New GSK Product Should Help Alleviate Hib Vaccine Shortage

The nation's supply of Haemophilus influenzae type b, or Hib, vaccine should see a much-needed upsurge in the coming weeks, thanks to the Aug. 19 FDA approval of GlaxoSmithKline's Hiberix as a booster dose for children ages 15 months to 4 years.

"The FDA approved Hiberix under the agency's accelerated approval pathway," said Karen Midthun, M.D., acting director of the agency's Center for Biologics Evaluation and Research, in an Aug. 19 news release. "This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations."

The CDC -- in consultation with its Advisory Committee on Immunization Practices, or ACIP, the AAFP and the American Academy of Pediatrics -- recommended June 25 that physicians reinstate the Hib booster dose for children ages 12-15 months who have completed the three-dose primary series. A booster dose also should be given to older children (i.e., those as old as 59 months) in whom the booster was deferred during their next routinely scheduled office visit.

A nationwide Hib vaccine shortage started in 2007, when Merck & Co. Inc. recalled a dozen lots of Hib-containing vaccine and later suspended production of its Hib-containing vaccine products. In response, 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.

Despite manufacturer sanofi pasteur's attempts to fill the Hib vaccine gap with its two Hib-containing vaccine products, the CDC began receiving case reports of invasive Hib disease in children last year, leading the agency to remind physicians of the need to complete the primary series using whatever vaccine was available, including combination products.

Meanwhile, Merck has posted information on its Web site (1-page PDF; About PDFs) saying that the company anticipates its monovalent Hib vaccine PedvaxHIB will return to the U.S. market by the first quarter of 2010, with the possibility of limited availability in the fourth quarter of 2009.

It remains unclear when Merck's combination Hib/hepatitis B vaccine, COMVAX, will return to the market.