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Aroutine childhood vaccine is being recalled because of potential contamination, but public health officials said Wednesday no short-term health threat exists.
New Jersey-based Merck & Co. Inc. recalled 1.2 million doses of its Haemophilus influenzae type b vaccine, commonly known as Hib, shipped from its Montgomery County plant since April. No adverse reactions have been reported.
"I want to emphasize this is not a health-threatening condition in the short run, but it will cause an inconvenience," said Dr. Julie Gerberding, director of the Centers for Disease Control and Protection. "We definitely expect a shortage."
She said it is not known how long or severe the shortage might be. Haemophilus influenzae causes meningitis, pneumonia, and respiratory and throat infections, but -- despite its name -- does not cause the flu.
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Merck makes about half of the 14 million vaccines given to U.S. children each year, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. The vaccine generally is given in a series of three shots at 2 months, 4 months and 12 months of age.
Routine testing by Merck uncovered a problem with the sterilization process that could allow micro-organisms to survive, potentially contaminating the vaccines, said Dr. Norman Baylor, director of the FDA's Office of Vaccine Research and Review.
However, the vaccines are tested routinely before they are distributed and "no contamination of the vaccine has been found," he said.
The equipment was contaminated with Bacillus cereus, most commonly associated foodborne illnesses causing gastrointestinal problems, said Merck spokeswoman Mary Elizabeth Blake.
The most likely adverse reaction to develop from a contaminated vaccine would be skin bumps or a rash near the injection site, and that would appear within the first week, Schuchat said.
About 190,000 of the doses recalled were a combination vaccine, known as COMVAX, which also protects against Hepatitis B, said Merck spokesman Chris Garland. The rest, known as PEDVAXHIB, were Hib vaccines only, he said.
The company does not expect to have either of the Hib vaccines available for 10 to 12 months, he said.
The other U.S. supplier, Lyon, France-based Sanofi Pasteur, plans to increase production to help offset the shortage, Schuchat said. How quickly that can be done is not yet known.
"It's of concern, but I don't think it's the end of the world. For a long period of time, we didn't have a vaccine," said Dr. Bruce Dixon, Allegheny County Health Department director. "There's enough time to catch up when the vaccine becomes (more) available again."
Before the vaccine became available in 1990, Haemophilus influenzae infected about 20,000 people in the United States each year, about 1,000 of whom died, according to the CDC.
About 94 percent of all children have received the vaccines, and, as a result, infections have declined to only about 100 cases a year in the United States, CDC officials said.
That high rate of coverage will help to protect the unvaccinated population by curtailing the spread of any infections, and no outbreaks are expected in the short term, Gerberding said. Other countries which have experienced Hib vaccine shortages have not seen outbreaks for more than a year, she said.
"We basically have a cushion of protection as we go into this recall," Schuchat said.
Children who have been vaccinated with one of the recalled doses will be fully protected against Hib and do not need to be revaccinated, Gerberding said.
Nationally, Alaskan native and American Indian children -- groups most susceptible to Hib infections -- will be given priority for getting available vaccinations, and experts will be analyzing data to decide how to prioritize distribution elsewhere, Schuchat said.
Merck notified federal authorities about a month ago that it would not have Hib available for shipment, but told them only early this week about the potential contamination, FDA and CDC officials said.
Blake said routine equipment testing in October alerted the company to a potential problem. In November, Merck notified federal authorities it was quarantining Hib vaccines pending further tests, she said.
Earlier this month, Merck determined the problem is most likely due to a change in the manufacturing process made in July 2006, and affects all Hib vaccines made since then, she said. The company still had most of that product, and recalled vaccines made between July and November 2006 but not shipped until April, Blake said.
She said Merck has not estimated the cost to the company of the recall and manufacturing changes.
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