Many of you have heard that a common vaccine from Merck (the “HIB” vaccine) has been recalled. Below are some questions and answers taken directly from the Centers of Disease Control website regarding the vaccine recall. We think it will help answer many of your questions. We would like to add that we had very few affected doses in the offices at the time of recall and they were taken by Merck Representatives the same morning that we received notice of the recall.
1. Why are these lots being recalled?
Merck is taking this step as a precautionary measure. The company cannot assure sterility for these specific vaccine lots. The potential contamination in these specific lots was identified as part of Merck’s standard evaluation of their manufacturing processes. In routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB® and COMVAX®, Merck identified the presence of a certain bacteria called Bacillus cereus. Sterility tests of the vaccine lots themselves have not found any contamination.
The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low. However, because they cannot guarantee the sterility of these specific lots of vaccine, Merck is conducting this recall.
2. Will children who received vaccine from affected lots need to be revaccinated
No. Children who received HIB vaccine from affected lots do not need to be revaccinated. No potency concerns have been identified for these affected lots.
3. What are the risks to children who received vaccine from affected lots?
Sterility tests of the vaccine lots themselves have not found any contamination. Merck has not received any reports of abscesses or disseminated B. cereus infection in children who received vaccines from affected lots. In addition, no problems have been detected by the Vaccine Adverse Event Reporting System (VAERS) related to the Hib vaccine affected by this recall. However, since sterility of the vaccine cannot be assured, if a child was vaccinated with a vial of PedvaxHIB® or COMVAX® that contained B. cereus or other microorganisms, there may be a risk of developing localized or disseminated infections. Immunocompromised children may be at the greater risk for these infections. These infections are most likely to occur within one week after vaccination.
4. What should providers tell their patients?
For the time being, providers should continue to use HIB vaccine not affected by this recall according to current ACIP recommendations. If concerned parents contact their providers, they should be informed that children who were vaccinated with vaccine affected by this recall do not need to be revaccinated. 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 contact their providers if such reactions occur. It should be emphasized that sterility tests of samples from the recalled lots have not found any contamination and the potential of contamination of any individual dose of Hib vaccine is very low.
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