December 16, 2009 Safety Not a Concern in H1N1 Vaccine RecallNo need for parents to re-vaccinate, says FDA, CDC

BATON ROUGE, Dec 16, 2009 - State Health Officer Jimmy Guidry, M.D., emphasized today that the voluntary recall of certain children's H1N1 vaccine by the vaccine manufacturer is not related to the vaccine's safety, and that this and all forms of the vaccine remain very safe.

Vaccine manufacturer Sanofi-Pasteur announced today that it is recalling four lots totaling about 800,000 doses of pre-filled syringes of H1N1 vaccine intended for use with children aged six months through 35 months. Louisiana vaccine providers have received about 10,900 doses of this particular form of vaccine, however, only 610 doses from the recalled lots have been administered statewide.

The lots were voluntarily recalled by the manufacturer after routine post-shipping tests of the vaccine found the vaccine to be slightly less potent than the manufacturer's license stipulates. However, even when just 20 percent as potent as called for, vaccines can still generate the needed response from the immune system. These lots of vaccine were found to be 88 percent as potent as specified. Therefore, there is no need to revaccinate those who received the slightly less potent vaccine.

The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention say that there are no safety concerns with these recalled lots of 2009 H1N1 vaccine. The vaccine in these lots is still expected to be effective in stimulating a protective response, federal health officials say, despite the slight reduction in the concentration of antigen, the active ingredient in the vaccine.

"Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed," Dr. Guidry said.

The CDC recommends that all children less than 10 years old get two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.

 "All vaccines are routinely tested for purity, potency and safety before release and after shipping," Dr. Guidry said. "According to the manufacturer, the four lots of vaccine recalled today by Sanofi-Pasteur met all required specifications at the time of release and shipment to distribution centers, but fell slightly short of specifications for potency several weeks after shipment."

The LDH Office of Public Health's Immunization Program has contacted all Louisiana providers who received the vaccine to notify them of the recall. The vaccine manufacturer will also send notification to providers who received doses for any of the four lots of recalled vaccine, along with information on how to return any unused vaccine.

The other forms of injectable vaccine provided in multi-dose vials and the single-dose, 0.5 mL pre-filled syringes for people 36 months and older continue to meet all specifications for potency, purity and safety.

"For children 6 months of age and older, vaccine is available in multidose vials. The vaccine in multidose vials is an effective vaccine for children," Dr. Guidry added.

There have been 1,892 lab-confirmed cases of the H1N1 flu and 40 H1N1-related deaths in the state of Louisiana. At least 206,000 Louisianians are estimated to have had the H1N1 flu this year, according to LDH and CDC data.

Children, young adults, people with medical conditions such as asthma, healthcare workers and caregivers for infants are all advised to get the vaccine.

The Louisiana Department of Health strives to protect and promote health statewide and to ensure access to medical, preventive and rehabilitative services for all state citizens. To learn more about LDH, visit http://www.dhh.louisiana.gov.