Hib vaccine shortage at clinics to continue until mid-2009
RAF MILDENHALL, England — An essential infant vaccine will continue to be in short supply at stateside and overseas military clinics until mid-2009 due to the drug manufacturer’s inability to resume full-scale production after a recall last year.
Merck & Co. Inc. announced in October that it would not be able to resume full-scale production until June or July of the Haemophilus influenzae type b (Hib) vaccine, a medicine it had to recall more than 1 million doses of in December 2007 because of contamination concerns.
Merck, one of two companies that manufacture the vaccine in the States, is awaiting approval from the U.S. Food and Drug Administration regarding procedures for manufacturing the vaccine before it can resume production, said Dr. Lance Rodewald, head of the Immunization Services Division at the national Centers for Disease Control and Prevention. For now, Sanofi Pasteur is the only company manufacturing the Hib vaccine.
There has been no reported increase in the Hib disease among the infant population in connection to the vaccine shortage, Rodewald said.
The Army’s European Regional Medical Command is following CDC guidance with its vaccine allotment, delaying booster doses to ensure that all newborns get the first few shots, according to spokesman Steve Davis.
U.S. Air Forces in Europe has been able to "flexibly resource" its Hib vaccine allotment for those who need it, according to spokesman Capt. Davina Petermann.
Infants are normally given three or four doses of the vaccines, depending on the brand, at 2, 4 and 6 months, then again at 12 to 15 months.
ERMC is also doing daily inventories of the vaccine at medical facilities and is working to make sure no clinic has fewer than five doses on hand at any given time, according to Davis.
"We’re still ensuring the patients get the Hib vaccine in accordance with the CDC guidelines," Davis said.
Clinics have to let ERMC know when they need more vaccine, he said, and ERMC will "cross-distribute" the vaccine between facilities, if necessary.
"If we have to drive the vaccine from one clinic to the other, we will do that," he said. "The key is that they’ve got to tell us."
Hib infections in babies can cause bacterial illness potentially leading to meningitis, bloodstream infections and pneumonia, according to the CDC. Hib does not cause the standard seasonal flu.
The CDC and other groups recommended that health care providers curb a booster dose at the one-year mark in the hope of stretching the available supply and getting every newborn those vital first few shots.
The booster doses help babies develop antibodies so that they are not carriers of the Hib disease, Rodewald said. The continued lack of booster shots means the disease could become more present in the baby population as supplies remain low.
In response to the prolonged shortage of Hib vaccine, Rodewald said, the bacterial meningitis group at the CDC will begin conducting studies next month to determine whether the disease is spreading among American children under 5 years old.
ERMC has multiple monitoring and reporting resources in place to track any kind of Hib outbreak or if an Hib case is suspected, Davis said.
Such data will be helpful if the vaccine shortage continues past June or July of next year, Rodewald said.
"Hopefully, the results won’t be needed because the shortage will be over," he said.
Rodewald said there is now a concern that the failure of so many young children to get the booster shots will increase the number of people carrying the Hib disease, regardless of whether it enters their bloodstream and sickens them.
In April, Stars and Stripes reported that the hospital at RAF Lakenheath, England, was out of vaccine, prompting officials at the Army’s Medical Research and Materiel Command in Germany to rush doses to the facility.
Since July, the command has been working with service branch liaisons in Europe to receive Hib vaccine orders on a monthly basis in order "to be wise stewards of the vaccine," said Maj. Kevin Ridderhoff, chief of the command’s clinical advisory division.
While stressing the logistical nature of his operation, the command’s leader, Col. Mitchell Brew, said his people are meeting all the Hib demands.
"I have not heard of any shortages or anything," Brew said.
Fast facts on Hib
• Haemophilus influenzae type b (Hib) is a bacteria that makes a young child’s immune system more vulnerable to other diseases and illnesses.
• In the United States, Hib occurs mainly in under-immunized children and infants.
• Two companies, Merck & Co. and Sanofi Pasteur, produce the vaccine. On Dec. 13, 2007, Merck announced a voluntary recall of its PedvaxHIB and Comvax vaccines, more than 1 million in all, due to a possible contamination of the vaccine.