By MIKE STOBBE, AP Medical WriterWed Dec 12, 5:48 PM ET
More than a million doses of a common vaccine given to babies as young as two months was being recalled Wednesday because of contamination risks, but the top U.S. health official said it was not a health threat.
The recall is for 1.2 million doses of the vaccine for Hib, which protects against meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at two months.
Drug maker Merck & Co., which announced the recall after testing showed a sterilization problem in a Pennsylvania factory, said concerned parents should contact their child's doctor.
"The potential for contamination of any individual vaccine is low," said Merck spokeswoman Kelly Dougherty.
Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.
"This is not a health threat in the short run, but it is an inconvenience," she said.
Dougherty could not immediately say whether the contamination seen at the factory involves a virus or bacteria. She said if someone were vaccinated with a contaminated shot, "There is a risk they could develop an infection." But she did not provide more details.
The recall is likely to heighten a debate over childhood vaccines and their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown such a connection.
This week New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from parents.
Merck, based in Whitehouse Station, N.J., is one of the few drug makers that produces a significant number of vaccines.
While the company took a black eye with its September 2004 withdrawal of the painkiller Vioxx due to increased risk of heart attacks and strokes, the company has been performing well recently. On Tuesday, it gave an upbeat assessment in its annual briefing for analysts.
Five weeks ago, Merck reached a deal to settle up to 50,000 Vioxx lawsuits for $4.85 billion, an amount expected to save the company millions in trial costs.
Its stock price has more than recovered from its post-Vioxx slump, a two-year-old restructuring plan is going well and profits are up. For example, Merck posted a 62 percent increase in its third-quarter profit as revenues jumped by double digits.
Associated Press Business Writer Linda A. Johnson contributed to this report.