The North Carolina Division of Public Health is notifying 345 health care providers across the state who received 113,700 recalled doses of a nasal mist form of the H1N1 vaccine.
The voluntary recall was initiated by the manufacturer, MedImmune, after routine testing showed the potency in some lots of vaccine has fallen below specified levels or is at risk of falling below those levels within the next week.
More information from the NC Division of Public Health follows:
The recall was announced Wednesday by the U.S. Centers for Disease Control (CDC). According to MedImmune and the CDC, there were no safety issues involved.
“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, said. “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 to health care providers in 74 counties across the state during the month of October, at the peak of vaccination demand. None of the vaccine was distributed to local health departments. 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.
North Carolina is anticipating receiving as many as 100,000 more doses of nasal mist vaccine for distribution to local health care providers.
“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-Barré syndrome; people with a weakened immune system; and people with long-term medical conditions including heart disease, kidney disease, and metabolic diseases, such as diabetes.