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December 13,
2007
Little Rock -- The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have announced a voluntary recall of a vaccine for children. Haemophilus influenzae type b (Hib) 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.
“We want to stress that this is not a health threat for the children of Arkansas,” said Paul Halverson, State Health Director at the Arkansas Department of Health (ADH). “Children who received vaccine from affected lots do not need to be revaccinated.”
No concerns have been 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 affected 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.
“As a precautionary measure, parents whose children have recently received a dose of the recalled vaccine should watch for any signs of infection such as redness and swelling at the injection site within seven days of receiving the vaccine,” said Dr. James Phillips, Infectious Disease Branch Director for ADH. “If they notice an unusual reaction, they should contact their doctor or health care provider. Any adverse event from using the affected vaccine would occur within about a week of the time the vaccine was given.”
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.
Providers who have received recalled vaccines are in the process of being contacted and are being asked to immediately discontinue use of any of the affected lots and to return the recalled vaccine to the manufacturer. The ADH Immunization Section staff is currently contacting the impacted Vaccines For Children (VFC) providers by phone with instructions to check Arkansas’ immunization registry called the “Immunization Network for Children” (INC) message board for the process for returning the affected vaccine.
According to the CY2006 National Immunization Survey, 91.0% (+5.6%) of children age 19 – 35 months surveyed have received 3 doses of Hib vaccine. The Hib vaccines currently available only protect against one type of Haemophilus influenzae disease and that is type b. Since 1998 to present day, there has only been one possible case (not culture confirmed) of Haemophilus influenzae type b in Arkansas, which was in an adult. There have been a total of 74 cases of Haemophilus influenzae reported in Arkansas since 1998, but there has only been the one possible case mentioned above of type b.
The Hib bacterium is commonly present in the nose and throat. Bacteria are transmitted from person to person in droplets through sneezing, 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, your local health department, or the ADH Immunization Program at 501-661-2169.
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