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For Release:
December 13, 2007

Fred M. Jacobs, M.D., J.D.

For Further Information Contact:
Thomas Slater

DHSS Offers Guidance During Voluntary Recall of Haemophilus influenzae type B (Hib) Vaccine


New Jersey’s vaccine supply has been affected by the recent voluntary recall of 10 lots of Haemophilus influenzae type B (Hib) vaccine and two lots of a combination Hib and Hepatitis B vaccine.  

While the recall does affect the state’s vaccine supply, it does not have a negative effect on our children’s health, nor will it require reimmunization of children who have received the affected vaccine.

The Department of Health and Senior Services’ Vaccine for Children Program has received and shipped an undetermined amount of doses from the affected lots of Hib vaccine.  The Department is working with the manufacturer to determine how many doses we received and where they were distributed.

Providers who have received recalled vaccines will be contacted and asked to immediately discontinue use of any of the affected lots and to return the recalled vaccine to the manufacturer.

“We want to emphasize this is not a health threat for New Jersey’s children,” said New Jersey Health Commissioner Fred M. Jacobs, M.D., J.D. “Children who have been vaccinated with affected lots of Hib vaccine do not need to be revaccinated.” 

According to the federal Centers for Disease Control and Prevention (CDC), there have been no concerns raised about vaccine effectiveness of the recalled vaccines.  The vaccine is being recalled as a preventive measure because the manufacturing company, Merck, cannot assure sterility for the 12 lots.  Sterility tests of samples from the recalled lots have not found any contamination and the potential of contamination of any individual dose of vaccine is very low.

“We are asking parents whose children have recently received a dose of the Hib vaccine to watch for any signs of infection such as redness and swelling at the injection site within seven days of receiving the vaccine,” said Dr. Eddy Bresnitz, State Epidemiologist and Deputy Commissioner. “If parents notice an unusual reaction, they should contact their health care provider.”  

Today, the Department of Health and Senior Services issued a public health alert message to physicians, local health departments and other agencies that explained details of the recall. 

Merck & Co. initiated a voluntary recall on Wednesday in the United States for ten lots of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and two lots of COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine].  The affected doses were distributed throughout the U.S. starting in April 2007. 

As a result of this recall, providers who only use Merck Hib vaccines may have none, some or all of their vaccine recalled, and about half of the Hib vaccine in CDC’s stockpile is being recalled.  

Current immunization rates in the U.S. for Hib vaccine are high.  In 2006, about 94 percent of U.S. children 19-35 months of age were vaccinated against Hib.  In New Jersey, the immunization rate is slightly higher than 93 percent for the same age group.  This has resulted in a dramatic decline in transmission of this disease; however, it has not gone away completely.    

The Hiib vaccine prevents meningitis (an infection of the covering of the brain and spinal cord), pneumonia (lung infection), epiglottitis (a severe throat infection), and other serious infections caused by a type of bacteria called Haemophilus influenzae type b. It is recommended for all children under 5 years old in the U.S., and it is usually given to infants starting at two months old. It is a different disease than the seasonal influenza virus.

The Hib bacterium is commonly present in the nose and throat and is the major type of Haemophilus influenza bacteria causes serious illness. Bacteria are transmitted from person to person in droplets through sneezing and coughing. Infected children may carry Hib bacteria without showing any signs or symptoms of illness, but they can still infect others. The risk of disease is highest for children between six months and two years of age.  Before Hib vaccine, about 20,000 children in the United States under 5 years old got severe Hib disease each year and nearly 1,000 people died.

If people have questions or concerns, please contact your physician, or the Department’s Immunization Program at 609-588-7520.

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