Hib vaccine recall forces CDC to defer booster dosage

The Centers for Disease Control and Prevention (CDC) on Wednesday announced a temporary change to its recommendations for a common childhood vaccine, called the Haemophilus influenzae type b vaccine (Hib vaccine), which protects against Hib that can cause meningitis, pneumonia and other serious infections.

The federal health officials have urged doctors to temporarily stop giving children the final booster shot of the Hib vaccine because of a recall-related shortage of the vaccine. The agency also recommends that health care providers keep track of which patients delayed a shot and bring them back once the supply improves.

Hib Vaccine is recommended for all children under 5 years old, with doses starting when children are 2 months old. The health officials generally recommend children get the three-shot vaccine at age 2 months, 4 months and then a booster at 12-15 months. But, CDC has deferred that last booster until the vaccine supply improves.

Merck & Co., Inc., one of the top seven pharmaceutical companies in the world, announced on December 12 that it has initiated a voluntary recall of 1.2 million doses of a common childhood vaccine due to concerns of potential contamination during the manufacturing process.

The Whitehouse Station, New Jersey-based drug maker, in association with the U.S. Food and Drug Administration and the CDC, has recalled 11 lots of its Haemophilus influenzae type B vaccine, Pedvaxhib and 2 lots of combination Haemophilus influenzae type B hepatitis B vaccine, Comvax.

The vaccine recall from US pharmaceutical giant Merck came after it identified a sterilization problem during routine testing of the manufacturing process at a plant in Pennsylvania, where these lots of vaccines were manufactured.

Merck said at the time that the recall is issued as a precautionary measure as no vaccine-associated health problems have been reported so far.

Meanwhile, CDC has said that kids at high risk for Hib disease should continue to receive the booster dose. Children with sickle cell disease, HIV, cancer, asplenia, as well as American Indian children, Alaska Native children and children with other immunodeficiency conditions and certain cancers should still get the Hib vaccine booster shot at ages 12-15 months, the agency recommends.

Merck and Sanofi Pasteur are the two American drug manufacturers who provides about half the U.S. supply of Hib vaccine, which has been recommended by the CDC to protect children against meningitis, pneumonia, blood stream and other serious infections since 1990.

The Hib vaccine has significantly reduced the cases of Haemophilus influenzae type b, which can cause bacterial meningitis- an infection of the covering of the brain and spinal cord, and pneumonia- a lung infection.

Since the Hib vaccination started annual cases of this disease have gone down from 20,000 to 100 a year. About 14 million doses of the Hib vaccine are given in the United States annually.