RALEIGH -- The state Division of Public Health has notified local health departments and private health care providers across the state -- including Durham -- of recalled doses of a nasal mist form of the H1N1 vaccine.
he voluntary recall was initiated by the manufacturer, MedImmune, after routine testing showed the potency in some lots of the vaccine has fallen below specified levels or is at risk of falling below those levels within the next week.
The recall was announced Wednesday by the U.S. Centers for Disease Control (CDC). According to MedImmune and the CDC, there are no safety issues involved.
The Durham County Health Department received and distributed approximately 1,700 doses of the non-safety-related recalled doses.
"We do not want people to become alarmed," said Gayle Harris, director of the Durham County Health Department. "There are no safety concerns with the lots that were recalled. The H1N1 vaccination remains the best way to be protected from the H1N1 influenza."
"As with last week's recall of pediatric vaccine, we are seeing how strict manufacturing standards for vaccine are in this country," said Beth Rowe-West, BSN, RN, head of the Immunization Branch of the N.C. Division of Public Health. "We see this as a preventive measure to ensure the vaccine we are giving to the public is going to protect them against the H1N1 virus."
According to Rowe-West, the vaccine included in the recall was sent out during the month of October, at the peak of vaccination demand. The manufacturer has said that the vaccine potency was at or above recommended levels when it was shipped; therefore, anyone who has already received vaccine from these lots should be protected against the virus and does not need to be re-immunized.
Harris said residents who received the recalled vaccine do not need to take any special action. It is still recommended that children younger than 10 years old should get two doses of the H1N1 vaccine. All doses left over from the recalled lots will be returned to the manufacturer. No recalled doses of the H1N1 vaccine will be used at future vaccination clinics.
Earlier, 17,900 doses of the H1N1 injectionable vaccine were recalled in North Carolina. The vaccinations, intended for children ages six months to 35 months of age, were voluntarily recalled. The Durham Health Department did not receive any of the recalled doses.
For additional information about the recalled lots of H1N1 vaccination in Durham County, contact Harris at (919) 560-7600.
"We want to reassure the public that nasal mist is safe and effective method of vaccination," Rowe-West said. "The best science we have supports using it for most healthy people between the ages of 2 and 49, with the exception of pregnant women."
Nasal mist was first introduced as a seasonal flu vaccine in 2003. It is a live vaccine that contains a weakened form of the flu virus and does not contain preservatives present in inactivated forms of vaccine. Studies in young children have shown nasal mist vaccine reduced seasonal influenza illness by 92 percent compared with placebo.
Nasal mist is not recommended for people with asthma, those with a history of Guillain-Barr
