Non-Safety-Related Voluntary Recall of Sanofi Pasteur H1N1 Vaccine Q and A
Q-Why are some lots of pediatric H1N1 vaccinebeing recalled from the market? A-Manufacturer Sanofi Pasteur noticed that the potency in some batches (called a “lot”) of pediatric syringes that had been distributed were later found to have dropped below a pre-specified limit. Q-Are there any concerns about safety of vaccines from these lots? A-No. There are no safety concerns with these lots of H1N1 vaccine. Q-Should infants and children who received vaccines from these lots be revaccinated? A-No. The vaccine potency is only slightly below the “specified” range. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Q-What action(s) should parents of children who have received vaccine from the recalled lots take? A-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. Q. How many shots will I need? Will two doses of vaccine be required? The CDC recommends that all children aged 6 months to 9 years and who have never received flu vaccine before receive 2 doses of vaccine for both for seasonal influenza vaccination and H1N1. The CDC further recommends that the two doses of H1N1 vaccine be separated by 4 weeks. However, if the second dose is separated from the first dose by at least 21 days, the second dose can be considered valid.
Q. Who will get the shot first? A. The target populations are as follows: (the order does not indicate priority) •Pregnant women •Persons who live with or provide care for infants under 6 months of age •Health care and emergency medical services personnel who have direct contact with patients or infectious material •Persons 6 months of age to 4 years of age •Children and adolescents aged 5-18 years who have medical conditions that put them at higher risk for influenza-related complications
Q. Will there be enough vaccine for everyone? A. Yes, the 2009 H1N1 vaccine will be available to everyone who wants to be vaccinated, but not all at once. Q. How will I get the vaccine? A. Once the vaccine is available, local health departments and health care systems will work together to share this information with the community. Wisconsin will follow the Center’s for Disease Control and Prevention’s (CDC) recommendations for administering the vaccine. This includes the use of target populations to assist public health prevent the spread of disease and protect those most vulnerable.
Source: Centers for Disease Control and Prevention (CDC)