Childhood Vaccine Manufacturer
Announces Recall
Vaccine manufacturer Merck & Co. recently announced that it has voluntarily recalled about 1.2 million doses of common childhood vaccines for pneumonia and meningitis after it discovered a sterilization problem at one of its factories where the vaccines are produced. These sterilization problems could lead to potential contamination of the vaccine. This recall is a precautionary measure only, and no illness in any child who has received the vaccine has yet been reported.
Merck has recalled 10 lots of its Hib (haemophilius influenzae type B) vaccine, and two lots of a combination vaccine for both Hib and hepatitis B. The Hib vaccine is given to children in three doses starting at age 2 months.
Officials from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) said children who have already received the vaccine are not at risk and that none of the children who have received the vaccine will need to be re-immunized.
CDC officials will release some of the agency's stockpile of the vaccine to alleviate immediate vaccine shortages, and other manufacturers may increase their production of the vaccine. Children who should receive the vaccine may have to wait for a new supply of vaccine, but their health will not be harmed by the delay.
Below are some FAQs about the vaccine recall. For more information, visit the CDC's Web site at www.cdc.gov.
1. What vaccine is being recalled?
Merck & Co. has voluntarily recalled 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 in the United States starting in April 2007.
2. Why is the vaccine being recalled?
The recall is voluntary, and Merck is taking this action because it cannot assure sterility of these specific vaccine lots. The potential contamination in these specific lots was identified as part of Merck's standard evaluation of its manufacturing processes.
However, sterility tests of the vaccine lots themselves have not found any contamination, and the potential for contamination of any individual vaccine is low. The Vaccine Adverse Event Reporting System (VAERS) will continue to monitor adverse events following vaccination if and as they are reported. Any potentially vaccine-related adverse reactions should be reported to VAERS at 1-800-822-7967, or at www.vaers.hhs.gov, and to Merck at 1-800-672-6372.
3. Will children who received vaccine from affected lots need to be revaccinated?
No.
4. Are children who were recently immunized with vaccine from affected lots at risk?
Although there have been no reports of any adverse reactions among children who have been vaccinated, parents of children recently vaccinated with recalled vaccine should watch for any signs of infection (such as redness and swelling at the injection site) and should contact their doctor if such reactions occur.
5. What is PAMF doing to respond to the recall? When will the new vaccine be available?
PAMF has pulled all of the recalled vaccine from its clinic facilities, and we are in the process of further assessing the situation based on the information from Merck and the CDC. However, we want to stress again that no illness in any child who has received the vaccine has yet been reported, and there is no need for revaccination.
We will provide you with more information as it becomes available. Please check back on our Web site for updates.
Thank you.
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