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Pedvax HIB and Comvax vaccine recall Merck has voluntarily recalled 10 lots of Pedvax HIB vaccine and 2 lots of COMVAX vaccine due to potential contamination during production. Sterility tests of the vaccine lots themselves have not found any contamination. The Sanilac Co. Health Department did not administer or distribute any of this vaccine. No evidence of adverse reactions related to the vaccines have been identified. 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 identifies as part of Merck’s standard evaluation of their manufacturing processes. In routine testing of the vaccine manufacturing equipment used to produce Pedvax HIB 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. What is the extent of the recall? About 1 million doses of vaccine are being recalled, including ten lots of Pedvax HIB and two lots of COMVAX that were distributed in the U>S> as well as vaccine lots within the CDC stockpile. 3. 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 vaccine lots.
4. What are the risks to children who received vaccine from affected lots? 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 Pedvax HIB 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. 5. How does this impact the nation’s Hib vaccine supply? Are there other Hib vaccine manufacturers? 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. CDC realizes that some providers will be faced with the prospect of having children to vaccinate with no vaccine available. There are two U.S. Hib vaccine manufacturers – Merck & Co., Inc. and sanofi Pasteur. In the past, each manufacturer has produced about half of the Nation’s Hib vaccine supply. 6. Will the shortage of Hib vaccine result in an increase in disease occurrence of Haempphilus Influenza type b? Fortunately, current immunization rates in the U.S. for Hib vaccine are high. In 2006, about 94% of U.S. children 19-35 months of age were vaccinated against Hib. This has resulted in dramatic decline in transmission of this bacteria; however, it has not gone away completely.
The basic interim recommendations are as follows: Defer administering the routine Hib vaccine booster administered at age 12-15 months except for specified high-risk groups.
For more information please contact your local Health Department. (Michigan Health Alert Network)
SANILAC COUNTY HEALTH DEPARTMENT171 DAWSON ST. SANDUSKY, MI. 48471
SANILAC COUNTY NOVEMBER/DECEMBER 2007
Note: Most critical violations are corrected before the inspector leaves the premises.
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