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Date: December 13, 2007
To: Vaccine Providers
From: Patricia Raymond, Immunization Program Manager
Re: Merck’s recall of certain lots of Hib (PedvaxHIB) vaccine
On December 12, 2007, Merck announced a recall of approximately 1 million doses of certain lots of their Hib vaccine products (PedvaxHIB and Comvax) distributed since April 2007. The vaccine was recalled as a precautionary measure due to a sterility issue and potential bacterial contamination of the vaccine. The Centers for Disease Control and Prevention (CDC) report that sterility tests have not identified any contamination and no problems have been reported to Merck or detected by the national Vaccine Adverse Event Reporting System (VAERS).
A total of ten PedvaxHIB lots have been recalled. Seven (7) of the recalled lots (~6000 doses) have been distributed in Rhode Island. The affected lot numbers are: (1) 0677U; (2) 0995U; (3) 1164U; (4) 0259U; (5) 0435U; (6) 0436U; (7) 0437U. No other lots of PedvaxHIB distributed in RI are affected by this recall. The Immunization Program will be contacting health care providers who have received these lot numbers throughout the day by phone/fax with further instructions.
The Centers for Disease Control and Prevention (CDC) and other health experts do not believe this situation presents any health threat to children. CDC reports that since sterility of the vaccine cannot be assured, children vaccinated with potentially affected vaccine may be a risk of developing localized or disseminated infections. Immunocompromised children may be at greater risk. If infection were to occur, it would most likely occur within one week after vaccination. No potency concerns have been identified for these vaccine lots—therefore children who received Hib vaccine from affected lots do not need to be revaccinated.
Guidelines for Providers
- Immediately discontinue use any of the affected lots remaining in your inventory.
- Continue to use your current supply of PedvaxHIB vaccine not affected by this recall according to the Advisory Committee on Immunization Practices (ACIP) recommendations
- Report any potentially vaccine-related adverse experiences to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (or at www.vaers.hhs.gov), and to Merck at 1-800-672-6372. If you have any questions concerning medical or other issues, please contact the Merck National Service Center at 1-800-672-6372.
CDC is working with the two U.S. Hib vaccine manufacturers (Merck and Sanofi Pasteur) to assess availability of Hib vaccine and timing of future supply and will issue additional guidelines as needed. We will be working with CDC’s vaccine distributor and Rhode Island providers to remove and replace any affected Hib vaccine. For questions contact Mark Francesconi, Vaccine Manager at 222-5988 or mark.francesconi@health.ri.gov.
For more information about the recall go to:
www.cdc.gov/vaccines/recs/recalls/hib-recall-faqs-12-12-07.htm |
