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Hib booster reinstated for 12-15-month-olds
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Health officials are reinstating the on-time booster dose of Haemophilus influenzae type b (Hib) vaccine for all children at 12-15 months who have completed the primary series.
However, supply constraints are tight enough that they are not encouraging a mass recall of all children who had a deferred dose, according to Jeanne Santoli, MD, MPH, deputy director of the immunization services division in the National Immunization Program at the CDC.
Santoli discussed the reinstated dose at the Advisory Committee on Immunization Practices meeting in Atlanta this morning.
She said Sanofi Pasteur plans to supply at least 18 million doses of Hib-containing vaccine, both the monovalent and combination products to the U.S. market this year.
Providers have been deferring the booster dose of Hib since December 2007, when Merck recalled several lots of its vaccine because of possible bacterial contamination. Sanofi officials stepped up production on their Hib products after the recall, but could not produce enough to include the booster dose. ACIP officials recommended at that time to move to a deferred schedule.
GlaxoSmithKline officials also presented data on their Hib conjugate vaccine, Hiberix, which has been submitted to the FDA for licensure. GlaxoSmithKline officials said the vaccine provides strong immune responses in children previously primed with Hib, regardless of vaccine or schedule, and that it is immunogenic when coadministered with other vaccines. GlaxoSmithKline has the capacity to produce more than 4 million doses of this product during 2009, Santoli said.
Merck officials also were in attendance at the meeting and said they are working closely with the FDA to reinstate limited supply of PedVaxHib in the fourth quarter of 2009, and hoped to reach full capacity by first quarter 2010.
In the interim, Santoli said that CDC officials are encouraging a “limited catchup” program for older children, meaning that those whose booster dose was deferred should receive their Hib booster a their next scheduled medical visit.
One CDC official, Michael Jackson, PhD, MPH, an epidemiologist with the CDC, said during the meeting that there is no sign of any surge in Hib cases, despite the shortage and some high-profile outbreaks of the disease. Jackson said CDC officials are carefully monitoring the situation.
CDC guidance on reinstating the booster is available in this week’s Morbidity and Mortality Weekly Report.
In related news, Santoli gave an update on the vaccine supply, noting that Merck’s hepatitis A and measles-mumps-rubella and varicella combination vaccine will not be available this year. Santoli noted that Merck officials are also planning to resume production of their monovalent vaccines, which drew some criticism from the committee, who had just voted less than two hours previously to back a preference for combination vaccines over separately administered injections. Committee members stressed that provider assessment is paramount in determining when to use combination vaccines, including assessing the number of vaccines available, vaccination status of the patient, likelihood of patient return visits, storage costs and patient preference.
– by Colleen Zacharyczuk
For more information:
Jackson ML, Santoli J. Surveillance of HIB during the vaccine shortage. Presented at: ACIP. June 25, 2009. Atlanta.