Merck Resumes Distribution of Monovalent Hib Vaccine

Recall of PedvaxHIB Led to Nationwide Shortage, Booster Deferrals

February 12, 2010 03:10 pm News Staff

Merck & Co. Inc. has announced that PedvaxHIB, the manufacturer's monovalent Haemophilus influenzae type b, or Hib, conjugate vaccine is back on the market after an absence of more than two years.

Order Vaccine Before March 25-April 5 Break in Merck Operations

Merck & Co. Inc.'s monovalent Haemophilus influenzae type b, or Hib, conjugate vaccine is back on the market, but physicians and health care facilities have a limited time to order any of the company's vaccines before the manufacturer suspends business transactions for almost two weeks to implement a software update.

Merck said on its Web site that from March 25 through April 5, it will not take orders by phone, fax or online. It plans to resume taking orders by phone and fax on April 6 and to resume taking online orders on April 7. The interruption of business also will affect shipping and order tracking, as well as processing credit card payments.

"Consider your vaccine inventory needs, and place your March through mid-April orders no later than the week of March 15 to ensure processing is complete, based upon supply, before the service interruption," the company said.

Merck recalled about 1 million doses of its Hib vaccines -- PedvaxHIB and the combination Hib/hepatitis B vaccine COMVAX -- in December 2007 after routine testing of equipment used to manufacture the vaccines identified the presence of the pathogen Bacillus cereus.

Merck, which suspended production of the two vaccines, initially planned to resume distribution in the fourth quarter of 2008. COMVAX remains unavailable, although Merck expects to begin shipping it later this summer.

In response to the recall and resulting vaccine shortage, the CDC, the AAFP and the American Academy of Pediatrics recommended temporarily deferring the Hib booster in healthy children not at high risk for invasive Hib disease.

Manufacturer sanofi pasteur attempted to fill the Hib vaccine gap by increasing production of its monovalent Hib vaccine product ActHIB and another combination product.

In August 2009, the FDA approved GlaxoSmithKline's Hiberix as a booster dose for children ages 15 months to 4 years. Soon after that, the AAFP adopted a CDC recommendation that physicians recall children who had not received a Hib booster dose.

The CDC's 2008 Immunization Survey( found that coverage with three or more doses of Hib vaccine decreased nearly 2 percent from the 2007 level -- to 90.9 percent -- because of the shortage, which contributed to outbreaks of invasive Hib disease in Minnesota and Pennsylvania.