ATLANTA — The Haemophilus influenzae type B vaccine shortage that began last December following a voluntary recall of 1.2 million lots of vaccine continues, so booster doses in most children still should be deferred.
Dr. Jeanne Santoli announced this recommendation at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
Interim recommendations made following the recall last year by Merck & Co., the maker of PedvaxHIB, called for deferral of the booster dose recommended for children aged 12–15 months, except in children at risk for Hib disease. Those at risk include children with asplenia, sickle cell disease, or leukemia or other malignant neoplastic diseases, and American Indian and Alaska Native children living in American Indian and Alaska Native communities, said Dr. Santoli of the CDC.
Since the interim plan was put in place, vaccine supply has been adequate to cover the more limited dosing schedule, thanks to vaccine supplies from Sanofi Pasteur, which manufactures two Hib vaccines (TriHIBit, a combination vaccine against diphtheria and tetanus toxoids and acellular pertussis/Hib, and ActHIB, a monovalent Hib vaccine).
The Sanofi Pasteur vaccines are being used for all children but American Indian and Alaska Native children living in American Indian and Alaska Native communities; these children are receiving vaccine from the CDC stockpile of Merck vaccines that were not recalled.
Merck had planned a return of PedvaxHIB to the U.S. market in the fourth quarter of this year, but the company announced on Oct. 17 that a return wouldn't be possible at this time.
“The reason for this delayed return is an additional manufacturing process change that requires a regulatory filing with the [U.S. Food and Drug Administration] that needs to be approved prior to a return to the market,” Dr. Santoli said.
As a result, the CDC will not change the interim Hib recommendations at this point. Providers should continue to register and track children in whom the booster dose is deferred to facilitate recall and reinstatement of the booster dose when the product becomes available, she said, adding that the CDC is working with Sanofi Pasteur as the company reviews capacity to serve the U.S. market. “They are confident they have sufficient doses … to cover the three-dose series through mid-2009, and the CDC stockpile has sufficient PedvaxHIB for American Indian and Alaska Native children living in those communities for this new, unexpected duration of the Hib shortage.”