Several lots of the Haemophilus influenzae type b (Hib) vaccine made by Merck have been recalled, according to officials from the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration.
Merck decided to recall 10 lots of PedvaxHIB and 2 lots of COMVAX, a combination Hib/hepatitis B vaccine, after a routine test of their manufacturing processes revealed a breach that might compromise vaccine sterility. At press time, no contamination had been discovered despite regular sterility testing of the finished product, and no reports of vaccine-related injury had been received by the CDC.
Children who received vaccines from the recalled lots should be monitored for vaccine site infections, likely appearing within a week of vaccination. They do not need to be revaccinated, according to the CDC.
The recall is likely to result in shortages of the Hib vaccine. Merck and Sanofi Pasteur . . . [Full Text of this Article]