Merck recalls children's vaccine

BY MICHELLE L. START Florida Weekly Correspondent

Bacteria found on a sterilization machine at Merck, the international developer, manufacturer and distributor of pharmaceuticals, could spell a shortage in Southwest Florida of the vaccine that protects children against pneumonia, meningitis and other serious infections.

"I think it's safe to say there is a likelihood of a shortage," said Kelley Dougherty, director of public affairs for Merck. "It will be the fourth quarter of 2008 before we will be able to distribute the product again."

The company recalled 1.2 million doses of the vaccines last week after finding Bacillus cereus bacteria on one of the sterilization machines. The company produces half of the 14 million vaccines that are given annually to children in the United States to protect them against infections.

The vaccines, which sell under the names PEDVAXHIB and COMVAX, were distributed beginning in April. Officials said they had no way to track which pediatricians and clinics received the vaccine.

Dr. John Iacuone, executive director of The Children's Hospital of Southwest Florida, said that although the vaccines may be scarce for some time, the likelihood of large-scale infections is minimal.

"Even if the vaccines are not available, the immunization rates in the United States are high," he said. "It would take some time for wide-spread infection to take hold."

The Centers for Disease Control and Prevention is urging children with sickle cell disease, leukemia and malignant neoplasms, HIV and certain other conditions, asplenia, as well as American Indian and Alaska Native children, to be given the vaccines that are available because they are at higher risk of developing the infections.

Doughtery said the vaccines in question were produced between April and November 2006. Additionally, she said tests have not shown that the vaccine itself was contaminated but the product is being recalled because the possibility could not be ruled out. SanofiPasteur in France also produces the vaccine, but officials there have said they are unsure whether they can ramp up production enough to meet current needs.

Thus far, no problems have been detected by the Vaccine Adverse Event Reporting System related to the vaccines affected by this recall, according to a statement by the Centers for Disease Control and Prevention. The Centers also said that since sterility of the vaccine cannot be assured, if a child was vaccinated with a vial of PedvaxHIB or COMVAX that contained B. cereus or other microorganisms, there may be a risk of developing localized or disseminated infections.

Children may be at the greater risk for these infections that are most likely to occur within one week after vaccination.

Parents concerned that their children may have received the vaccine should contact their pediatrician.

"The risk of actual contamination itself is low and if present, the level of contamination is also low," Doughtery said.