| |
Voluntary Recall of Certain Lots of PedvaxHIB and COMVAX Vaccine Produced by Merck & Co.
Did Facey purchase and utilize any of the vaccine that is effected by the voluntary recall?
The two vaccines involved in the recall are PedvaxHIB (Hemophilus influenza conjugate vaccine) and COMVAX (a combined vaccine of PedvaxHIB and Hepatitis-B vaccine). We do not use PedvaxHIB vaccine at Facey. We do use the COMVAX vaccine manufactured by Merck.
We have checked our records and found that we did receive COMVAX vaccine from the two lots that are part of the voluntary recall. Since September 2007, we have vaccinated 2,430 children with the COMVAX vaccine; only 259 children received vaccine from the recalled lots. None of the vaccine that we used prior to September 2007 was affected.
What are the risks to children who received vaccine from affected lots?
There is a very slight risk that the affected vaccines were contaminated during production with a bacterium called B. cerus.
The following information concerning risk was presented on the Centers for Disease Control (CDC) website as of December 13, 2007:
Sterility tests of the vaccine lots have not found any contamination. Merck has not received any reports of abscesses or disseminated B. cerus infection in children who received vaccines from affected lots. In addition, no problems have been detected by the Vaccine Adverse Event Reporting System 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 of these infections. These infections are most likely to occur within one week after vaccination.
What is Facey doing to communicate to parents of the children that received a COMVAX vaccination from the recalled lots?
Our first priority is to contact parents of children who were recently vaccinated to tell them to watch for any signs of infection (such as redness and swelling at the injection site) and to let them know to contact their Facey provider if such reactions occur.
Please note that the CDC website states: "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 doses of Hib vaccine is very low."
What is Facey doing with their current COMVAX inventory?
Effective Thursday, December 13, 2007, we are immediately discontinuing use of the affected COMVAX lots. We are following Merck's instructions for returning the recalled vaccine. All other doses of COMVAX that are not included in this recall can continue to be used as they have no risk of the contamination associated with the lots identified at risk.
Will children who received the vaccine from the affected lots need to be revaccinated?
This response is taken from the Centers for Disease Control (CDC) website as of December 13, 2007:
Children who received the Hib vaccine from affected lots do not need to be revaccinated. No potency concerns have been identified for these vaccine lots.
|
To return to the News & Events page, click here.
|
