected vaccine from the Health Department depots should call 586-8300 on Oahu or (800) 933-4832 from the neighbor islands.

For more information about the recall, see http://hsblinks.com/1jb or call CDC's toll-free information line, (800) CDC-INFO (800-232-4636).