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A Year After Recall, Hib Vaccine Shortage Continues

Nov 21, 2008 | Parker Waichman Alonso LLP

A shortage of an important childhood vaccine is expected to last until the middle of next year, the Centers for Disease Control (CDC) reports.  The Hib vaccine shortage began last year, after a Merck & Co. facility where it was made was closed due to bacterial contamination.  

Hib, or haemophilus influenzae type b, is a bacteria that can cause a serious form of pneumonia and a condition called bacterial meningitis.  According to the CDC,  Hib is the leading cause of bacterial meningitis in children under five years of age.  

Last year, Merck  recalled 1.2 million doses of  potentially defective PedvaxHIB vaccine and Comvax vaccine  because  the problems at the company’s Pennsylvania plant left doubts about their sterility.  Both vaccines protect against Hib, while Comvax also offers protection against hepatitis B.  The plant where those vaccines were made also manufactured Merck's controversial Gardasil vaccine, as well as several other childhood vaccines.

In April, the Food & Drug Administration (FDA) issued the Merck vaccine plant a warning letter after a November inspection turned up 45 areas of concern, including contaminated packaging of children’s vaccines, unwanted fibers on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk vaccine lots.  The FDA sent the letter after determining that Merck was not acting quickly enough to fix problems at the plant.

The warning letter said the company had failed to ensure that equipment for manufacturing and processing was “calibrated, inspected or checked according to a written program designed to assure proper performance.”  The letter also said that in the course of making vaccines, “failures are not fully investigated and documented”.

Children normally receive their first dose of the Hib vaccine at 2-4 months of age.   That first vaccination is then followed by a booster shot at 12-15 months.   But since last year's recall, the CDC has been telling doctors to defer giving the boosters.  

According to a report on Webmd, Merck is now saying it won't have new Hib vaccines available until 2009, so the CDC says the shortage is continuing.  

The CDC also said it has not seen an increase in Hib cases because of the shortage, but has asked health practitioners to increase surveillance of suspected Hib cases.  According to Webmd, the CDC warned that  health departments are not doing a good enough job of analyzing samples from children with suspected Hib infection.