CDC Reports Voluntary Recall of H1N1 Influenza Nasal Spray Vaccine
The Centers for Disease Control and Prevention (CDC) has sent out a health update regarding the voluntary recall by MedImmune of certain lots of monovalent 2009 H1N1 nasal spray vaccine due to a shortened shelf-life of the vaccine. There are no safety concerns with these lots.
MedImmune notified the CDC and FDA on December 18 and 21 that the potency of 13 lots of the H1N1 nasal spray vaccine had decreased below a pre-specified limit or were at risk of falling below that limit in the next week. This slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. All lots successfully passed pre-release testing for purity, potency and safety. However, because their potency is now or might soon be below the specified lower limit, MedImmune will send providers directions for returning any unused vaccine from these lots.
As part of its quality assurance program, the manufacturer of the nasal spray 2009 H1N1 influenza vaccine, MedImmune, performs routine, ongoing stability testing of the vaccine after it has been shipped to providers. Stability testing means measuring the strength of a vaccine over time.
There is no need to revaccinate persons who have received vaccine from these lots. People who received vaccine from the recalled lots do not need to take any action. All children younger than 10 years old should get the recommended two doses of 2009 H1N1 vaccine approximately a month apart. It is best to use the same type of vaccine for the first and second doses.
The 13 lots subject to the recall include approximately 4.7 million doses. These doses were shipped to CDC’s contract distributor in October and early November. Most of the doses are believed to have already been administered while fully potent and within specifications. However, there are almost certainly some doses that have not yet been used.
This recall does not affect 2009 H1N1 vaccine produced by other manufacturers. However, a similar recall was conducted recently, which involved lots from Sanofi Pasteur’s pediatric 2009 H1N1 vaccine in 0.25 mL pre-filled syringes.
Providers are being asked to return any vaccine in the following lots that remains unused to the manufacturer: 500754P, 500751P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P, 500762P, 500763P, 500764P, 500765P, and 500776P.
For More Information:
For Questions and Answers related to the withdrawn vaccine see
Call CDC’s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, which is available 24 hours a day, every day.
For manufacturer’s information about the recall, see http://www.medimmune.com/pdf/H1N1_Recall_QandA_122209.pdf
For manufacturer’s instructions to providers on actions to be taken, see http://www.medimmune.com/pdf/H1N1_Recall_letter_122209.pdf