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Hib Vaccine Recall Fallout Includes Worried Parents, Concerns Over Vaccine Shortage

Dec 14, 2007 | Parker Waichman LLP Yesterday’s Hib vaccine recall by Merck & Co.  has parents worried and health officials scrambling to head off a serious vaccine shortage.

Merck & Co. Inc. recalled about 1.2 million doses of defective vaccines—11 lots of PedvaxHIB vaccine and two lots of Comvax vaccine—this week when quality control checks revealed production equipment might not have been properly sterilized; vaccine production has been suspended indefinitely.  Vaccines involved protect against Hib—or Haemophilus influenzae type b—disease and other conditions; Comvax also prevents against hepatitis B.  Hib was the leading cause of bacterial meningitis in children under five years of age, according to the US Centers for Disease Control and Prevention (CDC).

The vaccines were manufactured in West Point, Pennsylvania, and distributed beginning April 2007.  All but one lot was distributed in the United States, the company said, adding that the potential for contamination of any individual vaccine is low—and—if present, the contamination level would be low.  Sterility tests of the recalled vaccine lots did not reveal any contamination, according to Merck, saying the recall does not affect other vaccines it manufactures.  Children who received the affected vaccine need not be re-vaccinated as efficacy was not compromised, according to the CDC's National Center for Immunization and Respiratory Diseases.

Meanwhile, pediatricians are rushing to stock up on the crucial baby shot and worried parents have been calling doctors’ offices to ask whether their children are safe if they recently got the Hib vaccine.  Parents were told there’s virtually no chance of anything but swelling and redness around the injection, which would have happened within a week; there have been no such reports.  But health officials are still scrambling over how to address the shortage.

Dr. Lance Rodewald, head of the CDC’s immunization services, said they and other medical groups are weighing options to stretch Hib vaccine supplies from the only other manufacturer, Sanofi Pasteur, and were waiting to hear whether it can boost production or shift some doses here that would be sold overseas.  He hopes to have recommendations next week.  The American Academy of Pediatrics is advising its 60,000 members to order now from Sanofi Pasteur and, if they run short, to delay the booster shot usually given at 12-15 months.

Merck supplies about half the 14 million doses of Hib vaccine used in the U.S. annually.  It said that in addition to the doses recalled—roughly four months worth of production—it quarantined nearly a year’s worth of other, possibly suspect doses, and doesn’t expect to supply any more until at least next October.  That means roughly two years of normal production is unavailable.

Sanofi Pasteur is saying, at best, they can get up to 50 doses per office, for now.  Many doctors, who do not have enough stock, feel the Sanofi Pasteur stock is not adequate.  Sanofi Pasteur spokeswoman Donna Cary said the company, a unit of Paris-based drug maker Sanofi-Aventis SA, is trying to provide for doctors’ immediate needs but is limiting them to a reasonable 30-day supply.  She said call volume was up 45 percent Thursday.

The CDC’s Rodewald said before the vaccine was introduced in the mid-1980s, there were about 20,000 U.S. cases a year of invasive Hib, which can cause brain damage, deafness, and death.

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